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Comparison of accuracy, repetency, and convenience between implant stability analysis instruments: a prospective multi-center clinical research

Status Approved

First Submitted Date

2020/12/15
Registered Date

2020/12/30
Last Updated Date

2023/11/22

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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	KCT0005721
Unique Protocol ID	202015X20
Public/Brief Title	Comparison of accuracy, repetency, and convenience between implant stability analysis instruments: a prospective multi-center clinical research
Scientific Title	Comparison of accuracy, repetency, and convenience between implant stability analysis instruments: a prospective multi-center clinical research
Acronym	ANY
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	2020GR0580
Approval Date	2020-12-10
Institutional Review Board Name	Korea University Guro Hospital Institutional Review Board
Institutional Review Board Address	148, Gurodong-ro, Guro-gu, Seoul
Institutional Review Board Telephone	02-2626-1964
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	jisuk shim
Title	Professor
Telephone	+82-2-2626-1923
Affiliation	Koera University Guro Hospital
Address	148, Gurodong-ro, Guro-gu, Seoul
Contact Person for Public Queries
Name	soyoung bae
Title	crc
Telephone	+82-2-2626-1923
Affiliation	Koera University Guro Hospital
Address	148, Gurodong-ro, Guro-gu, Seoul
Contact Person for Updating Information
Name	soyoung bae
Title	crc
Telephone	+82-2-2626-1923
Affiliation	Koera University Guro Hospital
Address	148, Gurodong-ro, Guro-gu, Seoul

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	Multi-center Number of center : 2
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 Anticipated
Target Number of Participant	60
Primary Completion Date	2022-12-30 , Anticipated
Study Completion Date	2022-12-30 , Anticipated
Name of Study	Koera University Guro Hospital
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,
Recruitment Status by Participating Study Site 2
Name of Study	Dankook University Dental Hostipal
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-01-04 ,

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	202015X20

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Koera University Guro Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Research and development goals ○The final goal: The accuracy, reproducibility, and accuracy of AnycheckTM, a new concept implant stability diagnostic device manufactured with domestic pure technology, To compare and evaluate convenience with other existing products, we intend to conduct a prospective multicenter clinical study. Target real patients The result of this study, which was derived as a result, will be the basis for clearly showing the excellence of AnycheckTM. It will be used as a data that can advance the accuracy one step further. Research and development content ○ Clinical trial design: The oral cavity is divided into 6 areas, and 10 implants are placed in each area. 3 types of implants Implant stability is measured using an implant stability diagnostic device. ○ Clinical study subjects: Patients 65 years of age or older who need implant surgery without alveolar bone graft ○ Evaluation of research results (1) Accuracy analysis of implant stability diagnosis device -Analyzing the accuracy of IST and PTV based on the proven ISQ values (2) Reproducibility analysis of implant stability diagnosis device -Measure one implant and analyze the reproducibility of numerical values (3) Convenience analysis of implant stability diagnosis device -Analyze the subject's comfort and the measurer's convenience through a survey when measuring the implant stability diagnosis device R&D achievements ○ AnycheckTM, an implant stability diagnostic device manufactured with pure domestic technology, is compared with existing diagnostic devices. Eggplant performs clinical verification for accuracy, reproducibility, and convenience, and establishes scientific basis for this ○ Through the results of this study, it is possible to confirm the change in accuracy of the stability diagnosis device according to the measurement area and measurement situation in the oral cavity. Well. These data are used as the basis for the calibration of AnycheckTM. ○ In elderly patients, the implant value of the elderly patients is confirmed by checking the timing of stabilization to the extent that the implants receive occlusal pressure. Present standards for fees ○ The results of this study will be published in a world-class SCI-level journal. Utilization plan and expected effect 1) Utilization plan ○ Based on the results of this study, it is used for targeting the global market and marketing. ○ Seeking product improvement based on the results of this study ○ Establishing standards for implant placement in elderly patients

Study Summary Information

Lay Summary

Research and development goals
○The final goal: The accuracy, reproducibility, and accuracy of AnycheckTM, a new concept implant stability diagnostic device manufactured with domestic pure technology,
To compare and evaluate convenience with other existing products, we intend to conduct a prospective multicenter clinical study. Target real patients
The result of this study, which was derived as a result, will be the basis for clearly showing the excellence of AnycheckTM.
It will be used as a data that can advance the accuracy one step further.

Research and development content
○ Clinical trial design: The oral cavity is divided into 6 areas, and 10 implants are placed in each area. 3 types of implants
Implant stability is measured using an implant stability diagnostic device.
○ Clinical study subjects: Patients 65 years of age or older who need implant surgery without alveolar bone graft
○ Evaluation of research results
(1) Accuracy analysis of implant stability diagnosis device
-Analyzing the accuracy of IST and PTV based on the proven ISQ values
(2) Reproducibility analysis of implant stability diagnosis device
-Measure one implant and analyze the reproducibility of numerical values
(3) Convenience analysis of implant stability diagnosis device
-Analyze the subject&#39;s comfort and the measurer&#39;s convenience through a survey when measuring the implant stability diagnosis device

R&D achievements
○ AnycheckTM, an implant stability diagnostic device manufactured with pure domestic technology, is compared with existing diagnostic devices.
Eggplant performs clinical verification for accuracy, reproducibility, and convenience, and establishes scientific basis for this
○ Through the results of this study, it is possible to confirm the change in accuracy of the stability diagnosis device according to the measurement area and measurement situation in the oral cavity.
Well. These data are used as the basis for the calibration of AnycheckTM.
○ In elderly patients, the implant value of the elderly patients is confirmed by checking the timing of stabilization to the extent that the implants receive occlusal pressure.
Present standards for fees
○ The results of this study will be published in a world-class SCI-level journal.

Utilization plan and expected effect
1) Utilization plan
○ Based on the results of this study, it is used for targeting the global market and marketing.
○ Seeking product improvement based on the results of this study
○ Establishing standards for implant placement in elderly patients

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	Diagnosis
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Medical Device
Intervention Description	Among the subjects who wish to participate in the clinical study, those who sign the clinical study consent form and satisfy the selection criteria are enrolled in this clinical study. Analyze the accuracy, reproducibility, and disparity of the device by measuring implant mobility while placing the implant.
Number of Arms	1
Arm 1	Arm Label Tooth loss patient
	Target Number of Participant 60
	Arm Type Experimental
	Arm Description Among the subjects who wish to participate in the clinical study, those who sign the clinical study consent form and satisfy the selection criteria are enrolled in this clinical study. Analyze the accuracy, reproducibility, and disparity of the device by measuring implant mobility while placing the implant.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K08.1)Loss of teeth due to accident, extraction or local periodontal disease Tooth loss patient
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~No Limit
	Description 1) Adults 65 years of age or older with strong motivation 2) A person who agrees to participate in clinical research and signs consent for clinical research 3) Patients planning to implant implants at Guro Hospital
Exclusion Criteria	1) If the implant is re-implanted after failure 2) In the case of a large range of bone grafts due to severe bone loss, 3) If the implant is placed immediately after tooth extraction 4) pregnant women 5) Patients with uncontrolled medical conditions 6) Patients with mental illness or suspected mental illness 7) Others who are inappropriate to participate in clinical research as judged by the head of clinical research because it may affect the results of clinical research ethically or 8) Others who have difficulty in implant placement surgery
Healthy Volunteers	No

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	/Safety/Efficacy
Outcome	Implant stability
Timepoint	Implant surgery day, 2 weeks after surgery, 1 month after surgery, 2 months after surgery, 3 months after surgery, 4 months after surgery
Secondary Outcome(s) 1
Outcome	Patient satisfaction survey
Timepoint	4 months after implant surgery

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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