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CTRI Number  CTRI/2025/07/091800 [Registered on: 27/07/2025] Trial Registered Prospectively
Last Modified On: 26/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare the effectiveness of different injections in treating oral submucous fibrosis  
Scientific Title of Study   Efficacy of Injection Placentrex, Platelet Rich Plasma (PRP) and Triamcinolone with Hyaluronidase in the management of oral submucous fibrosis: A Randomized 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 Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115,Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat-360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115,Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat-360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shreeya Sharma  
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, Rajkot, Gujarat 
Address  Room 115,Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat-360006

Rajkot
GUJARAT
360006
India 
Phone  8830388570  
Fax    
Email  shreeyasharma231@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self-sponsored 
Address  Room 115,Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat-360006 
Type of Sponsor  Other [Patients will be bearing the cost of treatments ] 
 
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 Shreeya Sharma  All India Institute of Medical Sciences, Rajkot  Room 115, Department of Dentistry, All India Institute of Medical Sciences, Rajkot, Gujarat-360006
Rajkot
GUJARAT 
8830388570

shreeyasharma231@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS, Rajkot   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Placentrex   Injection Placentrex 2ml administered intramuscosally once weekly for total duration of 6 weeks 
Comparator Agent  Placentrex,Platelet Rich Plasma (PRP),Traimcinolone with Hyaluronidase   Each intervention arm will serve as a comparator to the others in this multi-arm randomized trial. 
Intervention  Platelet Rich Plasma (PRP)  Injection Platelet Rich Plasma (PRP) 2ml administered intramucosally once weekly for total duration of 6 weeks 
Intervention  Triamcinolone with Hyaluronidase  Injection Triamcinolone with Hyaluronidase 2ml administered intramucosally once weekly for total duration of 6 weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with stage II and III oral submucous fibrosis grading based on mouth opening ranging from 15mm to 35mm
Patients having oral submucous fibrosis due to tobacco chewing habit
Patients who have already quit the tobacco chewing habit
 
 
ExclusionCriteria 
Details  Patients with stage I and IV OSMF grading based on mouth opening (less than 15mm and more than 35mm)
Patients who have already undergone surgeries/ medicinal treatment for oral submucous fibrosis in the past
Patients with systemic sclerosis or oral submucous fibrosis due to any other systemic condition
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in interincisal mouth opening (in mm)
measured using vernier calliper between upper and lower central incisors  
Baseline (Week 0),Week 2, Week 4, Week 6, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in burning sensation in oral mucosa using Visual Analog Scale(VAS)  Baseline (Week 0),Week 2, Week 4, Week 6, 3 months 
Change in blanching of oral mucosa assessed by clinical grading (subjective scale)  Baseline (Week 0),Week 2, Week 4, Week 6, 3 months 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   31/08/2025 
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="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  

 Patients diagnosed with OSMF and clinically graded as stage II and III OSMF according to Khanna and Andrade grading will be included. Demographic data with detailed history will be obtained about personal, habit and medical history followed by clinical examination and following parameters will be evaluated by mouth opening by maximal interincisal distance using vernier callipers, burning sensation will be assessed subjectively using visual analogue scale, colour of mucosa will be evaluated under natural light and this data will be numbered as  pink-1, pale pink-2, pale-3, blanched-4.The patients will be randomly allocated into the three groups. Randomization will be done according to computer generated block design. All patients will be counselled for habit cessation and will be undergoing oral prophylaxis before commencing the injection therapy. Intramucosal injections will be administered on the affected buccal mucosa and retromolar region o.2ml in each site once weekly for 6 weeks. All patients will be trained and  instructed to do mouth opening exercises using Heisters screw in every follow-up  throughout treatment period. Parameters will be evaluated every 2 weeks within the 6 weeks of injection therapy followed by 3 months

 
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