COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Efficacy of three toothbrushes on established gingivitis and plaque.

PURPOSE: To evaluate the efficacy of three toothbrushes [Colgate 3600 Deep Clean (AFT version), the Colgate 3600 Deep Clean (stapled version) and the Oral B Indicator] on the removal of established gingivitis and plaque.

METHODS: This examiner-blind, three-treatment, parallel clinical research study assessed plaque removal via the comparison of pre-to- post-brushing and 4-week plaque removal measured by the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis using the Löe & Silness Gingival Index. Qualifying adult male and female subjects from the Northern New Jersey area reported to the study site after refraining from any oral hygiene procedures for 12 hours; and from eating, drinking, or smoking for 4 hours. Following an examination for gingivitis and plaque (pre-brushing), they were randomized into three balanced groups, each group using one of the three study toothbrushes in the order specified by a pre-determined randomization plan. Subjects were instructed to brush their teeth for 1 minute under supervision with their assigned toothbrush and a commercially-available toothpaste (Colgate Cavity Protection), after which they were once again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 4 weeks. They again reported to the study site at which time they were evaluated for plaque and gingivitis.

RESULTS: 109 subjects complied with the protocol and completed the clinical study. For plaque removal, comparisons were made for whole mouth, at the gingival margin and at interproximal sites. The results of the study indicated that all three test toothbrushes provided statistically significantly reductions in pre- to post-brushing plaque index scores of up to 44.0%, 38.6% and 23.6% respectively, after a single toothbrushing. Relative to the Oral B Indicator toothbrush, the Colgate 360 degree Deep Clean toothbrush (AFT version) and Colgate 360 degrees Deep Clean toothbrush (stapled version) provided a statistically significantly greater removal of plaque of up to 107% and 93.0%, respectively, after a single toothbrushing. Also, the group using the Colgate 360 degree Deep Clean toothbrush (AFT version) and the Colgate 360 degree Deep Clean toothbrush (stapled version) exhibited a statistically significantly greater removal of plaque of up to 575% and 400%, respectively, when compared to the Oral B Indicator toothbrush after 4 weeks. The group using the Colgate 3600 Deep Clean toothbrush (AFT version) and the Colgate 3600 Deep Clean toothbrush (stapled version) exhibited statistically significantly greater reductions in gingivitis of up to 23% and 17%, respectively, and greater reductions in gingivitis severity (bleeding sites) of up to 73% and 52% respectively, as compared to the Oral B Indicator toothbrush after 4 weeks. There was no statistically significant difference between the two Colgate 3600 toothbrushes for any parameter and at any comparison time.

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