At-Home Care for Subjects With Periodontitis

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254770
• Other study ID #: OHC_OHC_Anthony_2019_10606
• Status: Completed
• Phase: N/A
• Start date: January 6, 2020
• Est. completion date: August 10, 2020

Study information

• Verified date: January 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: August 10, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Plaque
• Periodontitis

Intervention

Device:
• ADA approved Manual Toothbrush
ADA approved Manual Toothbrush
• Marketed Power Toothbrush
Marketed Power Toothbrush

Locations

Country	Name	City	State
United States	Salus Research, Inc	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.		6 months
Secondary	Change in supragingival plaque, as measured by Modified Plaque Index		6 months
Secondary	Change in clinical attachment level		6 months
Secondary	Change in periodontitis, as measured by probing pocket depth		6 months