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

Toothbrushing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04627324
• Other study ID #: 2-2008-0005
• Status: Completed
• Phase: N/A
• Start date: September 1, 2008
• Est. completion date: August 1, 2011

Study information

• Verified date: November 2020
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 1, 2011
• Est. primary completion date: August 1, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Toothbrushing

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	National Research Foundation of Korea

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, immediately after TBI (day 0), 1 week, 1 month and 10 month after TBI.
Primary	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).	Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.
Primary	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).	Baseline, immediately after TBI (day 0), 1 week, 1 month after TBI.