ToothbrushingNCT04627324
Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control
A study testing The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea) and Conventional toothbrush in people with Toothbrushing, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Toothbrushing
- What is being tested?
- The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea) and Conventional toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2008to 1 Aug 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- if they had gross dental caries or orthodontic appliances, or were medically compromised.
About this study
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.
Read the 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.
- Conditions
- Toothbrushing
- Being tested
- The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea), Conventional toothbrush
- Keywords
- Teledentistry, Schoolchildren, Oral hygiene, Computer, Smart toothbrush, Dental plaque
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 toothbrushDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI) | Experimental | 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. Receives: Device: The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea) |
| conventional toothbrushing instruction (TBI) | Active comparator | 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. Receives: Device: Conventional toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 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)
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).
Measured: Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Sep 2008
- Primary completion1 Aug 2011
- Study completion1 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ToothbrushingStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Kee-Deog Kim, Yonsei University
- Investigators
- Kee-Deog Kim, PhD, Study chair, Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627324
- Sponsor's protocol ID
- 2-2008-0005
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25391495Jeong JS, Kim KS, Lee JW, Kim KD, Park W. Efficacy of tooth brushing via a three-dimensional motion tracking system for dental plaque control in school children: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 22;22(1):626. doi: 10.1186/s12903-022-02665-6.
PubMed 36550451
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Using 3D Motion Tracking Toothbrush in Dental Plaque Control
- ClinicalTrials.gov ID
- NCT04627324
- Acronym / sponsor ID
- 2-2008-0005
- Conditions
- Toothbrushing
- Keywords
- Teledentistry, Schoolchildren, Oral hygiene, Computer, Smart toothbrush, Dental plaque
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 1 Aug 2011 (actual)
- Study completion
- 1 Aug 2011 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI) | Experimental | Device: The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)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. |
| conventional toothbrushing instruction (TBI) | Active comparator | Device: Conventional toothbrushParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- if they had gross dental caries or orthodontic appliances, or were medically compromised.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | The smart toothbrush and smart mirror (STM) system toothbrushing instruction (TBI) |
| Conventional toothbrushtoothbrushes 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. | Device | conventional toothbrushing instruction (TBI) |
Primary outcome
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Results publication: PubMed 25391495Kim 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.
- Derived from this study: PubMed 36550451Jeong JS, Kim KS, Lee JW, Kim KD, Park W. Efficacy of tooth brushing via a three-dimensional motion tracking system for dental plaque control in school children: a randomized controlled clinical trial. BMC Oral Health. 2022 Dec 22;22(1):626. doi: 10.1186/s12903-022-02665-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kee-Deog Kim, PhD study chair
Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea
Questions about this trial
What is this clinical trial studying?
A study testing The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea) and Conventional toothbrush in people with Toothbrushing, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627324, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.