COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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Stain Removal Assessment of Two Manual Toothbrushes with an Interproximal Tooth Stain Index.

OBJECTIVE: To assess a newly developed index to measure interproximal stain and evaluate the stain removal efficacy of two commercially available manual toothbrushes.

METHODS: This was a randomized, examiner-blind, parallel-group, two-treatment clinical trial of two weeks' duration. Subjects qualified for the study if they had an average Modified Lobene Stain Index of ≥ 1.5 from two anterior teeth. At baseline, subjects brushed in front of a mirror for one minute under supervision. All subjects were provided with a standard 0.243% sodium fluoride dentifrice and were randomly assigned either an Oral-B Pulsar manual brush (OBP) or a Colgate Whitening manual brush (CW) to use for two weeks. Stain was reassessed after two weeks of product use. Stain measurements were conducted using the Modified Lobene Stain Index and the new Interproximal Modified Lobene Stain Index, which allows for assessment of stain in hard-to-reach areas using the same area and intensity scales as the Modified Lobene Stain Index.

RESULTS: Use of the two manual brushes resulted in statistically significant reductions in surface stain relative to baseline after two weeks of use. Median stain reductions were 78% and 60% for the OBP and CW, respectively, as measured by the Modified Lobene Stain Index. The mean changes in the composite scores from baseline to week two were 1.85 and 1.57 for the two treatment groups, respectively. Statistically significant reductions from baseline were also found for the intensity and extent of stain measures (p < 0.001). Similar trends were found using the new Interproximal Modified Lobene Index. Composite median stain removal percentages versus baseline were 88% and 73% for the OBP and CW groups, respectively (p < 0.001). For the interproximal sites, a median stain removal of 92% was observed with the OBP brush and 83% reduction with the CW brush. For the gingival sites, the median stain removal percentages were 83% and 50%, respectively For the body region, a median stain removal of 100% was found for both treatment groups. No statistically significant differences were found between the two groups for the mean composite scores for either index.

CONCLUSION: Both manual brushes showed effective stain removal, including interproximal hard-to-reach sites. The Interproximal Modified Lobene Stain Index gave clinically relevant results consistent with the traditional Modified Lobene Stain Index, while allowing assessment of interproximal regions.

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