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Cecilia Heinisch, Karin Larsson, Johanna Mattsson, Stig Karlsson, Torgny Alstad and Ellen Bruzell
Objective: To compare two home-based over-the-counter (OTC) bleaching tray products with similar hydrogen peroxide (HP) concentrations with respect to tooth lightening efficacy and potential to induce negative side effects in tobacco- and non-tobacco users as well as degree of satisfaction with product handling. The HP concentrations were near the regulation limit for bleaching products of 6% set by the European Union in 2011.
Materials and Methods: The clinical trial was randomized, single-blind and included 41 patients (93% completed) who were allocated into three bleaching groups: non-tobacco users treated with either 16% (corresponding to 5.8% HP) or 22% (corresponding to 7.9% HP) carbamide peroxide (CP) and tobacco users treated with 22% CP. Total bleaching time was 10.5 hours within 14 days. Tooth shade was visually assessed using a commercial shade guide. Side effects and satisfaction with the bleaching outcome and product handling were reported through a perception scale and a questionnaire.
Results: Tooth lightening was similar (p>0.05) and significantly increased (p<0.05) for all groups. Patient age (> 31 years) was negatively correlated (p<0.05) and tobacco use was positively correlated (p<0.05) with bleaching efficacy. A percentage of 97% (n=38) of the patients experienced some form and degree of side effect, most frequently tooth hypersensitivity and gingival irritation. Patient satisfaction with the bleaching result was positively correlated with the user-friendliness of the product (p<0.05).
Conclusion: A large number of side effects were reported after bleaching treatment with OTC products after a short treatment time. Prior to bleaching, patients should be informed of the major individual differences in both bleaching efficacy and degree and number of side effects.