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CTRI Number  CTRI/2024/11/076819 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare and evaluate the effect of Topical Platelet Rich Fibrin in Orabase and 0.1 percent Topical Triamcinolone Acetonide in Orabase for management of Oral Lichen Planus - A Randomised Controlled Study. 
Scientific Title of Study   Comparative Evaluation of Topical Platelet Rich Fibrin in Orabase Versus 0.1 percent Topical Triamcinolone Acetonide in Orabase for management of Oral Lichen Planus - A Randomised Controlled Study. 
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 Suman B 
Designation  Associate Professor 
Affiliation  Government Dental college and Research Institute, Bangalore 
Address  Department of Oral Medicine and Radiology, Government Dental college and Research Institute, Fort, Victoria Hospital Campus, Bangalore, 560002

Bangalore
KARNATAKA
0
India 
Phone  9980839659  
Fax    
Email  drsumanag99@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Patel Ankita Navinbhai 
Designation  Postgraduate  
Affiliation  Government Dental college and Research Institute, Bangalore 
Address  Room no 316 BMCRI Ladies Hostel Victoria Hospital Campus New Tharagupet Bangalore 560002

Bangalore
KARNATAKA
0
India 
Phone  08140068705  
Fax    
Email  ankitapatel5332@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suman B 
Designation  Associate Professor 
Affiliation  Government Dental college and Research Institute, Bangalore 
Address  Department of Oral Medicine and Radiology, Government Dental college and Research Institute, Fort, Victoria Hospital Campus, Bangalore- 560002
Department of Oral Medicine and Radiology, Government Dental college and Research Institute, Fort, Victoria Hospital Campus, Bangalore- 560002
Bangalore
KARNATAKA
0
India 
Phone  09980839659  
Fax    
Email  drsumanag99@yahoo.com  
 
Source of Monetary or Material Support  
Government Dental College and Research Institute, Fort, Victoria Hospital Campus, Bangalore - 560002 
 
Primary Sponsor  
Name  Dr. Patel Ankita Navinbhai 
Address  Room no 2B BMCRI Ladies Hostel Victoria Hospital Campus New Tharagupet Bangalore 560002 
Type of Sponsor  Other [Self] 
 
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 Patel Ankita Navinbhai  Government Dental College and Research Institute, Bangalore  Room no -1, Department of Oral Medicine and Radiology, Government Dental College and Research Institute, Fort, Victoria Hospital Campus, Bangalore 560002
Bangalore
KARNATAKA 		 8140068705

ankitapatel5332@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Dental College and Research Institute   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% Topical triamcinolone acetonide in orabase   28 subjects diagnosed with Oral Lichen Planus will be treated with 0.1% Topical triamcinolone acetonide in orabase twice in a day till clinical resolution is achieved upto a maximum of 8 weeks 
Intervention  Topical Platelet-rich Fibrin in orabase   28 subjects diagnosed with Oral Lichen Planus will be treated with Topical Platelet-rich Fibrin in orabase thrice in a day till clinical resolution is achieved upto a maximum of 8 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects aged 18 to 60 years of both genders, diagnosed with symptomatic oral lichen planus clinically and histopathologically confirmed according to Modified WHO criteria.

2.Subjects who voluntarily consented to be a part of the study. 
 
ExclusionCriteria 
Details  1.Subjects who have received any topical treatment for OLP within the last 2 weeks or any systemic treatment for OLP within the past 3 months.

2.Subjects who are having Oral lichenoid reactions due to any medications, dental materials, diseases such as GVHD, tobacco, and so on.

3.Subjects with oral mucosal lesions other than OLP.

4.Subjects with a history of Anaemia (Hb less than 11g/dl) and Platelet count less than 150,000/mm3

5.Subjects with history of any medication, or conditions associated with bleeding disorders.

6.Subjects on anticoagulant therapy, chemotherapy or immunosuppressive medications.

7.Subjects with other autoimmune disease, malignancy, or hepatitis C virus infection.

8.Subjects for whom phlebotomy is contraindicated: evidence of cellulitis or abscess, presence of hematoma, presence of scar, recent venipuncture at the same location.

9.Subjects with systemic diseases where topical corticosteroids should be avoided.

10.Subjects receiving any systemic steroids for other systemic diseases.

11.Pregnant and lactating women.

12.Subjects with a habit of smoking 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
VAS score, Thongprasom score, number, clinical appearance, and recurrence of lesion  At the end of 0,1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 1 month, 2nd month,3rd month, 4 th month, 5th month, 6th month 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects if any  At the end of 0,1st week, 2nd week, 3rd week, 4th week, 5th week, 6th week, 7th week, 8th week, 1 month, 2nd month,3rd month, 4 th month, 5th month, 6th month 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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 3 
Date of First Enrollment (India)   25/11/2024 
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="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  

 56 Clinically and histopathologically proven cases of oral lichen planus reporting to department of Oral Medicine and Radiology will be recruited to the study. Followed by Baseline assessment of clinical parameters (VAS SCORE, THONGPRASOM SCORE, NUMBER OF LESION AND CLINICAL APPEARANCE). Randomized allocation of subjects into two groups: Group I of 28 subjects will be treated with Topical PRF-minced and mixed 1:1 w/w with orabase applied thrice daily till clinical resolution is achieved upto a maximum of 8 weeks and Group II of 28 subjects will be treated with Topical 0.1 % triamcinolone acetonide in orabase twice a day till clinical resolution is achieved upto a maximum of 8 weeks.For both the groups at the end of every week for eight weeks all the outcomes parameters (VAS SCORE, THONGPRASOM SCORE, NUMBER OF LESION AND CLINICAL APPEARANCE ) will be assessed and subsequently once a month  for six months followed by Statistical Analysis

 
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