Philips AirFlosser Study

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

Study Overview

• Status: Terminated
• Conditions: Gingivitis
• Intervention / Treatment: Device: Airflosser; Device: Manual Floss

• Study Type: Interventional
• Enrollment (Actual): 257
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts University School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Airflosser; Use of Airflosser	Device: Airflosser; Use of Philips Airflosser; Other Names: Philips Airflosser
Active Comparator: Manual Floss; Normal Routine	Device: Manual Floss; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group	The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.	Four Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gingival Inflammation	Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.	4 weeks
Number of Bleeding Sites	Compare the number of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.	2 Weeks
Plaque	Compare plaque as measured by the reduction and percent reduction in Residual Protein Concentration (RPC) following 2 and 4 weeks of use of the Sonicare AirFloss + MTB and Control Group.	4 Weeks
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Assess the safety of the Sonicare AirFloss + MTB treatment.	4 Months
Percentage of Bleeding Sites	Compare the percentage of bleeding sites in Modified Gingival Index following 2 weeks of use of the Sonicare AirFloss + Manual Toothbrush versus the Control Group.	2 Weeks

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: Philips Oral Healthcare
• Investigators: Principal Investigator: Gerard Kugel, DMD, MS, PhD, TUSDM

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 20, 2012
• First Submitted That Met QC Criteria: October 1, 2012
• First Posted (Estimate): October 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: moderate gingivitis
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: MAH-12-0081; 10438 (Other Identifier: TUSDM IRB)