At-Home Care for Subjects With Periodontitis

Philips

Status: Completed

Conditions: Periodontitis; Dental Plaque

Treatments: Device: ADA approved Manual Toothbrush; Device: Marketed Power Toothbrush

Study type: Interventional

Funder types: Industry

Identifiers

NCT04254770

OHC_OHC_Anthony_2019_10606

Details and patient eligibility

About

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).

Enrollment: 346 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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346 participants in 2 patient groups

ADA (American Dental Association) approved Manual Toothbrush

Active Comparator group

Treatment:

Device: ADA approved Manual Toothbrush

Marketed Power Toothbrush

Experimental group

Treatment:

Device: Marketed Power Toothbrush