Abstract
Background: A randomized clinical trial was performed to test the efficacy of a fluoridated hydrogen peroxide-based mouthrinse on gingivitis and tooth whitening in a two-phase study. The first phase (28 days) included the experimental gingivitis phase; the second phase (5 months) was the oral hygiene phase, which included rinsing. Methods: A total of 99 subjects were included in the study and were randomly assigned to receive either placebo or test mouthrinse. Clinical measures were chosen to reflect the gingival health and tooth whiteness in an intent-to-treat study design. Statistical analyses of clinical parameters related to gingival health and tooth color were conducted, using the method of generalized estimating equations (GEE), with an exchangeable working correlation to accommodate tooth-level data. Baseline differences between the groups were adjusted. Microbial samples taken at the beginning and at the end of the study were analyzed by DNA-DNA hybridization technique, to determine whether there was any adverse shift in supragingival flora. Results: Eastman bleeding index, modified gingival index, intensity of stain, and extent of stain were significantly reduced in the test group at 6 months compared to baseline (P