At-Home Care for Subjects With Periodontitis

Completed · Not applicable

Conditions studied: Periodontitis, Dental Plaque

In brief

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).

Key facts

Study ID: NCT04254770
Run by: Philips Clinical & Medical Affairs Global
People needed: 346
Starts: 2020-01-06
Expected to finish: 2020-08-10
Last updated by the study team: 2022-01-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Salus Research, Inc — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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