| CTRI Number |
CTRI/2024/11/076989 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study is to find out the beneficial action of vitamin A gel application over a wound caused by laser removal of white type of cancer patches in mouth. |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of vitamin A topical application in wound healing of laser ablation treatment in oral leukoplakia : A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Marshall David |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital, Cuddalore
Erstwhile Rajah Muthiah Dental College and Hospital Chidambaram
Cuddalore
Cuddalore
TAMIL NADU
608002
India |
| Phone |
7025137370 |
| Fax |
|
| Email |
dr.marshalldavid1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Ramasamy |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital, Cuddalore
Erstwhile Rajah Muthiah Dental College and Hospital Chidambaram
Cuddalore
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9677522853 |
| Fax |
|
| Email |
hod.omr.au@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Ramasamy |
| Designation |
Professor and Head |
| Affiliation |
Government Dental College and Hospital, Cuddalore |
| Address |
Department of Oral Medicine and Radiology
Government Dental College and Hospital, Cuddalore
Erstwhile Rajah Muthiah Dental College and Hospital Chidambaram
Cuddalore
Cuddalore
TAMIL NADU
608002
India |
| Phone |
9677522853 |
| Fax |
|
| Email |
hod.omr.au@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Cuddalore, Erstwhile Rajah Muthiah Dental College and Hospital, Chidambaram, Cuddalore, Tamilnadu- 608002 For infrastructure |
|
|
Primary Sponsor
|
| Name |
Dr Marshall David |
| Address |
Government Dental College and Hospital, Cuddalore, Erstwhile Rajah Muthiah Dental College and Hospital, Chidambaram, Cuddalore, Tamilnadu- 608002 |
| Type of Sponsor |
Other [self funding] |
|
|
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 Marshall David |
Government Dental College and Hospital |
Department of Oral Medicine and Radiology
Cuddalore
TAMIL NADU |
7025137370
dr.marshalldavid1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital, Cuddalore district, Annamalai nagar 608002, INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K132||Leukoplakia and other disturbancesof oral epithelium, including tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laser ablation and vitamin A topical application group |
Vitamin A application before 4 days of Laser ablation followed by 2 weeks of vitamin A topical application twice per day & routine oral antibiotics, analgesics and topical antimicrobial for 1 week(follow up 6 months) |
| Comparator Agent |
Laser ablation group |
Laser ablation followed by oral antibiotics, analgesics and topical antimicrobials(follow up 6 months) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Homogenous leukoplakia histopathologically diagnosed |
|
| ExclusionCriteria |
| Details |
Patients with cardiac pacemaker
Speckled and verrucous leukoplakia
Pregnant and lactating mothers
Extensive lesions(more than one anatomical site)
Individuals
Obese and under vitamin A supplements |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain
Wound healing |
Day 2, 1st week,2nd week,3rd week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relapse
Recurrence |
3rd and 6th month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study is a randomized, parallel group trial to evaluate the efficacy of Vitamin A topical application in postoperative pain and wound healing of laser ablation treatment in oral leukoplakia. The primary outcome of the study is to compare and evaluate postoperative pain and wound healing in laser ablation group and laser ablation followed by vitamin A topical application group for a period of 4 weeks. The secondary outcomes is to compare and evaluate relapse and recurrence in laser ablation group and laser ablation followed by vitamin A topical application group for a period of 6 months. Total sample size was calculated to be 30 including expected drop out rate of 20%. |