- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05594004
A Meta-analysis Comparing Toothbrushes on Plaque Removal and Gingival Health
October 21, 2022 updated by: Procter and Gamble
A Meta-analysis Comparing Electric and Manual Toothbrushes on Plaque Removal and Gingival Health
The aim of this analysis was to compare gingivitis- and plaque-reduction efficacy from randomized controlled trials (RCTs) up to six months long evaluating oscillating-rotating, sonic, and manual toothbrushes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2929
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 Study Locations
-
-
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
No
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
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Oscillating-Rotating electric toothbrush
Twice daily brushing
|
Oscillating-rotating electric toothbrush used twice daily
|
Sonic electric toothbrush
Twice daily brushing
|
Sonic electric toothbrush used twice daily
|
Manual toothbrush
Twice daily brushing
|
Manual 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 6 months (26 weeks)
|
Change from baseline as measured on number of bleeding sites ( via gingival bleeding index, Loe Silness index, Gingival Bleeding Index (GBI), Papillary bleeding index or Mazza gingival index).
|
Up to 6 months (26 weeks)
|
Dental Plaque Scores
Time Frame: Up to 6 months (26 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 6 months (26 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)
April 1, 2022
Primary Completion (Actual)
July 29, 2022
Study Completion (Actual)
July 29, 2022
Study Registration Dates
First Submitted
October 21, 2022
First Submitted That Met QC Criteria
October 21, 2022
First Posted (Actual)
October 26, 2022
Study Record Updates
Last Update Posted (Actual)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 21, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022BrushMetaAnalysis
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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