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Randomized Controlled Trial
. 2017 Mar;28(1 Spec No A):A36-44.

Gingival Health and Plaque Regrowth Response Following a Four-Week Interdental Hygiene Intervention

Anthony Mwatha  1 , Misty Olson  1 , Sonia Souza  1 , Marilyn Ward  1 , Wendy Jenkins  1 , Pejmon Amini  2 , John Gallob  2 , Theresa Fafard  2
Affiliations
  • PMID: 28422463
Randomized Controlled Trial

Gingival Health and Plaque Regrowth Response Following a Four-Week Interdental Hygiene Intervention

Anthony Mwatha et al. J Clin Dent. 2017 Mar.

Abstract

Objectives: To compare the efficacy of three adjunct interproximal cleaning methods versus a manual toothbrush alone on gingivitis, and demonstrate that the Philips Sonicare AirflossPro™ interproximal (IP) cleaning device provides a similar reduction in gingivitis and plaque compared to string floss.

Methods: A randomized, single-blind, parallel-design study was conducted on generally healthy adults exhibiting mild to moderate gingivitis. Eligible subjects were non-smokers, aged 18-65 years, with ≥ 0.5 per the Rustogi Modified Navy Plaque Index (RMNPI) and a Gingival Bleeding Index (GBI) of ≥ 1 on at least 10 sites. Eligible subjects were randomly assigned to use one of four oral hygiene regimens: manual toothbrush (MTB) alone; MTB plus string floss (SF); MTB plus Philips Sonicare AirflossPro used with Cool Mint Listerine® Antiseptic (AFPL); and MTB plus Philips Sonicare AirflossPro used with BreathRx™ (AFPB). Subjects were followed over a 28-day home-use period, with follow-up visits for efficacy and safety conducted at Days 14 and 28. All subjects were instructed to use the MTB twice daily and perform interproximal cleaning once daily, if assigned. Study efficacy endpoints included the Modified Gingival Index (MGI), Rustogi Modified Navy Plaque Index, and the Gingival Bleeding Index.

Results: Of 290 randomized subjects, 287 were followed to Day 14 and 286 were followed to Day 28. For the primary endpoint at Day 14, significantly larger reductions in MGI were observed in each of the three IP cleaning groups compared to MTB alone (p < 0.001). The adjusted mean reductions and standard error estimates (SE) for MGI expressed as a percent reduction from Baseline at Day 14 were: 0.22% (0.55%) for MTB; 4.30% (0.44%) for SF; 4.55% (0.45%) for AFPL; and 4.20% (0.44%) for AFPB. A non-inferiority test comparing AirflossPro to SF showed AirflossPro to be non-inferior to SF (p < 0.001).

Conclusions: The addition of interproximal cleaning to manual tooth brushing statistically significantly reduces gingivitis and plaque compared to manual tooth brushing alone. Among the adjunct interproximal cleaning regimens, AirflossPro provides a similar reduction in gingivitis and plaque to string floss. All study regimens were safe on oral tissues.

Keywords: Airfloss; Sonicare; biofilm; floss; gingivitis; interproximal cleaning; oral hygiene; plaque.

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Conflict of interest statement

Source for funding: AM, MO, SS, MW, and WJ are employees of Philips, maker of the Sonicare powered toothbrush that was tested in this study. PA, JG, and TF are employees of an independent clinical research site.

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