Evaluation of Tooth Color Modifications Using FP137 Take-Home Whitening Gels

Objective: To perform a seven-day evaluation of whitening efficacy, dentinal sensitivity and soft tissue irritation of take-home bleaching agents.

Methods: Randomized, split-arch clinical trial was conducted. Subjects (n=60) were randomized into three treatment groups (n=20/gp): Group 1- 6% H2O2; Group 2- 10% H2O2; Group 3- 15% H2O2 (FP 137, Dentsply). All subjects received two custom upper trays: T1 to whiten teeth #6-11; T2 randomized to whiten either right side (#6, 7, 8) or left side (#9, 10, 11) (n=10/gp). First application: teeth whitened using T1; second application: teeth whitened using T2. Subjects whitened teeth twice a day for seven days: one application of T1 and second application of T2. Gel was applied: 30 minutes (Groups 1, 2); 15 minutes (Group 3) per application. Shades were selected utilizing a VitaShade Guide by two calibrated evaluators; recordings were taken at Baseline, Day-4, Day-8, Day-22, 3- and 6-months.

Results: Statistical analysis used Kruskal-Wallis test for inter-group comparisons and Wilcoxon signed-rank test for comparisons within each group across different time points and comparisons of one side of mouth to other. There was no statistically significant difference in shade between groups; on left side and right side of the mouth. Groups showed improvements over baseline. Soft tissue irritation was lower in Group 1 (22.2%) as compared to Groups 2 and 3 (76.5% and 75.0%, p=0.0008). Using VAS, Group 1 demonstrated lower incidence and severity of sensitivity than Groups 2 and 3 (with the p-value 0.02 to 0.05).

Conclusion: There was no statistical significant difference between the three groups regarding whitening efficacy suggesting the second application resulted in no additional benefit. The use of 6% H2O2 (Group 1) showed lower soft tissue irritation, incidence and severity of sensitivity. All groups had a significant benefit over pre-treatment values. (Funded in part by Dentsply.)