Comparing Mouth Patches vs. Injections of Dexamethasone and Hyaluronidase in Treating Stage II Oral Stiffness - OSMF : A Clinical Trial

Comparative Evaluation of Efficacy of Dexamethasone 4mg and Hyaluronidase 0.5mg Mucoadhesive Patch with Intralesional Injection of Dexamethasone and Hyaluronidase for Oral Submucous Fibrosis Stage II: A Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/090605

Enrollment

Registered

2025-07-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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: Patients receive a Mucoadhesive Patch containing Dexamethasone 4 mg Hyaluronidase 0.5 mg: Patients (40 subjects) will be given mucoadhesive patch having combination of 4mg of dexamethas

2ml of 2% of lignocaine two times a week, along with mouth opening exercises for a period of 3 months

Eligibility

Inclusion criteria

Inclusion criteria: Patient aged between 16 to 60 years No history of prior treatment for the same Patients with OSMF stage II

Exclusion criteria

Exclusion criteria: Patients with known history of hypersensitivity to dexamethasone & hyaluronidase Patients who are diagnosed with other intra oral lesions Pregnant women and lactating mothers Immunocompromised patients

Design outcomes

Primary

Measure	Time frame
Increase in mouth openingTimepoint: baseline, 1st, 2nd, and 3rd month	—

Secondary

Measure	Time frame
Reduction in burning sensationTimepoint: baseline, 1st, 2nd, and 3rd month	—

Countries

India

Contacts

Public ContactDr. Aishwarya Bhave

Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital,Hingna

ashish.lanjekar@sdk-dentalcollege.edu.in9595052481

Outcome results

None listed

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