HealthyNCT05956262
The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
A study testing AR-toothbrush machine and Teach proper brushing skills in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary… Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AR-toothbrush machine and Teach proper brushing skills
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 601 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2021to 20 May 2022
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary school students 3 to 6 grades
Who cannot join
- Schoolchildren with disability certification.
- Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
- Disability to operate the AR system
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
About this study
The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.
Read the detailed description
A quasi-experimental design was conducted; ten intervention schools (AR group) and ten comparison schools were selected from elementary schools. Overall, grade 3-6 students in the AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Students in the CG received traditional classroom-based teaching. Baseline and follow-ups information was collected using dental plaque examinations and questionnaires. The generalized estimating equations(GEE) were used to evaluate the outcomes between two groups over time.
- Conditions
- Healthy
- Being tested
- AR-toothbrush machine, Teach proper brushing skills
- Keywords
- Augmented reality, dental plaque, schoolchildren
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR-toothbrush machineDevice
Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. The AR-based training system (PVIX Oral, EPED) digitized the steps of the toothbrushing technique applying optical tracking technology to enable the participants to obtain immediate scoring after the completion of practice. The scoring depends on the level of removing simulated dental plaque. The AR system was equipped with an optical tracking unit, a 3D training head model, and a wireless toothbrush. The toothbrushing practice time for the upper and lower jaw is 3 minutes, respectively. A tooth-brushing song played while the students implemented.
Teach proper brushing skillsBehavioural
Students in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. The students were taught by a well-trained dental hygienist using teaching aids (such as dental models, and toothbrushes).
| Study group | Role | What they receive |
|---|---|---|
| AR group | Experimental | Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Receives: Device: AR-toothbrush machine |
| traditional group | Experimental | Students in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. Receives: Behavioral: Teach proper brushing skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Control Record (PCR)
Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )
Measured: Change from Baseline at 2-week after intervention
Plaque Control Record (PCR)
Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )
Measured: Change from Baseline at 4-week after intervention
Self-efficacy
2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree
Measured: Change from Baseline at 2-week after intervention
Self-efficacy
2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree
Measured: Change from Baseline at 4-week after intervention
Skill of Toothbrushing
5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice
Measured: Change from Baseline at 2-week after intervention
Skill of Toothbrushing
5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice
Measured: Change from Baseline at 4-week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start25 Nov 2021
- Primary completion20 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 601 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956262
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20200073
- Status last verified
- Nov 2021
- First submitted
- 11 Jul 2023
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
- ClinicalTrials.gov ID
- NCT05956262
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20200073
- Conditions
- Healthy
- Keywords
- Augmented reality, dental plaque, schoolchildren
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- National Sun Yat-sen University
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 21 Jul 2023 (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.
The aim of this study An augmented reality (AR) simulation toothbrushing machine was developed to train proper brushing technique for children. The investigators aimed to evaluate the effects of AR brushing machine on knowledge of dental clearing skill, self-efficacy and dental plaque control in elementary schoolchildren in Taiwan.
Detailed description
A quasi-experimental design was conducted; ten intervention schools (AR group) and ten comparison schools were selected from elementary schools. Overall, grade 3-6 students in the AR group (n = 290) and the traditional group (n = 311), respectively. Students in the AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. Students in the CG received traditional classroom-based teaching. Baseline and follow-ups information was collected using dental plaque examinations and questionnaires. The generalized estimating equations(GEE) were used to evaluate the outcomes between two groups over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AR group | Experimental | Device: AR-toothbrush machineStudent in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. |
| traditional group | Experimental | Behavioral: Teach proper brushing skillsStudents in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Primary school students 3 to 6 grades
Key exclusion criteria (3 listed)
- Schoolchildren with disability certification.
- Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
- Disability to operate the AR system
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 |
|---|---|---|
| AR-toothbrush machineStudent in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals. The AR-based training system (PVIX Oral, EPED) digitized the steps of the toothbrushing technique applying optical tracking technology to enable the participants to obtain immediate scoring after the completion of practice. The scoring depends on the level of removing simulated dental plaque. The AR system was equipped with an optical tracking unit, a 3D training head model, and a wireless toothbrush. The toothbrushing practice time for the upper and lower jaw is 3 minutes, respectively. A tooth-brushing song played while the students implemented. | Device | AR group |
| Teach proper brushing skillsStudents in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals. The students were taught by a well-trained dental hygienist using teaching aids (such as dental models, and toothbrushes). | Behavioural | traditional group |
Primary outcome
Plaque Control Record (PCR)
Time frame: Change from Baseline at 2-week after intervention
Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )
Plaque Control Record (PCR)
Time frame: Change from Baseline at 4-week after intervention
Each tooth is divided into six surfaces, and the PCR record is calculated ( range 0-100% )
Self-efficacy
Time frame: Change from Baseline at 2-week after intervention
2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree
Self-efficacy
Time frame: Change from Baseline at 4-week after intervention
2 questions , e.g: I feel confident.Response 1 = strongly disagree 2 = Disagree 3 = Normal 4 = agree 5 = strongly agree
Skill of Toothbrushing
Time frame: Change from Baseline at 2-week after intervention
5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice
Skill of Toothbrushing
Time frame: Change from Baseline at 4-week after intervention
5 questions , e.g: The toothbrush is pressed against the gums at a 45-degree angle.Response multiple choice
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 21 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AR-toothbrush machine and Teach proper brushing skills in people with Healthy, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 3 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 21 Jul 2023. 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 Taiwan. 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?
Plaque Control Record (PCR) (time frame: Change from Baseline at 2-week after intervention). The study lists 6 primary outcomes in all. 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 21 Jul 2023.