Abstract
BACKGROUND: To evaluate the efficacy and safety of oral irrigator (OI) in controlling dental plaque and gingivitis. METHODS: Ninety participants diagnosed with gingivitis were randomly assigned to two groups, given a toothbrush combined with OI (WaterPik(®)) (test) or a toothbrush alone (control). The Turesky-Modified Quigley-Hein Plaque Index (T-QH), Modified Gingival Index (MGI), Bleeding Index (BI), and percentage of sites with bleeding on probing (BOP%) were evaluated at baseline, 4 weeks, 8 weeks, and 12 weeks. The full analysis set (FAS) and per-protocol set (PPS) were analyzed. Adverse events were recorded through electronic diaries and examinations. RESULTS: Of the 90 participants, the efficacy was assessed in the following numbers (FAS/PPS): test (45/33) and control (43/38). Compared with the control, MGI, BI, and BOP% were significantly lower in the test group after 4 weeks (4 weeks: p = 0.017, p = 0.001, and p = 0.001, respectively; 8 weeks and 12 weeks: p < 0.001 for all, FAS); T-QH was significantly lower after 8 weeks (8 weeks: p = 0.033; 12 weeks: p = 0.006, FAS). Transient gingival bleeding may be associated with OI. Self-reported pain and dentin hypersensitivity symptoms were similar between groups. CONCLUSIONS: As adjuncts to toothbrushing, OI demonstrated significantly better efficacy in controlling dental plaque and gingival inflammation with no substantial safety hazards.