A randomized, clinical evaluation of the safety and efficacy of a novel oral irrigator.
OBJECTIVE
To evaluate the safety and efficacy of the Braun Oral-B OxyJet (MD15) Oral Irrigator when used as an adjunct to manual brushing.


METHODS
64 subjects with mild-to-moderate gingivitis entered this randomized, parallel-group, examiner-blind 8-week study. Subjects were assigned to use either the MD15 and a manual brush, or a manual brush alone. Both groups 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 gingival index), gingival bleeding (angular bleeding index), and plaque (modified plaque index).


RESULTS
No adverse events related to study treatment were reported. Use of the MD15 in conjunction with manual brushing resulted in significant (P < 0.05) decreases from baseline in the plaque index at week 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 was not statistically significant (P = 0.069). The control group also showed significant decreases from baseline for the gingival index at week 8 and the bleeding index at weeks 4 and 8, but plaque scores were not significantly reduced. Although use of the MD15 plus brushing significantly reduced plaque levels from baseline, while brushing alone did not, the difference between the two groups did not achieve statistical significance (P = 0.065). Differences between the groups with respect to the gingival and bleeding indices were also not statistically significant. It is concluded that use of the OxyJet Oral Irrigator in conjunction with manual brushing is safe, reduces plaque and improves gingival health.
Frascella
J A
JA
TKL Research Inc., Paramus, New Jersey, USA.
Fernández
P
P
Gilbert
R D
RD
Cugini
M
M
D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D003742:Dental Devices, Home Care; D003774:Dental Plaque Index; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D005884:Gingival Hemorrhage / Q000628:therapy; D005891:Gingivitis / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010512:Periodontal Index; D012449:Safety; D016037:Single-Blind Method; D013223:Statistics as Topic; D007507:Therapeutic Irrigation / Q000295:instrumentation; D014099:Toothbrushing / Q000295:instrumentation; D016896:Treatment Outcome