At-Home Care for Subjects With Periodontitis

Not Applicable

Completed

• Conditions: Periodontitis; Dental Plaque
• Interventions: Device: ADA approved Manual Toothbrush; Device: Marketed Power Toothbrush

• Registration Number: NCT04254770
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-05
• Primary Completion: 2020-08-10
• Study Completion: 2020-08-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADA (American Dental Association) approved Manual Toothbrush	ADA approved Manual Toothbrush	-
Marketed Power Toothbrush	Marketed Power Toothbrush	-

Primary Outcome Measures

Name	Time	Method
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.	6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Salus Research, Inc; 🇺🇸 Fort Wayne, Indiana, United States