Exercise device to increase mouth opening in reduced mouth opening conditions
- 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
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.
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
Name Time Method 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
Name Time Method Difficulty in eating and swallowingTimepoint: 6 months