A Clinical Trial of Betamethasone, Hyaluronic Acid and Combination Of Betamethasone and Hyaluronic Acid in Treatment of Oral Submucous Fibrosis

Effectiveness of Betamethasone, Hyaluronic Acid and Combination of Betamethasone and Hyaluronic Acid in Treatment of Oral Submucous Fibrosis: A Randomised Control Double Blind Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009712

Enrollment

Registered

2017-09-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- OSMF patients

Interventions

Intervention1: 4 mg betamethasone (Bethnesol)or 1500 I.U Hyaluronidase (Hyanidase)or 4 mg betamethasone (Bethnesol) and 1500 I.U Hyaluronidase (Hyanidase): Frequency- Bi-weekly, Route of administratio

Eligibility

Inclusion criteria

Inclusion criteria: Clinically diagnosed OSMF patients with mouth opening greater than 18mm.

Exclusion criteria

Exclusion criteria: 1.Patients with mouth opening less than 18mm . 2.Patients with missing central incisors. 3.Patients with any concurrent lesion like leukoplakia, lichen planus, vesiculobullous lesions etc. 4.Pregnant and lactating female. 5.Patients with systemic history of diabetes mellitus, hypertension, thyroid disorders etc. 6.Patient either treated for OSMF or for malignancy arising in OSMF 7.Patients with history of drug allergy or hypersensitivity to hyaluronidase and betamethasone.

Design outcomes

Primary

Measure	Time frame
Maximum mouth openingTimepoint: Pre-treatment and post treatment after 5 weeks	—

Secondary

Measure	Time frame
VAS Scale QOL assesmentTimepoint: after 6 months	—

Countries

India

Contacts

Public ContactKavita Vanga

Nair Hospital Dental College

vangakavita25@gmail.com9970846364

Outcome results

None listed

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