| CTRI Number |
CTRI/2023/11/060376 [Registered on: 30/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Designs of Nasolabial Flaps in Patients Undergoing Surgical Intervention for Oral Submucous Fibrosis |
|
Scientific Title of Study
|
Comparative Evaluation of Conventional Nasolabial flap and Nasolabial flap with Fishtail Modification in patients undergoing surgical release of fibrous bands in Oral Submucous Fibrosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhar Wadhwani |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education |
| Address |
Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra
Datta Meghe Institute of Medical Sciences, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8007808088 |
| Fax |
|
| Email |
nikhar.wadhwani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Bhola |
| Designation |
Professor and Head, Department of Oral and Maxillofacial Surgery |
| Affiliation |
Datta Meghe Institute of Higher Education |
| Address |
Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra
Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8007808088 |
| Fax |
|
| Email |
drnitinbhola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikhar Wadhwani |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education |
| Address |
Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra
Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra
Wardha
MAHARASHTRA
442004
India |
| Phone |
8007808088 |
| Fax |
|
| Email |
nikhar.wadhwani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education, Sawangi, Wardha, Maharashtra, India - 442004 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences |
| Address |
Sawangi, Meghe |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikhar |
Acharya Vinobha Bhave Rural Hospital, Sawangi, Wardha, Maharashtra 442001 |
Department of Oral and Maxillofacial Surgery
Wardha
MAHARASHTRA |
8007808088
nikhar.wadhwani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, (2) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Nasolabial Flap |
This is the flap commonly used, which often causes widening of oral commissure. This will be evaluated over a period of 6 months post-operatively. |
| Intervention |
Fishtail modification of Nasolabial flap |
This is a modification of the conventional flap which we hypothesize will have lower commissure widening and better overall esthetics. This will be evaluated over a period of 6 months post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Grade IV OSMF |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional outcomes: Rate of flap failure |
Follow up at 2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Aesthetic outcomes: Widening of oral commissure, tearing at corner of mouth |
Follow up at 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/12/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nikhar.wadhwani@gmail.com].
- For how long will this data be available start date provided 01-03-2024 and end date provided 01-03-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Oral submucous fibrosis is a widespread condition affecting millions in the South Asian subcontinent. It is mainly prevalent due to the habitual consumption of Betel Nut, a variety of smokeless tobacco, which causes severe fibrosis of the oral mucosa, eventually leading to depleted quality of life due to reduction in mouth opening. There are various treatment modalities available, but surgery remains the one with best outcomes. Different flaps have been used to reconstruct the fibrotomy defect, the nasolabial flap is mostly preferred due to its versatility. We have brought forth a modification of this flap which will hypothetically reduce certain post operative complications such as tearing of the oral commissure, angular cheilitis, and widening of the corner of mouth. |