36541
document
Placebo-controlled trial evaluating safety with 12-months continuous use of 6 % hydrogen peroxide whitening strips . OBJECTIVE To assess the safety and tolerability of 6 % hydrogen peroxide whitening strips over 12 months . METHODS 80 adults were randomly assigned equally to one of two treatments : 6 % hydrogen peroxide strips or placebo strips . Strips were worn 5 min daily for 12 months . Safety and tolerability were assessed via oral status interviews and oral examinations at baseline and after 1 , 2 , 3 , 6 , 9 , and 12 months of use . RESULTS Tooth sensitivity and oral irritation were the two most common adverse events . After 12 months use , tooth sensitivity was reported by 10 % of subjects in the 6 % strip group with a 95 % confidence interval ( CI ) of ( 2.8 % , 23.7 % ) and 5 % of subjects in the placebo group with a 95 % CI of ( 0.6 % , 16.9 % ) . The occurrence of reported oral irritation was 0 % in the 6 % strip group with a 95 % CI of ( 0 % , 8.8 % ) and 2.5 % in the placebo strip group with a 95 % CI of ( 0.1 % , 13.2 % ) . The occurrence of observed oral irritation was also similar between groups . The groups did not differ significantly ( p > 0.67 ) for the percent of subjects with each type of adverse event . In the 6 % strip group , two subjects discontinued product use due to an adverse event ( tooth sensitivity ) compared to no subjects in the placebo group . Groups did not differ significantly ( p > 0.49 ) with respect to this outcome . CONCLUSION Use of 6 % hydrogen peroxide whitening strips over 12 months resulted in a safety profile similar to that seen with placebo strips .
36542
Intervention_Control
Placebo-controlled
36543
Intervention_Pharmacological
6 % hydrogen peroxide whitening strips
36544
Intervention_Pharmacological
6 % hydrogen peroxide whitening strips
36545
Intervention_Pharmacological
6 % hydrogen peroxide strips
36546
Intervention_Pharmacological
placebo strips
36547
Intervention_Pharmacological
6 % strip
36548
Intervention_Control
placebo
36549
Intervention_Pharmacological
6 % strip
36550
Intervention_Control
placebo strip
36551
Intervention_Pharmacological
6 % strip
36552
Intervention_Control
placebo
36553
Intervention_Pharmacological
6 % hydrogen peroxide whitening strips
36554
Intervention_Control
placebo strips
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Participant_Sample-size
80
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Participant_Age
adults