Title: Whitening Efficacy of a Peroxide-and Fluoride-containing Mouthrinse: A Three-week Study
Authors: Lisa Fitzgerald1, Lynn Friesen2, Roland Perfekt3, Michael Lynch1
1Johnson&Johnson, Morris Plains NJ, 2UMKC School of Dentistry, Kansas City, MO, 3Johnson&Johnson, Helsingborg, Sweden
Objective: To determine whitening efficacy of a peroxide-and fluoride-containing mouthrinse formulation (PAF).
Methods: This randomized, observer-blind, single-center, controlled, parallel-design, assessed the whitening potential of a PAF formulation plus brushing with a standard anti-cavity toothpaste versus brushing with standard anti-cavity toothpaste alone. Healthy volunteers who provided informed consent and met inclusion/exclusion criteria were enrolled. A total of 109 subjects were randomized into the two groups; Brushing Only (BO) or Brushing + PAF (B+PAF). Subjects used their assigned product(s) 2X a day for 21 days. Mean Lobene Stain Index composite scores (LSI) were measured on two pre-designated teeth. Assessments were at baseline, day 5 and weeks 1, 2, 3. Safety was assessed at each visit via oral examinations and subject-reported events. Analyses of mean LSI was performed hierarchically from week 3 assessment, sequentially going to the next earlier time point. ANCOVA models were used throughout with baseline as covariate.
Results: The B+PAF group showed an 83% reduction in stain as compared to BO. There were 9 adverse events documented between groups throughout the study. All events were considered mild. Overall the PAF formulation was well tolerated by the population tested.
Mean LSI | (BO)
| (B+PAF) | Estimated percent reduction B+PAF versus BO |
| Adjusted mean ± s.e |
| |
Baseline** | 2.81 ± 0.14 | 2.78 ± 0.12 |
|
Day 5 | 2.31 ± 0.064 | 1.52 ± 0.065 | - 34.0 * |
Week 1 | 2.12 ± 0.066 | 0.96 ± 0.067 | - 54.7 * |
Week 2
| 2.19 ± 0.054 | 0.51 ± 0.055 | - 76.6 * |
Week 3 | 2.30 ± 0.054 | 0.39 ± 0.055 | - 83.0* |
* statistically significant (p < 0.001) ** Observed mean ± s.e.
| |||
Conclusion: LISTERINE® Vibrant White significantly reduced tooth stain by 83% over a three-week period compared to brushing alone.
This abstract is based on research that was funded entirely or partially by an outside source: Johnson & Johnson Consumer and Personal Products Worldwide were responsible for the funding of this study.