Thirty-day evaluation of the Stimu-gum gingival stimulator and tooth polisher for clinical safety and efficacy.
Two clinical studies have been performed to assess the intraoral safety and efficacy of a mechanical device containing a rubber cup polisher and interdental stimulator (Stimu-gum). In the first study the potential for producing irritation of the oral mucosal tissues was evaluated in 19 subjects when the Stimu-gum product was used in an exaggerated manner, i.e., five times a day for seven days. No untoward effects attributed to use of the Stimu-gum product were observed or reported at anytime in the study. A thirty-day study on 64 subjects compared the Stimu-gum device with an Oral-B 35 manual toothbrush for safety, plaque removal and gingivitis evaluations, at baseline and after 15 and 30 days of product use. The Stimu-gum product and the Oral-B toothbrush were equally effective in removing overnight plaque. The Stimu-gum device was significantly more effective than the Oral-B toothbrush in reducing gingivitis scores at 30 days and bleeding on probing at 15 days. Bleeding on probing scores continued to be lower in the Stimu-gum group at 30 days; however, differences were not statistically significant compared to the Oral-B mean scores.
Yankell
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SL
Department of Periodontics and Dental Care Systems, University of Pennsylvania, School of Dental Medicine, Philadelphia 19104.
Raidl
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AE
Shi
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Emling
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RC
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D003742:Dental Devices, Home Care; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D016037:Single-Blind Method