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Accuracy of new device for dental implant installation

Status Approved

First Submitted Date

2020/04/16
Registered Date

2020/04/17
Last Updated Date

2020/04/16

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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	KCT0004939
Unique Protocol ID	20171110/16-2017-58/121
Public/Brief Title	Accuracy of new device for dental implant installation
Scientific Title	Accuracy of new device for dental implant installation
Acronym	ANDDII
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	16-2017-58
Approval Date	2018-05-14
Institutional Review Board Name	Seoul Metropolitan Government Seoul National University Boramae Medical Center Institutional Review Board
Institutional Review Board Address	20, Boramae-ro 5-gil, Dongjak-gu, Seoul
Institutional Review Board Telephone	02-870-1852
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	Yoon-Sic Han
Title	clinical professor
Telephone	+82-2-870-2495
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20, Boramae-ro 5 Gil, Dongjak-gu, Seoul, Korea
Contact Person for Public Queries
Name	Yoon-Sic Han
Title	clinical professor
Telephone	+82-2-870-2495
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20, Boramae-ro 5 Gil, Dongjak-gu, Seoul, Korea
Contact Person for Updating Information
Name	Yoon-Sic Han
Title	clinical professor
Telephone	+82-2-870-2495
Affiliation	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Address	20, Boramae-ro 5 Gil, Dongjak-gu, Seoul, 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	2020-04-13 Actual
Target Number of Participant	100
Primary Completion Date
Study Completion Date
Name of Study	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2020-04-13 ,

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	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul Metropolitan Government Seoul National University Boramae Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The implantation is performed by dividing the group (experimental group) with the new device and the group not using the new device (control group), and the accuracy of the new device is evaluated through radiographic and clinical analysis.

Study Summary Information

Lay Summary

The implantation is performed by dividing the group (experimental group) with the new device and the group not using the new device (control group), and the accuracy of the new device is evaluated through radiographic and clinical analysis.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Open
Allocation	RCT
Intervention Type	/Procedure/Surgery, Others (Whether to use implant stent)
Intervention Description	Analysis of differences in implant accuracy according to whether or not a dental implant stent (new device) is used
Number of Arms	2
Arm 1	Arm Label A group using a new device for implant placement
	Target Number of Participant 50
	Arm Type Experimental
	Arm Description A new device is used when placing a dental implant.
Arm 2	Arm Label A group that did not use a new device for implant placement
	Target Number of Participant 50
	Arm Type Active comparator
	Arm Description Do not use new devices when placing dental implants

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Etc tooth loss/The failure to retain teeth as a result of disease or injury.
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description - Adults 19 years of age or older (Those who have completed jaw growth) - Korean
Exclusion Criteria	-Those who are underage or have not completed jaw bone growth. - Subjects who need a large amount of bone graft due to severe alveolar atrophy, or who cannot perform implant surgery in the standard methods.
Healthy Volunteers

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	Central position, Fixture angulation, Fixture position of implants
Timepoint	Data collection complete
Secondary Outcome(s) 1
Outcome	Parallelism between implants in two or more implants
Timepoint	Data collection complete

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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