A randomized, clinical evaluation of the safety and efficacy of a novel oral irrigator

Purpose: To evaluate the safety and efficacy of the Braun Oral-B OxyJet (MD 15) Oral Irrigator when used as an adjunct to manual brushing. Materials a nd Methods: 64 subjects with mild-to-moderate gingivitis entered this rando mized, parallel-group, examiner-blind 8-week study. Subjects were assigned to use either the MD 15 and a manual brush, or a manual brush alone. Both g roups brushed twice daily; the MD15 subjects, in addition to brushing, also used the irrigator in the evening. Subjects were scored at baseline, week 4 and week 8 at up to 168 oral sites for gingival inflammation (modified gi ngival index), gingival bleeding (angular bleeding index), and plaque (modi fied plaque index). Results: No adverse events related to study treatment w ere reported. Use of the MD15 in conjunction with manual brushing resulted in significant (P < 0.05) decreases from baseline in the plaque index at we ek 8, the gingival index at week 4, and the bleeding index at weeks 4 and 8 . The gingival index was also decreased from baseline at week 8, but this w as not statistically significant (P = 0.069). The control group also showed significant decreases from baseline for the gingival index at week 8 and t he bleeding index at weeks 4 and 8, but plaque scores were not significantl y reduced. Although use of the MD15 plus brushing significantly reduced pla que levels from baseline, while brushing alone did not, the difference betw een the two groups did not achieve statistical significance (P = 0.065). Di fferences between the groups with respect to the gingival and bleeding indi ces were also not statistically significant. It is concluded that use of th e OxyJet Oral Irrigator in conjunction with manual brushing is safe, reduce s plaque and improves gingival health.