- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04017507
The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health
August 13, 2019 updated by: Procter and Gamble
The Effects of Oscillating-Rotating Electric Toothbrushes on Plaque and Gingival Health: A Meta-Analysis
The aim of this analysis was to compare the effects of oscillating-rotating (O-R), side-to-side (sonic), and manual toothbrushes on plaque and gingival health after multiple uses.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
2145
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
-
-
Ohio
-
Cincinnati, Ohio, United States, 45040
- Multiple P&G Investigation Clinical Sites
-
-
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 and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
This meta-analysis includes healthy adult male and females.
Description
Subjects were excluded from this study for the following reasons;
- pregnancy,
- rampant caries,
- severe periodontitis,
- at discretionary of the Principal Investigator.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Manual toothbrush
Twice daily brushing
|
Manual toothbrush used twice daily
|
|
Oscillating-rotating electric toothbrush
Twice daily brushing
|
Oscillating-rotating electric toothbrush used twice daily
|
|
Side-to-side electric toothbrush
Twice daily brushing
|
Side-to-side electric toothbrush used twice daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Bleeding Sites
Time Frame: Up to 12 weeks
|
Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Papillary bleeding index or Mazza gingival index).
|
Up to 12 weeks
|
|
Dental Plaque Scores
Time Frame: Up to 12 weeks
|
Change from baseline as measured by mean plaque score reduction from baseline (via Turesky's Modification of Quigley-Hein index, or Rustogi Modified Navy Plaque Index).
|
Up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 8, 2018
Primary Completion (ACTUAL)
November 30, 2018
Study Completion (ACTUAL)
November 30, 2018
Study Registration Dates
First Submitted
July 10, 2019
First Submitted That Met QC Criteria
July 10, 2019
First Posted (ACTUAL)
July 12, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019BrushMetaAnalysis
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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