Objective: To evaluate the safety and efficacy of the Oral Health System by Fresh Health Inc., used in conjunction with manual toothbrushing (Fresh + MTB) as compared to string floss and manual toothbrushing (floss + MTB) and manual toothbrushing (MTB) alone, as measured by clinical signs of gingivitis, plaque reduction, pocket depth, and bleeding.
Methods: One hundred ninety-two (192) generally healthy adults exhibiting signs of gingivitis completed this 30-day randomized, controlled, examiner-blinded, three-group parallel study design. All subjects were assigned a manual toothbrush and fluoride dentifrice, instructed to brush twice daily according to their normal habits, and provided with written and verbal instructions for all assigned products. Subjects in the control group used only the manual toothbrush and dentifrice. Subjects assigned to the string floss + MTB group were instructed to also floss once daily. Subjects assigned to the Fresh + MTB group were provided a Fresh Health Inc. custom-fit oral irrigator and instructed to use the device once daily with water for approximately 7 seconds in addition to toothbrushing. Gingivitis was assessed using the modified gingival index (MGI), bleeding on marginal probing was assessed via the gingival bleeding index (GBI), and plaque was measured using the Rustogi modified navy plaque index (RMNPI) at day 1, day 15, and day 30. Periodontal probing depth (PPD) and bleeding on probing (BOP) were measured at day 1 and day 30. Oral soft- and hard-tissue assessments were performed at all examination visits.
Results: There was no significant difference in age or sex between groups, and no significant difference in baseline MGI, GBI, RMNPI, BOP, and PPD values across groups. The Fresh + MTB group demonstrated statistically significantly better performance than the floss + MTB group and MTB group across all clinical indices at both 15 days and 30 days. At 30 days, the Fresh + MTB group showed a 40.9% improvement in whole-mouth MGI, which was significantly greater than the MTB and floss + MTB groups.