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

Primary Purpose

Toothbrushing

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)
Conventional toothbrush
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Toothbrushing focused on measuring Teledentistry, Schoolchildren, Oral hygiene, Computer, Smart toothbrush, Dental plaque

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

    conventional toothbrushing instruction (TBI)

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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).
    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).
    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).

    Secondary Outcome Measures

    Full Information

    First Posted
    November 2, 2020
    Last Updated
    November 12, 2020
    Sponsor
    Yonsei University
    Collaborators
    National Research Foundation of Korea
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04627324
    Brief Title
    Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control
    Official Title
    Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2008 (Actual)
    Primary Completion Date
    August 1, 2011 (Actual)
    Study Completion Date
    August 1, 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Yonsei University
    Collaborators
    National Research Foundation of Korea

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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 st study - 60 volunteers (adults) - The data for which have been published (reference) nd study - 42 volunteers (schoolchildren) - manuscript prepared 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Toothbrushing
    Keywords
    Teledentistry, Schoolchildren, Oral hygiene, Computer, Smart toothbrush, Dental plaque

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Masking Description
    A dental hygienist blinded to group assignment determined plaque status. Participants were randomly assigned into two equally sized groups by flipping a coin.
    Allocation
    Randomized
    Enrollment
    209 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    conventional toothbrushing instruction (TBI)
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)
    Intervention 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. (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.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional toothbrush
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from Baseline in plaque index at 10 month after TBI (1st study-adults)
    Description
    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).
    Time Frame
    Baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month after TBI.
    Title
    Change from Baseline in plaque index at 1 month after TBI (2nd study-schoolchildren)
    Description
    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).
    Time Frame
    Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.
    Title
    Change from Baseline in plaque index at 1 month after TBI (3rd study-adults and children)
    Description
    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).
    Time Frame
    Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kee-Deog Kim, PhD
    Organizational Affiliation
    Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25391495
    Citation
    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.
    Results Reference
    result

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

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