title: A clinical study of the safety and efficacy of a novel electric interdental cleaning device.
abstract: The safety and efficacy of an electric interdental cleaning device, the Braun Oral-B Interclean (ID2) (Braun AG, Kronberg, Germany), and an American Dental Association-approved manual floss were compared over a four-week period for their effect on interproximal plaque, gingivitis and papillary bleeding with 52 healthy volunteers. Eligible subjects had a complete dental examination before being randomly assigned to one of the two experimental groups. Subjects underwent a dental prophylaxis before receiving instructions in the use of their assigned device. The three parameters of plaque, gingivitis and papillary bleeding were evaluated at Days 1 and 30. The results showed a significant reduction from baseline in all three parameters for both treatment groups (p < 0.001) over the four-week period. There was a trend toward somewhat less interproximal plaque regrowth for subjects using manual floss over four weeks compared with those using the ID2, but the difference between groups was not statistically significant. The reduction in gingivitis was comparable between the groups. Similar reductions in papillary bleeding were demonstrated in the two groups. No significant soft tissue pathology was noted in either group. The results demonstrated no statistically significant difference between manual floss and the novel electric interdental cleaning device (ID2). After the 30-day clinical assessment, subjects entered the personal preference phase of the study. Each group crossed over to the other interdental cleaner, was instructed in its use, and directed to use it for an additional 30 days. At the end of this time, all subjects completed a questionnaire. Results from this part of the study revealed that significantly more subjects preferred the ID2 (69.5%) to floss (24.5%). Only 6% expressed no preference.
authors.affiliation: TKL Research, Inc. Paramus, New Jersey, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Gordon
authors.forename: J A
authors.initials: JA
authors.lastname: Frascella
authors.forename: R C
authors.initials: RC
authors.lastname: Reardon
mesh_terms: D000704:Analysis of Variance; D018592:Cross-Over Studies; D003742:Dental Devices, Home Care; D003773:Dental Plaque / Q000517:prevention & control; D003774:Dental Plaque Index; D004560:Electricity; D005260:Female; D005891:Gingivitis / Q000517:prevention & control; D006801:Humans; D008297:Male; D009910:Oral Hygiene / Q000295:instrumentation*; D017060:Patient Satisfaction; D010512:Periodontal Index; D016037:Single-Blind Method