bite force as a parameter for comparision between

i

BITE FORCE AS A PARAMETER FOR COMPARISION

BETWEEN 2.0 mm TITANIUM LOCKING MINIPLATES AND

2.0 mm TITANIUM 3-D MINIPLATES FOR MANDIBULAR

FRACTURES: A RANDOMISED CLINICAL TRIAL

By

Dr. RAHUL KUMAR SANKLECHA

Dissertation Submitted to the

Rajiv Gandhi University of Health Sciences, Bengaluru, Karnataka.

In partial fulfillment of the requirements for the degree of

MASTER OF DENTAL SURGERY

In

ORAL AND MAXILLOFACIAL SURGERY

Under the guidance of

Dr. K. S. MANJUNATHAM.D.S.

PROFESSOR and H.O.D.

DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY

SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL

HASSAN.

2016-2019

viii

LIST OF ABBREVIATIONS

SYMBOLS

ABBREVIATIONS

%

Percentage

3D

3 Dimensional

CDC

Centre for Disease Control

DCP

Dynamic Compression Plate

df

Degree of freedom

ECG

Electrocardiogram

EDCP

Eccentric Dynamic Compression Plate

IMF

Intermaxillary Fixation

MMF

Maxillomandibular Fixation

OPG

Orthopantomograph

PA View

Posteroanterior view

ix

LIST OF TABLES

Sl. No Tables Pg. No

Table 1 The gender wise distribution of samples 25

Table 2 Demographic data of study patients using Unpaired t test 25

Table 3 Mean duration of surgery in Group A and Group B patients 25

Table 4 Mean difference of bite force at incisor, right and left canine,

right and left premolar regions during 6 weeks interval using

Unpaired t test

26

Table 5 Comparison of bite force at Incisor region at different intervals

of time

27

Table 6 Comparison of bite force at Right Canine region at different

intervals of time

29

Table 7 Comparison of bite force at Left Canine region at different

intervals of time

31

Table 8 Comparison of bite force at Right Premolar region at different

intervals of time

33

Table 9 Comparison of bite force at Left Premolar region at different

intervals of time

35

x

LIST OF GRAPHS

Sl. No Graphs Pg. No

Table 1 Bite force difference in incisor region 37

Table 2 Bite force difference in right canine region 37

Table 3 Bite force difference in left canine region 38

Table 4 Bite force difference in right premolar region 38

Table 5 Bite force difference in left premolar region 39

xi

LIST OF FIGURES

Sl. No Figures Pg. No

Figure 1 Mechanism of Locking plate 45

Figure 2 Armamentarium 73

Figure 3 3D miniplate and screws used 73

Figure 4 Locking miniplate and screws 73

Figure 5 Digital bite force device 74

Figure 6 Measurement of bite force 74

Figure 7 Case 1: 3-dimensional miniplate (Group A) 75

Figure 7a 3D Preoperative OPG 75

Figure 7b Vestibular Incision 75

Figure 7c Exposure of fracture site 75

Figure 7d 3D plate fixation 75

Figure 7e Wound closure 75

Figure 7f Post-operative OPG 75

Figure 8 Case 2: Locking miniplate (Group B) 76

Figure 8a Preoperative OPG 76

Figure 8b Vestibular Incision 76

Figure 8c Exposure of fracture site 76

Figure 8d Locking miniplate fixation 76

Figure 8e Wound closure 76

Figure 8f Post-operative OPG 76

Abstract

1

ABSTRACT

“BITE FORCE AS A PARAMETER FOR COMPARISION

BETWEEN 2.0 mm TITANIUM LOCKING MINIPLATES AND

2.0 mm TITANIUM 3-D MINIPLATES FOR MANDIBULAR

FRACTURES: A RANDOMISED CLINICAL TRIAL”

Background & Objectives: To compare the efficacy of titanium 2-mm 3

dimensional miniplates with 2-mm titanium locking miniplates in the osteosynthesis

of mandibular fractures on the basis of bite force recordings.

Methods: A prospective randomized clinical trial was carried out for the treatment of

mandibular fractures using open reduction and internal fixation. The patients were

randomly divided into 2 groups, group A with 2-mm 3 dimensional titanium

miniplates and group B with 2-mm titanium locking miniplates. The assessment of

patients was done at weekly intervals for 6 weeks using bite force recordings.

Results: A total of 20 patients met the inclusion criteria, with 10 patients in each

group. In both the groups incisor, canine and premolar bite forces at the right and left

side increased at progressive follow up visits during 6 weeks. Statistically significant

difference was found only at the incisor region (p<0.001) whereas no statistically

significant differences were found at the other sites.

Interpretation & Conclusion: The clinical outcome of both the 3 dimensional and

locking miniplate systems in the present study were similar, however, following

Abstract

2

advantages with the use of 3 dimensional miniplates and locking miniplates can be

highlighted:

3 dimensional stability of the fracture site and simultaneous stabilization at

superior and inferior borders in fixation of mandibular fractures with 3 D

miniplates.

Locking miniplate can be used as a “one-plate-for-all” system minimizing the

number of fixation systems necessary to be stocked in the operating room.

Keywords: 3D plate system, Locking plate system, Mandibular fracture, Internal

fixation.

Introduction

3

INTRODUCTION

The individuality of a man is represented by his face, his identity is the key to

his personality and interaction. Any disfigurement of the face due to trauma or

otherwise would immensely affect an individual both physically and psychologically.

One of the most rewarding and demanding aspects of dental and surgical practice is

the management of the patient who has suffered facial trauma.

Despite the fact that the mandible is the largest and strongest facial bone, by

virtue of its prominence and its position on the face, is commonly fractured when

maxillofacial trauma is sustained. There are various anatomical and biomechanical

reasons for the increased vulnerability of the mandible to get fractured. The osteology

of the mandible, various muscle attachments and their influence, and the presence or

absence of dentition plays a vital role in producing the inherent weaknesses.

Therefore, fractures are seen more frequently in certain isolated areas such as the

angle, subcondylar region, region lateral to mental protuberance and mental foramen

region.1

Etiology of mandibular fractures varies, depending upon the population

studied. In the urban populations, road traffic accidents are more common while the

rural populations are often subjected to interpersonal violence. Other possible causes

of fracture of the lower jaw are due to:1,2

a) Assault injuries

b) Industrial injuries

c) Fall injuries

d) Sports related injuries

e) Interpersonal violence/assault

f) Pathologic fractures,

Introduction

4

g) Agricultural related injuries among the rural populations such as handling

submersible pumps without proper protective devices.

It was after World War II that the treatment modality has changed from closed

reduction to open reduction and direct fixation using transosseous wiring, bone plates

and screws. Modern traumatology started with the development of osteosynthesis,

which was a major innovation in craniomaxillofacial surgery3.

Open reduction with internal fixation [ORIF] which are in use today include

many techniques starting from wire osteosynthesis, Luhr’s Vitallium compression

plates, Schmoker and Spiessl’s dynamic compression plate [DCP], eccentric dynamic

compression plates [EDCP], reconstruction plate, monocortical noncompression

miniplates, lag screws, and 3- dimensional [3D] plates4 .

All of these methods are aimed to make patient return to function as soon as

possible and to avoid the need of long term IMF and to attain anatomic reduction,

achieve good occlusion with excellent aesthetic results. Dynamic compression plate,

eccentric dynamic compression plates were designed in such a way that when the

screws were tightened the two fractured fragments came into approximation as close

as possible. As the surgical technique was technique sensitive, many cases ended up

with step formation, infection, last but not the least cost factor also added to this5,6

.

But Champy’s miniplates and lag screws are less technique sensitive and produced

consistently good results with regard to occlusion and are economical and also helped

to avoid the need for long term IMF7.

The 3 dimensional titanium miniplate system is one of the newest internal semi rigid

fixations for maxillo-mandibular surgery in recent years. The shortcomings of rigid

and semi rigid fixation led to the development of 3-dimensional (3D) miniplates8

with

interconnecting cross struts. Unlike compression and reconstruction plates, their

Introduction

5

stability is not derived from the thickness of the plate. In combination with the

monocortical screws fixed to the outer cortex, the rectangular plate forms cuboids,

which possesses 3D stability. Although experimental studies on biomechanics have

confirmed sufficient stability of the 3D plating system, only a few studies have

previously reported clinical experiences with these plates in the treatment of

mandibular angle fractures. The 3 dimensional plating systems are based on the

principle of obtaining support through geometrically stable configuration. The

quadrangle geometry of plate assures a good stability in three dimensions of fractured

mandibular sites, since it offers good resistance against torque forces.

The management of trauma thus evolved greatly over the past many years

from supportive bandages, splints, circum-mandibular wiring, extra oral pins and

semirigid fixation with transosseous wiring to rigid fixation with compression plates

and more lately back to semirigid fixation with miniplates. Currently modifications in

miniplates like locking plates/screw system have been developed to overcome a few

disadvantages of conventional bone plate.9,10

There are a large number of experimental studies and a few clinical studies in

the literature which have proposed various biomechanical and technical advantages of

the 3-D miniplate system and the locking miniplate system and no study has

compared the bite force in patients treated with 3-D and locking miniplates and 2 mm

titanium locking miniplates till the commencement of this study. This prompted us to

perform the present study, to compare between these two systems of osteosynthesis in

the treatment of mandibular fractures based on the bite force recordings.

Aims & Objectives

6

AIMS AND OBJECTIVES

The aim of the study is to compare the efficacy of 3-dimensional

titanium miniplates with that of the titanium locking miniplates in the treatment of

mandibular fractures on the basis of bite force measurements to know the stability of

the miniplates.

The objective is to evaluate and compare the biomechanical function

between the two systems by measuring the maximal bite force preoperatively and at

1st to 6

th week postoperatively at weekly intervals.

Review of Literature

7

REVIEW OF LITERATURE

Historical insight improves understanding of current techniques and provides

the basis for the development of new methods. Even though the principles of the

treatment of mandibular fractures have changed drastically, the objective of re-

establishing the occlusion and masticatory function remains the same.

Brons and Boering (1970) introduced the lag-screw technique of

osteosynthesis. These screws had threads on the distal end and a smooth shank at the

proximal end which allowed compression of the segments between the outer and the

inner components.11

Schmoker and Niederdellmann(1973) developed the eccentric dynamic

compression plate (EDCP) which provided compression at the tension zones of

mandible. When the screws closest to the fracture were tightened, the fracture line

could be placed under compression, when eccentric terminals were tightened, the

alveolar segment would be reduced.12

Kahnberg K.E., A. Ridell (1980) conducted a study of bone plate fixation

with the fractures of mandible treated between 1970 to 1978, 1400 patients with

different jaw fractures were treated. They concluded that the plate fixation provides a

rigid stabilization of the fracture both in horizontal and vertical directions while

conventional wiring serves merely as a complement to the intermaxillary fixation. The

possibility to avoid intermaxillary fixation with bone plate fixation is a great

advantage especially in older edentulous patients with a single dislocated fracture. In

partially edentulous patient where remaining teeth don't occlude the bone plate

fixation serves as an alternative to IMF.13


8

William C. Ardary, (1989) Conducted a prospective evaluation which was

made of 71 patients with 102 mandible fractures treated with rigid internal

compression plate and screw osteosynthesis and allowed to function immediately

following surgery revealed that the method of internal fixation was an effective and

predictable alternative for the treatment of fractures of the mandible.14

Dodson TB, Perrott DH, Kaban LB and Gordon NC (1990) in their

prospective study of 92 patients with 143 uninfected, isolated mandibular fractures

compared standard therapy (closed or open reduction with wire osteosynthesis and 4

weeks of MMF) with rigid internal fixation (compression plates or screws with 2 days

of MMF) and found no statistically significant difference in the treatment results

between the two groups.15

Hayter J. P, Cawood J. I. (1993) Presented a review of the application of

mini plates in maxillofacial surgery, with an emphasis on maxillofacial trauma. The

functional advantages of mini plates were improved jaw function, in terms of mouth

opening and bite force; decreased weight loss and improved pulmonary function.

Other advantages were improved speech and oral hygiene, leading to enhanced social

interaction and ability to return to work earlier, particularly in jobs where

communication is important.16

Farmand M (1993) treated patients with three-dimensional mini plates

system. He used the plates in different age groups, in craniofacial orthognathic,

reconstructive surgeries and in trauma cases. He stated that the complication rate was

low and that the plates offered good stability against traction and torsional forces.17

Shetty V, McBrearty D, Fourney M and Caputo AA (1995) did a study on

6 sets of mandible analogue, each set consisting of 3 mandibles. Fracture was


9

simulated in the study models and EDCP, Wurzburg plate, Luhr plate, Lag screw,

Champy miniplate, Mennen clamp plate were used for fixation and a load of 22 DaN

was applied on all mandibles and the displacement along the fracture line to occlusal

forces, was measured and it was concluded that compression fixation system (EDCP,

Wurzburg, Luhrplate, Lag screw) are biomechanically superior to adaptive system

(Champy miniplate, Mennen clamp plate).18

Renton TF and Wiesenfeld D (1996) in their retrospective study on 205

cases of mandible fractures of which 83 were treated with mini plates following

Champy’s principles, 40 cases ignoring Champy’s principles and 82 cases by

transosseous wiring with a minimum follow up of 6 weeks and found that the patients

treated with miniplate osteosynthesis adhering to Champy’s principles were most

successful with minimal complication rates.19

Sikes JW, Smith BR, Mukherjee DP and Coward KA (1998) in an in vitro

study compared the fixation strengths of locking head and conventional screws in

fracture and reconstruction model and concluded that locking head screws provided

significantly increased resistance to displacement when only two screws per segment

were used in the reconstruction model. When four screws were used there was no

significant difference between locking head and conventional screw types. They also

postulated that the effect of bony buttressing is significant and may explain why

miniplate often fail in the atrophic mandible but are successful in fully dentate

patients.20

Herford AS and Ellis E III (1998) conducted a prospective study in 84

patients with mandibular fractures and continuity defects to examine the use of a

locking reconstruction bone plate/ screw system up to an average follow up of 16


10

weeks and found them to be simple and advantageous over conventional bone plates

by not requiring the plate to be compressed to bone in providing the stability.9

Ellis E III and Graham J (2002) in their prospective study of 80 fractures in

59 patients evaluated the use of a 2 mm locking plate/ screw system for mandibular

fracture treatment over a period of 6 weeks postoperatively. 102 locking plates were

applied to 80 fractures; 59 fractures received 1 plate and 21 received 2 plates without

postoperative maxillomandibular fixation. They concluded that the use of 2 mm

locking plate/ screw system was found to be simple and to provide sound fixation in

all cases.10

Bolourian R, Lazow S and Berger J (2002) in their prospective study on 44

mandibular fractures in 31 patients assessed the efficacy of intraoral treatment of

mandibular fractures using a 2.0 mm miniplate of titanium alloy and 2 weeks of MMF

followed up for a period of 8 weeks. A single 2.0 mm miniplate was adapted along

Champy’s lines of osteosynthesis and secured with four 8 mm, monocortical screws

and it was concluded that this is a viable treatment modality.21

Gerlach KL and Schwarz A (2002) in their prospective study examined bite

forces in 22 patients after treatment of mandibular angle fractures with miniplate

osteosynthesis according to Champy. Bite forces were recorded from 1st to 6th week

postoperatively, at weekly intervals using transducers at the incisor, right and left

canine; right and left molar regions with the subject seated with head upright, looking

forward, and in an unsupported head position and were compared with a control group

and concluded that after 1 week postoperatively only 31% of the maximal vertical

loading found in controls was registered which increased to 58% at the 6th week


11

postoperatively. In the present study, the above-mentioned methodology for bite force

measurement is used.22

Gabrielli MAC, Gabrielli MFR, Marcantonio E, and Hochuli-Vieira E

(2003) in their retrospective study of 191 patients with 280 mandibular fractures that

were treated with 2.0-mm mini plates without postoperative MMF found that the

overall incidence of complications, including infections, were similar to those

described for rigid fixation.23

Alpert B, Gutwald R and Schmelzeisen R (2003) in an article titled “New

innovations in craniomaxillofacial fixation- 2.0mm lock system” described in detail

the 2.0mm lock system and highlighted its following advantages:

• Locking 2.0 mini plates utilize double threaded screws which both lock to the

bone and the plate creating a mini- internal fixator.

• They form a more rigid construct with less distortion of the fracture or

osteotomy, and the screws do not loosen.

• They offer the prospect of less instrumentation and faster application.

• They are more retentive in cancellous bone, a significant advance in

cancellous block bone grafting.

• Interference with the vascularity of bone is minimal since the plate is not

pressed tightly against the bone.

They also described the 3 configurations of the lock system which are available

namely the thinner and medium varieties that are useful in transoral plating of

fractures utilizing the Champy technique and the heavier, longer variety used in

unilateral edentulous fractures in the symphysis and parasymphysis as well as an aid

to tumor resection and reconstruction with both free and vascularized grafts.24


12

Kirkpatrick D, Gandhi R and Sickels JEV (2003) in their retrospective

review of 56 locking reconstruction plates placed in 42 mandibular fracture patients of

which eight(19%) patients had preoperative infection which persisted in 3 (37.5%) of

them, 2 patients (5.8%) with 3 fracture sites (6.4%) developed postoperative infection

that required further intervention and all of them were heavy smokers. Thus the

postoperative infection was attributed to the history of preoperative infection and

smoking and concluded that the use of locking reconstruction plates can facilitate the

management of complicated fractures; however, it did not eliminate complications.25

Collins CP, Leonard GP, Tolas A and Alcalde R (2004) in their prospective

randomised clinical trial in 90 patients with 122 fractures compared standard 2.0-mm

monocortical plates (in 53 fracture sites) to 2.0-mm locking plates (in 64 fracture

sites) in the treatment of mandible fractures with a follow up of 6 weeks and found

that mandible fractures treated with 2.0-mm locking plates and 2.0-mm standard

plates present with similar short-term complication rates.26

Egol KA, Kubiak EN, Fulkerson E, Kummer FJ and Koval KJ (2004) in

a systemic review of complete orthopaedic literature to compare and contrast the

function and roles of conventional unlocked plates to locked plates in fracture fixation

concluded that the locking and conventional fixation techniques rely on completely

different mechanical principles and thus provides different environment for fracture

reduction and healing.27

Militsakh O, Wallace DI, Kriet D, Girod DA, Olvera MS and Tsuue TT

(2004) in their retrospective study on 43 patients with composite resection of the

mandible and reconstruction with osteocutaneous flap, which was fixed using 2.0 mm

locking reconstruction plates over an average period of 11 months, concluded that the


13

use of locking reconstruction plate is a reliable in settings of previously irradiated

mandible or in mandible where postoperative radiotherapy has been planned. Its

technical ease of application, contouring malleability and very low profile has proven

to be advantageous in oromandibular reconstruction.28

Gear AJL, Apasova E, Schmitz JP and Schubert W (2005) in their survey

on current trends in the management of simple, non-comminuted mandibular angle

fractures found that the preferred techniques were single miniplate on the superior

border (Champy technique); dual mini plates; a locking screw plate in the inferior

border only and 3-dimensional plates. A single miniplate on the superior border of the

mandible has become a preferred method of treatment among the AO faculty.29

Chritah A, Lazow SK, and Berger JR (2005) in their prospective study on

34 patients with 50 mandibular fractures treated with 2.0 mm locking miniplate/

screw system with a 1 week of MMF and a follow up of 6 weeks, found that primary

bone healing was achieved in 98% of cases, 3 complications (6%) were observed and

it was concluded that a single 2.0-mm locking miniplate placed along Champy’s ideal

line of osteosynthesis with four 8-mm monocortical locking screws plus 1 week of

MMF fixation is a reliable and effective treatment modality for mandibular

fractures.30

R.Mukerji, G.Mukerji, M.McGurk(2006) In this study they concluded that

the principles of treatment of mandibular fractures have changed recently, although

the objective of reestablishing the occlusion at masticatory function remains the same.

Splinting of teeth is an old way of immobilizing fractures but the advent of modern

biomaterials changed clinical practice towards plating the bone and early restoration


14

of function. They presented a brief historical overview of techniques and systems that

have been used for stabilization of mandibular fractures.3

Juergen Zix, Olivier Lieger, Tateyuki Lizuka (2007) The aim of this

follow-up study was to evaluate the clinical usefulness of a new type of 3 dimensional

(3D) mini plates for open reduction and monocortical fixation of mandibular angle

fractures. In 20 consecutive patients, noncomminuted mandibular angle fractures were

treated with open reduction and fixation using a 2 mm 3D miniplate by the transoral

approach. All patients were systematically monitored until six months

postoperatively. Among the outcome parameters recorded were an infection,

hardware failure, wound dehiscence, and sensory disturbance of the inferior alveolar

nerve. The 3D plating system described here is suitable for fixation of simple

mandibular angle fractures and is an easy to use alternative to conventional mini

plates. The system may be contraindicated in patients in whom insufficient

interfragmentary bone contact causes minor stability of the fracture.6

Sauerbier S, Schon R, Otten JE, Schmelzeisen R and Gutwald R (2008) in

their review have described the evolution of miniplate osteosynthesis and highlighted

its advantages like the intra-oral approach and the easy adaptability, and minimal

bone exposure required for its fixation.31

Saikrishna D, Shetty SK and Marimallappa TR (2009) in their prospective

randomised clinical study on 40 patients with mandibular fractures (20 in each group)

compared effectiveness of 2.0-mm locking mini-plates and screws over 2.0-mm

standard mini-plates and screws for the treatment over 6 weeks and concluded that

locking plate/screw system proved to be more rigid than conventional plate/screw


15

system, thereby reducing the need and duration of intermaxillary fixation. However,

there was no difference in complication rates.32

Jimson S, Sankar. A, Prasad. R (2009) gave the concept of three-

dimensional (3D) plates as “a geometrically closed quadrangular plate secured with

bone screws that creates stability in three dimensions”.42 patients with mandibular

fractures were treated with open reduction and fixation using SS mini plates,3D

plates, and titanium 3D plates through transoral/extraoral approaches under general

anesthesia with 14 patients in each group. Treatment outcomes were assessed for 6

months, which included the following criteria: occlusal stability, lingual splaying,

neurological deficit, infection, surgeon preference, and patient function. Titanium 3D

plate fixation proved to be advantageous over conventional miniplate and stainless

steel 3D plate fixation.33

Oguz Y, Uckan S, Ozden AU, Uckan E and Eser A (2009) did a finite

element analysis to evaluate the mechanical stresses over the bone and hardware after

sagittal split ramus osteotomy fixed with standard titanium or locking plates/ screws

and concluded that the looking miniplate/ screw system spreads the load over the

plate and screws and diminishes the amount of force transferred to each unit.34

Scolozzi P, Martinez A, Jaques B (2009) in their prospective study evaluated

45 patients with 74 linear in comminuted mandibular fractures treated with a single

2.0 mm A0 locking reconstruction plate without the use of the second plate over an

average follow up period of 10 months and found that the patients had satisfactory

fracture reduction and successful treatment outcome without major complications.35

Manoj Kumar Jain, K.S.Manjunath, B.K.Bhagawan, Dipit Shah(2010) in

their prospective study compared 3-D, 2mm SS plates with that of 2mm standard mini


16

plates using Champy’s principles of osteosynthesis and concluded that Champy’s

miniplate system is better and easier method than the 3D miniplate system for fixation

of mandibular fractures. The 3D miniplate system is unfavorable to use in cases of

oblique fractures and is also difficult to adapt in the mental foramen region and also

has excessive implant material. However, the operative time is shorter because of

simultaneous stabilization at both superior and inferior borders.36

Sauerbier S, Kuenz J, Hauptmann S, Hoogedijk CF, Liebehenschel N, Schon R,

et al. (2010) in their retrospective study on 53 patients with 56 mandibular fracture

evaluated the use of a 2.0-mm locking plate system and concluded that the use of a

2.0-mm locking plate system with its advantages of improved handling

characteristics, increased stability, shorter surgical time and preservation of bony

perfusion is a viable alternative to conventional manipulates in the management of

mandibular fractures.37

Ribeiro-Junior PD, Magro- Filho 0, Shastri KA, Papageorge MB (2010),

in an in vitro study on polyurethane hemimandibles with bone-like consistency

evaluated conventional and locking miniplate/screw systems for the treatment of

mandibular angle fractures by loading compressive stress until a 4 mm displacement

occurred between the fractured segments and found that looking plate/screw systems

provided significantly greater resistance to displacement than conventional ones (p <

.01) and thus, they concluded that the locking mini plates offered more resistance than

conventional mini plates.38

Manoj Goyal. Karan Marya.Sonia Chawla. Richa, Pandey (2011) In this

study they compared and evaluated postoperative complications and treatment

outcome in mandibular fracture fixation using 2.0mm titanium miniplates and 3-D


17

locking plates. Thirty patients were divided randomly into two groups of 15 each

(including comminuted and malunited fractures) Group A was treated with open

reduction internal fixation using 2.0mm mini plates and group B with 3-D locking

plates. A total of 5 complications were observed in four patients: implant exposure

and infection in the miniplate group and postoperative neurosensory deficit, implant

failure and implant exposure in a 3-D group. For fractures in symphysis and the

parasymphysis region, severely displaced angle fractures and for communicated

fractures, 3-D locking plate could be a better option.39

Singh V, Kumar I and Bhagol A (2011) in a prospective randomized study

on 50 patients with 76 fractures compared 2.0 mm locking plate system (36 fractures)

and nonlocking plate system (40 fractures) and concluded that both the systems

presented with similar short-term complication rates.40

Aggarwal M, Mohammad S, Singh RK, Singh V. (2011), in their

prospective randomised study on 20 patients with 32 fractures assessed bite force in

2-mm locking plates versus 2-mm standard plates at l, 3, and 6 weeks and 3 months

interval along with other clinical parameters and found that the use of locking mini

plates in mandibular fracture is efficacious enough to bear the masticatory loads

during osteosynthesis of the fracture. The locking mini plates provided the advantage

of a greater bite force, with clinical results almost similar to those seen with

nonlocking miniplate osteosynthesis.41

Gutwald Schon R, Metzger M, Kreutzer K, Rahn B, Sauerbier S (2011)

conducted a study in sheeps with an aim of comparing a combination of a locking

system with self-tapping (ST-L) or self- drilling- tapping (SF) screws and concluded

that the improved stability of the osteosynthesis with the ST-L system resulted in


18

early ossification of the osteotomy gap and with minimal amount of callus

formation.42

Mahmoud E.K, Hesham E, Mohamed M, H (2012) in their prospective

study, compared 2mm three-dimensional titanium mini plates with that of 2mm

conventional titanium mini-plates in symphyseal and parasymphyseal fractures of the

mandible. Total of 20 patients with 10 in each group was treated by ORIF and

followed up postoperatively for malocclusion, neurosensory deficit, wound

breakdown, infection, and presence of non-union/malunion. They concluded that 3D

miniplate system is a better and easier method comparatively but difficult to use in

cases of oblique fractures and those involving the mental nerve and there is excessive

implant material because of extra vertical bars.43

Laxmi Gandhi, Vivekananda SK (2012) evaluated the efficacy of 3D

titanium mini-plates in mandibular fractures in 20 patients over a period of 2 years

prospectively. Their aim was to analyse the structural stability of fractured fragments

after fixation, to evaluate biocompatibility and morbidity of 3D plating system. They

concluded that 3D titanium mini-plates provided good stabilization of fractured

fragments in three dimensions and ease of contouring and adapting. They are

biocompatible and no morbidity was seen in this study.44

Methodology

19

METHODOLOGY

SOURCE OF DATA:

This is a prospective randomized clinical trial done on 20 patients with mandibular

fractures who presented to the department of Oral and Maxillofacial Surgery, Sri

Hasanamba Dental College and Hospital and to the Hassan Institute of Medical

Sciences from November 2016 to September 2018 after obtaining the ethical

clearance.

METHOD OF COLLECTION OF DATA:

A randomized clinical trial was conducted in which 20 consecutive patients satisfying

the inclusion criterias as listed below, were randomly assigned to receive 2.0 mm

titanium 3-D miniplates (group A) and 2.0 mm titanium locking miniplates (group B)

with each group containing 10 patients.

Written consent was taken from the patients/guardians before undertaking the study

after explaining the nature of the procedure and possible discomforts and risks.

INCLUSION CRITERIA

1) Age of 18-50 years.

2) Patients with mandibular fractures in the interforaminal region.

3) No other facial bone fractures.

4) Uninfected fractures.

5) Dentition complete enough to apply Erich’s arch bar.

Methodology

20

The study design included a thorough case history taking in a case sheet which was

custom made for the study. Demographic data collected consisted of gender, age,

cause of fracture, duration between injury and surgery and the site of fracture.

Preoperative investigations that included complete hemogram, OPG/PA

skull/mandibular occlusal view. ECG and chest X ray were advised for patients

treated under general anaesthesia.

2.0 mm TITANIUM AND 3D MINIPLATE HARDWARE DETAILS:

(FIGURE- 3)

A 4 holed (2x2) titanium 3dimensional miniplate with interconnecting vertical bars

were used. The thickness of plate was 1mm.

Screws: The length was 8mm, width 2mm, diameter at its head was 3mm, and height

of the head was 1mm.

2.0 mm TITANIUM LOCKING MINIPLATE SYSTEM HARDWARE

DETAILS: (Figure-4)

EXCLUSION CRITERIA

Patients in whom intermaxillary fixation was medically contraindicated (epilepsy,

severe asthma, psychiatric condition)

1) Patients with systemic diseases (patients on chemotherapy and/or on

radiotherapy, osteopetrosis, osteoporosis).

2) Mandibular fracture associated with other maxillofacial fractures.

3) Fractures other than interforaminal fractures.

4) Multiple fractures.

5) Grossly infected fractures.

Methodology

21

A 4 holed titanium locking miniplate with bar was used. The thickness of plate was 1

mm.

Locking screws:

The length was 8mm, width 2mm, diameter at its head was 3mm, and height of the

head was 1mm.

Surgical technique:

All patients were given prophylactic antibiotic intravenously 30 minutes prior to the

procedure followed by two times daily for 3 days. Surgical procedures were carried

out under local anaesthesia/ general anaesthesia via nasotracheal intubation.

Armamentarium used for the study is shown in Figure 2. Reduction of the fracture

preoperatively was achieved using maxillary and mandibular arch bars. Following the

strict aseptic precautions, an appropriate intra/extraoral approach (translabial,

vestibular,) was selected based on the site. Fracture site was exposed after the

subperiosteal dissection, fractured segments were reduced and after achieving

adequate occlusion, MMF was done. Fixation was done using either a single 2.0 mm

titanium 3D plate/screw system (Group A) (Figure 7d) or 2.0 mm locking

miniplates/screw system applied as per Champy’s ‘ideal lines of osteosynthesis’

(Group B) (Figure 8d) and screws with dimensions of 2 mm x 8mm were used in

both the groups. Care was taken so as to place the screws lateral to the roots. MMF

was released intraoperatively and the passive occlusion was checked. A watertight

wound closure was achieved. Duration of procedure from incision to wound closure

was noted. Elastoplast pressure dressing was applied extraorally for 24 hrs

postoperatively. Patients were prescribed a 3 day course of oral antibiotics and 5-day

Methodology

22

course of analgesics and anti-inflammatory drugs and were advised to remain on soft

diet for 2 weeks.

Follow up:

Patients were followed up for a period of 6 weeks at weekly intervals. During each

follow up maximum bite forces at the incisor, canine and premolar region were

recorded by the same examiner with the help of a bite force device consisting of a

force transducer designed to measure the maximum force (in Kgs) exerted provided

with a digital indicator (Figure 5). All measurements were made with the patient

seated with the head upright, looking forward and in an unsupported natural head

position. The instrument could be conveniently positioned between a single pair of

antagonising cusps in the region of incisors, right and left canines and 1st

premolars.

The patients were advised to bite as forcefully as possible five times (Figure 6). The

highest value was recorded and entered in the data sheet.

Results were evaluated using paired t test for the intra group measurements and

unpaired t test for the inter group measurements for the bite force recordings and

Mann Whitney U test for other clinical parameters.

Sample Size Estimation

23

SAMPLE SIZE ESTIMATION

Before the start of the study, sd was obtained from previous study. According to the value

obtained for ‘n’; sample size of 10 per group was estimated for the present study.

n = 2*Z2

*S2

d

2

n = sample size per arm

z = 1.96

s = 0.57 KG (sd obtained from previous study )

d = 0.5 (allowable error)

n = 2*(1.96)2

*(0.57)2

(0.5)

2

n = 2*3.841*2.49

0.25

n = 10 per group

2 group * 10 = 20 sites

Result

24

RESULTS

Among 20 patients enrolled in the study, were 14 males and 6 females with 10

patients in group A and 10 in group B.

Average age of subjects in group A was 31.9 ± 11.723 years and that in group B was

34.4± 10.221 years.

Table 1 showing the gender wise distribution of sample between the groups.

There were 9(90%) male subjects and 1(10%) female subjects in group A, and there

were 5(50%) male subjects and 5(50%) female subjects in group B, there was no

statistically significant difference in proportion of male and female samples between

the groups (p=0.143).

Table 2 showing the mean age between the groups.

The mean age of samples in group A (locking system) was 31.9+11.723 and that in

group B (3D miniplate system) was 34.4+10.221, there was no statically significant

difference in mean age between both groups (p=0.617).

Table 3 showing the mean duration of surgery between the groups.

The mean duration of surgery in group A (locking system) was 58.0±12.064 and that

in group B (3D miniplate system) was 61.5±10.814 there was no statically significant

difference in duration of surgery between both groups (p=0.503).

Result

25

Table 1: showing the gender wise distribution of samples

CHI SQUARE TEST

GROUP

X2 df p

LOCKING 3D

SEX

FEMALE

Count 1 5

2.143 1 0.143

% 10.0% 50.0%

MALE

Count 9 5

% 90.0% 50.0%

Table 2: Demographic data of study patients using Unpaired t test

Unpaired t test

GROUP N Mean SD t df p

AGE

LOCKING 10 31.900 11.723

-.508 18 0.617

3D 10 34.400 10.221

Table 3: Mean duration of surgery in Group A and Group B patients

Unpaired t test

GROUP N Mean SD t df p

DURATION

OF SURGERY

LOCKING 10 58.0000 12.06464

-0.683 18 0.503

3D 10 61.5000 10.81409

Result

26

Table 4: Mean difference of bite force at incisor, right and left canine, right and

left premolar regions during 6 weeks interval using Unpaired t test

Unpaired t test

Mean

difference in

bite force GROUP N Mean SD t df p

INCISOR LOCKING 10 8.192 2.267

7.274 18 <0.001 3D 10 2.592 0.886

RIGHT

CANINE

LOCKING 10 9.579 3.090 -.400 18 0.694

3D 10 10.189 3.708

LEFT

CANINE

LOCKING 10 10.028 3.591 -.182 18 0.858

3D 10 10.281 2.532

RIGHT

PREMOLAR

LOCKING 10 10.765 2.166 .579 18 0.570

3D 10 10.090 2.980

LEFT

PREMOLAR

LOCKING 10 11.820 1.615 -.090 18 0.930

3D 10 11.922 3.213

The mean difference in bite force in incisor, canine and premolar region between

group A and group B was compared using Unpaired t test.

According to present study in the incisor region the mean difference in bite

force in group A (locking system) was 8.192 + 2.267 and mean difference in bite

force in group B (3D system) was 2.592+ 0.886, there was a statistical significant

difference in mean difference in bite force in the incisor region between group A and

group B (p<0.001). In the right canine region the mean difference in bite force in

group A (locking system) was 9.579 + 3.090 and mean difference in bite force in

group B (3D system) was 10.189 + 3.708, there was no statistical significant

difference in mean difference in bite force in the right canine region between group A

and group B (p=0.694). In the left canine region the mean difference in bite force in

group A (locking system) was 10.028 + 3.591 and mean difference in bite force in

group B (3D system) was 10.281+ 2.532, there was no statistical significant

Result

27

difference in mean difference in bite force in the left canine region between group A

and group B (p=0.858). In the right premolar region the mean difference in bite force

in group A (locking system) was 10.765+ 2.166 and mean difference in bite force in

group B (3D system) was 10.090+ 2.980, there was no statistical significant

difference in mean difference in bite force in the right premolar region between group

A and group B (p=0.570). In the left premolar region the mean difference in bite

force in group A (locking system) was 11.820+ 1.615 and mean difference in bite


difference in mean difference in bite force in the left premolar region between group

A and group B (p=0.930).

Table 5: Comparison of bite force at Incisor region at different intervals of time

Unpaired t test

Incisor GROUP N Mean SD t df P

PREOPERATIVE LOCKING 10 2.843 1.109

3.041 18 0.007 3D 10 1.554 0.752

1 WEEK LOCKING 10 4.733 1.588

4.594 18 <0.001 3D 10 2.098 0.875

2 WEEK LOCKING 10 6.456 2.244

4.853 18 <0.001 3D 10 2.686 0.998

3 WEEK LOCKING 10 7.578 2.327

5.955 18 <0.001 3D 10 2.899 0.868

4 WEEK LOCKING 10 8.911 2.339

6.651 18 <0.001 3D 10 3.454 1.121

5 WEEK LOCKING 10 10.053 2.902

6.439 18 <0.001 3D 10 3.874 0.884

6 WEEK LOCKING 10 11.035 2.724

7.765 18 <0.001 3D 10 4.146 0.668

Result

28

The mean bite force in the incisor region between group A and group B at different

time interval was compared using Unpaired t test.

According to present study in the incisor region the mean bite force at the

baseline (Preoperative period) in group A (locking system) was 2.843+1.109 and bite


difference in mean bite force in the incisor region between group A and group B at

baseline (p=0.007). In the incisor region the mean bite force at the 1st week in group

A (locking system) was 4.733+1.588 and bite force in group B (3D system) was

2.098+ 0.875, there was a statistical significant difference in mean bite force in the

incisor region between group A and group B at 1st week (p<0.001). In the incisor

region the mean bite force at the 2nd

week in group A (locking system) was

6.456+2.244 and bite force in group B (3D system) was 2.686+ 0.998, there was a

statistical significant difference in mean bite force in the incisor region between group

A and group B at 2nd

week (p<0.001). In the incisor region the mean bite force at the

3rd

week in group A (locking system) was 7.578+2.327 and bite force in group B

(3D system) was 2.899+ 0.868, there was a statistical significant difference in mean

bite force in the incisor region between group A and group B at 3rd

week (p<0.001).

In the incisor region the mean bite force at the 4th

week in group A (locking system)

was 8.911+2.339 and bite force in group B (3D system) was 3.454+ 1.121, there was

a statistical significant difference in mean bite force in the incisor region between

group A and group B at 4th

week (p<0.001). In the incisor region the mean bite force

at the 5th

week in group A (locking system) was 10.053+2.902 and bite force in

group B (3D system) was 3.874+ 0.884, there was a statistical significant difference

in mean bite force in the incisor region between group A and group B at 5th

week

(p<0.001). In the incisor region the mean bite force at the 6th

week in group A

Result

29

(locking system) was 11.035+2.724 and bite force in group B (3D system) was


incisor region between group A and group B at 6th

week (p<0.001).

Table 6: Comparison of bite force at Right Canine region at different intervals of

time

Unpaired t test

Right canine GROUP N Mean SD T df p


2.596 18 0.018 3D 10 2.342 1.147

1 WEEK LOCKING 10 5.779 1.776

2.736 18 0.014 3D 10 3.435 2.044

2 WEEK LOCKING 10 7.075 2.175

1.101 18 0.285 3D 10 5.793 2.969

3 WEEK LOCKING 10 8.243 2.289

0.857 18 0.402 3D 10 7.212 3.035

4 WEEK LOCKING 10 9.444 2.456

0.367 18 0.718 3D 10 9.012 2.802

5 WEEK LOCKING 10 10.998 2.951

0.574 18 0.573 3D 10 10.232 3.015

6 WEEK LOCKING 10 13.321 3.526

0.456 18 0.654 3D 10 12.531 4.186

The mean bite force in the right canine region between group A and group B at

different time interval was compared using Unpaired t test.

According to present study in the right canine region the mean bite force at the

baseline(Preoperative period) in group A (locking system) was 3.743+1.261 and bite


difference in mean bite force in the right canine region between group A and group B

at baseline (p=0.018). In the right canine region the mean bite force at the 1st week in

Result

30

group A (locking system) was 5.779+1.776 and bite force in group B (3D system)

was 3.435+ 2.044, there was a statistical significant difference in mean bite force in

the right canine region between group A and group B at 1st week (p=0.014). In the

right canine region the mean bite force at the 2nd



no statistical significant difference in mean bite force in the right canine region

between group A and group B at 2nd

week (p=0.285). In the right canine region the

mean bite force at the 3rd

week in group A (locking system) was 8.243+ 2.289and

bite force in group B (3D system) was 7.212+3.035, there was no statistical

significant difference in mean bite force in the right canine region between group A

and group B at 3rd

week (p=0.402). In the right canine region the mean bite force at

the 4th


(3D system) was 9.012+2.802, there was no statistical significant difference in mean

bite force in the right canine region between group A and group B at 4th

week

(p=0.718). In the right canine region the mean bite force at the 5th

week in group A


10.232+ 3.015, there was no statistical significant difference in mean bite force in the

right canine region between group A and group B at 5th

week (p=0.573). In the right

canine region the mean bite force at the 6th


13.321+3.526 and bite force in group B (3D system) was 12.531+ 4.186, there was a

statistical significant difference in mean bite force in the right canine region between


week (p=0.654).

Result

31

Table 7: Comparison of bite force at Left Canine region at different intervals of

time

Unpaired t test

Left canine GROUP N Mean SD t df p


2.630 18 0.017 3D 10 2.479 1.085

1 WEEK LOCKING 10 5.978 1.666

4.166 18 0.001 3D 10 3.196 1.297

2 WEEK LOCKING 10 7.498 1.881

1.471 18 0.159 3D 10 6.027 2.541

3 WEEK LOCKING 10 9.117 2.403

1.740 18 0.099 3D 10 7.073 2.831

4 WEEK LOCKING 10 9.860 2.837

0.908 18 0.376 3D 10 8.714 2.806

5 WEEK LOCKING 10 12.047 3.144

1.314 18 0.205 3D 10 10.268 2.903

6 WEEK LOCKING 10 13.905 3.953

0.720 18 0.481 3D 10 12.760 3.105

The mean bite force in the left canine region between group A and group B at

different time interval was compared using unpaired t test.

According to present study in the left canine region the mean bite force at the

baseline(Preoperative period) in group A (locking system) was 3.877+1.284 and bite


difference in mean bite force in the left canine region between group A and group B at

baseline (p=0.017). In the left canine region the mean bite force at the 1st week in

group A (locking system) was 5.978+1.666 and bite force in group B (3D system)

was 3.196+ 1.297, there was a statistical significant difference in mean bite force in

the left canine region between group A and group B at 1st week (p=0.001). In the left

canine region the mean bite force at the 2nd


Result

32

7.498+1.881 and bite force in group B (3D system) was 6.027+ 2.541, there was no

statistical significant difference in mean bite force in the left canine region between

group A and group B at 2nd

week (p=0.159). In the left canine region the mean bite

force at the 3rd

week in group A (locking system) was 9.117 + 2.403 and bite force in

group B (3D system) was 7.073+2.831, there was no statistical significant difference

in mean bite force in the left canine region between group A and group B at 3rd

week

(p=0.099). In the left canine region the mean bite force at the 4th

week in group A


8.714+2.806, there was no statistical significant difference in mean bite force in the

left canine region between group A and group B at 4th

week (p=0.376). In the left

canine region the mean bite force at the 5th


12.047+3.144 and bite force in group B (3D system) was 10.268+ 2.903, there was no

statistical significant difference in mean bite force in the left canine region between


week (p=0.205). In the left canine region the mean bite

force at the 6th

week in group A (locking system) was 13.905+3.953 and bite force in

group B (3D system) was 12.760+3.105, there was a statistical significant difference

in mean bite force in the left canine region between group A and group B at 6th

week

(p=0.481).

Result

33

Table 8: Comparison of bite force at Right Premolar region at different intervals

of time

Unpaired t test

Right premolar GROUP N Mean SD t df p


3.731 18 0.002 3D 10 3.218 0.831

1 WEEK LOCKING 10 6.278 1.320

2.333 18 0.031 3D 10 4.625 1.810

2 WEEK LOCKING 10 7.641 1.452

0.836 18 0.414 3D 10 6.831 2.698

3 WEEK LOCKING 10 9.409 0.982

0.776 18 0.448 3D 10 8.819 2.195

4 WEEK LOCKING 10 11.292 1.670

0.987 18 0.337 3D 10 10.574 1.580

5 WEEK LOCKING 10 13.708 1.714

2.527 18 0.021 3D 10 11.019 2.894

6 WEEK LOCKING 10 15.801 1.754

2.220 18 0.040 3D 10 13.308 3.087

The mean bite force in the right premolar region between group A and group B at


According to present study in the right premolar region the mean bite force at the



difference in mean bite force in the right premolar region between group A and group

B at baseline (p=0.002). In the right premolar region the mean bite force at the 1st

week in group A (locking system) was 6.278+1.320 and bite force in group B (3D

system) was 4.625+ 1.810, there was a statistical significant difference in mean bite

force in the right premolar region between group A and group B at 1st week

(p=0.031). In the right premolar region the mean bite force at the 2nd

week in group A

(locking system) was 7.641+1.452 and bite force in group B (3D system) was 6.831+

Result

34

2.698, there was no statistical significant difference in mean bite force in the right

premolar region between group A and group B at 2nd

week (p=0.414). In the right

premolar region the mean bite force at the 3rd


9.409+ 0.982 and bite force in group B (3D system) was 8.819+2.192, there was no

statistical significant difference in mean bite force in the right premolar region

between group A and group B at 3rd

week (p=0.448). In the right premolar region the

mean bite force at the 4th

week in group A (locking system) was 11.292+1.670 and


significant difference in mean bite force in the right premolar region between group A

and group B at 4th

week (p=0.337). In the right premolar region the mean bite force at

the 5th


(3D system) was 11.019 + 2.894, there was a statistical significant difference in mean

bite force in the right premolar region between group A and group B at 5th

week

(p=0.021). In the right premolar region the mean bite force at the 6th

week in group A



right premolar region between group A and group B at 6th

week (p=0.040).

Result

35

Table 9: Comparison of bite force at Left Premolar region at different intervals

of time

Unpaired t test

Left premolar GROUP N Mean SD t df p


2.673 18 0.016 3D 10 3.630 0.816

1 WEEK LOCKING 10 7.087 1.768

1.962 18 0.065 3D 10 5.438 1.984

2 WEEK LOCKING 10 8.621 1.604

1.220 18 0.238 3D 10 7.392 2.751

3 WEEK LOCKING 10 10.342 1.747

.513 18 0.614 3D 10 9.811 2.765

4 WEEK LOCKING 10 12.983 2.317

1.260 18 0.224 3D 10 11.500 2.914

5 WEEK LOCKING 10 14.943 1.337

1.531 18 0.143 3D 10 13.207 3.328

6 WEEK LOCKING 10 16.866 1.309

1.209 18 0.242 3D 10 15.552 3.177

The mean bite force in the left premolar region between group A and group B at


According to present study in the left premolar region the mean bite force at the


force in group B (3D system) was 3.630+0.816, there was a statistical significant

difference in mean bite force in the left premolar region between group A and group

B at baseline (p=0.016). In the left premolar region the mean bite force at the 1st week

in group A (locking system) was 7.087+1.768 and bite force in group B (3D system)

was 5.438+1.984, there was no statistical significant difference in mean bite force in

the left premolar region between group A and group B at 1st week (p=0.065). In the

left premolar region the mean bite force at the 2nd



Result

36

no statistical significant difference in mean bite force in the left premolar region

between group A and group B at 2nd

week (p=0.238). In the left premolar region the

mean bite force at the 3rd

week in group A (locking system) was 10.342 ± 1.747 and


significant difference in mean bite force in the left premolar region between group A

and group B at 3rd

week (p=0.614). In the left premolar region the mean bite force at

the 4th

week in group A (locking system) was 12.983 ± 2.317 and bite force in group

B (3D system) was 11.500+2.916, there was no statistical significant difference in

mean bite force in the left premolar region between group A and group B at 4th

week

(p=0.224). In the left premolar region the mean bite force at the 5th

week in group A


13.207+3.328, there was no statistical significant difference in mean bite force in the

left premolar region between group A and group B at 5th

week (p=0.143). In the left

premolar region the mean bite force at the 6th


16.866+1.309 and bite force in group B (3D system) was 15.552 ± 3.177, there was a

statistical significant difference in mean bite force in the left premolar region between


week (p=0.242).

Result

37

GRAPHS

Graph 1: Bite force difference in incisor region

Graph 2: Bite force difference in right canine region

Result

38

Graph 3: Bite force difference in left canine region

Graph 4: Bite force difference in right premolar region

Result

39

Graph 5: Bite force difference in left premolar region

Discussion

40

DISCUSSION

As the saying goes, the only permanent thing in this world is change, for the treatment

of mandibular fractures the newer methods have been tried and older ones have had

improvements. The strategic position of the mandible on the facial skeleton and its

unique role in mastication, deglutition, phonation and aesthetics compels the clinician

to give immediate attention when the lower jaw is injured.

It is well established that the bone healing is optimized by precise anatomic

reduction and rigid immobilization. Once fractures are reduced and immobilized

optimal bone repair is dependent on preservation and maintenance of intact blood

supply. Movement of fractures causes disruption of the osteogenic elements and

capillaries. This results in formation of poorly vascularized fibrous tissue which gives

rise to complications in fracture healing, like fibrous union or sometimes even non-

union.

With advances in our understanding of bone healing after the fracture, there has

been a transformation from anatomic fixation principle to a more biomechanical

fixation principle, in the management of fractures. Various designs of internal fixation

devices are constantly being modified and its biomechanical potentials explored to a

maximum extent.

Today, internal fixation devices such as miniplates, are widely used in traumatology

of maxillofacial area and they have replaced conservative treatment with MMF. But

MMF remains an important and effective tool especially in cases where plates cannot

be used due to economical, personal and logistic reasons. Research continues to focus

on the size, shape, number and biomechanics of plate/screws systems to improve

surgical outcomes.

Discussion

41

Open reduction and internal fixation of mandibular fractures with bone plates was

first described by Schede in 18884.General acceptance of open osteosynthesis did not

appear in maxillofacial literature until an organised research by AO in 1950.Luhr,

Spissel and others derived inspiration from orthopaedic biomechanical studies

performed by Schenk.Champy‟s experiment with miniplates further delineated the

“Ideal lines of Osteosynthesis” with the mandible. Wire osteosynthesis was followed

many years before the plates invention which did not provide stability in 3

dimensions.

In 1913, Lambotte recommended an aluminium geometrically closed quadrangular

plate secured with bone screws for the treatment of fractures of mandibular body via

an extraoral approach. He found that, when the fragments were repositioned properly,

this specially designed plate osteosynthesis offered sufficient stability without further

immobilization45

. Furthermore this system was superior to that of wire osteosynthesis.

Complications of miniplates especially in the angle region have been described in

30% of cases, like movement and loosening of screws leading to failure of fracture

treatment with other limitations of standard miniplates such as need for precise

adaptations and less stability across fracture line46

.

Mostafa Farmand introduced new 3D plating system. The shape of 3D plate is

basically quadrangular geometrically consisting of two horizontal plates

interconnected by vertical struts where they provide stability in three dimensions.

These unique plate consists of square or rectangular units 2x2,3x2,4x2 holes and

provides increased torsional stability which are in consideration with studies shown

by Jimson et al in 2009. The 3D miniplate itself is a misnomer as the plates

Discussion

42

themselves are not 3 dimensional but hold the fracture segments rigidly by resisting

the 3 dimensional forces namely shearing, bending and torsional forces acting on the

fracture site in function.47

Similarly, in the present study, a positive correlation was found between the

preoperative and postoperative weeks and the bite force for the anterior and posterior

regions of the fracture sites in both groups. There was a progressive increase in the

bite force readings from the preoperative period to 6 weeks post operatively in both

the groups. At other regions the bite force in both the groups increased at the same

rate with no statistically significant difference.

In conclusion the results from this study suggests that fixation of non communited

mandibular symphysis and parasymphysis fractures with a 2.0mm 3D miniplates

provides three dimensional stability and carries low morbidity and infection rates,

supporting the studies carried out by Jimson S et al (2009)33

and Goyal. M et al

(2011).39

The 3D plating system have provided the following features:

1. The quadrangle geometry of plate assures a three dimensional stability of

fracture site as it offers good resistance against torque forces.

2. Early restoration of mandibular functions postoperatively.

3. Simplicity, malleability, low profile and ease of application.

4. Less postoperative surgical morbidity.

5. Less operating time.

6. Easy adaptability of the plate.

Discussion

43

The possible limitations of these plates are:

1. Excessive implant material due to the extra vertical bars incorporated for

countering the torque forces limits its use.

2. Difficult to use in communited fractures.

3. Cost of these plates which is slightly more than the conventional plates.

4. Difficult to adapt at the mental foramen region.

The ideal method of treating mandibular fractures is the one that establishes a

functional therapy by movement. Therefore, it should aim for the following48

1. Reestablishment of the lost occlusion

2. Perfect anatomic reduction.

Complete and stable fixation, allowing painless mobilisation of the injured

region.

3. Maintenance of blood supply of the fractured fragments and of the

surrounding tissues.

The biomechanical requirements for ideal osteosynthesis are that48

The plates and screws should withstand the various stresses due to the tensile

and tortional forces to which the mandibular bone is typically subjected to.

The plates have to be malleable for easy adaptation to the bone surface,

especially in the curved symphysis and molar region to secure anatomical

reduction and to restore perfect occlusion.

The dimensions of the plate should ensure minimal periosteal elevation and

fracture site exposure; furthermore, the Oral mucosa must be able to cover the

plate without any difficulty, without any dead space around the plate and head

of the screws

The size of the screws has to be appropriate for the thickness of the cortex.

Discussion

44

This study define ideal line of osteosynthesis in the mandible which corresponds to

the course of a tension line at the base of the alveolar process inferior to the root

apices. In that region a plate can be fixed with monocortical screws as follows-48

Behind the mental foramina the plate is applied immediately below the dental

roots and above the inferior alveolar nerve.

At the angle of the jaw the plate is placed ideally on the inner broad surface of

the external oblique line; if this has been destroyed, the plate is fixed on the

external cortex as high as possible.

In the anterior region, between the mental foramina, in addition to the sub

apical plate, another plate near the lower border of the mandible is necessary

to neutralize the torsion forces.

The result of such a monocortical, stable, dynamic osteosynthesis is the neutralization

of the distraction and torsion forces exerted on the fracture site, while physiological

self compression strains are restored. These developments helped in early functional

recovery of the patients thereby improving the quality of life. Several biomechanical

studies have been conducted to evaluate the post operative functional aspects of the

jaws.48

Over the last two decades miniplate osteosynthesis has induced a revolution in

mandibular fracture treatment. This modern system provides better handling, higher

stability and less pressure on the bone and they have great advantages, like the intra-

oral approach and the easy adaptability. In addition, it is no longer necessary to

expose bone extensively. But with the standard miniplates, loosening of the screws

due to transmission of pressure to the underlying bone led to loss of fracture stability

and then fixation failure. Nevertheless complications in miniplate osteosynthesis of

Discussion

45

the mandible especially in the angle region have been described in upto 30% of cases,

like movement and loosening of screws leading to failure of fracture treatment.46

Fixation failure results in fracture mobility that can subsequently lead to infections,

non union and/or malunion. Fixation fails by a number of mechanisms which include:

improper fixation, fracture of the plate, loosening of the screws, devitalization of bone

around screws. Other limitations of standard miniplates include need for precise

adaptations and less stability across the fracture line.

Figure 1: (A) Left : primary stability of the conventional miniplate system depends

on friction (blue arrows) between screw, plate and bone. Right: distribution of load in

a conventional miniplate screw (green arrow), counterforce of the bone for

compensating axial forces (red arrow). (B) Left: the 3- dimensional frame (white box)

is the major principle of stability of the mini – locking system. Right: distribution of

load in a mini – locking screw. The screw‟s geometry distributes load (green arrow)

Discussion

46

to several spots (red arrows): the bone between the thread ridges above the pivot (blue

dot) is under pressure load (yellow arrows), while the opposite happens to the bone on

the other side below the assumed pivot.

These led to the introduction of locking plate system by Ralf Gutwald. He did the first

in vitro biomechanical comparison of the standard and locking miniplate system in

1999 and found that locking plates were more stable at the angle region.49

The first

clinical study comparing the two systems was published by Ellis et al in 2002.10

This

new design of Mini-Locking plate provided locking of the screws on both the plate

and the bone interface, either side of the fracture. Thus, a frame construct was

achieved on either side of the fracture fragments. (Figure: 1). This provided better

stability of the fracure fragments, and thus better healing environment, when

compared to the conventional plates, while retaining the same miniature dimensions.27

It was also proved that the fracture gap and torsion forces at the fracture site were

significantly low in locking plates when compared to that of conventional plates.

They proposed that the frame construct model prevents any pressure from

accumulating beneath the plates and hence prevents any interference of vascular

supply of the bone. Thus, the periosteum grows beneath the plates and over the

fracture site without any interference. The improved immobilization of the fracture

segments, along with the abundant and interruped blood supply, gives a stable

environment for callus formation; the healing enters the phase of remodelling without

delay. Thus, the callus is remodeled into new bone that is capable of taking up the

biomechanical forces, at a faster rate. Hence it is postulated that function is restored

earlier with locking plates.

The newer locked plates control the axial orientation of the screw to the plate, thereby

enhancing screw – beam – bone construct stability by creating a single beam

Discussion

47

construct. A single- beam construct is created when there is no movement between the

components of the beam, i.e., the plate, screw and bone. Single – beam constructs are

4times stronger than load – sharing beam constructs where motion occurs between the

individual components of the beam construct. Locked plates are single-beam

constructs by design. In contrast, conventional plates can function as single-beam

constructs only in the ideal circumstances (good bone that permits screw torques >3

Nm, sufficient coefficient of friction between the plate and the bone, and

physiological loads <1200N) where there is no motion between the plate and the

bone. When these ideal circumstances cannot be met, the locked plate will continue to

function as a single-beam construct, whereas the conventional plate is likely to fail,

particularly if it is functioning as a load bearing device.27

Advantages of the locking system over the standard miniplates:

1. Locking plate do not require precise adaptation of the plate to the underlying

bone50

without this intimate contact in the conventional system tightening of

the screws will cause drawing of the bone segments towards the plate resulting

in alterations in the position of osseous segments and the occlusal relationship.

As human mandible shows an uneven surface, adapting conventional

miniplates to the contours of the bone compensates for such an uneven

surface. However, repeated bending may cause material fatigue and create

predetermined breaking points.37

In locking plate as the screws are tightened

they “lock” to the plate, thus stabilizing the segments without the need to

compress the bone.

2. The locking screws are unlikely to loosen from the bone plate even if the

screw is inserted into the fracture gap or a comminuted segment. Thus, the

Discussion

48

incidence of inflammatory complications from loosening of the hard ware is

decreased.9

3. The amount of stability provided across the fracture segments is greater.27

4. They do not disrupt the underlying cortical bone perfusion as much as the

conventional plates which compress the undersurface of the bone plate to the

cortical bone.27

5. The locking screw plate system also reduces compressive forces between the

undersurface of the plate and lateral bony cortex compared with a

conventional mandibular plate. In a locking screw plate system, forces are

generated between the threaded portion of the plate and the screw. This limits

stress shielding effect and creates a more stable fixation over a period of

time.51

6. Locking plates can be used in all type of mandibular fracture including

comminuted and infected fractures of ramus, angle, body, parasymphysis and

symphysis.

Disadvantages of locking plates:

1. The disadvantages of locking plates are that these plates require to „center‟ the

drill hole with the plate hole to ensure perpendicular placement of the screw. If

screws are not placed perpendicular to plate the screw will not engage the

threaded plate hole precisely and therefore will not lock.

2. Another disadvantage of locking plates, it is little expensive when compared to

the conventional plates.52

Inspite of all the advantages that, these locking plates and screw offer to the surgeon,

they are still far from being the perfect treatment modality. Though clinically more

Discussion

49

effcient than a conventional plate, the locking plate still has the same complication

rates.26,52

Herzberg noticed a higher rate of complications when the interval between trauma and

surgical treatment is delayed more than 6 days.37

However, according to Ellis et al,

there is no convincing evidence in the literature correlating the delay in treatment of

mandibular fractures with the increase in the postoperative complications, such as

infection.53

Even in the present study, no such correlation was found.

Scolozzi et al used single AO 2mm locking reconstruction plate in linear non

comminuted mandibular fractures and found sound bone healing with no major

complications.35

In our study we used single 2mm locking miniplate in 10 fractures

(symphysis and parasymphysis region) and achieved similar results like above

mentioned study without any major complications.

Coredy and co – workers state that the friction between the screw and plate is the

main weak point of the entire fixation.54

In the locking plate system the thread on the

screw locks into the congruent thread of the plate, transforming the screws and plate

into a unit, creating a rigid splint with higher mechanical stability which corresponds

to the principle of an external fixator, where the friction between the plate and the

bone is totally avoided.55

This was easily experienced in the present study by us.

In the prospective study by Cawood, 5.7 % of mandibular fractures, excluding

additional condylar neck fractures, treated by miniplates osteosynthesis had

malocclusion detected on review.56

Champy et al. reported a 4.8% malocclusion rate

in their group treated by miniplate osteosynthesis.57

The first biomechanical

comparison of locking plates found in the maxillofacial surgical literature was made

by Gutwald in 1999 and they concluded that a higher stability was achieved with the

locking plates.49

So, favoring the other similar studies, in the present study inspite of

Discussion

50

using a single locking miniplate at the symphysis and parasymphysis region (n=10) in

comparison of two standard miniplates as per Champy‟s principles no instances of

segmental mobility were noted.

Cawood showed mental parasthesia in 8% of cases of mandibular fractures treated by

miniplate osteosynthesis.56

In another study postoperative parasthesia was found to be

31.52%.23

in a recent study, higher incidence of temporary parasthesia in patients

treated with locking miniplates as compared to the standard miniplates was observed

and was attributed to the necessity for more tissue retraction to accommodate the drill

guide and subsequent placement of perpendicular screws.32

However, in the present

study no instances of mental nerve parasthesia were noted. This difference may be

due to differences in the proximity of the fracture line to the mental foramen, to the

differences in technical expertise of the operator and lastly to the smaller sample size

of the present study.

The bite force is related to a number of factors, including tactile impulses, pain and

pressure reception in the periodontal ligament, the number of residual teeth and

patient age, because a reduction in bite force can occur with age owing to the age-

dependent deterioration of the dentition. It has long been known that a neuromuscular

protective mechanism occurs throughout the body. For instance, one of the first

protective mechanisms called into play when a fracture occurs is “muscle splinting” in

which selective components of the neuromuscular system are activated or deactivated

to remove the force from the damaged bone. In 1994, Tate et al stated that sufficient

internal fixation hardware should be applied to resist the maximal force of

mastication. Thus, they hypothesized that the stability of fracture segment would be

ensured even under the full function of the masticatory system.

Discussion

51

The amount of force generated by the patients with untreated as well as treated

fractures is much less. Furthermore, one must remember that the data reported

concerned the maximal voluntary bite force (i.e., the maximum bite force an

individual can voluntarily generate) the amount of force used during functional

activities would probably be much less. Hence, the fixation requirements, determined

from the maximal voluntarily bite force of noninjured subjects, might be inflated, and

this fixation requirement is perhaps a semirigid form of fixation such as monocortical

fixation.41

In 2002, Gerlach and Schwarz in their study bite force of treated

mandibular angle fractures concluded that the maximal bite force in patients with

mandibular fractures treated with miniplate osteosynthesis had reached only 31% at 1

week postoperatively compared with a healthy control group. These values had

increased to 58% at 6 weeks postoperatively.22

Similarly in the present study, a positive co relation was found between post -

operative anterior and posterior bite force in both the groups. There was a progressive

increase in the bite force readings from the pre – operative to 6 weeks post operatively

in both the groups. The mean difference between the two groups is statistically not

significant at right canine region (p= 0.694), left canine (p= 0.858), right premolar (p=

0.570), left premolar (p= 0.930) regions. But mean difference between the 2 groups is

statistically significant at incisor region with p<0.001. Hence there is no statistically

significant difference in the stability of 3-D miniplates and locking miniplate systems.

Limitations of the present study include the shorter follow up period and a smaller

sample size. Better comparison could have been carried out if the study was done on

isolated mandibular fractures at a particular fractured site of mandible. To show

significant improvements of locking plate / screw system or 3D plates/ screws, further

studies with a larger sample size with longer follow up is required.

Conclusion

52

CONCLUSION

The clinical outcome of both 3D and locking miniplate systems in the present study

were similar, however the following advantages of 3D and locking miniplates can be

highlighted:

Advantages of locking miniplate system-

Can be used as a “one-plate-for-all” system minimizing the number of fixation

systems necessary to be stocked in the operating room.

Lesser trauma to the periosteum and soft tissues with lesser amount of

hardware.

Advantages of 3D miniplate system-

Fixation of mandibular fractures with 3 Dimensional plates facilitates

simultaneous reduction and stabilization at both the superior and inferior

borders.

Post operative long term intermaxillary fixation can be avoided as good

stability was achieved with these plates.

The 3D plates were found to be of high standard in profile, strong yet

malleable, facilitating reduction and stabilization at both the superior and

inferior borders giving three dimensional stability at the fracture site.

Though we cannot comment on the rigidity and malleability of the 3 dimensional

plates and locking plates compared to other systems without a control group or

comparative study with other plating systems our statement is thoroughly based only

on our clinical experience. Further studies are necessary to set gold standards for

Conclusion

53

these plating systems with a control group and comparative studies with the above

mentioned plating systems.

Summary

54

SUMMARY

The study was designed with the aim to compare the efficacy of 3-dimensional

titanium miniplates with that of the titanium locking miniplates in the treatment of

mandibular fractures. Internal fixation using Champy’s miniplates is the preferred

mode of managing mandibular fractures in the interforaminal region. The patients

who required open reduction and internal fixation were selected for the study. As the

case required, the procedures were done under general anaesthesia or local

anaesthesia. The approaches used were both intraoral and extra oral as the case

required. . Patients were evaluated at 1st week to 6

th week for the treatment results and

the complications that might develop. None of the cases reported any immediate or

delayed complications. Malocclusion and hardware failure were not noticed in any of

the cases.

In our study A 4 holed (2x2) titanium 3-dimensional miniplate with interconnecting

vertical bars and a 4 holed titanium locking miniplate with bar was used and there is

no statistically significant difference in the efficacy of 3-D miniplate and Locking

miniplate systems but further prospective randomized comparative studies with larger

sample size and longer follow up are needed to ascertain these findings

authoritatively.

References

55

REFERENCES

1) Gassner R, Tuli T, Hachl O, Rudisch A, Ulmer H. Craniomaxillofacial trauma a 10 year

review of 9543 cases with 21067 injuries. J CraniomaxillofacSurg 2003;31:51-61.

2) Brasileiro BF, PasseriLA : Epidemiological analysis of maxillofacial fractures in Brazil :

a 5-year prospective study. Oral Surg Oral Med Oral Pathol Oral RadiolEndod

2006;102:28-34.

3) Mukerji, M. McGurk. Mandibular fractures: Historical Perspective. British J Oral

MaxillofacSurg 2006; 44: 222-228.

4) Andrew J. L. Gear, Apasova E, Schmitz JP and Schubert W. Treatment modalities for

mandibular angle fractures. J Oral MaxillofacSurg 2005; 63: 655-663.

5) Alkan.A, N. Celebi, B Ozden, B Bas and S. Inal. Biomechanical comparison of different

plating techniques in repair of mandibular angle fractures. Oral Surg Oral Med Oral Path

Oral RadiolEndod 2007; 104:752-756.

6) Zix J, Lieger O and Iizuka T. Use of Straight and Curved 3-Dimensional Titanium

Miniplates for Fracture Fixation at the Mandibular Angle. J Oral Maxillofac Surgery

2007; 65:1758-1763.

7) Peter Bui, NagiDemian, and Patrick Beetar. Infection Rate in Mandibular Angle

Fractures Treated With a 2.0-mm 8-Hole Curved Strut Plate. J Oral MaxillofacSurg

2009; 67: 804-808.

8) Tams J, Loon JP, Otten E, Rozema FR and Bos RRM. A three-dimensional study of

bending and torsion moments for different fracture sites in the mandible: an in vitro

study. Int. J Oral MaxillofacSurg 1997; 26: 383-388.

References

56

9) Herford AS, Ellis E III. Use of locking reconstruction bone plate/screw system for

mandibular surgery. J Oral MaxillofacSurg 1998;56:1261-1265.

10) Ellis E III, Graham J. use of a 2.0 mm locking plate/screw system for mandibular

surgery. J Oral MaxillofacSurg 2002;60:642-645.

11) Brons R, Boering G. Fracture of mandibular body treated by stable internal fixation: A

preliminary report. J Oral Surg 1970;28:407.

12) Ellis E III. Rigid skeletal fixation of fractures. J Oral Maxillofac Surg 1993;51:163-173.

13) Kahn Berg K.E. & A .Ridell: Bone Plate Fixation of Mandibular Fractures:Int. J Oral

MaxillofacSurg: 1980: 9: 267 – 273.

14) William C. Ardary. Prospective Clinical Evaluation of the use of Compression Plates and

Screws in the Management of Mandibular Fractures. Journal of Oral Maxillofacial

Surgery1989;47: 1150-1153.

15) Dodson TB, Perrott DH and Kaban LB, Gordon NC. Fixation of Mandibular Fractures: A

Comparative Analysis of Rigid Internal Fixation and Standard Fixation Techniques. J.

Oral Max FacSurg 1990; 48: 362 - 366.

16) J.P.Hayter,J.I.Cawood. The functional case for miniplates in maxillofacial surgery.

Int.J.Oral Maxillofacial Surgery1993;22:91-96.

17) Farmand M. : The 3d Plating System In Maxillofacial Surgery : J

OralMaxillofacSurg : 1993 : 51(3) : 166 – 167.

18) Shetty V, McBrearty D, Fourney M, Caputo AA. Fracture line stability as a function of

the internal fixation system: An invitro comparison using a mandibular angle fracture

model. J Oral MaxillofacSurg 1995;53:791-801.

References

57

19) Renton TF and Wiesenfeld D: Mandibular fracture osteosynthesis: a comparison of three

techniques. Br J Oral MaxillofacSurg 1996;34:166-73.

20) Sikes JW, Smith BR, Mukherjee DB, Coward KA. Comparison of fixation strengths of

locking head and conventional screws, in fracture and reconstruction models. J Oral

MaxillofacSurg 1998;56:468-473.

21) Bolourian R, Lazow S, Berger J. Transoral 2.0 mm Miniplate fixation of mandibular

fractures plus 2 weeks maxillomandibular fixation: A prospective study. J Oral

MaxillofacSurg 2002; 60:167–170.

22) Gerlach KL, Schwarz A. Bite forces in patients after treatment of Mandibular angle

fractures with miniplateosteosynthesis according to Champy. Int J Oral MaxillofacSurg

2002;31:345–348.

23) Gabrielli MAC, Gabrielli MFR, Marcantonio E, Hochuli-Vieira E. Fixation of

mandibular fractures with 2.0-mm miniplates: review of 191 Cases. J Oral


24) Alpert B, Gutwald R, Schmelzeisen R. New innovations in craniomaxillofacial fixation;

the 2.0 lock system. Keio J Med 2003;52:120-127.

25) Kirkpatrik D, Gandhi R, Sickels JEV. Infections associated with locking reconstruction

plates: A retrospective review. J Oral MaxillofacSurg 2003;61:462-466.

26) Collins CP, Leonard GP, Tolas A, and Alcalde R. A prospective randomized clinical trial

comparing 2.0-mm locking plates to 2.0-mm standard plates in treatment of mandible

fractures. J Oral MaxillofacSurg 2004;62:1392-1395.

27) EgolKa, Kubiac EN, Fulkerson E, Kummer FJ, Koval KJ. Biomechanics of locked plates

and screws. J Orthop Trauma 2004;18:488-493.

http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Wiesenfeld%20D%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus

References

58

28) Militsakh ON, Wallace DI, Kriet D, Girod DA, Olvera MS, Tsue TT. Use of the 2.0mm

locking reconstruction plate in primary oromandibular reconstruction after composite

resection. Otolaryngol Head Neck Surg 2004;131:660-5.

29) Gear AJL, Apasova E, Schmitz JP, Schubert W. Treatment modalities for mandibular

angle fractures. J Oral MaxillofacSurg 2005;63:655-663.

30) Chritah A, Lazow SK, Julius R, Berger JR. Transoral 2.0mm locking miniplate fixation

of mandibular fractures plus 1 week of maxillomandibular fixation: A prospective study.

J Oral MaxillofacSurg 2005;63:1737-1741.

31) Sauerbier S, Schon R, Otten JE, Schmelzeisen R, Gutwald R. The development of plate

osteosynthesis for the treatment of fractures of the mandibular body - A literature review.

J CraniomaxillofacSurg 2008; 36,251-259.

32) Saikrishna D, Shetty SK, Marimallappa TR. A comparison between 2.0mm standard and

2.0mm locking miniplates in the management of mandibular fractures. J Maxillofac Oral

Surg 2009;8:145-149

33) Jimson S, Sankar A, Prasad R. Comparative study of stainless steel miniplates, three

dimensional plate and titanium three dimensional plate for fixation of mandibular

fractures. Int J of maxillofac Surg.2009;03:380.

34) Oguz Y, Uckan S, Ozden AU, Uckan E, Eser A. Stability of locking and conventional 2.0

mm miniplate/ screw systems after sagittal split ramus osteotomy : finite element

analysis. Oral Surg Oral Med Oral Pathol Oral RadiolEndod 2009; 108: 174-177.

35) Scolozzi P, Martinez A, Jaques B. treatment of linear mandibular fractures using a single

2.0mm AO locking reconstruction plate: Is a second plate necessary ?. J Oral


References

59

36) Manoj Kumar Jain, K.S.Manjunath,B.K.Bhagwan, Dipit.K.Shah. Compaison of 3 -

dimensional and standard miniplate fixation in the management of mandibular fractures.

J. Oral Maxillofacial Surg 2010;68:1568-1572.

37) Sauerbier S, Kuenz J, Hauptmann S, Hoogendijk CF, Liebehenschel N, Schon R et al.

Clinical aspects of a 2.0mm locking plate system for mandibular fracture surgery. J

CranioMaxillofacSurg 2010;38:501-504.

38) Riberio-Junior PD, Magro- Filho O, Shastri KA, Papageorge MB. In vitro evaluation of

conventional and locking miniplate/screw systems for the treatment of mandibular angle

fractures. Int J Oral MaxillofacSurg 2010;39:1109-1114.

39) Goyal M, Marya K, Chawla S, Pandey R. Mandibular Osteosynthesis: A Comparative

Evaluation of Two Different Fixation Using 2.0mm Titanium Miniplates and 3-D

Locking Plates. J. Maxillofac. Oral Surg.2011; 10(1):32-37.

40) Singh V, Kumar I, Bhagol A. Comparative evaluation of 2.0mm locking plate system

versus 2.0mm non locking plate system for mandibular fracture; A prospective

randomized study. Int J Oral MaxillofacSurg 2011;40:372-377.

41) Aggarwal M, Mohammed S, Singh RK, Singh V. Prospective randomized clinical trial

comparing bite force in 2.0mm locking plate versus 2.0mm standard plates in treatment

of mandibular fractures. J Oral MaxillofacSurg 2011;69:1995-2000.

42) Gutwald Schon R, Metzger M, Kreutzer K, Rahn B, Sauerbier S. Miniplateosteosynthesis

with four different systems in sheep. Int J Oral MaxillofacSurg 2011;40:94-102.

43) Mahmoud E.K, Hesham E, Mohamed M.H. Titanium Three Dimensional Miniplate

versus Conventional Titanium Miniplate in Fixation of Anterior Mandibular

Fractures.Life Science Journal 2012;9(2).

References

60

44) LaxmiGandi,Vivekanand S.K. Three Dimensional Bone Plating System in the

Management of Mandibular Fractures-A Clinical Study.Annals and Essence of Dentistry

2012;vol IV(2):104-110.

45) Peter Ward Booth, Stephan A.S, Jarg-Erich H. Maxillofacial surgery Vol 1, 2nd

editon,

74-76.

46) Ellis E 3rd

, Walker L. Treatment of mandibular angle fractures using two non

compression miniplates. J Oral Maxillofac Surg. 1994;52:1032-6.

47) Vijay E, Balakrishnan R. Three dimensional miniplate fixation in mandibular fractures.

Indian J Multidisciplinary Dent. 2011;1(2).

48) Haerle F, Champy M, Terry B. Atlas of craniomaxillofacial osteosynthesis: microplates,

miniplates and screws 2nd

edition. Thieme; 2009.p.3-5.

49) Gutwald R, Buscher P, Sehramm A, Rahn B, Gellrich N-C, Schmelzeisen R.

Biomechanical stability og internal mini-fixation-system in maxillofacial osteosynthesis.

Med Biol Eng Compot 1999;37:280-1.

50) Haug RH, Street CC, Goltz M. Does plate adaptation affects stability ? A biomechanical

comparison of locking and non locking plates. J Oral Maxillofac Surg 2002;60:1319-

1326.

51) Chiodo TA, Ziccardi VB, Janal M, Sabitini C. Failure strength of 2.0 locking vs 2.0

conventional synthes mandibular plates: A laboratory model. J Oral Maxillofac Surg

2006;64:1475-1479.

52) Gellrich NC, Suarez-Cunqueiro MM, Otero- Cepeda XL, Schon R, Schmelzeiscn R,

Gutwald R. Comparative study of locking plates in mandibular reconstruction after

References

61

ablative tumor surgery: THORP Versus UniLOCk system. J Oral Maxillofac Surg.

2004;62:186-193.

53) Ellis E III, Miles BA. Fractures of mandible: A technical prospective. Plast Reconstr

Surg 2007;120:76-89.

54) Coredy J, Borgeaud M, Perren SM. Force transfer between the plate and the bone;

Relative importance of the bending stiffness of the screws fiction between plate and

bone. Int J Surg 2000;31:21-8.

55) Gutwald R, Alpert B, Schmelzeisen R. Principle and stability of locking plates. Keio J

Med 2003;52:21-24.

56) Cawood JI. Small plate osteosynthesis of mandibular fractures. Br J Oral Maxillofac Surg

1985;23:77-91.

57) Champy M, Lodde JP, Schmitt R, Jaeger JH, Muster D. Mandibular osteosynthesis by

miniature screwed plates via buccal approach. J Oral Maxillofac Surg 1978;6:14-21.

Consent Form

62

CONSENT FORM

Sri Hasanamba Dental College and Hospital, Hassan

Department Of Oral and Maxillofacial Surgery

Investigators:

Rahul Kumar Sanklecha Dr.K.S.Manjunatha

(P G student) (Guide)

WRITTEN CONSENT

Name of the participant: Hospital number

Address Age/Sex

Phone no :

I have been told and have gone through the information provided about the study

“BITE FORCE AS A PARAMETER FOR COMPARISION BETWEEN 2.0 mm TITANIUM LOCKING MINIPLATES

AND 2.0 mm TITANIUM 3-D MINIPLATES FOR MANDIBULAR FRACTURES: A RANDOMISED CLINICAL

TRIAL.” and I have understood it. I was given the opportunity to seek clarifications for my doubts

and I am satisfied with the answers provided to my questions.

I hereby give my consent to participate/ do not want to participate in the study*

Date signature/ thumb impression

*strike out the inapplicable

Statement of witness

I the undersigned was a witness to the briefing and administration of consent. The

information about the study and the procedure was explained to me in an

understandable language.

Name of witness Signature

Proforma Prototype

64

PROFORMA PROTOTYPE

Sri Hasanamba Dental College And Hospital, Hassan

Department Of Oral And Maxillofacial Surgery

Proforma for clinical dissertation

BITE FORCE AS A PARAMETER FOR COMPARISION BETWEEN 2.0 mm

TITANIUM LOCKING MINIPLATES AND 2.0 mm TITANIUM 3-D MINIPLATES

FOR MANDIBULAR FRACTURES: A RANDOMISED CLINICAL TRIAL

Name of the post-graduate trainee: DR. RAHUL KUMAR SANKLECHA

Academic session: 2016-2019

Case no.: Date:

1. NAME OF THE PATIENT:

2. AGE/SEX:

3. O.P. NO.:

4. ADDRESS:

5. PHONE NO.:

6. OCCUPATION:

7. CHIEF COMPLAINT:

8. HISTORY OF PRESENT ILLNESS:

Proforma Prototype

65

9. ON EXAMINATION

EXTRAORAL EXAMINATION

INTRAORAL EXAMINATION

10. PROVISIONAL DIAGNOSIS:

11. INVESTIGATIONS: BLOOD- CT- HB%-

BT- HIV-

HbsAg-

URINE-

12. LOCAL INVESTIGATIONS:

CONVENTIONAL-

SPECIAL (C.T./M.R.I.)-

13. RADIOGRAPHIC INTERPRETATION:

Proforma Prototype

66

14. FINAL DIAGNOSIS:

15. TREATMENT PLAN:

16. TREATMENT DONE:

i. Antibiotics and analgesics:

ii. Procedure:

iii. Type of plate and screws used:

TITANIUM LOCKING MINIPLATE (GROUP A):

TITANIUM 3-D MINIPLATE (GROUP B):

iv. No. of plates used:

v. Duration of surgery:

Proforma Prototype

67

vi. EVALUATION OF BITEFORCE FOR COMPARISON:

1. BITE FORCE MEASUREMENTS:

PRE-

OPERATIVE

1ST

WEEK

2ND

WEEK

3RD

WEEK

4TH

WEEK

5TH

WEEK

6TH

WEEK

INCISORS

CANINE

(RIGHT)

CANINE

(LEFT)

PREMOLAR

(RIGHT)

PREMOLAR

(LEFT)

SIGNATURE OF THE POSTGRADUATE SIGNATURE OF THE GUIDE

Figures

73

FIGURES

Fig 2: Armamentarium

Fig 3: 3D miniplate and screws used in this study

Fig 4: Locking miniplate and screws

Figures

74

Fig 5: Digital bite force device

Fig 6: Measurement of bite force

Figures

75

Fig 7a: 3D Preoperative OPG

Fig 7b: Vestibular Incision Fig 7c: Exposure of fracture site

Fig 7d: 3D plate fixation Fig 7e: Wound closure

Fig 7f: Post-operative OPG

Figures

76

Fig 8a: Preoperative OPG

Fig 8b: Vestibular Incision Fig 8c: Exposure of fracture site

Fig 8d: Locking plate

fixation Fig 8e: Wound closure

Fig 8f: Post-operative OPG

Figures

77

PATIENT INFORMATION SHEET

You are being requested to take part in a study titled-

“BITE FORCE AS A PARAMETER FOR COMPARISION BETWEEN 2.0 mm

TITANIUM LOCKING MINIPLATES AND 2.0 mm TITANIUM 3-D

MINIPLATES FOR MANDIBULAR FRACTURES: A RANDOMISED

CLINICAL TRIAL”

The aim of the study is to compare the efficacy of titanium locking miniplates with that

of the titanium 3-dimensional miniplates in the treatment of mandibular fractures on the

basis of bite force measurements and to evaluate and compare the biomechanical function

between the two systems by measuring the maximal bite force preoperatively and

postoperatively.

Patients enrolled in this study will be entitled for a follow up period of 6 weeks.

For any clarifications, patients can contact Dr. Rahul Kumar Sanklecha,

Department of Oral and Maxillofacial Surgery, Sri Hasanamba Dental College and

Hospital, Vidyanagar, Hassan.

Contact number: 8147411158

bite force as a parameter for comparision between

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