- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05956262
The Effect of Portable AR on Tooth Brushing Skill for Elementary School Students
July 19, 2023 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
601
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
-
-
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital
-
-
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
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Primary school students 3 to 6 grades
Exclusion Criteria:
- Schoolchildren with disability certification.
- Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
- Disability to operate the AR system
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: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AR group
Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals.
|
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.
|
|
Experimental: traditional group
Students in the traditional group received a two-time repeated 10-minute lesson regarding proper toothbrushing skills in the classroom at two-week intervals.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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% )
|
Change from Baseline at 2-week after intervention
|
|
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% )
|
Change from Baseline at 4-week after intervention
|
|
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
|
Change from Baseline at 2-week after intervention
|
|
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
|
Change from Baseline at 4-week after intervention
|
|
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
|
Change from Baseline at 2-week after intervention
|
|
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
|
Change from Baseline at 4-week after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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)
November 25, 2021
Primary Completion (Actual)
May 20, 2022
Study Completion (Actual)
May 20, 2022
Study Registration Dates
First Submitted
July 11, 2023
First Submitted That Met QC Criteria
July 19, 2023
First Posted (Actual)
July 21, 2023
Study Record Updates
Last Update Posted (Actual)
July 21, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- KMUHIRB-SV(I)-20200073
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.
Clinical Trials on Healthy
-
University of Vermont Medical CenterAvocado Nutrition CenterRecruitingHealthy | Healthy Volunteers | Healthy Subjects | Healthy Volunteer | Healthy Adult | Healthy Volunteers Only | Healthy Male and Female Subjects | Healthy Non-smokersUnited States
-
Dragonfly TherapeuticsRecruitingHealthy | Healthy Participants | Healthy Adult Females | Volunteer | Healthy Adult MaleAustralia
-
University of PalermoCompletedHealthy | Healthy Volunteers | Healthy Subjects | Healthy Participants | Static Stretching | Stretch | StretchingItaly
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Umm Al-Qura UniversityActive, not recruitingHealthy | Healthy Participants | Healthy Adult | Healthy Women | Healthy Adult Females | Healthy Adult Participants | Healthy Young Adults | Healthy Adult Female Participants | Healthy Adult Male | Poor Sleep Quality | Healthy (Controls) | Poor Sleeping Quality | Healthy Adult Male Subjects | Health Adult SubjectsSaudi Arabia
-
University of PalermoCompletedHealthy Participants | Healthy Adult Participants | Healthy Young AdultsItaly
-
PfizerNot yet recruitingHealthy | Healthy AdultsUnited States
-
Atisama TherapeuticsRecruitingHealthy | Healthy SmokerAustralia
Clinical Trials on AR-toothbrush machine
-
University of BaghdadNot yet recruitingPlaque Induced Gingivitis | Toothbrushing | ComplianceIraq
-
Heba HelalRecruiting
-
Shahid Beheshti UniversityCompletedPlaque RemovalIran, Islamic Republic of
-
Azienda Socio Sanitaria Territoriale degli Spedali...Completed
-
Procter and GambleCompletedGingivitis | Dental PlaqueCanada
-
Pamukkale UniversityCompletedOral Microbial Colonization | Periodontal Health | Periodontal ParametersTurkey (Türkiye)
-
Procter and GambleCompletedGingivitis | Dental PlaqueUnited States
-
Marmara UniversityCompletedPlaque, DentalTurkey
-
Pamukkale UniversityCompletedPeriodontal Inflammation | Toothbrushing | Orthodontic TreatmentTurkey
-
Jouf UniversityCompletedPlaque | Children, AdultSaudi Arabia