| CTRI Number |
CTRI/2025/06/088000 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study on the effect of laser light therapy and steroid ointment in patients with white patches in the mouth that is oral lichen planus |
|
Scientific Title of Study
|
Comparison of Laser Photobiomodulation and Topical 0.05 percentage Clobetasol Propionate in the treatment of Oral lichen planus :A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranchini V |
| Designation |
PG resident |
| Affiliation |
Kerala university of health sciences |
| Address |
KMCT Dental College,Manassery
Kozhikode
KERALA
673602
India |
| Phone |
|
| Fax |
|
| Email |
ranchiniv2023@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ashir K R |
| Designation |
Professor |
| Affiliation |
Kerala university of health sciences |
| Address |
Oral medicine and radiology
KMCT dental College
Kozhikode
KERALA
673602
India |
| Phone |
|
| Fax |
|
| Email |
ashirkr@kmctdentalcollege.org |
|
Details of Contact Person
Public Query
|
| Name |
Ranchini V |
| Designation |
Prinicipal investigator |
| Affiliation |
Kerala university of health sciences |
| Address |
KMCT Dental College,Mukkam
Kozhikode
KERALA
673602
India |
| Phone |
|
| Fax |
|
| Email |
ranchiniv2023@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KMCT Dental College |
| Address |
KMCT Dental College ,Mukkam,Manassery,Calicut,673602 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 |
| DrRanchini V |
KMCT Dental College |
Department of Oral Medicine and Radiology
Mukkam
Manassery
Kozhikode
KERALA |
09207273105
ranchiniv2023@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCT Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Oral lichen planus |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clobetasol Propionate 0.05 percentage |
Topical Application TID for 4 week |
| Intervention |
Photobiomodulation Therapy |
4 J per point for 10 seconds a total of 8 sessions in a month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Normal physical examination results before medication |
|
| ExclusionCriteria |
| Details |
Presence of severe systemic diseases or other severe oral mucous diseases or under cancer treatment
Previous history of photobiomodulation therapy
History of anti-inflammatory drugs treatment within a month
Presence of lichenoid reaction caused by amalgam fillings or drugs known to cause drug induced lichenoid reaction
Pregnancy intention of pregnancy lactation or recent use of steroid hormone based contraceptives
OLP patients with skin lesions
History of psychiatric disorders
Participation in any other clinical trials in the 3 months before enrollment in this study
Those lesions with epithelial dysplasia in histopathological evaluation
Patient who are allergic to the drugs used in the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain severity measured using the Visual Analog Scale and reduction in lesion severity assessed using the REU score that is Reticulation Erythema Ulceration |
At baseline 2 weeks 4 weeks after 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
11/06/2025 |
| 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="0"
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 - 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
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ranchiniv2023@gmail.com].
- For how long will this data be available start date provided 05-06-2025 and end date provided 05-06-2030?
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 Lichen Planus (OLP) is a chronic mucocutaneous condition commonly affecting the oral mucosa, often associated with burning sensation and discomfort. Topical corticosteroids, such as clobetasol propionate, are considered the standard treatment. However, their long-term use may result in adverse effects. Photobiomodulation therapy (PBM), using low-level laser therapy, has emerged as a non-invasive alternative with potential anti-inflammatory and analgesic effects.
This interventional, parallel-group clinical trial aims to compare the efficacy of PBM and topical clobetasol propionate in patients diagnosed with symptomatic oral lichen planus. A total of 44 participants will be randomly allocated into two groups: one receiving PBM and the other treated with clobetasol 0.05% ointment. Outcomes will be assessed using Visual Analog Scale (VAS) for pain and REU score (Reticulation, Erythema, Ulceration) for lesion severity over a period of 2weeks,4 weeks and one month.
The study seeks to evaluate whether PBM can provide similar or superior symptom relief with fewer side effects compared to conventional steroid therapy |