Philips AirFlosser Study

Gingivitis Clinical Trial

Official title:

An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01700348
• Other study ID #: MAH-12-0081
• Secondary ID: 10438
• Status: Terminated
• Phase: N/A
• Start date: August 2012
• Est. completion date: February 2013

Study information

• Verified date: July 2019
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 257
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingivitis

Intervention

Device:
• Airflosser
Use of Philips Airflosser
• Manual Floss
Active Comparator

Locations

Country	Name	City	State
United States	Tufts University School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	Philips Oral Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Assess the safety of the Sonicare AirFloss + MTB treatment.	4 Months
Secondary	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