- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04675736
Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.
December 17, 2020 updated by: Mahidol University
Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface: An in Vitro Study.
Objective
- To determine the optimum brushing force for dental plaque removal.
- To investigate the effect of brushing force on enamel characteristic.
Hypothesis H0 : Structural tooth loss is not significantly different between before and after brushing with excessive force on enamel surface.
H1 : Structural tooth loss is significantly different between before and after brushing with excessive force on enamel surface.
Study design: Experimental study
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
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
-
-
Bangkok
-
Ratchathewi, Bangkok, Thailand, 10400
- Faculty of Dentistry
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- extracted bovine incisors
Exclusion Criteria:
- no
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: brushing force
|
Using duplication method, vertical force was applied from 1-5.5 N in linear mesial-distal brushing motion at 4 strokes per second for 5 seconds Force was increase 0.5 N in every testing until plaque was completely removed from enamel surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
optimum force
Time Frame: 5 seconds
|
The toothbrush holder was adjusted allowing toothbrush bristle to press onto the tooth surface until the loading monitor indicated the designated vertical loading force.
Loading force was applied from a minimum of 1 N, with an increment of 1 N to a maximum of 6 N. The optimum force which remove all dental plaque from tooth surface will recorded.
|
5 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kanyawat rattanasuwan, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok Thailand
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 1, 2019
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
April 1, 2020
Study Registration Dates
First Submitted
September 2, 2020
First Submitted That Met QC Criteria
December 17, 2020
First Posted (Actual)
December 19, 2020
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 17, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-DT/PY-IRB 2017/DT105
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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