Clinical trial NCT04627324: 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
Overall status: COMPLETED
Phase: NA
Conditions: Toothbrushing
Keywords: Teledentistry
Schoolchildren
Oral hygiene
Computer
Smart toothbrush
Dental plaque
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2020-11-13
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

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.

Primary outcomes:
measure: Change from Baseline in plaque index at 10 month after TBI (1st study-adults)
timeFrame: Baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month after TBI.
measure: Change from Baseline in plaque index at 1 month after TBI (2nd study-schoolchildren)
timeFrame: Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.
measure: Change from Baseline in plaque index at 1 month after TBI (3rd study-adults and children)
timeFrame: Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Advanced General Dentistry College of Dentistry, Yonsei University, Seoul, Korea
name: Kee-Deog Kim, PhD
role: STUDY_CHAIR
References:
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.