| 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
|
|
|
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
|
|
|
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
|
|
|
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 |