| CTRI Number |
CTRI/2024/09/073579 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [MODIFIED CARNOYS AND 5 FU ] |
| Study Design |
Other |
|
Public Title of Study
|
Does 5-flurouracil overweight the modified Carnoy’s solution for chemical cauterisation after peripheral ostectomy in patients with odontogenic keratocyst ?: a comparative study |
|
Scientific Title of Study
|
Comparative Evaluation of Post-Operative outcomes of Modified Carnoy’s Solution Versus 5-Flurouracial Used For Chemical Cauterization Following Enucleation And Peripheral Ostectomy In Patients With Odontogenickerato Cyst |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIDHI VIJAY KUMAR BODIWALA |
| Designation |
PG student |
| Affiliation |
|
| Address |
Oral and maxillo-facial surgery, room no. 4, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education (DU), Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
07741013662 |
| Fax |
|
| Email |
nidhi19697bodiwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nidhi Bodiwala |
| Designation |
PG student |
| Affiliation |
|
| Address |
Oral and maxillo-facial surgery, room no. 4, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education (DU), Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
07741013662 |
| Fax |
|
| Email |
nidhi19697bodiwala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Nidhi Bodiwala |
| Designation |
PG student |
| Affiliation |
|
| Address |
Oral and maxillo-facial surgery, room no. 4, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education (DU), Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
07741013662 |
| Fax |
|
| Email |
nidhi19697bodiwala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Life Style pharmacy, DMIHER (DU) campus, Sawangi Meghe, Wardha (M.S), India- 442001 |
|
|
Primary Sponsor
|
| Name |
Dr NIdhi Vijaykumar Bodiwala |
| Address |
Oral and maxillo-facial surgery, room no. 4, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education (DU), Sawangi Meghe- 442001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Bodiwala |
Sharad Pawar Dental Collage and Hospital, DMIHER (DU) |
Oral and maxillo-facial surgery, room no. 4, Sharad Pawar Dental College and Hospital, Datta Meghe Institute of Higher Education (DU), Sawangi Meghe
Wardha
MAHARASHTRA |
07741013662
-
nidhi19697bodiwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DMIHER (DU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K099||Cyst of oral region, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
5FU |
GROUP II – TRETMENT WITH 5-FU
After peripheral ostectomy sterile ribbon gauze will be coated with 5-FU (500 mg ampule) 10 ml and packed into the surgical cavity. Wound will be closed in usual manner leaving a small end exposed into oral cavity, and removed after 24 hrs postoperatively.
Followed by primary closure with the help of 3-0 vicryl .All the surgical procedure performed by senior surgeon, having a considerable experience in head and neck surgery. Patient will be kept on regular follow-up where clinical and radiological evaluation (CBCT) will be done in an interval of 6 months, 12 months and 18 months.
|
| Comparator Agent |
Modified Carnoy’s Solution |
GROUP I -TRETMENT WITH MODIFIED CARNOY’S SOLUTION
After enucleation, cavity will be covered with modified Carnoy solution (60% ethanol, and 10% glacial acetic acid, 1 g of ferric chloride) for 3 min, followed by thorough irrigation with normal saline. To preserve nerve Vaseline gauze will be applied. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients included in this study will be histologically proven cases of OKC with the age range of 18 - 70 years.
2. Patients having cystic lesion of size more than 2 cm in greatest diameter.
3. Patient having interincisal mouth opening of at least 30mm.
4. Patients who are non-smokers and non-alcoholic.
|
|
| ExclusionCriteria |
| Details |
1. Patients having cystic lesion of size less than 2 cm in diameter.
2. All patients who are contraindicated with multiple cystic lesion
3. All previously treated patient with same diagnosis of OKC.
4. Patients with immunocompromised status.
5. Pregnant and Lactating females.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess the rate of Odontogenic keratocyst recurrence within a defined follow-up period.
5-Fluorouracil (5-FU): Compare the recurrence rate with that of Modified Carnoy’s Solution.
|
6 month ,12 month and 18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NA |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
12/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study aims to compare and evaluate the post-operative outcomes with respect to recurrence rate of modified Carnoy’s solution versus 5-Flurouracial used for chemical cauterization following enucleation and peripheral ostectomy in patients with odontogenic keratocyst. Odontogenic cysts are one of the common entities in head and neck region which is a pathological cavity having fluid, semifluid or gaseous contents and which is not created by the accumulation of pus. It may or may not be lined by epithelium and can exist as single or multiple cavities. Cyst without cystic linings is termed as pseudo-cysts. Odontogenic cysts are usually missed-diagnosed when symptomless unless they are infected or have an destructive nature showing adjacent bone resorption resulting in large bony cavities. Radicular cysts comprising of 48.67% are the most commonly occurring of all odontogenic cysts, followed by follicular cysts and odontogenic keratocyst. |