Gum Health and Plaque Regrowth Response Following 4-week Interdental Hygiene Intervention

Objectives: To evaluate the effect of adjunct interproximal cleaning modalities versus a manual toothbrush control on gum health and plaque following a 28-day home use period.
Methods: This IRB approved, randomized, single-blinded parallel-design study was conducted in 287 healthy adults (mean age 35.7 years, 184females/103males). Eligible subjects were non-smokers, aged 18-65 years, with >0.5 per Rustogi Modified Navy Plaque Index (RMNPI) and >10 bleeding sites per Gingival Bleeding Index (GBI). Enrolled subjects underwent a Modified Gingival Index (MGI) and Oral Soft Tissue(OST) assessment and were then randomly allocated to use one of the following oral hygiene cleaning modalities for a 28-day home use period; manual toothbrush (MTB) alone, MTB plus string floss (SF), MTB plus Sonicare AirflossPro with Rinse (AFPR), either BreathRx or Cool Mint Listerine. Subjects were to use MTB twice daily, and perform interproximal cleaning once daily, if assigned. Subjects returned to clinic at Day14 for an interim safety and efficacy evaluation (RMNPI, MGI, GBI, OST), and then finally at Day28 for final exams. Subjects were then dismissed from study.

Results: For RMNPI, Overall LSMeans(SE), Baseline, Day14 and Day28 outcomes were as follows, respectively; for MTB 0.66(0.00), 0.61(0.01) and 0.61(0.01), for SF 0.63(0.01), 0.53(0.01) and 0.47(0.01), for AFPR 0.64(0.00), 0.54(0.00) and 0.49(0.00).

For GBI, Overall LSMeans(SE), Baseline, Day14 and Day28 outcomes were as follows, respectively; for MTB 0.19(0.01), 0.19(0.01), 0.19(0.01), for SF 0.2(0.01), 0.15(0.00) and 0.11(0.00), for AFPR 0.2(0.01), 0.15(0.00) and 0.12(0.00).

For MGI, Overall LSMeans(SE), Basline, Day14 and Day28 outcomes were as follows, respectively; for MTB 2.24(0.02), 2.25(0.01) and 2.23(0.02), for SF 2.25(0.02), 2.15 (0.01) and 2.0(0.01), for AFPR 2.26(0.01), 2.15(0.01) and 2.05(0.01).

Conclusions: The use of adjunct interproximal cleaning regimens significantly improves surface plaque removal and gum health versus MTB alone. Among interproximal modalities, AFPR is non-inferior to SF for all efficacy metrics at all time points.