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
  Purpose

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 Intervention
Gingivitis
Device: Airflosser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque

Resource links provided by NLM:


Further study details as provided by Tufts University School of Dental Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 257
Study Start Date: August 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Airflosser
Use of Airflosser
Device: Airflosser
Use of Philips Airflosser
Other Name: Philips Airflosser
No Intervention: Manual Floss
Normal Routine

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01700348

Locations
United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University School of Dental Medicine
Philips Oral Healthcare
Tufts University
Investigators
Principal Investigator: Gerard Kugel, DMD, MS, PhD TUSDM
  More Information

No publications provided

Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT01700348     History of Changes
Other Study ID Numbers: MAH-12-0081, 10438
Study First Received: August 20, 2012
Last Updated: May 8, 2013
Health Authority: United States: The Office for Human Research Protections
United States: Department of Health and Human Services
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Tufts University School of Dental Medicine:
moderate gingivitis

Additional relevant MeSH terms:
Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 01, 2014