| CTRI Number |
CTRI/2026/04/108276 [Registered on: 13/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to compare two types of injections for improving cheek flexibility, reducing burning sensation, pain in patients with oral submucous fibrosis |
|
Scientific Title of Study
|
Comparative evaluation of intralesional triamcinolone and hyaluronidase versus platelet rich fibrin iPRF and hyaluronidase in the treatment of grade II and grade III oral submucous fibrosis a randomized clinical 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 Parag Wankhede |
| Designation |
Postgraduate |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Outpatient Department (OPD), Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune – 411018, Maharashtra, India
Pune
MAHARASHTRA
411018
India |
| Phone |
9028500612 |
| Fax |
|
| Email |
wankhede.parag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Paul Maini |
| Designation |
Professor, Department of Oral Medicine and Radiology |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Outpatient Department, Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune – 411018, Maharashtra, India
Pune
MAHARASHTRA
411018
India |
| Phone |
7973358337 |
| Fax |
|
| Email |
anuj.maini@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parag Wankhede |
| Designation |
Postgraduate |
| Affiliation |
Dr. D. Y. Patil Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Outpatient department, Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar. Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028500612 |
| Fax |
|
| Email |
wankhede.parag@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Parag Wankhede |
| Address |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital, Sant Tukaram Nagar, Pimpri, Pune – 411018, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Parag Wankhede |
Dr. D. Y. Patil Dental College and Hospital |
Department of Oral Medicine and Radiology, Dr. D. Y. Patil Dental College and Hospital. Pimpri 411018.
Pune
MAHARASHTRA |
02027805001
wankhede.parag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. D. Y. Patil Vidhyapeeth, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable platelet rich fibrin with Hyaluronidase |
Intralesional injection of 1 mL injectable Platelet Rich Fibrin (iPRF) combined with 1 mL Hyaluronidase administered into the fibrous bands in the buccal mucosa using split-mouth design. iPRF is prepared using low-speed centrifugation protocol and injected into the submucosal plane. |
| Comparator Agent |
Triamcinolone Acetonide with Hyaluronidase |
Intralesional injection of Triamcinolone Acetonide (40 mg/mL) 1 mL combined with 1 mL Hyaluronidase administered into the fibrous bands in the buccal mucosa. The injections are given into the submucosal plane using split-mouth design. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 18 years and above.
2. Patients clinically diagnosed with Grade II and Grade III Oral Submucous Fibrosis according to Khanna and Andrade classification (1995).
3. Presence of bilateral fibrous bands in the buccal mucosa.
4. Patients willing to participate in the study and provide written informed consent.
5. Patients willing to cease the habit completely
|
|
| ExclusionCriteria |
| Details |
1. Patients currently taking systemic medications that may influence treatment outcomes.
2. Patients with platelet disorders or coagulation abnormalities.
3. Patients with systemic conditions contraindicating minor procedures.
4. Patients unwilling to participate or provide informed consent.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is no statistically significant difference between intralesional triamcinolone acetonide with hyaluronidase and injectable platelet-rich fibrin (iPRF) with hyaluronidase in improving burning sensation, pain during mouth opening, cheek flexibility, and mouth opening in patients with Grade II and Grade III Oral Submucous Fibrosis. |
bi weekly for five weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in maximum interincisal mouth opening (in mm) measured using Vernier caliper |
Baseline & at the end of 5 weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
27/04/2026 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a prospective randomized split-mouth clinical trial designed to evaluate and compare the clinical efficacy of two intralesional treatment modalities in the management of Oral Submucous Fibrosis (OSMF).
A total of 20 patients diagnosed with Grade II and Grade III OSMF were included. In each patient, both treatment modalities were administered on opposite sides of the buccal mucosa, allowing intra-individual comparison. The interventions included:
-
Injectable Platelet-Rich Fibrin (iPRF) with Hyaluronidase (test side)
-
Triamcinolone Acetonide with Hyaluronidase (control side)
Treatment was carried out over 10 bi-weekly sessions, with regular follow-up assessments.
The primary clinical parameters evaluated were:
-
Burning sensation (VAS)
-
Pain during mouth opening (VAS)
-
Cheek flexibility (measured in cm)
-
Maximum mouth opening (interincisal distance)
The study aimed to determine whether iPRF, a regenerative therapy, provides superior clinical outcomes compared to conventional corticosteroid therapy, particularly in terms of symptomatic relief and functional improvement.
Statistical analysis was performed using paired comparisons and repeated measures ANOVA to assess intra-group and inter-group differences. |