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
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
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
NCT ID
NCT04627324
First Posted
November 2, 2020
Last Updated
November 12, 2020
Sponsor
Yonsei University
Collaborators
National Research Foundation of Korea
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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