A pilot clinical trial was conducted to determine the effectiveness of the FRESH Oral Care System on reducing clinical signs of gum disease as compared to manual toothbrushing alone.
Thirty-one adult subjects completed the 30-day randomized, examiner-blinded clinical trial, with 16 subjects randomly assigned to the control group, and 15 subjects randomly assigned to the FRESH Oral Care System group. All subjects used an ADA standard manual toothbrush and ADA accepted fluoride toothpaste, and were instructed to brush 2x daily according to their usual habits. The test group included 1x daily use of a prototype FRESH Oral Care System. Clinical measures of inflammation were evaluated at 6 sites per tooth using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI), and plaque was measured using the Turesky Modified Quigley-Hein Plaque Index (TMQHI).
Significant improvements in MGI and GBI were reported interproximally for the FRESH Oral Care System group compared to the control group (p<0.001) at both 15 days and 30 days. With a 24.4% improvement in MGI and an 88.9% improvement in GBI reported at interproximal sites over a 30-day period, the FRESH Oral Care System was 4.3X and 4.0X as effective as the control group, respectively. Interproximal plaque reduction was 5.1X as effective as the control group. Additionally, the FRESH Oral Care System group saw baseline-adjusted mean improvements in interproximal MGI and GBI of 13.8% and 87.0%, respectively, from baseline to 15 days.
The addition of the FRESH Oral Care System to manual toothbrushing resulted in significant reductions in interproximal gum disease compared to manual brushing alone after both 15 days and 30 days of use, and was up to 4.3X as effective as brushing alone in reducing clinical signs of gum disease.