Abstract

The primary objective of this proposal is to evaluate the efficacy of vitamin supplementation (beta-carotene, vitamin C, and vitamin E) in the treatment of oral mucosal lesions. Specifically, we plan to recruit 200 patients with oral mucosal lesions over a three year period. The following data will be obtained: diagnostic biopsy, measurement of the lesion size, clinical photographs, serum and tissue samples to determine vitamin levels, exposure to risk factors, and diet history. Clinical and biochemical evaluations will occur 1, 3, 6, and 9 months after initiation of supplementation. This will permit a statistical comparison of changes in the oral lesions to vitamin levels in the blood and tissue, exposure to risk factors, and diet. Based on the sample size, the estimated power of the repeated measures ANOVA to detect a difference among the four groups is 81% and is 86% for multinomial logistic analysis. The significance of this double-blind randomized clinical trial is that it will determine if vitamin supplementation at this dosage can reduce the size or oral mucosal lesions.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project (R01)
Project #
1R01DE009523-01A1
Application #
3223273
Study Section
Oral Biology and Medicine Subcommittee 1 (OBM)
Project Start
1991-03-01
Project End
1994-02-28
Budget Start
1991-03-01
Budget End
1992-02-29
Support Year
1
Fiscal Year
1991
Total Cost
Indirect Cost

  Institution

Name
Virginia Commonwealth University
Department
Type
Schools of Dentistry
DUNS #
City
Richmond
State
VA
Country
United States
Zip Code
23298

  Publications

Brandt, R B; Doyle, B A; Chan, W et al. (1997) The effects of running stress on plasma vitamin A levels in rats. Food Chem Toxicol 35:459-63
Kaugars, G E; Silverman Jr, S; Lovas, J G et al. (1996) Use of antioxidant supplements in the treatment of human oral leukoplakia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 81:5-14
Brandt, R B; Kaugars, G E; Riley, W T et al. (1996) Evaluation of serum and tissue levels of alpha-tocopherol. Biochem Mol Med 57:64-6
Kaugars, G; Silverman Jr, S (1995) The use of 13-cis-retinoic acid in the treatment of oral leukoplakia: short-term observations. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 79:264-5
Kaugars, G E; Silverman Jr, S; Lovas, J G et al. (1994) A clinical trial of antioxidant supplements in the treatment of oral leukoplakia. Oral Surg Oral Med Oral Pathol 78:462-8
Brandt, R; Kaugars, G E; Riley, W T et al. (1994) Evaluation of serum and tissue levels of beta-carotene. Biochem Med Metab Biol 51:55-60
Kaugars, G E; Silverman Jr, S; Lovas, J G et al. (1993) A review of the use of antioxidant supplements in the treatment of human oral leukoplakia. J Cell Biochem Suppl 17F:292-8