Friday, July 26, 2013

Safety and efficacy of a high-adhesion whitening strip under extended wear regimen

I would love to see a split test between trays and strips. MJ

Volume 41, Supplement 3, August 2013, Pages e46–e52
Journal of Color and Apperance in Dentistry

Abstract

Objectives

This randomized, parallel group, single centre clinical trial was conducted to evaluate the safety and compare the whitening efficacy for an extended wear of an experimental 9.5% H2O2 high-adhesion whitening strip, relative to a marketed 10% H2O2 control strip.

Methods

Twenty-nine eligible adult volunteers were randomly assigned to either a treatment series with an experimental 9.5% H2O2 high-adhesion whitening strip at home for 2 h, once a day, for 8 days; or a marketed 10% H2O2 whitening strip for 30 min, on a similar daily regimen. Tooth color/whitening progression was recorded under standardized lighting conditions at baseline, day 3, day 5, and day 9, via digital imaging. Outcomes were reported using the CIELAB system. Usage safety was also assessed at each follow-up visit. Whitening efficacy for each group was investigated using a paired-difference t-test. The treatment groups were compared among each other using the analysis of covariance, with the baseline value and age as the covariates.

Results

Both treatment groups demonstrated statistically significant mean color improvement from baseline for b* (yellowness) and L* (lightness) at each post-baseline visit. In addition, the 2-h high-adhesion strips demonstrated significantly greater improvement in b* and L* relative to the 30-min strip group at each follow-up visit.

Conclusions

The 2-h regimen for the 9.5% H2O2 high-adhesion whitening strip was more efficient for tooth whitening than the 30-min regimen of 10% H2O2 whitening strip. Both treatments were well tolerated and the use of the test products during the study time frame was considered safe.

Clinical relevance

Extending the daily wear time of whitening strips can improve the efficacy of the treatment and ultimately shorten the length of the treatment without any significant adverse effects.

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