Efficacy and Safety of an Innovative Intraoral Cleaning Device—A Randomized Controlled Clinical Trial

Objective This two‐centre, double‐blind, randomized, parallel‐group study compared the efficacy and safety of a novel powered full‐mouth cleaning device system (FMCD) with habitual toothbrushing (CG) in patients with generalized gingivitis over 6 weeks. Methods Participants between 18 and 65 years with generalized plaque‐induced gingivitis were randomly assigned to FMCD ( n = 62) or CG ( n = 61). At baseline and after 6 weeks, participants were clinically examined. The primary outcome parameter was the change of bleeding on marginal probing (BOMP). As secondary parameters, the extended Turesky modified Quigley Hein plaque index (PI), gingival abrasions (GA), pocket probing depth (PPD), clinical attachment level (CAL), gingival recessions (GR), oral health impact profile and motivational factors for toothbrushing were evaluated. Results BOMP did not differ significantly between FMCD and CG neither at baseline (FMCD: 66.90% ± 19.28%/CG: 64.13% ± 18.50%; p = 0.415) nor did the change after 6 weeks (FMCD: 0.17% ± 15.93%; −3.47% ± 14.01%; p = 0.181). PI did not differ significantly between groups at baseline (FMCD: 2.95 ± 0.45/CG: 2.96 ± 0.41; p = 0.948), but the change after 6 weeks differed statistically significantly between the groups (FMCD: 0.16 ± 0.41/CG: −0.06 ± 0.39; p = 0.003). GA and GR showed clinically minor though statistically significant differences between the groups that were not considered clinically relevant. No other secondary outcomes differed between groups. There were no serious adverse events. Conclusion The FMCD seems to be equally effective compared to a habitually used toothbrush regarding parameters of gingivitis but slightly less effective with regard to parameters of plaque.