Methods and Protocols (Oct 2023)
Efficacy of Sonic-Powered and Manual Toothbrushes on Plaque-Induced Gingivitis in Pregnant Women: A Randomized Controlled Trial
Abstract
Hormonal changes and physiological alterations in pregnancy increase the susceptibility of the woman to oral diseases such as plaque-induced gingivitis. In individual oral prophylaxis, effective tooth brushing can reduce gingival inflammation. Therefore, it is necessary to update the scientific evidence to identify which type of toothbrush, manual or sonic-powered, is most effective in reducing the incidence of gingivitis in pregnant women. The aim of this clinical trial is to compare the biofilm control effectiveness of two manual and two sonic toothbrushes in pregnant women. This study is designed as a four-arm, parallel, randomized controlled trial with an allocation ratio of 1:1:1:1. The pregnant woman will be included at 15–18 weeks of amenorrhea and followed for 3 months. The primary outcome will be the change in the incidence of gingival bleeding from a baseline and various follow-up periods of the study. Secondary outcomes measures will be to compare clinical effects of the toothbrushes tested on (i) gingival inflammation, (ii) dental plaque, (iii) gingival attachment and (iv) periodontal pocket; and to assess toothbrush acceptability. Thus, identifying the best device for effective tooth brushing in pregnancy could be helpful in reducing and improving the incidence of gingival inflammation.
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