Objectives: A clinical study was conducted to evaluate cumulative use whitening response of a hydrogen peroxide whitening pre-brush mouthrinse. Methods: A randomized, examiner-blind, parallel-group, 6-week clinical trial evaluated the efficacy and safety of a whitening pre-brushing mouthrinse relative to normal toothbrushing without peroxide or pre-rinsing. The study population was 23 healthy adults with evident tooth discoloration (A2+), and no history of previous whitening. Subjects were randomly assigned 2:1 to a 2% hydrogen peroxide mouthrinse (Listerine® Whitening Pre-Rinse) followed by a regular anticavity toothpaste (Crest® Cavity Protection), or a regular anticavity toothpaste without pre-rinsing. Usage was unsupervised twice daily following manufacturers' instructions over a 6 week period. Tooth whitening efficacy was measured in CIELAB units from standard digital images, while safety was assessed from clinical examination and interview. Results: Groups were balanced on baseline demographics, behavior and tooth color. All subjects completed the 6-week study. For the maxillary teeth, Week 6 adjusted mean ± SE Db* (reduction in yellowness) was 0.09 ± 0.108 for the pre-rinse+dentifrice group and 0.40 ± 0.148 for the dentifrice group alone. Adjusted mean ± SE DL* was 0.25 ± 0.097 for the combination group and 0.26 ± 0.133 for the dentifrice control. Groups did not differ significantly with respect to end-of-treatment Db* (p = 0.11) or DL* (p = 0.97). Outcomes were similar on mandibular teeth (p > 0.12). Except for one report of stomatitis in the pre-rinse+dentifrice group, all adverse events were mild, and none contributed to dropout. Conclusion: After 6-weeks adjunctive use, a 2% hydrogen peroxide pre-rinse showed no significant tooth color improvement versus regular toothbrushing.

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