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JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
The Effect of Use of a Sonic Power Toothbrush and a Manual Toothbrush Control on Plaque and Gingivitis.
Journal of Clinical Dentistry 2017 March
OBJECTIVES: To compare the ability of the Philips Sonicare DiamondClean power toothbrush and the ADA Reference manual toothbrush to reduce plaque and gingival inflammation by routine manual toothbrush users.
METHODS: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate.
RESULTS: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001).
CONCLUSIONS: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.
METHODS: This was a randomized, single-blind, parallel-design study. Eligible subjects were generally healthy non-smokers who exhibited mild to moderate gingivitis upon study entry. Enrolled subjects were randomly allocated to commence twice-daily home use of either a Philips Sonicare DiamondClean (DiamondClean) power toothbrush or an ADA reference manual toothbrush (MTB) for a period of four weeks. Clinical safety and efficacy were assessed after a two- and four-week period of home use. Statistical analysis was performed for the modified intent to treat (mITT) population using a mixed model with the Baseline score as a covariate.
RESULTS: A total of 182 volunteers were screened, 144 (72 per treatment) were randomized, and 142 subjects completed this study. Following four weeks of use, the Least Square (LS) Mean SE) percent reduction in surface plaque was 34.9% (1.8) for DiamondClean and 8.0% (1.7) for MTB, (p < 0.0001). At the same four-week time point, the LS Mean (SE) percent reduction in gingival inflammation for DiamondClean was 25.5% (1.9) and 19.1% (1.9) for MTB (p = 0.0213). For gingival bleeding, the LS Mean (SE) percent reduction in sites with gingival bleeding for DiamondClean was 57.4% (3.06) and 31.4% (3.04) for MTB (p < 0.0001).
CONCLUSIONS: The Philips Sonicare DiamondClean power toothbrush was statistically significantly more effective than a manual toothbrush in reducing supragingival plaque, gingival inflammation, and gingival bleeding following a four-week period of home use. Both products were safe for home use.
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