Philips AirFlosser Study

Not Applicable

Terminated

• Conditions: Gingivitis
• Interventions: Device: Manual Floss; Device: Airflosser

• Registration Number: NCT01700348
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-10-01
• Study First Posted: 2012-10-04
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2015-02-26
• Results First Submitted QC: 2015-05-28
• Results First Posted: 2015-05-29
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 257

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Floss	Manual Floss	Normal Routine
Airflosser	Airflosser	Use of Airflosser

Primary Outcome Measures

Name	Time	Method
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group	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

Name	Time	Method
Plaque	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.
Percentage of Bleeding Sites	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.
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	4 Months	Assess the safety of the Sonicare AirFloss + MTB treatment.
Gingival Inflammation	4 weeks	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	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.

Trial Locations

Locations (1)

Tufts University School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States