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Completed

NCT Number: NCT04627324

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Conventional Toothbrush

Device

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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • National Research Foundation of Korea

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 13, 2020
Registry last updated
Nov 17, 2020

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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