The Efficacy and Safety of Oral Irrigator on the Control of Dental Plaque and Gingivitis: A Randomized, Single-Blind, Parallel-Group Clinical Trial

Xiaolin Ren, Jing He, Ran Cheng, Yulun Chen, Yong Xiang, Yuhan Zhang, Sulan Jiang, Jia Li, Li Cheng () and Tao Hu
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Xiaolin Ren: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Jing He: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Ran Cheng: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Yulun Chen: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Yong Xiang: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Yuhan Zhang: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Sulan Jiang: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Jia Li: State Institute of Drug Clinical Trial, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Li Cheng: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China
Tao Hu: State Key Laboratory of Oral Diseases, National Clinical Research Center for Oral Diseases, Department of Preventive Dentistry, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China

IJERPH, 2023, vol. 20, issue 4, 1-15

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.

Keywords: oral hygiene; oral irrigator; dental plaque; gingivitis; clinical trial (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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