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CTRI Number  CTRI/2026/04/108890 [Registered on: 21/04/2026] Trial Registered Prospectively
Last Modified On: 20/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of steroid gel in treatment of Oral Lesions 
Scientific Title of Study   Effectiveness of Topical Betamethasone Nanogel in the treatment of Oral Lichen Planus - A Clinical 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 SHARAN KAUR MANN 
Designation  POST GRADUATE 
Affiliation  SAVEETHA DENTAL COLLEGE AND HOSPITALS 
Address  SAVEETHA DENTAL COLLEGE AND HOSPITALS, SAVEETHA UNIVERSITY, POONAMALLEE HIGH ROAD, CHENNAI

Chennai
TAMIL NADU
600077
India 
Phone  9930083443  
Fax    
Email  SHARANMANN97@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  DR SHARAN KAUR MANN 
Designation  POST GRADUATE 
Affiliation  SAVEETHA DENTAL COLLEGE AND HOSPITALS 
Address  SAVEETHA DENTAL COLLEGE AND HOSPITALS, SAVEETHA UNIVERSITY, POONAMALLEE HIGH ROAD, CHENNAI

Chennai
TAMIL NADU
600077
India 
Phone  9930083443  
Fax    
Email  SHARANMANN97@GMAIL.COM  
 
Details of Contact Person
Public Query  
Name  DR SHARAN KAUR MANN 
Designation  POST GRADUATE 
Affiliation  SAVEETHA DENTAL COLLEGE AND HOSPITALS 
Address  SAVEETHA DENTAL COLLEGE AND HOSPITALS, SAVEETHA UNIVERSITY, POONAMALLEE HIGH ROAD, CHENNAI

Chennai
TAMIL NADU
600077
India 
Phone  9930083443  
Fax    
Email  SHARANMANN97@GMAIL.COM  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR SHARAN KAUR MANN 
Address  CLINIC 20, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, SAVEETHA DENTAL COLLEGE AND HOSPITALS, POONAMALLEE HIGH ROAD, CHENNAI-600077, INDIA 
Type of Sponsor  Other [SELF-FUNDED] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SHARAN KAUR MANN  SAVEETHA DENTAL COLLEGE AND HOSPITALS   CLINIC 20, DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY, SAVEETHA DENTAL COLLEGE AND HOSPITALS, POONAMALLEE HIGH ROAD, CHENNAI
Chennai
TAMIL NADU 		 9930083443

SHARANMANN97@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SAVEETHA DENTAL COLLEGE-INSTITUTIONAL HUMAN ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L439||Lichen planus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BETAMETHASONE NANOGEL  FORMULATION OF BETAMETHASONE NANOGEL FOR THE TREATMENT OF ORAL LICHEN PLANUS. FREQUENCY WILL BE TWICE APPLICATION DAILY WITH 2 REVIEWS ON 15TH AND 30TH DAY FROM BASELINE. 
Comparator Agent  TRIAMCINOLONE ACETONIDE BUCCAL PASTE  COMMERCIALLY AVAILABLE FOR THE TREATMENT OF ORAL LICHEN PLANUS. FREQUENCY WILL BE TWICE APPLICATION DAILY WITH 2 REVIEWS ON 15TH AND 30TH DAY FROM BASELINE. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  PATIENTS WITH SYMPTOMATIC ORAL LICHEN PLANUS 
 
ExclusionCriteria 
Details  1. ALLERGIC TO STEROIDS
2. PATIENTS WITH COMORBIDITIES
3. PRESENCE OF LICHENOID REACTION BY FILLINGS/DRUGS
4. PREGNANT LADIES 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. SYMPTOM RELIEF
2. REDUCTION IN LESION SIZE
 		 2 REVIEWS ON 15TH AND 30TH DAY FROM BASELINE.
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL
 		 NIL
 
 
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   Phase 1 
Date of First Enrollment (India)   01/05/2026 
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 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 - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [SHARANMANN97@GMAIL.COM].

  6. For how long will this data be available start date provided 09-01-2027 and end date provided 31-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Study focuses is on formulation and evaluating the effectiveness of betamethasone nanogel in the treatment of oral lichen planus. Betamethasone is available as oral systemic tablets and the same tablet is also being used as a mouthwash for topical treatment in India, so this trial is being conducted for a longer drug release and interaction with affected oral mucosa in return leading to faster healing of the lesion.
 
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