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CTRI Number  CTRI/2026/01/100564 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of three different treatments for patients with oral lichen planus 
Scientific Title of Study   COMPARATIVE EVALUATION OF EFFICACY OF INTRALESIONAL LOW MOLECULAR WEIGHT HEPARIN, INTRALESIONAL INJECTION OF TRIAMCINOLONE ACETONIDE AND PHOTO-BIOMODULATION IN ORAL LICHEN PLANUS: A RANDOMIZED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SIMRAN JEET SINDHU 
Designation  Postgraduate  
Affiliation  subharti dental college and hospital 
Address  ROOM NO 1 ORAL MEDICINE AND RADIOLOGY SUBHARTI DENTAL COLLEGE MEERUT

Meerut
UTTAR PRADESH
250005
India 
Phone  9068883651  
Fax    
Email  sindhusimran221998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SWATI GUPTA 
Designation  PROFESSOR  
Affiliation  SUBHARTI DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 1 ORAL MEDICINE AND RADIOLOGY SUBHARTI DENTAL COLLEGE MEERUT

Meerut
UTTAR PRADESH
250005
India 
Phone  9634927286  
Fax    
Email  drswatig@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  DRSANGEETA MALIK 
Designation  PROFESSOR 
Affiliation  SUBHARTI DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 1 ORAL MEDICINE AND RADIOLOGY SUBHARTI DENTAL COLLEGE MEERUT

Meerut
UTTAR PRADESH
250005
India 
Phone  9675208572  
Fax    
Email  shubhsiddhi@gmail.com  
 
Source of Monetary or Material Support  
SUBHARTI DENTAL COLLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  subharti dental college  
Address  SUBHARTI DENTAL COLLEGE AND HOSPITAL SWAMIVIVEKANAND SUBHARTI UNIVERSITY SUBHARTIPURAM, NH58 DELHI HARIDWAR BYPASS ROAD MEERUT 250005 UTTARPRADESH INDIA 
Type of Sponsor  Other [private dental college] 
 
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 
DrSimran jeet PRINCIPAL INVESTIGATOR  Subharti Dental College and Hospital  oral medicine and radiology department room no. 1
Meerut
UTTAR PRADESH 		 9068883651

sindhusimran221998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University ethics committee medical swami vivekanand subharti university meerut  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intralesional injection of low molecular weight heparin  • Group A will consist of 24 patients clinically diagnosed with symptomatic oral lichen planus. In these 24 patients intralesional injection of low molecular weight heparin (Enoxaparin) will be given once in a week till the lesion regresses or for a maximum period of 8 weeks, whichever is earlier.  
Intervention  Intralesional Injection of Triamcinolone acetonide  Group B will consist of 24 patients clinically diagnosed with symptomatic oral lichen planus. In these 24 patients intralesional injection of triamcinolone acetonide will be given once in a week till the lesion regresses or for a maximum period of 8 weeks, whichever is earlier. 
Intervention  photobiomodulation therapy  Group C will consist of 24 patients clinically diagnosed with symptomatic oral lichen planus. In these 24 patients Photobiomodulation therapy will be given two days in a week till the lesion regresses or for a maximum period of 8 weeks, whichever is earlier. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Above 18 years of age.
2. Patients clinically diagnosed with symptomatic oral lichen planus.
3. Patients who will give consent for the treatment.
 
 
ExclusionCriteria 
Details  1. Hospitalized patients and pregnant females.
2. Kidney and liver failure patients.
3. History of bleeding diathesis, uncontrolled hypertension, cerebrovascular accident, peptic ulcer.
4. Hypersensitivity to heparin and heparin derivatives and a history of heparin-induced thrombocytopenia.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
reduction in burning sensation measured by visual analog scale and clinical improvement in lesion size and appearance measured by thongprasom scoring criteria and improvement in quality of life which is measured by American chronic pain association  6 month and 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Recurrence rate   6 months after completion of treatment 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   20/01/2026 
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="0"
Months="6"
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   Oral lichen planus is a chronic inflammatory disease that commonly affect the skin and the oral mucosa although the mucous membrane such as conjuctiva, oesophagus and genitalia can also be affected with predominance towards the middle age female patients cause burning sensation pain, and discomfort significantly affecting patient quality of life.Corticosteroid have been considered the first choice agent for the management of OLP. Corticosteroids are especially helpful in the management of OLP in view of their anti-inflammatory effect and anti-immunological properties . Intralesional injection of Triamcinolone acetonide has shown successful result in oral lichen planus  however continuous and prolonged use is associated with many systemic adverse effect such as bad taste, nausea, facial swelling, dryness, mucosal atrophy, candida infection, granuloma formation, hypersensitivity reaction, delayed wound healing,  and in later stages; hypothalamus pituitary adrenal suppression.Due to serious side effects encountered during long term use of corticosteroids alternative therapies are tried, one among them are Low molecular weight heparin .
 Heparin is an anticoagulant that inhibits the development and progression of clot formation. Low molecular weight heparin in low doses has lymphoid antiproliferative and immunomodulatory properties. Another treatment option is Photobiomodulation (PBM), in which a laser (at 630 to 980nm wavelength, output power of 20 to 300 mW and an exposure time of 10 s to 15 min) is used to beneficially influence cell metabolism, without harm to the cells.The present study is an effort to evaluate the therapeutic effect of low molecular weight heparin(Enoxaparin) intralesional injections, photobiomodulation and comparing it with intralesional injection of steroids, and also is an effort to understand the adverse effect of these therapeutic modalities & any effect on relapse/ recurrence of oral lichen planus.

 

  
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