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Remote oral management and improvement of oral hygiene by smart toothbrush type in children

Status Approved

First Submitted Date

2021/03/18
Registered Date

2021/03/25
Last Updated Date

2021/03/18

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006029
Unique Protocol ID	2-2020-0082
Public/Brief Title	Remote oral management and improvement of oral hygiene by smart toothbrush type in children
Scientific Title	Remote oral management and improvement of oral hygiene by smart toothbrush type in children
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2-2020-0082
Approval Date	2021-01-07
Institutional Review Board Name	Yonsei University Dental Hospital, Institutional Review Board
Institutional Review Board Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul
Institutional Review Board Telephone	02-2228-8613
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Jeseon Song
Title	Professor
Telephone	+82-2-2228-3176
Affiliation	Yonsei University Health System, Dental Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Taeyang Lee
Title	Researcher
Telephone	+82-2-2228-3170
Affiliation	Yonsei University Health System, Dental Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Taeyang Lee
Title	Researcher
Telephone	+82-2-2228-3170
Affiliation	Yonsei University Health System, Dental Hospital
Address	50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-01-22 Actual
Target Number of Participant	75
Primary Completion Date	2022-01-06 , Anticipated
Study Completion Date	2022-01-06 , Anticipated
Name of Study	Yonsei University Health System, Dental Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-01-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Health & Welfare
Organization Type	Government
Project ID	HI20C1055

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Yonsei University Health System, Dental Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Through the correct toothbrush education and remote oral hygiene management of the subject through a device that measures brushing habits in children and data input from the device, it evaluates the plaque status of teeth to improve brushing and oral care habits.

Study Summary Information

Lay Summary

Through the correct toothbrush education and remote oral hygiene management of the subject through a device that measures brushing habits in children and data input from the device, it evaluates the plaque status of teeth to improve brushing and oral care habits.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Prospective
Target Number of Participant	75
Cohort/Group Number	3
Cohort/ Group 1	Cohort/Group Label Normal-Toothbrush
Cohort/ Group 1	Cohort/Group Description As a control group for comparing smart toothbrushes, education for oral hygiene management is the same and helps children to have proper brushing habits.
Cohort/ Group 2	Cohort/Group Label Mombrush
Cohort/ Group 2	Cohort/Group Description Mombrush is a device that helps you to have proper and correct brushing habits by age and oral health. It has functions such as learning to brush standard brushing, and evaluating brushing skill. You can receive brushing training and feedback through the app.
Cohort/ Group 3	Cohort/Group Label Oral-B
Cohort/ Group 3	Cohort/Group Description Oral-B Smart Toothbrush is a smart electric toothbrush equipped with a Bluetooth connection function and is linked with a dedicated app to provide functions necessary for oral care such as an oral care tip timer.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	-Children under 12 years of age who visited the Department of Pediatric Dentistry at Yonsei University Dental College Hospital -Patients with mixed dentition with both primary and permanent teeth -Patients who voluntarily agreed to participate in this study -Vulnerable subjects, including employees of researchers at research institutes -Pediatric patients with erupting maxillary and mandibular central incisors and first molars
Sampling Method	Non-probabilistic extraction method, selecting a subject with consent according to the subject's age and dentition status
Condition(s)/Problem(s)	Not Applicable-Etc Dentition, Mixed in Child
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 6Year~12Year
	Description -Children under 12 years of age who visited the Department of Pediatric Dentistry at Yonsei University Dental College Hospital -Patients with mixed dentition with both primary and permanent teeth -Patients who voluntarily agreed to participate in this study -Vulnerable subjects, including employees of researchers at research institutes -Pediatric patients with erupting maxillary and mandibular central incisors and first molars
Exclusion Criteria	-Patients receiving head and neck radiation therapy (including patients with disabilities who lack medical skills) -In case the test subject withdraws consent -Patients judged to be inappropriate by other clinicians
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Plaque Index
Timepoint	First visit, 1 month later, 3 months later
Secondary Outcome(s) 1
Outcome	Q-ray cam (QLF detection)
Timepoint	First visit, 1 month later, 3 months later

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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