At-Home Care for Subjects With Periodontitis

January 24, 2022 updated by: Philips Clinical & Medical Affairs Global

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Salus Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: ADA (American Dental Association) approved Manual Toothbrush
Device: ADA approved Manual Toothbrush
ADA approved Manual Toothbrush
EXPERIMENTAL: Marketed Power Toothbrush
Device: Marketed Power Toothbrush
Marketed Power Toothbrush

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in supragingival plaque, as measured by Modified Plaque Index
Time Frame: 6 months
6 months
Change in clinical attachment level
Time Frame: 6 months
6 months
Change in periodontitis, as measured by probing pocket depth
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2020

Primary Completion (ACTUAL)

August 10, 2020

Study Completion (ACTUAL)

August 10, 2020

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

February 3, 2020

First Posted (ACTUAL)

February 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OHC_OHC_Anthony_2019_10606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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