Objective: To assess the effect of alpha-tocopherol and beta-carotene supplementation on the prevalence of oral mucosal lesions in smokers.
Design: An end-point examination of a random sample of participants in a controlled trial for 5-7 years (Alpha-Tocopherol Beta-Carotene Cancer Prevention Study) in Helsinki, Finland.
Subjects: A total of 409 white male cigarette smokers, aged 55-74 years who received either alpha-tocopherol (50 mg per day) or beta-carotene (20 mg per day) supplementation, both of these or placebo capsules.
Methods: Clinical examination of oral mucosae, histological examination of lesions showing leukoplakia and cytological examination of buccal epithelium. Statistical analysis using Fisher's exact test.
Results: No statistically significant differences were found between the study groups either in the prevalence of oral mucosal lesions or in the cells of unkeratinized epithelium. Leukoplakia was present in 24 (5.9%) of the subjects. Seven lesions showed dysplasia.
Conclusion: The present study on oral health does not support the hypothesis that alpha-tocopherol or beta-carotene supplementation plays an essential role in preventing oral mucosal changes in smokers.