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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 346
- Locations
- 1
- Primary Endpoint
- Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
ADA (American Dental Association) approved Manual Toothbrush
Intervention: ADA approved Manual Toothbrush (Device)
Marketed Power Toothbrush
Intervention: Marketed Power Toothbrush (Device)
Outcomes
Primary Outcomes
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Time Frame: 6 months
Secondary Outcomes
- Change in clinical attachment level(6 months)
- Change in supragingival plaque, as measured by Modified Plaque Index(6 months)
- Change in periodontitis, as measured by probing pocket depth(6 months)