Assessing the Impact of Oral Pentoxifylline and Vitamin E on Oral Submucous Fibrosis
Phase 2
- Conditions
- Health Condition 1: 3- Administration
- Registration Number
- CTRI/2024/04/066118
- Lead Sponsor
- Government College of Dentistry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1)All new clinically diagnosed cases of OSMF between age group 18-55 years.
2)Patients who were willing to quit gutkha, areca nut and/or with tobacco chewing habit.
3)Patients who were ready to give their consent for the treatment.
Exclusion Criteria
1)Patients who have disclosed medical history for major diseases.
2)Patients with coexisting disease or disorder of the orofacial region other than OSMF which may interfere with the study protocol.
3)Patients with or having a history of oral cancer.
4)Patients with the inadequate reference point (i.e. incisal edges of the central incisors) for measuring interincisal distance.
5)Patients with limited mouth opening reasons other than OSMF.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To eliminate the signs & symptoms, halt disease progression & reduce the predisposition for malignant transformation. <br/ ><br>Timepoint: baseline <br/ ><br>1month <br/ ><br>2month <br/ ><br>3month <br/ ><br>6months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1) To assess improvement in mouth opening. <br/ ><br>2) To assess relief from intolerance to spicy food. <br/ ><br>3) To evaluate difference in pain on opening mouth wide in control & study group. <br/ ><br>4) To evaluate difference in cheek flexibility, tongue protrusion, blanching & depapillation of tongue and the extent of fibrous bands. <br/ ><br>Timepoint: baseline <br/ ><br>1month <br/ ><br>2month <br/ ><br>3month <br/ ><br>6months