Back to resultsAt-Home Care for Subjects With Periodontitis
Primary Purpose
Periodontitis, Dental Plaque
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ADA approved Manual Toothbrush
Marketed Power Toothbrush
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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
Sites / Locations
- Salus Research, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ADA (American Dental Association) approved Manual Toothbrush
Marketed Power Toothbrush
Arm Description
Outcomes
Primary Outcome Measures
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Secondary Outcome Measures
Change in supragingival plaque, as measured by Modified Plaque Index
Change in clinical attachment level
Change in periodontitis, as measured by probing pocket depth
Full Information
NCT ID
NCT04254770
First Posted
January 29, 2020
Last Updated
January 24, 2022
Sponsor
Philips Clinical & Medical Affairs Global
1. Study Identification
Unique Protocol Identification Number
NCT04254770
Brief Title
At-Home Care for Subjects With Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2020 (Actual)
Primary Completion Date
August 10, 2020 (Actual)
Study Completion Date
August 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Clinical & Medical Affairs Global
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Dental Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
346 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADA (American Dental Association) approved Manual Toothbrush
Arm Type
Active Comparator
Arm Title
Marketed Power Toothbrush
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ADA approved Manual Toothbrush
Intervention Description
ADA approved Manual Toothbrush
Intervention Type
Device
Intervention Name(s)
Marketed Power Toothbrush
Intervention Description
Marketed Power Toothbrush
Primary Outcome Measure Information:
Title
Change in symptoms of inflammation of the periodontium, as measured by Bleeding on Probing.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in supragingival plaque, as measured by Modified Plaque Index
Time Frame
6 months
Title
Change in clinical attachment level
Time Frame
6 months
Title
Change in periodontitis, as measured by probing pocket depth
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Salus Research, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
At-Home Care for Subjects With Periodontitis
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