Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control

November 12, 2020 updated by: Kee-Deog Kim, Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

The investigators evaluated the efficacy of TBI with a STM system by analyzing the reductions of the modified Quigley-Hein plaque index in

  1. st study - 60 volunteers (adults) - The data for which have been published (reference)
  2. nd study - 42 volunteers (schoolchildren) - manuscript prepared
  3. rd study - 60 volunteers (adults and children)

These participants were separated randomly into two groups: conventional TBI (control group) and STM system TBI (experimental group).

The changes in the plaque indexes were recorded immediately, 1 week, 1 month, and 10 months (1st study only) after TBI.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Not Applicable

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI)
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)

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.
ACTIVE_COMPARATOR: conventional toothbrushing instruction (TBI)
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in plaque index at 10 month after TBI (1st study-adults)
Time Frame: Baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month after TBI.

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

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Collaborators

National Research Foundation of Korea

Investigators

  • Study Chair: Kee-Deog Kim, PhD, Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2008

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (ACTUAL)

November 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-2008-0005

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.

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