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CTRI Number  CTRI/2026/01/101326 [Registered on: 16/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Other (Specify) [Photobiomodulation Therapy]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Lasers versus steroids: which works best for the treatment of oral lichen planus? 
Scientific Title of Study   Effectiveness Of Photobiomodulation Therapy Compared to Triamcinolone Acetonide in Treating Oral Lichen Planus: A Randomised 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 Shivangi Vasta 
Designation  Postgraduate Student Master of Dental Surgery  
Affiliation  Goa Dental College and Hospital 
Address  Department no 1, Room 1A, Department of oral medicine and radiology, Goa Dental College and Hospital, Bambolim-Goa 403202.
C4 SAPNA HEIGHTS, St.inez, Panaji.
North Goa
GOA
403202
India 
Phone  9673284443  
Fax    
Email  shivangimay1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manisha Khorate 
Designation  Professor and Head of the Department  
Affiliation  Goa Dental College and Hospital 
Address  Department no 1, Department of Oral Medicine and Radiology, Goa Dental College and Hospital, Bambolim Goa, 403202.

North Goa
GOA
403202
India 
Phone  9823213773  
Fax    
Email  khoratemanisha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shivangi Vasta 
Designation  Postgraduate Student Master of Dental Surgery  
Affiliation  Goa Dental College and Hospital 
Address  Department no 1, Room 1A, Department of oral medicine and radiology, Goa Dental College and Hospital, Bambolim-Goa 403202.
C4 SAPNA HEIGHTS, St.inez, Panaji.
North Goa
GOA
403202
India 
Phone  9673284443  
Fax    
Email  shivangimay1997@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Goa Dental College and Hospital 
Address  Bambolim, Goa. 403202 
Type of Sponsor  Government medical 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 
Dr Shivangi Vasta  Goa Dental College and Hospital   Department no 1, Department of oral medicine and radiology, Goa Dental College and Hospital, Bambolim Goa, 403202.
North Goa
GOA 
9673284443

shivangimay1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital instituition review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  0.1% Triamcinolone Acetonide  Control Group will be prescribed 0.1% Triamcinolone Acetonide to be applied over affected area thrice daily for 15 minutes over the affected area for 4 weeks 
Intervention  photobiomodulation therapy   Will receive photobiomodulation therapy with 660nm wavelength 3 times in a week for 4 weeks.  
Intervention  photobiomodulation therapy  Will receive photobiomodulation therapy with 660nm wavelength 2 times in a week for 4 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with erosive oral lichen planus diagnosed by clinical examination that complied with WHO modified criteria (2003) for OLP diagnosis.
Patient above 20 years of age.
Patient willing to participate in the study. 
 
ExclusionCriteria 
Details  Patients currently on corticosteroid therapy or had been on treatment during the past 3 months.
Patients administering anti-inflammatory drugs, illicit drugs, any medications associated with oral lichenoid reactions, or treatment for cancer.
Patients with any uncontrolled systemic diseases, pregnant or breast-feeding women, and smokers.
Presence of amalgam restorations near the OLP lesions.
Patients with associated cutaneous lesions.
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assessed by estimating and comparing the clinical size and presentation of the lesion Thongprasom sign score along with VAS scores at baseline and post treatment.
 
Outcome will be assessed by estimating and comparing the clinical size and presentation of the lesion Thongprasom sign score along with VAS scores at baseline and post treatment.
 
 
Secondary Outcome  
Outcome  TimePoints 
Photobiomodulation therapy is more effective 3 times a week or 2 times a week  Assessment will be done at Day 1, Day 7, Day 14, Day 30, Day 60 & Day 90 
 
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)   10/02/2026 
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 - NO
Brief Summary  

Source Of Data:  The present study will be conducted at the Oral Medicine &Radiology Department of the Goa Dental College & Hospital, Bambolim, Goa. The patients of either sex reporting to the Department with clinical and histopathological diagnosis as a case of Oral Lichen Planus will be included in the prospective clinical trial after obtaining informed consent.

Method of collection of Data including sampling procedure:

Study design: Two-arm randomized (1:1), controlled clinical trial. The study will include subjects with clinically and histopathologically diagnosed cases of Oral Lichen Planus, these patients will be equally divided into experimental and control group. The experimental group will receive Photobiomodulation therapy, 10 sessions for 4 weeks where subgroup 1 will receive  Photobiomodulation therapy 2 times a week and subgroup 2 will receive  Photobiomodulation therapy 3 times a week. Control group will be given 0.1percent triamcinolone acetonide which will be instructed to use thrice daily for 15 minutes over the affected area for 4 weeks.

Sampling method: permuted block method

Sample size: 30

Inclusion Criteria:

Patients were enrolled in the study when they had erosive oral lichen planus diagnosed by clinical examination that complied with WHO modified criteria (2003) for OLP diagnosis.

Patients with biopsy proved Oral Lichen Planus lesions.

Patient above 20 years of age.

Patient willing to participate in the study.

Exclusion Criteria:

Patients currently on corticosteroid therapy or had been on treatment during the past 3 months.

Patients administering anti-inflammatory drugs, illicit drugs, any medications associated with oral lichenoid reactions, or treatment for cancer.

Patients with any uncontrolled systemic diseases, pregnant or breast-feeding women, and smokers.

Presence of amalgam restorations near the OLP lesions.

Pregnant or lactating females.

Patients with associated cutaneous lesions.

Patient not willing to participate.

Materials:

Methods:   Detailed history with clinical examination of the patients will be carried out

Following treatment will be given to patient prior to starting of treatment

Oral Prophylaxis regiment including subgingival scaling, polishing, root planning, curettage or other forms of periodontal surgery as required / recommended by the Department of periodontics.

Restorations of silver amalgam which were identified by the patients as having been done and followed by occurrence of Oral Lichen Planus within 6-8 months of filling being done would be replaced with other restorative materials as per indication.

The patient in the study will be randomly classified into experimental and control

group.

Experimental Group will be given photobiomodulation therapy over affected area.

Control Group will be prescribed 0.1 percent Triamcinolone Acetonide to be applied over affected area thrice daily. As per the lesion resolution tapering of oral paste will be

done.

Patient will be evaluated in three follow-up sessions, after 1, 2, 3 months.

Outcome will be assessed by estimating and comparing the clinical size and presentation of the lesion along with VAS scores at baseline and post

treatment.

 

Clinical Estimation of The Lesion

The lesions size will be measured and the appearance will be evaluated by the

Thongprasom sign score.

Thongprasom sign score

Score 5 = white striae with erosive area & gt;1 cm2

Score 4 = white striae with erosive area & lt;1 cm2

Score 3 = white striae with atrophic area & gt;1 cm2

Score 2 = white striae with atrophic area & lt;1 cm2

Score 1 = no lesions

 

Patients will also be examined for burning sensation using VAS Scale. Scores ranged

from 0 (no pain) to 10 (extreme pain).

 
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