Philips AirFlosser Study

Tufts University

Status

Terminated

Conditions

Gingivitis

Treatments

Device: Airflosser

Device: Manual Floss

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01700348

MAH-12-0081

10438

Details and patient eligibility

About

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

Enrollment

257 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

4.1 Inclusion Criteria

Subjects accepted into the study must meet the following requirements:

are 18-70 years;
are in generally good health;
have a minimum of 20 natural teeth (excluding 3rd molars);
have 1 qualifying test site in each posterior quadrant;
are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted);
Irregular Flossers defined as using dental floss ≤ 2 days a week;
be willing and able to comply with study procedures and be available at all times required for participation;
have a Gingival Bleeding Index > 1 on at least 20 sites;
be a non-smoker.

4.2 Exclusion Criteria Subjects will be excluded from the study if they;

have systemic diseases such as Down's syndrome, or known AIDS/HIV;
have insulin dependent Diabetes;
are pregnant or nursing by subject report;
have a cardiac pacemaker or AICD;
are undergoing or require extensive dental or orthodontic treatment;
require antibiotic treatment for dental appointments;
have used antibiotics within 4 weeks of enrollment;
are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin);
have heavy deposits of calculus, either supragingival and/or subgingival;
have severe gingivitis or periodontitis;
have extensive crown or bridge work and/or rampant decay;
are currently use bleaching trays;
have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
have a professional prophylaxis within 4 weeks of study;
have participated in a prior study ≤ 20 days;
are employed by an oral healthcare products company or dental research institution.