Evaluation of the safety and efficacy of an automated flossing device: a randomized controlled trial.

OBJECTIVE

To evaluate the safety and efficacy of a newly developed automated flossing device (AF).

METHODOLOGY

Subjects were recruited from a university campus via announcements, and were randomly assigned to a control (C), manual (M), or automated (A) group. Subjects brushed twice a day and treatment groups used their respective floss daily. The safety assessment (SA), plaque index (PI), and gingival index (GI) were measured at days one, 15, and 30. A pre- and post-intervention PI was measured at days 15 and 30.

RESULTS

The majority of subjects (n=76) were students, mean age +/- SD of 23.3 +/- 5.2 years. Based on one-way analysis of covariance, C had a higher mean PI score than A at days 15 (p = 0.019) and 30 (p < 0.001), and M had a higher mean PI score than A at day 30 (p = 0.022). The C had a higher mean GI score than A at day 30 (p = 0.034). The SA included trauma associated with improper use of the AF for two subjects.

CONCLUSION

At four weeks, the AF removed more interproximal plaque than M, and there was less interdental inflammation compared to brushing alone. The AF is safe and effective when used properly, and demonstrates great promise as an alternative to manual floss.