A study to compare two types of injections for improving cheek flexibility, reducing burning sensation, pain in patients with oral submucous fibrosis

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 - NIL

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108276

Enrollment

Registered

2026-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: 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

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: bi weekly for five weeks	—

Secondary

Measure	Time frame
Increase in maximum interincisal mouth opening (in mm) measured using Vernier caliperTimepoint: Baseline & at the end of 5 weeks	—

Countries

India

Contacts

Public ContactDr Parag Wankhede

Dr. D. Y. Patil Dental College and Hospital, Pune

anuj.maini@dpu.edu.in7973358337

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026