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Effectiveness of a domestic absorbable membrane with enhanced shielding function for tissue regeneration in defect areas: a multicenter, comparative, and controlled clinical trial

Effectiveness of a domestic absorbable membrane with enhanced shielding function for tissue regeneration in defect areas: a multicenter, comparative, and controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008998
Enrollment
60
Registered
2023-11-30
Start date
2022-07-29
Completion date
Unknown
Last updated
2026-08-10

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 : After transplanting alveolar bone to the alveolar bone defect, cut the shielding film to an appropriate size and apply it. After a certain period of time, oral scanning and CBCT evalu

Sponsors

dentium
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 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

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

Design outcomes

Primary

MeasureTime frame
Evaluation of the stability of the grafted bone material

Secondary

MeasureTime frame
Comparative evaluation of bone augmentation through oral scanning

Countries

Korea, Republic of

Contacts

Public Contacthyoeun choe

Hallym University

shine467@naver.com+82-31-380-1513

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Aug 25, 2026