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Bone regeneration of 3D printed customized ceramic scaffold with PDRN(Polydeoxyribonucleotide): clinical trial

Bone regeneration of 3D printed customized ceramic scaffold with PDRN(Polydeoxyribonucleotide): clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0009145
Enrollment
6
Registered
2024-01-30
Start date
2022-06-22
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Radiological analysis by using CBCT between 3D printing customized bone material only and 3D printing customized bone material with PDRN

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years of age who has completed the skeletal growth 2) Patients with bone loss after removal of severe atrophy of alveolar ridge and cyst 3) If the patient is a non-smoker or smokes less than 1 pack (20 cigarettes) per day 4) Patients who voluntarily decided to participate in this clinical trial and agreed to the consent form of the subject in writing.

Exclusion criteria

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) If the patient smokes more than 1 pack (20 cigarettes) per day 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

Design outcomes

Primary

MeasureTime frame
Evaluation of the stability of the grafted bone material

Secondary

MeasureTime frame
Verification of the clinical safety/efficacy, assessment of the abnormal response, evaluation of the new bone through Micro CT analysis

Countries

Korea, Republic of

Contacts

Public ContactHEEYOUNG LEE

Hallym University Medical Center

newhealth2020@naver.com+82-31-380-1513

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026