NCT05956262

Brief 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 schoolchildren in Taiwan.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
601

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 25, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2023

Completed
Last Updated

July 21, 2023

Status Verified

November 1, 2021

Enrollment Period

6 months

First QC Date

July 11, 2023

Last Update Submit

July 19, 2023

Conditions

Healthy

Keywords

Augmented realitydental plaqueschoolchildren

Outcome Measures

Primary Outcomes (6)

  • Plaque Control Record (PCR)

    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)

    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

    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

    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

    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

    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

Study Arms (2)

AR group

EXPERIMENTAL

Student in AR group received a two-time repeated AR-based training for 30 minutes at two-week intervals.

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.

Behavioral: Teach proper brushing skills

Interventions

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.

AR group
Teach proper brushing skillsBEHAVIORAL

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).

traditional group

Eligibility Criteria

Age9 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Primary school students 3 to 6 grades

You may not qualify if:

  • Schoolchildren with disability certification.
  • Schoolchildren with congenital severe oral diseases (eg. cleft lip and palate )
  • Disability to operate the AR system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 21, 2023

Study Start

November 25, 2021

Primary Completion

May 20, 2022

Study Completion

May 20, 2022

Last Updated

July 21, 2023

Record last verified: 2021-11

Locations

TW(1)