Randomized controlled trial evaluating concurrent gingivitis and stain effects of a two-step dentifrice/gel sequence.

PURPOSE: A randomized controlled trial was conducted to evaluate the clinical efficacy of a two-step dentifrice/whitening gel oral hygiene sequence on natural gingivitis and extrinsic stain. METHODS: The population consisted of healthy adults with clinical evidence of gingivitis and extrinsic stain. Consent, demographic information and clinical measurements were collected, after which subjects were randomized to treatment. Eligible subjects were dispensed blinded test kits containing over-labeled two-step 0.454% SnF(2) dentifrice then 3% H(2)O(2) whitening gel sequence or a regular 0.76% NaMFP dentifrice control (Colgate Cavity Protection), plus a regular soft manual toothbrush and instructions for use. Efficacy was assessed blind-to-treatment using the Gingivitis Bleeding Index (GBI) measured whole-mouth and the composite Lobene Stain Index (LSI) measured on the anterior dentition. Treatments were compared at Week 1 and Week 3 versus baseline for DeltaGBI and DeltaLSI using a two-sided 5% level of significance. RESULTS: A total of 61 subjects with a mean (SD) age of 33.4 (12.0) years were enrolled. Overall baseline means (SD) were 0.16 (0.05) for GBI and 1.30 (0.94) for LSI. After 1 week, only the two-step 0.454% SnF(2) dentifrice then 3% H(2) O(2) whitening gel sequence demonstrated significant (P< 0.0001) reductions in both gingivitis and stain. Adjusted means for the changes with the dentifrice/gel sequence and control were -0.055 and -0.001 for DeltaGBI, and -0.619 and -0.095 for DeltaLSI, with groups differing significantly (P< 0.0001) on gingivitis and stain improvement. Outcomes at Week 3 were generally similar, with groups differing on bleeding and stain. Treatments were generally well-tolerated. CLINICAL SIGNIFICANCE: In a randomized controlled trial, use of a two-step 0.454% SnF(2) dentifrice then 3% H(2) O(2) whitening gel sequence yielded concurrent improvements in gingivitis and stain compared to regular oral hygiene.