Objectives: To study the clinical safety profile of two different whitening products using a paint on formulation or a customized tray designed for at home bleaching.
Methods: 60 patients attending a Portuguese dental school clinic were recruited for this study. This was a two arm parallel RCT in which each patient was randomized to one of two groups: Vivastyle Paint On Plus (PO+) with 6 % hydrogen peroxide (HP) designed as a paint on formulation or Vivastyle 10% (VS10) with 10% Carbamide Peroxide (CP) designed for customized tray at home use (both from Vivadent, Lichenstein PL). Bleaching regimen was followed as determined by manufacturer protocols. Safety parameters assessed were: Total amount of HP applied (THP) determined by a cerium based titration method, HP released into the saliva (HPS) and HP remaining in oral cavity and tray/varnish after the bleaching period (HPR) determined by an established photometric method and expressed in Mean±S.E.M. of mg of HP per kg of bodyweight (mg/kg/bw). Mean differences were tested with Student t Test, significance level was set at α= 0.05. Total systemic HP exposure was recorded for each patient as over or under 0.26 mg/kg/day which is the threshold value for over exposure obtained from literature. This study was approved by the local ethical committee.
Results:
Product | THP (mg/kg/bw) | HPS (mg/kg/bw) | HPR (mg/kg/bw) | |||
Mean | S.E.M. | Mean | S.E.M. | Mean | S.E.M. | |
VS10 | 5.437E-01 | 3.818E-02 | 4.773E-02 | 5,368E-03 | 4,700E-02 | 9,917E-03 |
PO+ | 1.091E-01 | 7.400E-03 | 4.742E-03 | 8,600E-04 | 2,525E-04 | 6,000E-05 |
Conclusions: The results of this study suggest that both Paint on and tray whitening bleaching using 6% HP and 10% CP are safe regarding HP systemic exposure.