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Exercise device to increase mouth opening in reduced mouth opening conditions

Not Applicable
Conditions
Health Condition 1: null- Oral submucous fibrosis
Registration Number
CTRI/2013/05/003609
Lead Sponsor
Government Dental College and Hospital Nagpur
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
225
Inclusion Criteria

Oral submucous fibrosis patients who agrees to participate in the clinical trial and assures to cooperate to undergo the intervention and ready to come for the follow up visits.

Exclusion Criteria

1. Patients with istory of systemic disease with hepatic, respiratory, renal, cardiac or haematological disease.

2. Patients with presence of any malignancy associated.

3. Patient with persistent infection or severe

infection in the last 3 months.

4. Patient who cannot be relied upon to comply or who are unwilling to sign informed consent.

5. Patients requiring treatment during the study period with drugs not permitted by the study protocol.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Interincisal distance on maximum mouth opening in mm <br/ ><br>2. Visual Analogue Scale in percentage for burning sensationTimepoint: 1. 6 months <br/ ><br>2. 6 months
Secondary Outcome Measures
NameTimeMethod
Difficulty in eating and swallowingTimepoint: 6 months
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