Skip to content

A Clinical trial of Betamethasone in OSF.

A Randomised control trial of the Corticosteroids in OSF.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/04/005696
Enrollment
60
Registered
2015-04-13
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- Oral Submucous Fibrosis

Interventions

Intervention1: Injection Betamethasone and Injection Hyaluronidase.: injections of betamethasone sodium phosphate, 4mg/ml(Betnesol-GSK GlaxoSmithKline Pharmaceuticals Limited, Dr. Annie Beasant Road,

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with burning sensation of the oral cavity (either on eating hot and spicy food or on eating regular food) 2. Limited opening of the mouth. 3. Fibrosis of the oral cavity. 4. A positive history of current consumption of areca nut products 5. Histopathological report of OSF

Exclusion criteria

Exclusion criteria: 1. History of any medical illness or systemic disease like diabetes, hypertension, multiple allergies etc. 2. Patients undergoing any immunotherapy or active treatment for OSF or had undergone treatment for OSF within the last three months. 3. Mouth opening less than 15mms or greater than 45 mm. 4. Pregnant or lactating patients or patients intending on becoming pregnant in the next six months. 5. Patients who had used steroid harmone based contraceptive in last one month.

Design outcomes

Primary

MeasureTime frame
Mouth openingTimepoint: Weekly for 10 weeks

Secondary

MeasureTime frame
Burning sensation in the oral cavityTimepoint: Weekly for 10 weeks

Countries

India

Contacts

Public ContactKaustubh Sansare

Nair hospital dental college

kaustubhsansare@yahoo.com9821237185

Outcome results

None listed

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