Clinical Trial: Curved Soft-Picks on Plaque Accumulation on Patients With Gingivitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of Curved Design Soft-Picks on Plaque Accumulation on Patients With Signs of Gingivitis

Brief Summary: The aim of this study is to evaluate the efficacy of a new interdental cleaning device (Soft-Picks Advanced), as compared to a leading brand floss; and, how ease of use can promote the establishment of a hygienic routine of cleaning interproximal spaces.

Detailed Summary: The Soft-Picks Advanced has a new curved design allowing a user to easily access to difficult interdental sites, such as spaces between premolars and molars. This study is a single center with parallel design, single blinded, which will randomize eligible subjects into two treatment groups.
Sponsor: Sunstar Americas

Current Primary Outcome:

  • Modification of the Quigley-Hein Plaque Index [ Time Frame: 14 weeks ]
  • Modification of the Quigley-Hein Plaque Index [ Time Frame: 28 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Performance of an assigned product based on user experience [ Time Frame: 28 weeks ]
    The questionnaire should indicate the level of product familiarity and overall usage satisfaction.
  • UNC Modified Gingival Index [ Time Frame: 28 weeks ]
  • Bleeding on Probing [ Time Frame: 28 weeks ]
  • Probing Pocket Depth [ Time Frame: 28 weeks ]


Original Secondary Outcome: Same as current

Information By: Sunstar Americas

Dates:
Date Received: August 25, 2016
Date Started: December 2016
Date Completion:
Last Updated: May 17, 2017
Last Verified: May 2017