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A Clinical trial of Betamethasone in OSF.

Phase 4
Conditions
Health Condition 1: null- Oral Submucous Fibrosis
Registration Number
CTRI/2015/04/005696
Lead Sponsor
none
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
60
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mouth openingTimepoint: Weekly for 10 weeks
Secondary Outcome Measures
NameTimeMethod
Burning sensation in the oral cavityTimepoint: Weekly for 10 weeks
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