A HOSPITAL BASED STUDY TO COMPARE THE EFFICACY OF LYCOPENE AND SERRATIOPEPTIDASE IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS
Phase 3
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2022/12/047901
- Lead Sponsor
- HUMAIRA HUSSAI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
For establishment of oral submucous fibrosis diagnosis, two parame-ters mentioned below were to be satisfied for inclusion in the pre-sent study-
(a) Positive history of chewing areca nut or one of its commercial preparations, difficulty in swallowing and chewing and burning sen-sation on eating spicy foods.
(b) Restricted mouth opening and changes in the oral mucous mem-brane including the presence of palpable vertical fibrous bands, stiffness and blanching.
Exclusion Criteria
Individuals with other associated oral mucosal lesions or systemic diseases, systemic conditions like pregnancy, lactating mother and those not willing for follow-up.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The outcome of both the drugs will be comparedTimepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method 1.The OSMF will be graded clinically according to the classification of Ranganathan et al <br/ ><br>2.The mouth opening will be measured with a Vernier Caliper between the incisal tips of both the arches <br/ ><br>3.Burning sensation will be gauged based on Visual Analogue Scale ranging from 0- 10 <br/ ><br>4.The degree of protrusion of tongue will be recorded in millimeters from the incisal edge of the lower teeth to the tip of tongue. <br/ ><br>5.Palpatory findings will be recorded as positive when a lack of suppleness and palpable fibrous bands or marked stiffness will be evident for the areas of the right and left buccal mucosa, lips and floor of mouth. <br/ ><br>6.The site of the bands and its extent (including segmentation) in all the groups will be recorded at the initial visit and later compared with weekly interval using the criteria: 1 as Improved, 0 no change and -1 as worsen <br/ ><br>Timepoint: Recalled every week for 4 Weeks