Objective: The purpose of the clinical study was to evaluate response of a 5.3% hydrogen peroxide tooth whitening strip system in conditions of fluorosis or other white/brown enamel discoloration. Methods: A total of 46 subjects 10 to 18 years of age used 5.3% hydrogen peroxide whitening strips. Of these, 18 subjects (39%) had visible fluorosis or other white/brown enamel discoloration prior to treatment, while the remaining 28 subjects had more uniform yellow tooth discoloration. Treatment was twice daily over an 8-week period (maxillary arch followed by mandibular arch), with efficacy measured using digital image analysis. Results: Mean baseline tooth color was less yellow (p =0.01) and brighter (p =0.08) among subjects with enamel discoloration. The following changes (CIE units) were noted:

	Enamel Discoloration		No Enamel Discoloration
DL*	2wks: 1.9	4wks: 2.3	2wks 2.0	4wks 2.2
Db*	2wks -2.0	4wks -2.4	2wks -2.2	4wks -2.9
DE*	2wks 3.1	4wks 3.8	2wks 3.2	4wks 3.9

Both groups experienced significant (p < 0.0001) color improvements after 2 or 4 weeks whitening strip treatment. The two diagnostic categories did not differ significantly (p > 0.30) with respect to response at any time points. Less than 11% of subjects reported tooth sensitivity or oral irritation, and no subject discontinued treatment early due to an adverse event. Conclusion: These data demonstrated statistically significant improvement in color for pre-teens and teens with enamel discoloration, similar in magnitude to that seen for children without these enamel defects.

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