Philips AirFlosser Study

Study Overview
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Brief Summary
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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

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

Conditions
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Gingivitis

Intervention / Treatment
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* Device: Airflosser
* Device: Manual Floss


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Airflosser<br>Use of Airflosser | Device: Airflosser<br>* Use of Philips Airflosser<br>* Other names: Philips Airflosser;|
| Active Comparator: Manual Floss<br>Normal Routine | Device: Manual Floss<br>* Active Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Assess the safety of the Sonicare AirFloss + MTB treatment. | 4 Months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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moderate gingivitis