| CTRI Number |
CTRI/2025/01/079275 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Clobetasol Propionate 0.05% Mouthwash in treating Symptomatic Oral Lichen Planus. |
|
Scientific Title of Study
|
Effectiveness of Clobetasol Propionate mouthwash, Clobetasol gel, and Triamcinolone Acetonide paste in the treatment of Symptomatic Oral Lichen Planus – 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 Neha Gadakari |
| Designation |
Ph.D. Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur ,Dharwad Karnataka |
| Address |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9481116657 |
| Fax |
|
| Email |
nehagadakari374@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Venkatesh Naikmasur |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur, Dharwad Karnataka |
| Address |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9886028856 |
| Fax |
|
| Email |
drvnmasur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Venkatesh Naikmasur |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Sattur ,Dharwad Karnataka |
| Address |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Dharwad
KARNATAKA
580009
India |
| Phone |
9886028856 |
| Fax |
|
| Email |
drvnmasur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fellowship provided by Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
580009 |
|
|
Primary Sponsor
|
| Name |
SDM College of Dental Sciences and Hospital Sattur Dharwad |
| Address |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital
Sattur, Dharwad Karnataka India 580009 |
| Type of Sponsor |
Other [SDM College of Dental Sciences and Hospital Sattur Dharwad 580009] |
|
|
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 Neha |
Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital |
Department of Oral Medicine and Radiology
Room no 1
Sattur, Dharwad Karnataka
Dharwad
KARNATAKA |
9481116657
nehagadakari374@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CLOBETASOL PROPIONATE MOUTHWASH |
Clobetasol Propionate 0.05% and the patient is advised to use it typically by swishing around the mouth for 5 minutes and then expectorating without swallowing about 3 times per day for a total duration of 2 months.
|
| Comparator Agent |
Triamcinolone Acetonide paste and clobetasol gel |
Triamcinolone Acetonide 0.1%paste
Clobetasol gel 0.05% for the treatment of symptomatic Oral Lichen Planus
The gel/paste is applied with the fingertip on the affected oral mucosa about 3 times per day for 2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
Subjects with symptomatic Oral Lichen Planus who have been confirmed histologically.
Subjects above 18 years who have consented to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
Patients who have known allergies to steroids
Patients with uncontrolled hypertension and diabetes
Patients suffering from debilitating systemic illness.
Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Based on the present study, the most effective topical steroid therapy for Oral Lichen Planus considering efficacy, safety, acceptability, feasibility, and patient compliance will be developed.
|
Patients will have weekly visits during the 4-week treatment period and a follow-up visit once in 2 weeks for 1 month.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of patients will be assessed based on questionnaire |
3 years |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
01/12/2025 |
| 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="3"
Months="6"
Days="5" |
|
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
|
Oral lichen planus is an autoimmune disorder affecting the oral cavity. The present study evolves in the comparison of the efficacy of the drug in the treatment of oral lichen planus. Topical steroids remain the mainstay for the treatment of oral lichen planus which contains triamcinolone acetonide which has several disadvantages, for which the present study entails in analyzing the efficacy of clobetasol propionate mouthwash with mucoadhesive polymer in the treatment of symptomatic oral lichen planus |