Philips AirFlosser Study



Status:Terminated
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:18 - 70
Updated:3/14/2019
Start Date:August 2012
End Date:February 2013

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An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque

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


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.
We found this trial at
1
site
Boston, Massachusetts 02111
?
mi
from
Boston, MA
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