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Philips AirFlosser Study

Primary Purpose

Gingivitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Airflosser
Manual Floss
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring moderate gingivitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Airflosser

Manual Floss

Arm Description

Use of Airflosser

Normal Routine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gingival Inflammation
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
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
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
Assess the safety of the Sonicare AirFloss + MTB treatment.
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.

Full Information

First Posted
August 20, 2012
Last Updated
July 26, 2019
Sponsor
Tufts University
Collaborators
Philips Oral Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT01700348
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated by financier due to low accrual & high number of protocol deviations.
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
Collaborators
Philips Oral Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
moderate gingivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
257 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Airflosser
Arm Type
Experimental
Arm Description
Use of Airflosser
Arm Title
Manual Floss
Arm Type
Active Comparator
Arm Description
Normal Routine
Intervention Type
Device
Intervention Name(s)
Airflosser
Other Intervention Name(s)
Philips Airflosser
Intervention Description
Use of Philips Airflosser
Intervention Type
Device
Intervention Name(s)
Manual Floss
Intervention Description
Active Comparator
Primary Outcome Measure Information:
Title
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
Description
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.
Time Frame
Four Months
Secondary Outcome Measure Information:
Title
Gingival Inflammation
Description
Evaluate the effect of the Sonicare AirFloss + MTB treatment on gingival inflammation as measured after 2 and 4 weeks versus baseline.
Time Frame
4 weeks
Title
Number of Bleeding Sites
Description
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.
Time Frame
2 Weeks
Title
Plaque
Description
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.
Time Frame
4 Weeks
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Description
Assess the safety of the Sonicare AirFloss + MTB treatment.
Time Frame
4 Months
Title
Percentage of Bleeding Sites
Description
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.
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Kugel, DMD, MS, PhD
Organizational Affiliation
TUSDM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

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Philips AirFlosser Study

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