At-Home Care for Subjects With Periodontitis

Philips Clinical & Medical Affairs Global346 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

346

Conditions

Periodontitis Dental Plaque

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

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 supragingival plaque, as measured by Modified Plaque Index

Time frame: 6 months

Change in clinical attachment level

Time frame: 6 months

Change in periodontitis, as measured by probing pocket depth

Time frame: 6 months

At-Home Care for Subjects With Periodontitis

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes