A multi-centre trial for the treatment of oral leukoplakia with the aid of chemopreventive agents
- Conditions
- Oral leukoplakia
- Registration Number
- JPRN-UMIN000002933
- Lead Sponsor
- Department of Maxillofacial Surgery, Aichi-Gakuin University School of Dentistry
- Brief Summary
The overall clinical response rate in the experimental arm (low dose of beta-carotene and vitamin C) was 17.4% and 4.3% in the placebo arm (P=0.346). During the follow-up period (median 60 months), two subjects in the experimental arm and three subjects in the control arm developed oral cancer. The relative risk for supplementing with beta-carotene and vitamin C was 0.77 (95%CI: 0.28-1.89) (P=0.580) by the Cox proportional hazards model. No untoward side effects have been noted. The supplemental low dose of beta-carotene and vitamin C for oral leukoplakia among non-smokers were neither effective for clinical remission nor for protection against cancer development statistically. (The Annual Conference of the British Association of Oral Surgeons ,December 2009, Birmingham,UK)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 46
Not provided
1) Any other specific disorders that could appear as a white lesion such as frictional keratosis, hairly leukoplakia, leukoedema, oral lichen planus and erythroplakia 2) Severe dysplasia, carcinoma in situ or micro-invasive carcinoma 3) Current smokers 4) Having adverse medical problems 5) Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical remission
- Secondary Outcome Measures
Name Time Method ikelihood of malignant transformation