Clinical Evaluation on Extrinsic Stain Prevention of a Commercial Dentifrice

Objectives: The purpose of this pilot clinical study was to determine the preventive effect of a test dentifrice on dental stain accumulation after dental prophylaxis. Methods: The study was designed as a randomized, double-blind, parallel arm study. Test dentifrice contained disodium POE alkyl sulfosuccinate that was demonstrated preventive effect of stain accumulation in vitro and micronized high cleaning silica (Ora2 stainclear paste, RDA120, SUNSTAR Inc.). Placebo dentifrice (RDA90) does not contained active ingredients as above. 48 subjects, who were judged as tending to accumulate extrinsic stain by dentists and consented to participate, were included in the study. At baseline, initial pictures of the facial surfaces of the four mandibular incisors with shade guides were taken after dental prophylaxis. Then the subjects were randomly assigned into two groups and instructed to brush their teeth once or more daily with a provided commercial toothbrush and the test or the placebo dentifrice during the study. After three months, final pictures were taken as well as baseline. Six doctors and hygienists evaluated stain accumulation on each tooth comparing the initial and final pictures with the following criteria, (0)no additional stain, (1)light additional stain, (2)moderate additional stain, (3)heavy additional stain. The total of four teeth scores, which were averages of four evaluations of each tooth without minimum and maximum, was calculated as the stain score of the subject individual. Results: 21 subjects in the test dentifrice group and 20 subjects in the placebo dentifrice group completed this study. The stain score of the test dentifrice group (mean;1.35, SE;0.52) differed significantly from that of the placebo dentifrice group (mean;2.89, SE;0.60) (p<0.05, t-test). Conclusions: This study indicated that the use of the "Ora2 stainclear paste" was effective in prevention of extrinsic dental stain accumulation after dental prophylaxis, as compared to a placebo dentifrice.