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Evaluation of the 3D printed customized pure ceramic scaffold

Status Approved

First Submitted Date

2020/11/26
Registered Date

2021/01/04
Last Updated Date

2023/11/09

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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	KCT0005732
Unique Protocol ID	HALLYM 2020-06-020-004
Public/Brief Title	3D printed customized ceramic scaffold
Scientific Title	Evaluation of the 3D printed customized pure ceramic scaffold
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	HALLYM 2020-06-020-004
Approval Date	2020-11-17
Institutional Review Board Name	Hallym University Medical Center institutional review board
Institutional Review Board Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do
Institutional Review Board Telephone	031-380-1975
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	soohwan byun
Title	assistant professor
Telephone	+82-31-380-3870
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Heeyoung LEE
Title	researcher
Telephone	+82-31-380-3870
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Heeyoung LEE
Title	researcher
Telephone	+82-31-380-3870
Affiliation	Hallym University Medical Center
Address	22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 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	Multi-center Number of center : 2
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-01-21 Actual
Target Number of Participant	60
Primary Completion Date	2022-04-30 , Anticipated
Study Completion Date	2022-12-31 , Anticipated
Name of Study	Hallym University Medical Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-01-21 ,
Recruitment Status by Participating Study Site 2
Name of Study	Seoul National University Dental Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-02-03 ,

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	HALLYM 2020-06-020

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Hallym University Medical Center-Hangang
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	3D printed customized ceramic scaffold is estimated to show prominent clinical results compared to the conventional guided bone regeneration method in patients presenting atrophy of the alveolar ridge. Multicenter Randomized Clinical Trial : The evaluation of safety and efficacy of 3D printed customized ceramic scaffold by designating the control group as the patients who underwent the conventional procedure of guided bone regeneration (GBR) and the study group as those who underwent bone graft with 3D printed customized bone graft materials. 1. Primary endpoint -Safety of the grafted bone material 2. Secondary endpoint -Clinical assessment (complications and clinician's preferences) -Radiological and histological evaluation of the regenerated bone with Micro CT (Radiological and histological assessment of the bone extracted from the prepared site for implant installation )

Study Summary Information

Lay Summary

3D printed customized ceramic scaffold is estimated to show prominent clinical results compared to the conventional guided bone regeneration method in patients presenting atrophy of the alveolar ridge. 

Multicenter Randomized Clinical Trial
: The evaluation of safety and efficacy of 3D printed customized ceramic scaffold by designating the control group as the patients who underwent the conventional procedure of guided bone regeneration (GBR) and the study group as those who underwent bone graft with 3D printed customized bone graft materials.

1. Primary endpoint
-Safety of the grafted bone material
2. Secondary endpoint
-Clinical assessment (complications and clinician&#39;s preferences)
-Radiological and histological evaluation of the regenerated bone with Micro CT (Radiological and histological assessment  of the bone extracted from the prepared site for implant installation )

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	Factorial
Blinding/Masking	Single
Blinded Subject	Subject
Allocation	RCT
Intervention Type	Medical Device
Intervention Description	3D printed customized ceramic scaffold is estimated to show prominent clinical results compared to the conventional guided bone regeneration method in patients presenting atrophy of the alveolar ridge.
Number of Arms	2
Arm 1	Arm Label Patient-specific bone grafting using 3D printing is performed on bone defects that require bone grafts for implants.
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Radiation and histological analysis evaluation of parameters related to bone mass, bone density, and bone structure of bone graft sites.
Arm 2	Arm Label A general bone transplant procedure is performed on bone defects that require bone transplantation for implants.
	Target Number of Participant 30
	Arm Type Active comparator
	Arm Description Radiation and histological analysis evaluation of parameters related to bone mass, bone density, and bone structure of bone graft sites.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K08.2)Atrophy of edentulous alveolar ridge Atrophy of Alveolar ridge
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~75Year
	Description 1) Patients over 20 years of age who has completed the skeletal growth 2) Patients without disease or with a disease that is well controlled. 3) Patients who have more than one tooth missing and need the bone graft procedure for implant restoration : Dentium implantation scheduled 4) Patients who voluntarily decided to participate in this clinical trial and agreed to the consent form of the subject in writing. 5) Patients who are willing to visit the clinic during a follow-up period and comply with a clinical trial plan
Exclusion Criteria	1) Patients who are pregnant 2) Patients who have metabolic diseases (uncontrolled diabetes, etc.) 3) Patients taking drugs that can affect bone metabolism – bisphosphonates, rhPTH, denosumab, etc. 4) Patients with uncontrolled gingivitis, periodontitis, or dental caries 5) Patients who have received radiation therapy in the treatment area 6) Patients with the hemorrhagic disease or need to take anticoagulants 7) Patients allergic to bone graft/implant materials 8) Smokers 9) Other improper patients who are thought to be inappropriate for participation due to the ethical issue, or because it may affect the results of the clinical trial
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	/Safety/Efficacy
Outcome	Evaluation of the stability of the grafted bone material
Timepoint	Six months after bone grafting
Secondary Outcome(s) 1
Outcome	Verification of the clinical safety/efficacy, assessment of the abnormal response, evaluation of the new bone through Micro CT and histologic analysis
Timepoint	Six months after bone grafting

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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