NCT04627324

Brief Summary

The objective of this study was to compare the efficacy of computer-assisted TBI (toothbrushing instruction) using a smart toothbrush and smart mirror (STM system) in plaque control to that of conventional TBI.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.9 years

First QC Date

November 2, 2020

Last Update Submit

November 12, 2020

Conditions

Toothbrushing

Keywords

TeledentistrySchoolchildrenOral hygieneComputerSmart toothbrushDental plaque

Outcome Measures

Primary Outcomes (3)

  • Change from Baseline in plaque index at 10 month after TBI (1st study-adults)

    The effects of smart toothbrush and smart mirror (STM) system TBI and conventional TBI on dental plaque in adults were compared in this study. Plaque examination was scored on the buccal and lingual surface of all teeth. The Turesky Modification of the Quigley-Hein index was scored between 0 (no plaque) and 5 (plaque covering ≥ two-thirds of the tooth crown) The percentages of plaque removal at each surfaces and whole mouth were determined with the formula: percentage plaque reduction = pre-post / pre X100 (pre=prebrushing plaque value; post=postbrushing plaque value).

    Baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month after TBI.

  • Change from Baseline in plaque index at 1 month after TBI (2nd study-schoolchildren)

    The effects of smart toothbrush and smart mirror (STM) system TBI and conventional TBI on dental plaque in schoolchildren were compared in this study. Plaque examination was scored on the buccal and lingual surface of all teeth (if a permanent tooth had not erupted yet, the primary tooth in the corresponding area was tested). The Turesky Modification of the Quigley-Hein index was scored between 0 (no plaque) and 5 (plaque covering ≥ two-thirds of the tooth crown) The percentages of plaque removal at each surfaces and whole mouth were determined with the formula: percentage plaque reduction = pre-post / pre X100 (pre=prebrushing plaque value; post=postbrushing plaque value).

    Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.

  • Change from Baseline in plaque index at 1 month after TBI (3rd study-adults and children)

    The effects of smart toothbrush and smart mirror (STM) system TBI and conventional TBI on dental plaque in adults and children were compared in this study. Plaque examination was scored on the buccal and lingual surface of all teeth (if a permanent tooth had not erupted yet, the primary tooth in the corresponding area was tested). The Turesky Modification of the Quigley-Hein index was scored between 0 (no plaque) and 5 (plaque covering ≥ two-thirds of the tooth crown) The percentages of plaque removal at each surfaces and whole mouth were determined with the formula: percentage plaque reduction = pre-post / pre X100 (pre=prebrushing plaque value; post=postbrushing plaque value).

    Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.

Study Arms (2)

The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI)

EXPERIMENTAL

Participants received using the STM system TBI. The plaque indexes were evaluated at baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month (1st study only) after TBI.

Device: The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)

conventional toothbrushing instruction (TBI)

ACTIVE COMPARATOR

Participants received using conventional TBI. The plaque indexes were evaluated at baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month (1st study only) after TBI.

Device: Conventional toothbrush

Interventions

The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)DEVICE

The STM system comprises a smart mirror, which is integrated into a computer monitor, and a 3D motion-capture device inside of a modified toothbrush holder. The computer program displays a toothbrushing animation in the mirror. Toothbrush motions detected by sensors embedded inside the holder are captured and sent to the server for analysis. (used only during the test visits) Participants had to brush their teeth at home (using toothbrushes with a flat-trimmed nylon bristle of identical type and length.) for 3 min thrice daily, after meals, as recommended by the Korean Dental Association.

The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI)
Conventional toothbrushDEVICE

toothbrushes with a flat-trimmed nylon bristle of identical type and length. Participants had to brush their teeth at home for 3 min thrice daily, after meals, as recommended by the Korean Dental Association.

conventional toothbrushing instruction (TBI)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with poor oral conditions need more toothbrush instruction
  • Participants were required to have their gingivitis and baseline plaque scores \>1.5 (the Turesky Modification of the Quigley-Hein index)

You may not qualify if:

  • if they had gross dental caries or orthodontic appliances, or were medically compromised.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kim KD, Jeong JS, Lee HN, Gu Y, Kim KS, Lee JW, Park W. Efficacy of computer-assisted, 3D motion-capture toothbrushing instruction. Clin Oral Investig. 2015 Jul;19(6):1389-94. doi: 10.1007/s00784-014-1350-y. Epub 2014 Nov 14.

    PMID: 25391495RESULT

  • Jeong JS, Kim KS, Lee JW, Kim KD, Park W. Efficacy of tooth brushing via a three-dimensional motion tracking system for dental plaque control in school children: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 22;22(1):626. doi: 10.1186/s12903-022-02665-6.

    PMID: 36550451DERIVED

MeSH Terms

Conditions

Dental Plaque

Interventions

Microscopy, Scanning TunnelingDrug Delivery Systems

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Scanning ProbeMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesDrug TherapyTherapeutics

Study Officials

  • Kee-Deog Kim, PhD

    Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
A dental hygienist blinded to group assignment determined plaque status. Participants were randomly assigned into two equally sized groups by flipping a coin.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 13, 2020

Study Start

September 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 17, 2020

Record last verified: 2020-11