To see effect of 3 different treatment modalities for white patch in oral cavity
Phase 4
Completed
- Conditions
- Health Condition 1: K132- Leukoplakia and other disturbancesof oral epithelium, including tongueHealth Condition 2: null- Oral Leukoplakia
- Registration Number
- CTRI/2016/12/007571
- Lead Sponsor
- Maulana Azad Institute of Dental Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 84
Inclusion Criteria
Patients with white lesion or mixed red and white lesion of oral mucosa clinically diagnosed as leukoplakia based on criteria from World Health Organization
Exclusion Criteria
1. Any white patch caused by friction
2. Patients with severe systemic disease including pregnant women, respiratory, cardiovascular, renal & hepatic disease
3. Those not willing to Participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response was graded based on size of lesion as: <br/ ><br>1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) <br/ ><br>2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) <br/ ><br>3. Stable response: no response or no change in size of lesion <br/ ><br>4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion. <br/ ><br>Timepoint: Response was graded based on size of lesion as: <br/ ><br>1. Complete response: gross response revealed no evidence of lesion for at least 4 weeks (approx. 100%) <br/ ><br>2. Partial response: decrease of less than 50% of the lesion size (approx. 50%) <br/ ><br>3. Stable response: no response or no change in size of lesion <br/ ><br>4. Disease progression: unequivocal increase in size of lesion or appearance of a new lesion. <br/ ><br>
- Secondary Outcome Measures
Name Time Method To report any malignant transformation or conversion to malignancy at any time during 9 months follow upTimepoint: Regular follow up was done at interval of 4 weeks upto 9 months. Any suspicious lesion was biopsied at interim stage.