the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel CharacteristicNCT04675736
Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface.
A study testing brushing force in people with the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic, run by Mahidol University at 1 site in Thailand.
Trial summary
Objective 1. To determine the optimum brushing force for dental plaque removal. 2. 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic
- What is being tested?
- brushing force
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2019to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- extracted bovine incisors
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Being tested
- brushing force
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brushing forceProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| brushing force | Experimental | Not described Receives: Procedure: brushing force |
What is being measured
The primary outcome is the main question the study is designed to answer.
optimum force
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.
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel CharacteristicStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kanyawat rattanasuwan, Study director, Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04675736
- Sponsor's protocol ID
- MU-DT/PY-IRB 2017/DT105
- Status last verified
- Dec 2020
- First submitted
- 2 Sep 2020
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Optimum Brushing Force on Dental Plaque Removal and the Abrasive Effect of Brushing Force on Enamel Surface: An in Vitro Study.
- ClinicalTrials.gov ID
- NCT04675736
- Acronym / sponsor ID
- MU-DT/PY-IRB 2017/DT105
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| brushing force | Experimental | Procedure: brushing force |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- extracted bovine incisors
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brushing forceUsing 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 | Procedure or surgery | brushing force |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kanyawat rattanasuwan study director
Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mahidol University, Bangkok Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brushing force in people with the Optimum Brushing Force for Dental Plaque Removal and the Effect of Brushing Force on Enamel Characteristic, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
optimum force (time frame: 5 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.