At-Home Care for Subjects With Periodontitis

Study Overview
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Brief Summary
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The effect of use of powered toothbrushing in patients exhibiting periodontal inflammation has been observed repeatedly in clinical studies conducted over a 20+ year period. Whether these subjects also had periodontitis, or not, was not a collected data metric as it was outside the scope of the Investigation. This study, therefore, will specifically include and document that a subject exhibits periodontitis upon study entry, and measure the ensuing response following professional treatment of scaling and root planing, followed by home use of the assigned study products (powered or manual toothbrushing).

Official Title
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A Randomized, Parallel-design Study to Evaluate the Effects of Home Use of the Sonicare Powered Toothbrush and a Manual Toothbrush on Subjects With Periodontitis

Conditions
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Periodontitis, Dental Plaque

Intervention / Treatment
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* Device: ADA approved Manual Toothbrush
* Device: Marketed Power Toothbrush


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-75 years Exhibiting Stage I or II periodontitis Minimum of 20 'scorable' teeth (excluding 3rd molars) Regular manual toothbrush user Have a minimum average plaque score of > 1.8 per Modified Plaque Index scoring with 3-6 hours plaque accumulation Agree to desist use of interproximal cleaning aids and other prohibited devices or medicaments during the study period Be a non-smoker (> 10 years), or never smoker Exclusion Criteria: Have a cardiac pacemaker or implanted cardiac defibrillator Have uncontrolled Insulin-Dependent Diabetes Have current use of antibiotic medications or use within 4 weeks of enrollment Have current use of prescription-dose anti-inflammatory medications or anticoagulants Have excessive gingival recession, per Investigator/Examiner discretion Have heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion Have had a professional prophylaxis within 4 weeks of the study Prior chemotherapy, immunotherapy or radiation therapy within last 10 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Active Comparator: ADA (American Dental Association) approved Manual Toothbrush<br> | Device: ADA approved Manual Toothbrush<br>* ADA approved Manual Toothbrush<br>|
| Experimental: Marketed Power Toothbrush<br> | Device: Marketed Power Toothbrush<br>* Marketed Power Toothbrush<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in supragingival plaque, as measured by Modified Plaque Index |  | 6 months | 
| Change in clinical attachment level |  | 6 months | 
| Change in periodontitis, as measured by probing pocket depth |  | 6 months |