A Study Comparing Two Injection Treatments for Patients with Oral Submucous Fibrosis (OSMF): Dexamethasone with Hyaluronidase vs Platelet-Rich Plasma (PRP), and Their Effects on Mouth Opening and Symptoms

Comparative evaluation of Injection dexamethasone with Hyaluronidase and Injection Platelet Rich Plasma (PRP) in Management of Oral Submucous Fibrosis (OSMF)- A randomized controlled trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092173

Enrollment

Registered

2025-08-01

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

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 Health Condition 2: K135- Oral submucous fibrosis

Interventions

Intervention1: Platelet rich plasma: Patients of intervention group will be given freshly prepared Platelet rich plasma from their own blood sample, for that blood sample of 10 ml will be withdrawn an

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with age greater than 18 years and of either gender 2) Individuals with clinically diagnosed oral submucous fibrosis in stages I II and III (according to the classification of Nagesh and Bailoor 1993) 3) Patients who are willing to participate in the study

Exclusion criteria

Exclusion criteria: 1) Patients who did not give consent for participation. 2) Patients in which steroids are contraindicated. 3) Patients with systemic disorders. (Patients on anticoagulant therapy diabetes mellitus hypertension bronchitis) 4) Patients with severely reduced mouth-opening 5) Pregnant women and lactating mothers

Design outcomes

Primary

Measure	Time frame
Efficacy of Triamcinolone acetonide with hyaluronidase injection versus Platelet rich plasma injection in OSMF patients in parameters as 1.Mouth opening (Inter-incisal distance IID) 2.Burning sensation and pain 3.cheek flexibilityTimepoint: The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.	—

Measure

Time frame

Efficacy of Triamcinolone acetonide with hyaluronidase injection versus Platelet rich plasma injection in OSMF patients in parameters as 1.Mouth opening (Inter-incisal distance IID) 2.Burning sensation and pain 3.cheek flexibilityTimepoint: The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.

—

Secondary

Measure	Time frame
NILTimepoint: NIL	—

Countries

India

Contacts

Public ContactDr Sneha Sarang

Professor and head of department

drmaheshschavan@gmail.com9823623445

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026