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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 RAJ IV, 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 SUBJ ECT FOR DISSERTATION


1. NAME OF THE CANDIDATE: DR. KAPOOR PRATHMESH RAJ IV


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 ADJ UNCT 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 2
nd
to 4
th
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 1
st
day, 7
th
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 2
nd
,
7
th
day & 14
th
day.
4. Soft tissue healing will be evaluated by Landrys Healing Index & presence/absence of wound
dehiscence & necrosis will be recorded on 7
th
& 14
th
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 7
th
day, 14
th
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 J C: 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. J ackson IT, Potparic Z, Fasching M, et al. Penetration of the skull base by dissecting keratocyst. J
Craniomaxillofac Surg1993; 21:31925.

11. Irvine GH, Bowerman J E: 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, 1
st
day,
7
th
day, 7
th
day & 1 month after surgery.

Time period VAS score
Preoperatively
1
st
day
7
th
day
14
th
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 7
th
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
<6 (1) Reduced sensation
Time LTS PP STPD MTPD GSS
7
th
day
14
th
day
6 month
1 year

Evaluation of Facial Swelling:

To evaluate the swelling, markings with permanent marker were made prior to the surgery on
the following facial regions: the angle of the mandible, the tragus, the labial commissure, the
nasal border, lateral & medial cantus of eye, and on the soft pogonion. The measurements are
made on day 7 & 14 with nylon thread between angle of mandible & other six points. The sum
of measurements is taken as final recorded measurement.

Percentage of Facial swelling = Recorded post-operative Recorded Pre-operative
measurement measurement
___________________________________________x 100

Pre-operative measurement

Time Percentage facial swelling
7
th
day
14
th
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% & <50% of tissue red
- Response to palpation: No Bleeding
- Granulation tissue: none
- Incision magins: no connective tissue exposed

4 Very Good - Tissue Colour: <25% red
- Response to palpation: no bleeding
- Granulation tissue: none
- Incision margins: no connective tissue exposed
5 Excellent - Tissue Colour: All tissue pink
- Response to palpation: no bleeding
- Granulation tissue: none
- Incision margins: no connective tissue exposed


Time Healing Index score
7
th
day
14
th
day

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 7
th
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
7
th
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 Raji v 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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