Philips AirFlosser Study

This study has been terminated.
(Study terminated by Sponsor)
Sponsor:
Collaborators:
Philips Oral Healthcare
Tufts University
Information provided by (Responsible Party):
Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier:
NCT01700348
First received: August 20, 2012
Last updated: May 8, 2013
Last verified: May 2013

August 20, 2012
May 8, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
The effect of Sonicare AirFloss + MTB treatment versus the Control Group [ Time Frame: Four Months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01700348 on ClinicalTrials.gov Archive Site
  • Gingival inflammation [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.
  • number of bleeding sites [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    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.
  • Plaque [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    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.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]
    Assess the safety of the Sonicare AirFloss + MTB treatment.
  • Percentage of Bleeding Sites [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Gingivitis
Device: Airflosser
Use of Philips Airflosser
Other Name: Philips Airflosser
  • Experimental: Airflosser
    Use of Airflosser
    Intervention: Device: Airflosser
  • No Intervention: Manual Floss
    Normal Routine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
257
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01700348
MAH-12-0081, 10438
No
Tufts University School of Dental Medicine
Tufts University School of Dental Medicine
  • Philips Oral Healthcare
  • Tufts University
Principal Investigator: Gerard Kugel, DMD, MS, PhD TUSDM
Tufts University School of Dental Medicine
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP