Objective: To evaluate the effect of a substantive 19% sodium percarbonate bleaching film on tooth colour, oral hygiene and gingival health. Methods: 51 healthy adults were randomized to either test (bleaching film, Crest®/ Blend-a-Med® Night Effects™ -25 persons) or control (placebo film – 26 persons) group, after balancing for age, smoking and baseline colour. Test products were self-applied to facial surfaces of teeth and left overnight, daily for 2 weeks. Data were collected at baseline, 7, 14 days and 3, 6 months. Tooth colour response was measured objectively using L*a*b* values resulting from digital image analysis. Oral health status was evaluated from Gingival Index (Loe-Silness) and Plaque Index (Turesky Modification of Quigley-Hein -Q-H) measurements. Results: After two weeks the test group showed a significant change in composite tooth colour. Mean DW was –2.36±0.84 in the test group, versus –0.29± 0.42 in controls. Similar results were seen for other colour parameters. A significant reduction of GI in the test and control groups was equal: 33,3% (p<0.001, p=0.008), respectively. Day-14 mean Q-H was reduced about 14% (p=0.003) in test group and 19% (p<0.001) in controls. Reductions in GI and Q-H in both groups were maintained at 6 months. Differences in GI and Q-H between test and control groups were not significant. No significant adverse effects were observed in either group. Conclusions: This study demonstrates the percarbonate bleaching film is both safe and effective for tooth whitening. A similar improvement in oral hygiene and gingival health was found in both groups.

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