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

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ClinicalTrials.gov Identifier: NCT04627324
Recruitment Status : Completed
First Posted : November 13, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Kee-Deog Kim, Yonsei University

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.

Condition or disease Intervention/treatment Phase
Toothbrushing Device: The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea) Device: Conventional toothbrush Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Prevention
Official Title: Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control
Actual Study Start Date : September 1, 2008
Actual Primary Completion Date : August 1, 2011
Actual Study Completion Date : August 1, 2011

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.





Primary Outcome Measures :
  1. 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).


  2. 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).


  3. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04627324


Sponsors and Collaborators
Yonsei University
National Research Foundation of Korea
Investigators
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Study Chair: Kee-Deog Kim, PhD Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea
Publications of Results:
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Responsible Party: Kee-Deog Kim, Professor, Yonsei University
ClinicalTrials.gov Identifier: NCT04627324    
Other Study ID Numbers: 2-2008-0005
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kee-Deog Kim, Yonsei University:
Teledentistry
Schoolchildren
Oral hygiene
Computer
Smart toothbrush
Dental plaque
Additional relevant MeSH terms:
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Dental Plaque
Dental Deposits
Tooth Diseases
Stomatognathic Diseases