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clinical trial research to evaluate the safety and efficacy of domestic absorbable membrane(LYSOGEDE®) and foreign absorbable membrane(Bio-Gide®)

clinical trial research to evaluate the safety and efficacy of domestic absorbable membrane(LYSOGEDE®) and foreign absorbable membrane(Bio-Gide®) used the most in clinical field.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0001815
Enrollment
66
Registered
2016-02-12
Start date
2014-11-03
Completion date
Unknown
Last updated
2019-03-11

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 : periodontal disease patient needed ridge preservation surgery are applied once the domestic absorbalble membrane or foreign absorbable membrane and conducted follow-up to 6-month afte

Sponsors

Ministry of Health & Welfare
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Only adults over 20 years old ? need a tooth extraction due to periodontal disease in the maxilla or mandible - patients have clinical attachment loss of more than 5mm in the area, grade 3 in tooth mobility - patients required bone grafts for therapeutic purposes, such as in the area of the implant

Exclusion criteria

Exclusion criteria: ? pregnant woman ? Uncontrolled hypertension or with diabetes ? In patients with a history or current malignant disease jaws ? Serious cardiovascular disease, respiratory disease, heart disease, liver disease, digestive disorders, blood disorders and neurological disorders • Patients with Psychiatric Disorders and merging ? Patients with hyperthyroidism or hypothyroidism. ? Patients with a history of drug allergy ? Depression or anxiety disorder altitude, and the patient is determined to influence the efficacy assessment ? Or patients with a history of drug or alcohol abuse within 1 year currently Abuse ? Patients deemed suitable by the investigator or research enforcer this study

Design outcomes

Primary

MeasureTime frame
Engraftment and absorption evaluation of the bone graft material using a Cone-beam CT;evaluating the efficacy using Cone-beam CT for the measurement volume level the surrounding tissue preparatione before and after surgery.;Full preparation before surgery value through impression, and then change the form and volume measurement

Secondary

MeasureTime frame
Adverse Reactions - Immune rejection;inflammation

Countries

Korea, Republic of

Contacts

Public ContactJinju Kim

Seoul National University Dental Hospital

pearl1294@hanmail.net+82-2-2072-3056

Outcome results

None listed

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