Effect of oral health on oral leukoplakia - a clinical trial
Active, not recruiting
- Conditions
- Oral Leukoplakia
- Registration Number
- CTRI/2017/03/008108
- Brief Summary
This study is a randomized, open label, parallel group, single-centre clinical trail, assessing the effect of improving oral health on clinical regression of oral leukoplakia. The primary outcome measures will be 50% regression of oral leukoplakia size within 6 weeks. The secondary outcome will be up to 100% regression of oral leukoplakia size at 3 - 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- Any form of Oral Leukoplakia, homogenous/non-homogenous diagnosed by clinical inspection and palpation.
- Patients with Oral Leukoplakia willing to quit their tobacco habit after habit cessation counselling.
Exclusion Criteria
- Patients not willing to participate in the study.
- Patients not willing to quit the tobacco habit.
- Patients who have undergone procedures required for oral health improvement (e.g., periodontic/endodontic treatment) within last 6 months.
- Patients who were on medication/ underwent any treatment for Oral Leukoplakia.
- Patients with Oral Leukoplakia along with malignant and other premalignant conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 50% regression of Oral leukoplakia size after improving oral hygiene 6 weeks
- Secondary Outcome Measures
Name Time Method Up to 100% regression of Oral leukoplakia size after improving oral hygiene 3- 6 months
Trial Locations
- Locations (1)
Department of Oral Medicine and Radiology, room number 1, Narayana Dental College
🇮🇳Nellore, ANDHRA PRADESH, India
Department of Oral Medicine and Radiology, room number 1, Narayana Dental College🇮🇳Nellore, ANDHRA PRADESH, IndiaDr Rakesh Kumar MannePrincipal investigator9704014747rmannae@rediffmail.com