injectable dimeralized bonematrix

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DENTAL IMPLANTS J Oral Maxillofac Surg 69:134-141, 2011 Efficacy of Injectable Demineralized Bone Matrix as Graft Material During Sinus Elevation Surgery With Simultaneous Implant Placement in the Posterior Maxilla: Clinical Evaluation of 49 Sinuses Tassos Irinakis, DDS, Dip Perio, MSc, FRCD(C)* Purpose: The purpose of the present retrospective investigation was to evaluate the survivability and success of single implants placed simultaneously during direct sinus lifts with allograft forms of bone and to investigate the effect demineralized bone matrix paste has on time management and membrane integrity during these procedures. Materials and Methods: The charts of 49 consecutively treated nonsmoking patients who had met the inclusion criteria were examined. All the patients had undergone unilateral direct sinus augmentation using the lateral window technique, during which only 1 implant (minimum 10 mm in length) was placed in the premolar or molar maxillary region. All implants were submerged using a 2-stage technique and with at least 3 mm of residual sinus floor bone height. The control group of 27 patients had received particulate allograft bone as the graft material, and the 22 test patients had received allograft bone in a paste form (DynaBlast). No implants were loaded before a minimum of 6 months from the date of fixture placement. All implant-supported single crowns in the present study had been functioning for at least 12 months. All patients were seen immediately after placement of the final crown and were requested to return to the surgeon’s practice for 1 annual radiographic follow-up examination. The range of follow-up for these patients was 12 to 24 months based entirely on patient compliance. This interval constituted the loading time. The patients were not seen by the specialist in between the “final crown” appointment (original radiograph) and the “annual” follow-up evaluation (final radiograph). No patients experienced complications that required surgical re-entry. The average loading time for the control group was 13.62 months and was 18.77 months for the test group. The survivability and success of the implants were studied, along with the operative time, between the 2 groups. Statistical analysis was performed for various comparisons in the present study. Results: None of the fixtures placed in these patients failed. The success and survivability criteria as stated were met for all 49 implants, regardless of the allograft formulation used. The average operative time in the control group was 70.11 minutes and was 62.36 minutes in the test group. This difference was statistically significant (P .05). Conclusions: Using an injectable formulation of allograft material during simultaneous direct sinus lift and implant placement seems to be an acceptable alternative to particulate forms of allograft bone. In addition, when using the injectable graft evaluated in our study, a statistically significant 11% decrease in the operative time resulted. © 2011 American Association of Oral and Maxillofacial Surgeons J Oral Maxillofac Surg 69:134-141, 2011 *Associate Clinical Professor, Director, Graduate Periodontics Program, Division of Periodontics and Implant Surgery, University of British Columbia, Faculty of Dentistry, Vancouver, BC, Canada. Address correspondence and reprint requests to Dr Irinakis: Graduate Periodontics Program, Division of Periodontics and Im- plant Surgery, University of British Columbia, Faculty of Dentistry, Suite 205, 777 West Broadway, Vancouver, BC V5Z 4J7 Canada; e-mail: [email protected] © 2011 American Association of Oral and Maxillofacial Surgeons 0278-2391/11/6901-0019$36.00/0 doi:10.1016/j.joms.2010.07.028 134

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Page 1: injectable dimeralized bonematrix

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DENTAL IMPLANTS

Oral Maxillofac Surg9:134-141, 2011

Efficacy of Injectable Demineralized BoneMatrix as Graft Material During SinusElevation Surgery With SimultaneousImplant Placement in the Posterior

Maxilla: Clinical Evaluation of 49 SinusesTassos Irinakis, DDS, Dip Perio, MSc, FRCD(C)*

Purpose: The purpose of the present retrospective investigation was to evaluate the survivability andsuccess of single implants placed simultaneously during direct sinus lifts with allograft forms of bone andto investigate the effect demineralized bone matrix paste has on time management and membraneintegrity during these procedures.

Materials and Methods: The charts of 49 consecutively treated nonsmoking patients who had met theinclusion criteria were examined. All the patients had undergone unilateral direct sinus augmentationusing the lateral window technique, during which only 1 implant (minimum 10 mm in length) wasplaced in the premolar or molar maxillary region. All implants were submerged using a 2-stage techniqueand with at least 3 mm of residual sinus floor bone height. The control group of 27 patients had receivedparticulate allograft bone as the graft material, and the 22 test patients had received allograft bone in apaste form (DynaBlast). No implants were loaded before a minimum of 6 months from the date of fixtureplacement. All implant-supported single crowns in the present study had been functioning for at least 12months. All patients were seen immediately after placement of the final crown and were requested toreturn to the surgeon’s practice for 1 annual radiographic follow-up examination. The range of follow-upfor these patients was 12 to 24 months based entirely on patient compliance. This interval constitutedthe loading time. The patients were not seen by the specialist in between the “final crown” appointment(original radiograph) and the “annual” follow-up evaluation (final radiograph). No patients experiencedcomplications that required surgical re-entry. The average loading time for the control group was 13.62months and was 18.77 months for the test group. The survivability and success of the implants werestudied, along with the operative time, between the 2 groups. Statistical analysis was performed forvarious comparisons in the present study.

Results: None of the fixtures placed in these patients failed. The success and survivability criteria asstated were met for all 49 implants, regardless of the allograft formulation used. The average operativetime in the control group was 70.11 minutes and was 62.36 minutes in the test group. This differencewas statistically significant (P � .05).

Conclusions: Using an injectable formulation of allograft material during simultaneous direct sinus liftand implant placement seems to be an acceptable alternative to particulate forms of allograft bone. Inaddition, when using the injectable graft evaluated in our study, a statistically significant 11% decrease inthe operative time resulted.© 2011 American Association of Oral and Maxillofacial Surgeons

J Oral Maxillofac Surg 69:134-141, 2011

*Associate Clinical Professor, Director, Graduate Periodontics

rogram, Division of Periodontics and Implant Surgery, University

f British Columbia, Faculty of Dentistry, Vancouver, BC, Canada.

Address correspondence and reprint requests to Dr Irinakis:

raduate Periodontics Program, Division of Periodontics and Im-

lant Surgery, University of British Columbia, Faculty of Dentistry,

Suite 205, 777 West Broadway, Vancouver, BC V5Z 4J7 Canada;

e-mail: [email protected]

© 2011 American Association of Oral and Maxillofacial Surgeons

0278-2391/11/6901-0019$36.00/0

doi:10.1016/j.joms.2010.07.028

134

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TASSOS IRINAKIS 135

mplant placement in the edentulous posterior max-lla is often challenged by the quantity of availableone. Sinus augmentation procedures have been im-lemented to overcome this, and experienced sur-eons will frequently place their implants concur-ently during sinus augmentation surgery. The mostommonly used form of graft material has been par-iculate grafts, from autogenous to allogenic to xeno-enic to alloplastic. A more user-friendly form of allo-raft material (eg, injectable demineralized boneatrix [DBM] paste, DynaBlast, Keystone Dental, Bur-

ington, MA) has also been suggested as an alternativeorm of allograft material to decrease the time neededor graft insertion, the pressures applied to the schnei-erian membrane during placement, and the extrasi-us overflow of graft particles.The direct sinus lift procedure uses a lateral osse-

us window to gain access to the maxillary sinusavity. In the past, direct sinus lifts were mostly per-ormed as “stand-alone” procedures that were fol-owed by implant placement several months later.inus augmentation with simultaneous implant place-ent has gained in popularity and is now commonly

sed by more experienced clinicians in the appropri-te clinical circumstances.

Simultaneous implant placement during direct si-us lifts has been described in more recent studiessing various bone graft materials1-4 or without usingny grafts.5-7

The decision to place an implant concurrently withinus elevation surgery is usually determined by theperator’s experience and the amount of residualinus floor bone height the surgeon is comfortableith. Some studies have advocated a cutoff point of 5m to enhance the chances of favorable primary

tability of the implant.1,5,7 Other studies have pro-ided results for cases in which the initial sinus flooreight included those with a height of less than 5m.3,4,6,8,9 The primary goal in every case has been to

chieve favorable primary stability of the implantshen placed simultaneously with sinus lift surgery.hese studies of simultaneous placement have allhown excellent short-term and long-term implanturvival rates ranging from 100% in the short-termtudies (1 year) to 94.2% in the long-term (9- to 10-ear studies), regardless of the initial bone heightvailable. The histologic findings have also been fa-orable and have confirmed the bone turnover of theaterials used (graft replacement) with time.The quality of grafted bone, speed of osseous turn-

ver, density of the bone formed, and timeline ofmplant placement is also dependent on the form ofhe bone graft and the particle size in particulaterafts.10 The most popular forms of grafting materialor sinus augmentations have been particulate bone.

maller size particles in particulate formulations pro- h

ote faster osteoconduction. In addition, histomor-hometric analysis of these formulations has revealedsignificantly greater density of newly formed bone

n the early postimplantation period.10,11

Interest has been given to novel injectable forms ofone grafts. Such a formulation would potentiallyllow easier application with less force on the mem-rane during its placement and would likely decreasehe time needed to complete the procedure. Dyna-last paste (Keystone Dental) is an injectable form ofBM with cancellous bone chips (Fig 1). DBM, in an

njectable form with a carrier agent, has been inves-igated in several animal studies (very few of themnvolved sinus grafting), but only 5 clinical studies ofumans evaluating injectable DBM on implants inrafted sinuses have been published. In addition,one of these studies12-16 included cases with simul-aneous implant placement with direct sinus lift sur-ery. All implants were placed 6 to 9 months after thenjectable DBM had been administered under theifted sinus lining.

The purpose of the present retrospective investiga-ion was to evaluate 1) the survivability and success ofndosseous implants at 1 year after loading, whenlaced simultaneously with an injectable DBM pasteuring sinus augmentation surgery; and 2) the effectf the paste form of DynaBlast (Keystone Dental) onther aspects of the surgical procedure itself, such asime management and membrane integrity.

To the best of the author’s knowledge, this inves-igation is the first study evaluating simultaneous im-lant placement in human sinuses grafted with a DBMaste.

aterials and Methods

The institutional review board (known as the Clin-cal Research Ethics Board; the University of Britisholumbia, Clinical Research Ethics Board number for

he present study was H10-00464) at the University ofritish Columbia approved the present study.The present retrospective analysis included a co-

FIGURE 1. Syringe with injectable DynaBlast paste.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

ort of 49 patients (27 in the control group and 22 in

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136 SIMULTANEOUS DBM AND IMPLANTS IN SINUS

he test group), who each had undergone unilateralirect sinus lift using the lateral window techniqueith bone augmentation using allograft material. All

ecords evaluated were from consecutively treatedatients who had met the inclusion criteria. The in-lusion criteria are listed in Table 1. The inclusionriteria were strict and limited the sample size. Allinus procedures and implant placements were per-ormed by the same surgeon (T.I.) using the sameechnique in terms of incisions, osseous window cre-tion, hand and piezosurgery burs, membrane reflec-ion, bone graft application, window coverage anduturing materials and methods, implant installationechnique, and implant exposure and healing abut-ent placement technique (as discussed in subse-

uent paragraphs). Postoperative instructions weretandardized, including the medications prescribed.he details of the technique have been described in arevious study.17

Each case was a single implant of a maxillary molarr premolar site. Some edentulous sites that receivedreatment were neighbored by adjacent natural teeththus sharing some of the occlusal forces) and othersere acting as free-end situations without any distalcclusal support from the natural dentition. The pa-ient inclusion criteria were set to exclude currentmokers and patients with history of sinus problemsnd uncontrolled systemic health conditions. All pa-ients had inadequate residual bone height at theinus floor of the edentulous site to support an im-lant of 10 mm or more. In all these cases, the indi-ect sinus lift technique (or osteotome technique)as not feasible either because of the limited boneeight available for this technique or the presence ofrotruding septa or other anatomic interference orariations that would likely lead to a high risk of a

Table 1. INCLUSION CRITERIA FOR PRESENTRETROSPECTIVE INVESTIGATION

Systemically healthyCurrently, nonsmokers (must have quit �5 y previously)Absence of history of sinus infectionsUnilateral sinus surgery with only 1 implant placedCone beam computed tomography scan used for surgeryImplant placed either Nobel Replace Groovy or Nobel

Active (rough surface)Implant placed with 2-stage technique and fully

submergedImplant functionally loaded for �12 mo to comply with

suggested success criteriaAllograft bone used in sinus augmentation procedureMinimal initial sinus floor height 3 mmAll records evaluated were from patients consecutively

treated in private practice.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

embrane tear.TM

All patients underwent cone beam computed to-ography using either an iCat (Imaging Sciences In-

ernational, Hatfield, PA) or a NewTom (ImageWorksorporation, Elmsford, NY) scanner, with a radiology

eport from an oral and maxillofacial radiologist. Allesults were evaluated using the computer and the 1:1rintout report from the radiology center. The initialinus floor bone height had to be a minimum of 3 mms indicated on the computed tomography scan to beonsidered for simultaneous implant placement. Theinus floor bone height ranged from 3.0 to 8.5 mm inhe control group and 3.2 to 6.3 mm in the test group.

The patient population in both groups was similarn terms of medical history, with no current smokersn either group. The control patients had 14 premolarites (51.85%) and 13 molar sites grafted. All premolarites were bound by adjacent teeth. Only 5 sites in theontrol group were “free-end” situations without dis-al natural tooth support (18.5% of cases and 38.4% ofolars in the control group). The test group had onlypremolar sites grafted (9%), with the rest singleolar sites, of which 11 (50% of cases and 55% ofolars in this group) were free-end. The mean patient

ge of the control and test group was 46.7 and 60.5ears, respectively (Table 2).

GRAFTING MATERIALS AND SINUS INSTRUMENTS

The bone graft material was allograft material foroth groups. The material used in the control groupas particulate allograft with a small particle size of

.25 to 1.0 mm. Three different commercial productsere used (MinerOss, BioHorizons, Birmingham, AL;

Table 2. SUMMARY OF PATIENT DEMOGRAPHICS

Demographic

Control Group(Particulate Bone;

n � 27)Test Group

(DynaBlast; 22)

ge (yr)Mean 46.7 60.5Range 26-68 33-74

ender (n)Female 19 8Male 8 14

mplant placement siteMolar 12 16Premolar 15 8

mplant length (n)10 mm 11 (40.74) 2 (9.09)�10 mm 16 (59.26) 20 (90.91)

verage implantdiameter (mm) 4.39 4.8

verage implantlength (mm) 11.39 12.82

ree-end (in arch)single implant (n) 5 (18.52) 11 (50)

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

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TASSOS IRINAKIS 137

uros, Zimmer, Carlsbad, CA; and Rocky Mountain,ocky Mountain Tissue Bank, Aurora, CO). The testroup all received an injectable paste form of allograftaterial (ie, DynaBlast, Keystone Dental). All lateral

sseous windows were covered by a resorbable col-agen membrane before flap repositioning. All mem-ranes in the test group were 15 � 20 mm NeoMemembranes (Citagenix, Laval, QC, Canada). The mem-

ranes used in the control group were either the 15 �0-mm NeoMem (Citagenix) or 15 � 20-mm BioMendxtend (Zimmer). The corner edges of each mem-rane were rounded by scissors before placementver the window.A set of 2 sinus membrane elevation instrumentsere used that were developed by the author (ie, SL

RINAKIS 1 and the SL IRINAKIS 2; G Hartzell & Son,oncord, CA). A uniquely shaped sinus bone con-enser was also developed and used for all proce-ures (BC IRINAKIS; G Hartzell & Son). Two smallembrane perforations were noted during mem-

rane elevation in the control group and were ad-ressed with application of an appropriately sizedollagen membrane to repair them. A detailed de-cription of this membrane repair method has beenreviously reported.17

TECHNIQUE

Once the membrane was reflected (and once theamaged membrane had been repaired in the cases ofembrane perforation) and freely mobile, a small

mount of bone graft was placed into the sinus cavitynder the schneiderian membrane and in contact

IGURE 2. DynaBlast paste applied partially across sinus cavitylong medial sinus wall, “reflecting” and “stabilizing” schneide-ian membrane in its final superior position. It will maintain ituperiorly while the surgeon places the immediate implant withoutear of the implant cutting drills or the implant itself encroaching ont during placement.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

ith the medial wall of the sinus cavity. This smallTM

mount of injectable graft secured the membrane in alifted” position and protected it during the implantlacement maneuvers (Fig 2). At that point, each

mplant was placed, using the appropriate drillingequence and protocol, as indicated by the manufac-urer (Nobel Biocare, Zurich-Flughafen, Switzerland)nd was positioned “flush” with the crestal bone ofhe edentulous ridge (Fig 3). A submerged 2-stagepproach was followed; thus, a cover screw was handightened over the implant. All implants achievedrimary stability during placement, with torque val-es of 15 to 70 Ncm. Once the implant was placed,he process of graft placement into the sinus re-umed. Graft material was placed around the intrasi-us implant and eventually completely covered it andealed off the osseous lateral window. A resorbableembrane was then always placed over the osseousindow, and the flap was repositioned in its originalosition. The sutures were always resorbable gut su-ures (either 4-0 or 5-0) for any vertical incisions andonresorbable CV-5 GoreTex sutures for crestal inci-ions (Fig 4). All sites received a simultaneouslylaced implant that was 1 of the following 2 Nobeliocare Systems (Nobel Replace Groovy or Nobelctive Internal).

IGURE 3. Implant has been placed in its final position. Duringrilling and installation, the sinus membrane was maintained supe-iorly by the previous partial application of the DynaBlast paste.nce the implant has been fully seated, a cover screw is placed, in

ompliance with a 2-stage technique. After this stage, the remain-er of the sinus cavity (and peri-implant area) will be filled withBM paste to seal off the osseous window and then covered withresorbable membrane.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

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138 SIMULTANEOUS DBM AND IMPLANTS IN SINUS

All patients received 1 tablet of 4 mg dexametha-one preoperatively, 2 tablets of clavulin 875 mgamoxicillin 875 mg and clavulanate 125 mg), and a-minute rinse with chlorhexidine gluconate 0.12%.or patients allergic to penicillin, a loading dose of00 mg clindamycin was administered.The postoperative medication regimen was stan-

ardized for all patients in both groups. The onlyhange occurred in the choice of postoperative anti-iotic if a patient was allergic to 1 of the ingredients.ll the patients received the following 5 medications:) a combination of amoxicillin 875 mg and clavu-

anate 125 mg twice daily for 1 week (allergic patientsould receive clindamycin 300 mg three times daily

or 1 week); 2) dexamethasone 4 mg once daily for 3o 4 days; 3) chlorhexidine gluconate 0.12% mouthinse twice daily for 10 to 14 days; 4) an over-the-ounter nasal decongestant spray to take 2 puffs inach nostril three time daily for 4 days; and 5) anver-the-counter nasal decongestant tablet or capsuleo take (as prescribed on the package) for 1 week.he patients were seen for their postoperative visitnd suture removal within 10 to 14 days.

All implants were submerged for a minimum of 6onths before uncovering (second-stage surgery) andlacement of a transmucosal healing abutment using aoft tissue biopsy punch. Impressions were alwaysaken within 2 weeks, and delivery of the final oremporary functional prostheses occurred within andditional 2 weeks. At that point, the implant wasonsidered “loaded,” regardless of whether the pros-hesis was temporary or final, as long as it was func-

IGURE 4. Suture protocol was always chromic gut sutures forertical release incisions and Gore-Tex CV-5 sutures for midcrestalncision.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

ioning. Our baseline radiograph for the purposes ofTM

ur measurements was taken at this point, immedi-tely after loading. The follow-up radiograph (finaladiograph for the purposes of the present study) wascheduled for 12 months later. Because of patientompliance, this radiograph was taken 12 to 24onths later.No complications requiring surgical re-entry were

oted. The patients were not seen by the surgeonithin the period from the baseline radiograph ap-ointment to the final radiograph appointment.All 49 consecutively treated patients did eventually

isit the surgeon’s office for the final follow-up radio-raph. It took some of them up to 2 years but noatient was lost to follow-up.

RADIOGRAPHIC DATA AND SUCCESS CRITERIA

The radiographs (bitewings, periapical, and ortho-antomogram for each patient) were taken at the endf the surgery appointment and immediately after the

nitial functional crown was placed (regardless ofhether it was temporary or final) to serve for im-lant placement control and the baseline radio-raphic measurements for the sinus grafts and therestal bone levels at time “zero” of initial loading. Alladiographs were taken to ensure they were “diagnos-ic” (ie, with the threads clearly discernible to enablerofessional judgment of the radiograph) (Fig 5).Bitewing radiographs (in which the entire length of

he implant was most commonly visible) were takengain at a minimum of 12 months after functionaloading of the implant and compared with the thoset baseline (ie, time of functional crown insertion).his radiographic evaluation, combined with the ap-ropriate clinical criteria as described by Smith and

IGURE 5. Example of Nobel Active implant simultaneouslylaced during sinus lateral window augmentation procedure withynaBlast. Threads are visible, making this radiograph “diagnos-

ic” and allowing the surgeon to draw information and conclusionsrom it.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

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TASSOS IRINAKIS 139

arb18 in 1989, have been readily accepted as theeference standard. However, they have not definedhe quantity of marginal bone loss acceptable fromlacement to the date of loading. Thus, the successriteria used in the present study were developed andecognized during the International Congress of Oralmplantologists Pisa Consensus Conference and re-orted by Misch et al19 in 2008. These criteria sug-ested successful implants were those that did notxperience any pain with function, any mobility, anyxudate history, or more than 2 mm of radiographicone loss since the placement date.In addition to these criteria, for the purpose of the

resent study, the author added 2 more parametersor success—1 radiographic and 1 clinical. The fol-owing additional radiographic parameter for success

as that the bone loss would not exceed 1.5 mmrom surgical placement to the final assessment in theresent study (ie, a minimum of 1 year after loading).ll implants were Nobel Biocare, whether Nobel Re-lace or Nobel Active. The most coronal part of these

mplants have a collar (rough surfaced, just as for theest of the implant body) and the height is 0.9 mm forhe narrow platform implants and 1.3 mm for theegular platform implants in the Nobel Active system.n the Nobel Replace system, the collar height is set at.5 mm. The exact technical specifications of each

mplant system were provided by Nobel Biocare.herefore, as long as the bone loss on the diagnosticadiographs did not exceed the collar height of themplant (or the corresponding thread at 1.5 mm onhe Nobel Active Implants), the implants were con-idered to have met the success criteria set for theresent investigation. In addition, because conven-ional radiographs only offer information on theone loss observed on the mesial and distal surfacesf the implant, an additional detailed clinical assess-ent was performed (constituting of the additional

linical parameter of success added to the successriteria for the present study) to determine whetherny peri-implant attachment loss had occurred onhe loaded implant supported crowns that couldndicate bone loss at the facial and/or palatal as-ects of the implant. These 2 additional successriteria led to the modified list of success criteriased in the present investigation (Table 3). Usinghe diagnostic radiographs taken at the loadingaseline point and 1 year or later after loading, inssociation with the peri-implant attachment leveleasurements, and evaluating this information

gainst the implant design specifications, the inves-igator was able to determine whether the function-lly loaded implants in these 49 sinuses met the

riteria for success as defined for the present study. c

STATISTICAL ANALYSIS

Descriptive statistics and nonparametric analysesere used. The groups were nearly identical in manyf the aspects evaluated and offered similar results. Aann-Whitney U test was used to determine whetherstatistically significant difference was present in theeriod necessary to perform the procedure using theforms of allograft product. The computer programalculating Companion was used for the analysis. Theull hypothesis would suggest that no difference wasresent between the 2 allografts with regard to theime needed for sinus lift/implant placement surgery,nd the alternative hypothesis would suggest a differ-nce is present between the 2 forms of allograft ma-erial with regard to the total operative time.

esults

A careful examination was performed of the diag-ostically acceptable peri-apical and bitewing radio-raphs taken of implant placement and the final as-essment visit (�12 months after functional loading).sing the design specifications of the implants offeredy Nobel Biocare, it was clearly determined that no

mplants in either group had interproximal bone lossxceeding the 1.5-mm mark. The clinical assessmentf the peri-implant sulci also produced favorable re-ults (Table 4). Thus, all 27 implants in the controlroup and 22 implants in the test group were deemeduccessful when functionally loaded for at least 1ear.The only differences found between the 2 groupsere the age of the population, length of time in

oading, and length of time for the actual surgicalrocedure. The Mann-Whitney U test found a statisti-ally significant difference in the operative time forhe injectable paste form of the allograft versus thearticulate form (P � .05); thus, the null hypothesis

Table 3. IMPLANT SUCCESS CRITERIA

No pain or tenderness on functionNo mobilityOverall interproximal radiographic bone loss �2 mm

from time of initial implant placementInterproximal radiographic bone loss �1.5 mm from time

of crown placement and initial functional loading to 1yr of functional loading

No pathologic peri-implant attachment loss indicatingbone loss on facial or palatal aspects of implant

No exudate historyThese implant success criteria were first presented by

Misch et al,19 with the exception of the third andfourth criteria, which were added by the author.

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

ould be rejected in favor of the alternative hypothe-

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140 SIMULTANEOUS DBM AND IMPLANTS IN SINUS

is. The paste form seemed to be significantly faster ints application.

All other compared parameters, including the im-lant length, initial placement torque, period sub-erged, quantity of grafted bone, and initial sinus

oor height, were nearly identical (Table 2).

iscussion

The injectable paste form of the allograft evaluatedn the present investigation is produced such that theBM is carried in a mixture of cancellous bone chips

n a reverse-phase medium (poloxamer 407). The de-ineralized bone can potentially stimulate (osteoin-

uce) new bone production, and the cancellous bonehips assist in creating a scaffold (osteoconduction) athe grafting site. Poloxamer 407 provides a method ofelivery with uniquely favorable properties. It pro-ides a reverse-phase medium that is influenced by tem-

Table 4. SUMMARY OF SUBJECTS’ SURGERY ANDPOSTOPERATIVE RESULTS

Variable

Control Group(Particulate Bone;

n � 27)

Test Group(DynaBlast;

n � 22)

esidual sinus floor/initialbone height (mm)

Mean 5.09 4.66Range 3.0-8.5 3.2-6.3

nitial torque atplacement (Ncm)

Mean � SD 41.48 � 14.06 43.86 � 16.72Range 15-65 15-60

mplant submergedinterval (mo)

Mean 6.8 6.68Range 6-11 6-11

unctionally loadedinterval (mo)

Mean 13.62 18.77Range 12-24 13-22

verage operative time(min)

Mean 70.11 62.36Range 55-90 40-95

one graft quantity (cm3) 2.20 2.21inal assessment findings

(mm)Midfacial probing

depth 3.63 2.91Midpalatal probing

depth 3.26 3.05Average interproximal

probing depth 3.50 3.39mplants meeting success

criteria (%) 100 (27/27) 100 (22/22)

assos Irinakis. Simultaneous DBM and Implants in Sinus. J Oralaxillofac Surg 2011.

erature changes. As the material is placed within the s

inus with a greater local temperature (compared withhe room temperature), the material “hardens,” provid-ng improved handling properties. Injectable DBMs ineverse-phase mediums have been shown to offer favor-ble bone formation, as seen in histologic analyses ofifferent animal and human studies.13,15,20,21

As with any implant placement surgery, primarytability is of paramount importance. This is especiallyrue when placing implants simultaneously with sinusrafting procedures, because the quantity of bone isarticularly compromised. The graft material itself,hether particulate or paste, will not offer any addi-

ional stability to the simultaneously placed implant.hus, the design of the implant can play a significantole in assisting with increased primary torque, suchs was shown by Irinakis and Wiebe22,23 in theirtudies of the NobelActive implants. In the presentnvestigation, both implant types achieved favorablenitial stability, although the NobelActive implantsonsistently provided greater torque values. Becausecceptable stability was achieved with either implant,his parameter was not analyzed further.

A statistically significant difference was noted in theime needed for surgery depending on the structuralorm of the allograft material placed. The surgicalrocedure was shorter in the test group by 7.75inutes (or 11% faster) compared with the control

roup. In addition, considering the clinical differ-nces of using these materials, more favorable resultsere noted for the DBM paste form of the allograft.

or example, the particulate form of bone requiresgentle” application without “compaction” within theinus to maintain its osteoconductive characteristicsnd promote faster healing than if it were “com-acted” and “crushed.”10,24,25 Often, this is not pos-ible, because the surgeon needs to compress thearticles to “push” them further under the liftedchneiderian membrane. This could potentially leado an undetected membrane perforation or tear. Fur-hermore, it is common for particles to “spread” alonghe surgical bed on the external perimeter of thesseous lateral window. During simultaneous implantlacement, when the implant is in place and thedditional bone graft is applied to cover the implantnd seal off the window, a slight danger exists of theetal instrument accidentally touching the implant

urface as the bone particles are applied/compressedithin the sinus to fill the void. With the injectable

orm, this is easily avoided.Within the limitations of the present study, the

esults have shown that for an experienced surgeonsing injectable DynaBlast instead of particulate boneuring a direct sinus lift with simultaneous implantlacement is an acceptable alternative to particulate

orms of allograft material. In addition, it has been

hown in histologic studies that the quality and quan-
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TASSOS IRINAKIS 141

ity of bone formation around the implants with thisone formula are comparable to those noted witharticulate bone.The short-term loading results at 1 year indicated

mplant success comparable to those noted for si-uses grafted with the mainstream particulate allo-rafts. In the present investigation, both bone groupsad 100% success, with at least 12 months of loadedingle crowns. In addition, the injectable paste formf the allograft appears to have other advantages com-ared with the small-size particulate form such as aeduced operative time and decreasing the possiblentraoperative and postoperative challenges.

cknowledgments

The author would like to thank Assistant Clinical Professor Pennyatzimanolakis (University of British Columbia, Faculty of Den-

istry) for her advice, assistance, and guidance in the statisticalnalysis. The author would also like to thank Dr Hannu Larjava,rofessor and Chair of the Division of Periodontics (University ofritish Columbia, Faculty of Dentistry) for his review and advice onhe final report.

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