RESUMO
PURPOSE: To assess tooth color changes and tolerability with use of a hydrogen peroxide whitening strip compared to a regimen of a strip, rinse and paste for tooth whitening. METHODS: This was a single-center, parallel-group, double-blind, randomized controlled clinical trial. Qualified generally healthy adult participants were assigned to one of two treatment groups. The test group included peroxide-free strips, a fluoride-free whitening toothpaste, and a whitening mouthwash (all Lumineux Oral Essentials); all test products contain plant-based oils (coconut, sage, and lemon peel) and Dead Sea salt. The control group included hydrogen peroxide whitening strips (Crest 3DWhitestrips Classic White) and a sodium fluoride non-whitening toothpaste (Crest). Both groups used a soft manual toothbrush (Oral-B). Strips (for both groups) and rinse (for test group) were used once daily. Changes in tooth color were assessed objectively and quantitatively by digital image analysis after 7, 10 and 14 treatments. RESULTS: 50 participants were enrolled and randomized to treatment and 48 completed the trial. Participants had an average age of 40.8 years (range 18 to 62 years) and 64% were female. At the end of treatment, the test group did not provide statistically significant changes in yellowness (b*) or lightness (L*) from baseline (P≥ 0.411), whereas the control group demonstrated a statistically significant mean yellowness reduction (SD) of 1.55 (0.703) and a mean lightness improvement (SD) of 1.57 (1.141) compared to baseline (P< 0.001 for both). The control group also provided statistically significantly greater mean yellowness reductions and mean lightness improvements compared to the test group at all time points (P< 0.002). Products in both groups were well tolerated, with minor oral irritation and tooth sensitivity representing the most common findings during treatment. CLINICAL SIGNIFICANCE: The Crest Whitestrips control whitening strip provided significant tooth whitening efficacy, whereas the Lumineux Oral Essentials test regimen containing plant-based oils and Dead Sea salt did not. This evidence is important for dental professionals to consider when making recommendations for patients seeking at-home whitening treatments.