Philips AirFlosser Study
NCT01700348 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 257
Last updated 2019-08-06
Summary
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.
The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
Conditions
- Gingivitis
Interventions
- DEVICE
-
Airflosser
Use of Philips Airflosser
- DEVICE
-
Manual Floss
Active Comparator
Sponsors & Collaborators
-
Philips Oral Healthcare
collaborator INDUSTRY -
Tufts University
lead OTHER
Principal Investigators
-
Gerard Kugel, DMD, MS, PhD · TUSDM
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-02-28
- Completion
- 2013-02-28
Countries
- United States
Study Locations
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