Appendix A

Name of the P.G. College Nair Hospital Dental College Department Oral & Maxillofacial Surgery Name of the Guide & College Name Dr. Neelam N. Andrade,

Nair Hospital Dental College Contact Number of Guide +919821126837

Through: The Dean. To, The Registrar, MUHS, Nashik 422004.

Sub.: Submission of Title of Synopsis of Dissertation

Respected Sir/ Madam, I, Dr. KAPOOR PRATHMESH RAJIV, have registered for M.D.S. in Oral & Maxillofacial Surgery in the 2012 batch under the guidance of Dr. Neelam N. Andrade, Professor & Head, Department of Oral & Maxillofacial Surgery, Nair Hospital Dental College. I am due to appear for MDS in Oral & Maxillofacial Surgery in May 2015. I am submitting herewith my Title of Synopsis of Dissertation as mentioned below and as suggested by my aforesaid guide. Title of Synopsis Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC). Kindly accept and register my Title of Synopsis of Dissertation.

. ............................ Dr. Kapoor Prathmesh Rajiv Dr. Neelam N. Andrade

. (HOD Name & signature with Dept. Seal) .. (Signature & Seal of Dean of College)

Date: To, The Dean, Nair Hospital Dental College, Mumbai. Subject: Permission to carry out a study for dissertation in partial fulfillment of requirement of M.D.S., as per M.U.H.S., Nashik. Respected Madam,

I, Kapoor Prathmesh Rajiv, first year Postgraduate Student in the Department of Oral & Maxillofacial Surgery wish to carry out a study entitled Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC)., under the guidance of Dr. Neelam N. Andrade, Professor & Head, Department of Oral & Maxillofacial Surgery. As per M.U.H.S. regulations, I need to submit the topic and synopsis of my dissertation with an approval letter by the college. You are requested to kindly forward my proposal to the Ethics Committee for necessary approval and oblige. Thanking You. Yours sincerely, Dr. Kapoor Prathmesh Rajiv, Dr. Neelam N. Andrade, Postgraduate Student, Professor & Head, Department of Oral & Department of Oral & Maxillofacial Surgery, Maxillofacial Surgery, Nair Hospital Dental College. Nair Hospital Dental College.

APPENDIX B REPORT OF ETHICS COMMITTEE

Department Oral & Maxillofacial Surgery Candidate admitted year 2012 Course and Subject MDS, Oral & Maxillofacial Surgery College Name & Address Nair Hospital Dental College, Mumbai -08 Reference No. . Date: To, Dr. Kapoor Prathmesh Rajiv, Department of Oral & Maxillofacial Surgery, Nair Hospital Dental College, Dr.A.L.Nair Road, Mumbai Central, Mumbai -400008

Sub: Research Proposal titled Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC).

Ref:-.

(Letter/ Proposal of Student) Dear Student, The above mentioned research proposal of Title of Synopsis was discussed in the Ethics Committee meeting held on . at our College. (Date) Ethics Committee has unanimously approved your Title of Synopsis. This work will be done under the guidance and supervision of your guide Dr. Neelam N. Andrade. (Signature) . (Name) Chairperson, Ethics Committee . (College Name)

APPLICATION FORM ETHICS COMMITTEE

NAIR HOSPITAL DENTAL COLLEGE, MUMBAI-8

Date:

To,

The Chairperson/ Secretary,

Ethics Committee,

Nair Hospital Dental College,

Mumbai-8.

Sir/ Madam,

I hereby submit documents related to the following research proposal for Ethics Review and approval:

Title: Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC). Name of Chief Investigator: Dr. Kapoor Prathmesh Rajiv.

Designation: Post Graduate Student, Department of Oral & Maxillofacial Surgery.

Site of Research: Nair Hospital Dental College, Mumbai.

Name of Guide: Dr. Neelam N. Andrade.

Designation: Professor & Head, Department of Oral & Maxillofacial Surgery.

Thanking you,

Yours sincerely,

CHIEF INVESTIGATOR SIGNATURE OF GUIDE

SIGNATURE OF HOD

To, Date:

The Ethics Committee,

Nair Hospital Dental College,

Mumbai.

Through: Head of Department of Oral & Maxillofacial Surgery

Subject: Permission to carry out a study titled Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC).

Respected Sir/ Madam,

I, Dr. Kapoor Prathmesh Rajiv, first year Postgraduate Student in the Dept. of Oral & Maxillofacial Surgery wish to carry out the above mentioned study under the guidance of Dr. N. N. Andrade, Professor & Head of Department of Oral & Maxillofacial Surgery.

I am hereby submitting the topic and synopsis of my dissertation for approval by the College Ethics Committee.

Kindly give me permission and oblige.

Thanking You.

Yours sincerely,

Dr. Kapoor Prathmesh Rajiv, Dr. Neelam N. Andrade,

Postgraduate Student, Prof. & Head,

Department of Oral & Department of Oral &

Maxillofacial Surgery, Maxillofacial Surgery,

Nair Hospital Dental College. Nair Hospital Dental College.

MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE: DR. KAPOOR PRATHMESH RAJIV 2. NAME OF THE GUIDE: DR. NEELAM N. ANDRADE 3. NAME OF THE INSTITUTION: NAIR HOSPITAL DENTAL COLLEGE 4. COURSE OF STUDY: MASTER OF DENTAL SURGERY 5. SUBJECT: ORAL AND MAXILLOFACIAL SURGERY 6. DATE OF ADMISSION: 15-5-2012 7. TITLE OF RESEARCH PROJECT: EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC)

TITLE: EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC). . INTRODUCTION: Odontogenic Keratocyst (OKC) term was introduced by Philipsen in 1956. It is a benign developmental cystic lesion and almost certainly represents the lesion that used to be known as a primordial cyst. Odontogenic keratocyst traditional is said to have two histological sub types: Parakeratinised & Orthokeratinised. The present nomenclature describes the Parakeratinised Odontogenic Keratocyst as a benign cystic tumour named Keratocystic Odontogenic Tumour (KCOT) & the Orthokeratinised Odontogenic Keratocyst is considered as benign cystic lesion & is named Orthokeratinised Odontogenic Cyst (OOC). The term OKC is still used synonymously with KCOT or OOC. The lesion is thought to be originating from the remnants of the dental lamina or proliferation of basal mucosal cells in the retromolar area & has a high predilection for involving the posterior body & ascending ramus of the mandible. Majority of the cases occur in the 2nd to 4th decade with a slight male predilection. It has a typical histologic appearance consisting of an epithelial lining of five to six cells thick and polarization of the basal layer on the basement membrane. KCOT has a parakeratinised epithelial lining whereas OOC has an orthokeratinised lining. Multiple KCOT is a hallmark feature of Nevoid Basal Cell Carcinoma Syndrome & multiple KCOT is thought to represent an incomplete penetrance of the syndrome with higher chances of recurrence. Parakeratinised Odontogenic Keratocyst has been quoted as having a recurrence rate varying from 25% to 60% following conservative management such as simple enucleation. The recurrence following conservative enucleation & aggressive clinical behavior has led to its classification as an aggressive benign neoplasm KCOT separating it from the not so aggressive cystic lesion OCC. Many theories have been proposed for the recurrence of these lesions which include the following but are not limited to:- 1) Increased aggressiveness & mitotic rate of cystic epithelial lining, 2) Highly friable nature of the lining making it difficult to remove the lesion in Toto, 3) Presence of epithelial budding & daughter cysts in the periphery of the lesion, 4) Development of a new unrelated lesion. Due to this exceedingly high recurrence rate following conservative plain enucleation, alternative treatments have been actively pursued to decrease the recurrence rate but, at the same time, to not subject the patient to radical surgery with loss of teeth, bone, nerves and other vital structures. These treatment modalities include:

1) Decompression or Marsupalization 2) Cystectomy with peripheral ostectomy

a) En bloc resection without continuity defect b) Enucleation with 1mm peripheral bone removal

3) Enucleation with physiochemical methods a) Liquid Nitrogen b) Carnoys solution

4) Combination of the above

Carnoys solution is a chemical tissue fixative that was popularized by Stoelinga in the year 1973 for the conservative management of OKC. It penetrates bone to a predictable, time-dependent depth. A 5-minute application will penetrate bone to a depth of 1.54 mm, nerve to a depth of 0.15 mm and mucosa to a depth of 0.51 mm. Application of the Carnoys solution can be either prior to enucleation or afterwards. However, the treatment of the bony cavity after enucleation allows for easier removal of the cyst lining and better identification of cystic tissue remnants. The surrounding vital tissues such as nerves, mucosa are isolated from the solution by paraffin/ vaseline lubricated gauzes & Carnoys solution is applied by cotton tipped swab stick besides a ribbon gauge soaked in Carnoys solution can be placed in the cavity for a period of 5 minutes after which the cavity is thoroughly irrigated with saline. The composition of Carnoys Solution for 10 ml is: Carnoys solution (Cutler and Zollinger, 1933). Absolute alcohol 6 ml Chloroform 3 ml Glacial acetic acid 1 ml Ferric chloride 1 g

AIM: The aim of the study is to determine the efficacy of Carnoys Solution along with Enucleation & Peripheral Ostectomy in the treatment of Keratocystic Odontogenic Tumour & Orthokeratinised Odontogenic Cyst. OBJECTIVES:

1. Evaluate any specific clinical, histological or radiographic finding associated with the recurrence with the treatment modality over a minimum follow up period of 1 year.

2. Evaluate effect of Carnoys solution on soft & hard tissue healing.

3. Incidence of Infection.

4. Evaluate Pain & swelling.

5. To monitor the effect of Carnoys solution on the development of neurosensory deficit & its recovery.

PATIENTS & METHOD:

Source of data:- The patients will be selected from the OPD of the dept. of OMFS, NHDC, Mumbai, whose informed consent will be taken prior to the procedure. A minimum number of 25 cystic lesions will be selected. Inclusion criteria:

1. Any patient with a cystic lesion involving the jaw bones in which histopathology & radiography are suggestive of KCOT/OOC preoperatively & which is later confirmed by excisional biopsy as KCOT/OOC.

2. Should have at least minimum 8mm of vital bone at the inferior border of the mandible. 3. Recurrent lesion: A new lesion developing in the same anatomical region as previous

lesion which is confirmed as KCOT/OOC. 4. Patients with Nevoid Basal Cell Carcinoma Syndrome will be included.

Exclusion criteria:

1. Patients who do not present themselves for follow up. 2. Patients who refuse to give consent for being included in the study. 3. Incisional biopsy report suggests that the lesion is not a KCOT/OOC. 4. Patient known to be allergic to any constituent of Carnoys Solution. 5. Large Perforation of inferior border of the mandible. 6. Lesion extending into the orbital floor & the pterygopataline fossa.

PROCEDURE: Patient will be selected from OPD of NHDC, Mumbai. Detailed case history will be taken. Pre- operative medical & radiographic investigations will be done & informed consent will be taken. Cystic lesion aspiration & incisional biopsy will be done under local anesthesia. Screening for syndrome in patients with multiple cysts will be conducted. Teeth that are found involved in the lesion will be pre-operatively endodontically treated. Pre-operative Oral prophylaxis & Restorative treatment whenever possible will be completed. Baseline parameters like neurosensory deficit, facial measurements etc. will be recorded in the case record form. Patients will be taken under general anesthesia via nasal or oro-endotracheal intubation & scrubbed & draped according to standard aseptic technique. Local anesthesia with adrenaline will be infiltrated into the vestibular area & a sulcular or vestibular incision will be taken & the mucoperiosteal flap will be reflected. If the cyst has perforated the cortex then the cyst will be removed with the overlying mucosa. An opening will be made in the overlying cortex with a drill or rongeur approximately 1/3 to 1/2 the diameter of the cyst. Care will be taken not to perforate the cystic lining. Periosteal elevator or sinus curettes will be used to separate the cystic lining from the bone. The lining may be friable & at times will need to be removed piecemeal. The cyst will be enucleated and the bony cavity will be evaluated for any remnants of the cyst. Any bony scalloping or septa will be removed with round vulcanite bur. Peripheral Ostectomy (mechanical curettage) will be carried out with round bur to remove any epithelial remnants in the bone. Surrounding soft tissue will be protected with moist paraffin / Vaseline lubricated gauze & vital structures may be electively protected with petrolatum jelly for example sinus lining may be protected by impression compound & inferior alveolar neurovascular bundle protected by sterile polyethylene sheet cut out. Freshly prepared Carnoys solution will be applied to the area with cotton tipped swab stick & ribbon gauze soaked in Carnoys solution will be allowed to remain in contact for a period of 5 minutes. This would turn the bone brown & fix any epithelial lining remnants which can then be easily removed. The cavity will then be thoroughly irrigated with saline solution. Hemostasis will be achieved & in case if it is felt that the bony defect is weathered the native bone then the native bone will be bridged bone plate/ reconstruction plate or intermaxillary ligation will be done for 4-6 weeks. Primary closure will be done. A drain or pressure dressing may be placed. Post-operative antibiotic & analgesics will be prescribed. Post-operative neurosensory recording, pain, swelling & soft tissue healing will be assessed. Patient will be followed up for at least 1 year & appropriate radiographic examination will be done to evaluate for recurrence of cystic lesions (lesion in the same anatomical region as the surgery). Clinical Parameters:

1. Recurrence will be evaluated on appropriate radiographs at interval of 6 months. 2. Pain will be evaluated by Visual Analog Scale on 1st day, 7th day, 14 day after surgery. Use of

analgesics will be recorded. 3. Facial swelling will be evaluated by measuring distance between 7 predetermined points on 2nd ,

7th day & 14th day. 4. Soft tissue healing will be evaluated by Landrys Healing Index & presence/absence of wound

dehiscence & necrosis will be recorded on 7th & 14th day. 5. Hard tissue healing will be determined by using CBCT at immediate post-operative & at 1 year

to determine bone fill by comparing relative density with reference point 6. Incidence of pathological fracture will be recorded

7. Standard Neurological test will be done according to specifications of Gheta et al to evaluate neural function on 7th day, 14th day, 6 months, 1year.

8. Any other complications related to the surgery/lesion will be recorded.

Patients with cystic lesion of the jaws

Filling of patient record form

Pre- operative radiographic investigation

Aspiration/Cytology/incisional biopsy

Confirmation of KCOT/OOC

Informed consent

Excision of overlying mucosa (if necessary)

Enucleation with mechanical curettage

Application of Carnoys solution for 5 minutes

Irrigation of cavity with saline, hemostasis, Use of bone plate/ reconstruction plate/ IML (if necessary)

Primary closure

Post-operative base line radiographs

Post-operative recording neural deficit, pain, swelling,

soft tissue healing, bone fill

Follow up with radiographic evaluation for any recurrence

Statistical Analysis: Suitable Statistical tests will be used for Evaluation of the efficacy of Carnoys Solution as an adjunct with Enucleation & Peripheral Ostectomy in the management of Keratocystic Odontogenic Tumour (KCOT) & Orthokeratinised Odontogenic Cyst (OOC).

References: 1. Pathology and genetics of head and neck tumours. WHO classification of tumours series, Geneva, 2005, World HealthOrganization.

2.Shear M: The aggressive nature of the odontogenic keratocyst: is it a benign cystic neoplasm? Part 2. Proliferation and genetic studies, Oral Oncol38:323-331, 2002. 3. Crowley T, Kaugars GE, Gunsolley JC: Odontogenic keratocysts: a clinical and histologic comparison of the parakeratin and orthokeratin variants, J Oral MaxillofacSurg50:22-26, 1992. 4. Browne RM: The odontogenic keratocyst. Histological features and their correlation with clinical behaviour, Br Dent J 131:249- 259, 1971. 5. Pogrel MA: Decompression and marsupialization as definitive treatment for keratocystsa partial retraction, J OralMaxillofacSurg65:362-363, 2007. 6.Stoelinga PJ: Excision of the overlying, attached mucosa, in conjunction with cyst enucleation and treatment of the bony defect with Carnoy solution, Oral MaxillofacSurg Clin North Am 15:407-414, 2003. 7.Stoelinga PJ: Long-term follow-up on keratocysts treated according to a defined protocol, Int J Oral MaxillofacSurg30:14-25, 2001. 8.Voorsmit RA, Stoelinga PJ, van Haelst UJ: The management of keratocysts, J Maxillofac Surg9:228-236, 1981. 9. Schmidt BL, Pogrel MA: The use of enucleationand liquid nitrogen cryotherapy in the management of odontogenic keratocysts, JOral MaxillofacSurg59:720-725, discussion 726-727, 2001. 10. Jackson IT, Potparic Z, Fasching M, et al. Penetration of the skull base by dissecting keratocyst. J Craniomaxillofac Surg1993; 21:31925. 11. Irvine GH, Bowerman JE: Mandibular keratocysts: surgical management, Br J OralMaxillofacSurg23:204-209, 1985

Case Record Form

Patients name: Reg. No.: Age: IP no.: Sex: Address: Phone no.: Date of diagnosis/ reporting to NHDC: Date of surgery: Onset: Associate symptoms

Pain Swelling Neurosensory alterations

IAN Lingual Any other

Recurrent / New lesion If recurrent details of previous lesion: Previous diagnosis Treatment if any: Clinical Parameters: Fluctuance Crepitus/ egg shell cracking Mobility of teeth Displacement of:

IAN Adjacent structures Teeth Incidental finding or complain Localization:

Radiographic features: Diagram of OPG: Radiographic parameters

Radio density Borders Adjacent structures Unilocular Signs of cortical perforation Erosion of maxillary buccal plate Multiple lesions

Correlation of x ray & clinical features:

No relation to teeth Cyst appears as true dentigerous Partially attached to follicle of teeth (lateral follicular) & somewhat to periodontium as well Cyst attached to lateral periodontium but not to apical related Crown erupted into the cyst

CT imaging: Date: Impression Abnormality noted Cortical perforation Location of perforation

Provisional diagnosis: Aspiration date Incisional Biopsy date Report diagnosis date Details of surgery: Intra operative incidence Final Histopathology report on the excised specimen: Date Diagnosis: Orthokeratinised

H/p of overlying mucosa Micro cysts Budding of basal cells Follow up Evaluation of recurrence:

Appropriate radiographs will be taken at intervals of six months to check for recurrence. If cystic lesion is suspected on radiograph area will be explored & lesion will be removed according to treatment protocol & send for histopathological examination. A lesion is considered recurrent if it occurs in the same anatomical area as it was removed earlier. If proven histopathologically to be KCOT/ OOC it will be recorded as recurrence present or else it would be recorded as recurrence absent.

Time Recurrrence ( presence / absence)

6 months

1 year

1 years

Evaluation of Pain:

Visual Analog Scale (VAS) of 100mm will be used to evaluate the pain pre-operatively, 1st day, 7th day, 7th day & 1 month after surgery.

Time period VAS score

Preoperatively

1st day

7th day

14th day

Use of analgesics along with dosage to control of pain will also be recorded.

Analgesic used Dosage Frequency duration

Evaluation of Neurosensory Deficit:

Clinical neurosensory testing will be performed on all patients preoperatively on 7th day, 1 month, 6 months after surgery. All tests will be carried out in a calm room with the patient relaxed and comfortable & eyes closed.

Different skin & mucosal areas were evaluated for inferior alveolar, lingual & infraorbital nerves. Neurosensory test used will be according to criteria of Gheta et al

Light touch sensation Myelinated A beta fibers were examined by light touch sensation test. Monofilaments using 20 mm long nylon monofilament suture material (3-0, 4-0, 5-0, and 6-0), & results will be tabulated as follows: Response Scores Positive to 6-0 monofilament 4 Positive to 5-0 monofilament 3 Positive to 4-0 monofilament 2 Positive to 3-0 monofilament 1 Negative response 0 Pin-prick sensation The small myelinated A delta and C fibres, which convey pain stimuli were evaluated with a pin-prick sensation test. It was performed using the tip of a dental probe applied very slightly to the different areas. An appropriate response was determined as the perception of the tip of the probe as a sharp pain. Response Score

Positive response 1 Negative response 2

Static two-point discrimination test & Moving two-point discrimination test:

Difference between preoperative and postoperative two point discrimination will be recorded as scores to determine level of deficit in slow & rapid adapting A beta fibers.

Difference Score No difference 5 12 mm 4 23 mm 3 34 mm 2 56 mm 1 6 mm 0

Global sensitivity score will be calculated by adding Qualitative Score (Light touch score + Pin prick score) + Quantitative score ( Static + Moving two point discrimination score)

Global scores Classification 12 (4) Normal sensation 1012 (3) Subnormal sensation 69 (2) Intermediate sensation

Percentage of Facial swelling = Recorded post-operative Recorded Pre-operative measurement measurement ___________________________________________x 100 Pre-operative measurement Time Percentage facial swelling 7th day 14th day Evaluation of soft tissue healing: Soft tissue healing will be evaluated by modified Healing Index of Landry on day 7 & 2 week 1 very poor - Tissue colour :> 50% tissue red

- Response to palpation bleeding - Granulation tissue present - Incision margins: not epithelialized, with loss of epithelium beyond

incision margin - Suppuration present

2 poor - Tissue colour:: > 50% tissue red

- Response to palpation bleeding - Granulation tissue present - Incision margins: not epithelialized, with connective tissue exposed

3 Good - Tissue colour: >25% &

Presence or absence of wound dehiscence or necrosis will be recorded

Hard Tissue Healing:

A reference point in the CBCT slice which is not pathologically involved will be taken as reference point & its position will be recorded 3 dimensionally to anatomical bony landmarks. The relative density of the reference point will be recorded in comparison to center of the surgical defect (whose position is also recorded from bony anatomical landmarks). This comparison in radiodensity is done on 7th day post-operative & 1 year. Bone fill is consider to be present if the radiodensity of centre of surgical field increases in comparison to reference point. Measurements of bone fill will be done.

Time Relative density of center of defect/ reference

Inference ( bone fill)- present/ absent

7th day

1 year

Presence/ absence of fracture will be evaluated on serial radiographs. If bone plate/ reconstruction plate or IML is placed post-surgery then it would be recorded as NA (not applicable

Fracture Present / absent/ NA Time if present

Infection Evaluation:

Site is considered infected if there is pain, swelling & discharge of purulent fluid from the surgical site requiring treatment with antibiotics with or without surgical drainage of the site.

It is recorded as follows:

Time Infection present / absent Duration of infection Treatment given

SUMMARY SHEET (Common for Ethics Committee and Research Society approval)

1. TITLE: EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC). 2. PRINCIPAL INVESTIGATOR: Dr. Kapoor Prathmesh Rajiv 3. NAME OF THE GUIDE: Dr. Neelam N. Andrade 4. WHAT IS OBJECTIVE OF THE TRIAL?

1. Evaluate any specific clinical, histological or radiographic finding associated with recurrence following above treatment modality over a follow up period of at least 1 year.

2. Evaluate effect of Carnoys solution on soft tissue healing & hard tissue healing.

3. Incidence of Infection.

4. Evaluate effect of Carnoys solution on pain & swelling.

5. To monitor the effect of Carnoys solution on the development of neurosensory deficit & its return.

5. WHO ARE THE SUBJECTS IN THE STUDY?

Sample Size: 25 cystic lesions Patients reporting to OPD of dept. of OMFS, NHDC, Mumbai & requiring Enucleation & Peripheral Ostectomy (mechanical curettage) along with Carnoys solution as a treatment modality.

6. DETAILS ABOUT THE PROCEDURE

Patients would have to undergo Enucleation & Peripheral Ostectomy (mechanical Curettage) with application of Carnoys solution. They would undergo appropriate radiographic imaging at time of follow up period to evaluate the clinical & radiographic parameters.

7. WHAT IS DURATION OF TRIAL?

18 months

8. WHAT IS THE TRIAL DESIGN?

Prospective study 9. DO YOU INTEND TO PERFORM INVASIVE PROCEDURE ON THE PATIENTS?

Yes 10. ARE YOU GOING TO COLLABORATE WITH ANY OTHER INSITITUTE/ LABORATORY? GIVE DETAILS?

Yes (for clinical consultation & radiological examination in Nevoid Basal Cell Carcinoma Syndrome patients.) 11. ARE YOU GOING TO PAY INCENTIVE TO THE TRIAL SUBJECTS?

No 12. WHAT IS THE DEGREE OF RISK INVOLVED IN THE STUDY?

Minimum: same as any surgical procedure. 13. WHAT IS THE BENEFIT TO THE PATIENT OF THIS STUDY?

1. Conservative treatment modality with decrease in loss of bone, nerve or loss of maxillary and mandibular continuity. 2. Lower incidence of recurrence that would have required further

intervention. 3. Early detection of recurrent or new lesions. 4. Very low morbidity & maintenance of aesthetics

14. WHAT IS BENEFIT TO THE COMMUNITY?

Will provide in the future a treatment modality for treatment of OKC with low morbidity & high efficacy & help provide better service of patients.

Dr. Kapoor Prathmesh Rajiv Dr. N. N. Andrade (POST GRADUATE STUDENT) (POSTGRADUATE GUIDE)

Date: PATIENT INFORMATION SHEET

The research project entitled EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC). is being conducted as a dissertation project by Dr. Kapoor Prathmesh Rajiv for his MDS Oral and Maxillofacial Surgery dissertation for MUHS, Nashik in the Department of Oral & Maxillofacial Surgery, Nair Hospital Dental College, Mumbai. This study intends to determine the efficacy of Carnoys Solution along with Enucleation & Peripheral Ostectomy (Mechanical Curettage) in treatment of Odontogenic Keratocyst. The risk involved in this procedure is similar to any of the regular surgical procedures. In this study, you will be participating as patient. After obtaining your consent for participation, you will be required to undergo the required preoperative and postoperative assessments. The procedure involves removing the lesion from your jaw/jaws followed by application of an agent (Carnoys Solution) that eliminate any residual pathological tissue. The patient (you) will be kept on a regular follow-up during which you closely monitored with appropriate radiographs. Hereby, your nature of the participation into this study is totally voluntary and you can withdraw at any time without giving any reason which will not make any difference to your standard care. Any discomfort should be reported to the doctor offering the therapy where you will be given appropriate treatment. The project has been reviewed by the local Ethics Committee of NHDC. You should contact the below mentioned person in case of any queries. Dr. Kapoor Prathmesh Rajiv Dr. Neelam N. Andrade Post Graduate Student, Professor & Head, Department of Oral & Department of Oral & Maxillofacial Surgery, Maxillofacial Surgery, Nair Hospital Dental College, Nair Hospital Dental College, Mumbai. Mumbai.

INFORMED CONSENT

I__________________________________ aged__, Resident of _________________________ have been explained in my own language i.e.________________ that I understand best. I, exercising my free power of choice hereby give consent to be included in the study entitled: EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC). The explanation given to me about the clinical study is in detail & to my satisfaction. I am also aware that I can withdraw from the study any time without giving any reason. Therefore I am giving consent for the above study. Name & signature of subject Signature of Doctor Name & signature of witness Date: Place:

CONSENT FOR TREATMENT OKC WITH CARNOYS SOLUTION Patients Name and Date: You have the right to be given information about your planned surgery so that you can decide if you want to have the surgery. You will be asked to sign this form saying you understand what will be done, the risks that can happen and the other kinds of treatment that you could have. Diagnosis: __________________________________________ Planned Treatment is: ________________________________________________________________________________________________________________________ Enucleation & Peripheral Ostectomy along with use of Carnoys solution is surgical procedure in which a lesion from your jaw will be removed & an agent applied to the surrounding bone to eliminate any residual pathological tissue. After this procedure, you will be kept under follow up during which you will be closely evaluate for the recurrence of the lesion. Like all procedures there are risks in performing the procedure which include the following:

1. There is risk of injury to the nerve that supplies feeling to the tongue and teeth. In most cases the altered sensation is temporary but in rare cases can be permanent.

2. Hardware failure may occur. 3. Risk of infection requiring additional treatment. 4. If my doctor finds a different condition than expected and feels that a different surgery or

more surgery needs to be done, I agree to have it done.

I have been informed that I will be required to get appropriate radiographic at various intervals after the procedure.

CONSENT I understand that my doctor cant promise that everything will be perfect. I have read and understood the above and give my consent to surgery. I have given a complete and truthful medical history, including all medicines, drug use, pregnancy, etc. All of my questions have been answered before signing this form. Patients Signature Date Doctors Signature Date Witness Signature Date

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vkWMksUVkstsuhd Tyaumar ds-lh-vks-Vh- vW.M vkWFkksZ dsjWVhukbLM vkWMksUVkstsuhd lhLV Aao.Aao.saI-,;kaP;k

mipkjke/;s .

;k ifj{k.kke/;s rqepk :X.k Eg.kwu lekosk dsyk tkbZy- rqeph ?ksrY;kuarj] rqeph mipkjkiqohZ o uarj rikl.kh gks.kkj ;k izf;se/;s rqeP;k tcM;ke/kwu fod`rh dkIMSaI saMpk- saaQaavaa:

ivaVaqyaa-cao naava:- Da^. iSaxakaMcao naava:- Da^.nialama AnDaDo maUK SalyaSaas~ ivaBaaga p/aofosar AaoOr ivaBaaga p/mauK ([isptLacao naava:- naayar rgNaalaya dMt mahavaIdyaalaya) M MmaUK SalyaSaas~ ivaBaaga dUrQvanaI naMbar :- 9769435984 ([isptLacao naava:- naayar rgNaalayadMtmahavaIdyaalaya)

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dsjWVksflLVhd vkWMksUVkstsuhd ds-lh-vks-Vh- vW.M vkWFkksZ dsjWVhukbLM vkWMksUVkstsukds lhLV vks- vks- saI.

ifj{k.kklkBh ijokuxh nsr vkgs-

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g;k djhrk eyk dkj.k ns.;kph vV fdaok cka/khydh ukgh-

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vWl vWu ,MT;qvaDV ohFk bU;qDyh,ku vW.M isfjQsjy AaoisTekTmaI bu fVVesaV vkWQ dsjWVksflLVhd vkWMksUVkstsuhd

Tyaumar ds-lh-vks-Vh- vW.M vkWFkksZ dsjWVhukbLM vkWMksUVkstsukds lhLV vks- vks- saI. gsrw ifj{k.k lfEefyr gksus

dh lgerh nsrk @ nsrh gwW-

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nh x;h gSa] eSa mlls iw.kZr;k larqV gwW- eq>s ;g Hkh crk;k x;k gSa dh eSa fcuk dkju crk;s fdlh Hkh le; bl

ifj{k.k ls vius vkidks vyx dj ldrk gwW-

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ejht ds gLrk{kj ,oa uke % uke

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fjlpZ izkstsDV & bOgWY;q,ku vkWQ ,fQdlh vkWQ dWjukWbl lksY;qku vWl vWu ,MT;qvaDV ohFk bU;qDyh,ku vW.M isfjQsjy AaoisTekTmaI bu fVVesaV vkWQ dsjWVksflLVhd vkWMksUVkstsuhd Tyaumar ds-lh-vks-Vh- vW.M vkWFkksZ dsjWVhukbLM vkWMksUVkstsukds lhLV Aao.Aao.saI- yah ijh{k.k MkW- izFkesk diwj ko vH;kl ka ivaYaya hO | egkjkV oSn;dh; fon;kfiB ko inO;qkj vH;kle

ko varxZr yah ifj{k.k egkfon;ky; ka uko & uk;j :X.kky; nar egkfon;ky; vksjy ltZjh/ew[k kY;kkL=

foHkkxkr |

ka dWjukWbl lksY;qku va bU;qDyh,ku vW.M isfjQsjy AaoisTekTmaI hO |

, Aap | , Aapkao krnaa pDogaa| kao (dWjukWbl lksY;qku) lagaayaa jaayaogaa |

() -

[sa prIxaNamaoM Aapka sahBaaga saMpUNa-tyaa eoicCk haogaa. evaM Aap [sa prIxaNamaMo kBaIBaI iksaIBaI karNa ko ibanaa AsahBaagaI hao

sakto hOM. [saka Aapko ]pcaarpr kao[- Asar nahIM haogaa [sakI hma Aapkao gvaahI doto hOM. Aapkao Agar tklaIf hao rhI hao tao Aap

turMt Da^@Trko pasa AaeM. Aapkao [sa prIxaNa sao kao[-BaI Aaiqa-k laaBa nahI haogaa.

[sa prIxaNakao naayar Asptalako eiqa@sa kimaTIsao maanyata p`aPt hOM.

SaMkainarsanako ilae saMpk- kroM.

:- Da^. :- Da^.nialama AnDaDo maUK SalyaSaas~ ivaBaaga p/aofosar AaoOr ivaBaaga p/mauK ( :- naayar rgNaalayadMtmahavaIdyaalaya) M MmaUK SalyaSaas~ ivaBaaga dUrQvanaI naMbar :- 9769435984 ( :- naayar rgNaalayadMtmahavaIdyaalaya)

Thanking You.Yours sincerely,1. NAME OF THE CANDIDATE: DR. KAPOOR PRATHMESH RAJIV2. NAME OF THE GUIDE: DR. NEELAM N. ANDRADE3. NAME OF THE INSTITUTION: NAIR HOSPITAL DENTAL COLLEGE4. COURSE OF STUDY: MASTER OF DENTAL SURGERY5. SUBJECT: ORAL AND MAXILLOFACIAL SURGERY6. DATE OF ADMISSION: 15-5-20127. TITLE OF RESEARCH PROJECT:EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC)TITLE: EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC)..The research project entitled EVALUATION OF THE EFFICACY OF CARNOYS SOLUTION AS AN ADJUNCT WITH ENUCLEATION & PERIPHERAL OSTECTOMY IN THE MANAGEMENT OF KERATOCYSTIC ODONTOGENIC TUMOUR (KCOT) & ORTHOKERATINISED ODONTOGENIC CYST (OOC). is being condu...