Clinical trial NCT01700348: Philips AirFlosser Study
Official title: An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gingivitis
Keywords: moderate gingivitis
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Philips Oral Healthcare
First posted: 2012-10-04
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
timeFrame: Four Months
Secondary outcomes:
measure: Gingival Inflammation
timeFrame: 4 weeks
measure: Number of Bleeding Sites
timeFrame: 2 Weeks
measure: Plaque
timeFrame: 4 Weeks
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4 Months
measure: Percentage of Bleeding Sites
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: TUSDM
name: Gerard Kugel, DMD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: