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Philips AirFlosser Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01700348
Recruitment Status : Terminated (Terminated by financier due to low accrual & high number of protocol deviations.)
First Posted : October 4, 2012
Results First Posted : May 29, 2015
Last Update Posted : August 6, 2019
Philips Oral Healthcare
Information provided by (Responsible Party):
Tufts University

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

Condition or disease Intervention/treatment Phase
Gingivitis Device: Airflosser Device: Manual Floss Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 257 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque
Study Start Date : August 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Experimental: Airflosser
Use of Airflosser
Device: Airflosser
Use of Philips Airflosser
Other Name: Philips Airflosser

Active Comparator: Manual Floss
Normal Routine
Device: Manual Floss
Active Comparator

Primary Outcome Measures :
  1. The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group [ Time Frame: Four Months ]
    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.

Secondary Outcome Measures :
  1. Gingival Inflammation [ Time Frame: 4 weeks ]
    Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.

  2. Number of Bleeding Sites [ Time Frame: 2 Weeks ]
    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.

  3. Plaque [ Time Frame: 4 Weeks ]
    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. Number of Participants With Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 Months ]
    Assess the safety of the Sonicare AirFloss + MTB treatment.

  5. Percentage of Bleeding Sites [ Time Frame: 2 Weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01700348

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United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Philips Oral Healthcare
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Principal Investigator: Gerard Kugel, DMD, MS, PhD TUSDM
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Responsible Party: Tufts University Identifier: NCT01700348    
Other Study ID Numbers: MAH-12-0081
10438 ( Other Identifier: TUSDM IRB )
First Posted: October 4, 2012    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: August 6, 2019
Last Verified: July 2019
Keywords provided by Tufts University:
moderate gingivitis
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases