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; Tao Hu

doi:10.3390/ijerph20043726

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

Int J Environ Res Public Health. 2023 Feb 20;20(4):3726. doi: 10.3390/ijerph20043726.

Authors

Xiaolin Ren¹, Jing He¹, Ran Cheng¹, Yulun Chen¹, Yong Xiang¹, Yuhan Zhang¹, Sulan Jiang¹, Jia Li², Li Cheng¹, Tao Hu¹

Affiliations

¹ 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.
² State Institute of Drug Clinical Trial, West China Hospital of Stomatology, Sichuan University, Chengdu 610041, China.

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: clinical trial; dental plaque; gingivitis; oral hygiene; oral irrigator.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Dental Plaque*
Gingivitis*
Humans
Single-Blind Method
Toothbrushing
Treatment Outcome