NCT06783660 PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction
| NCT ID | NCT06783660 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NIBEC Co., Ltd. |
| Condition | Alveolar Ridge Augmentation |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2025-01-08 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This clinical trial aims to compare the efficacy and safety of applying "PeptiCol EZgraft" in extraction socket preservation procedures against "Regenomer," in terms of reducing the amount of alveolar bone change during the healing process following tooth extraction.
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 19 to 75 years. 2. Systemically healthy or with mild systemic disease, classified as ASA I or II. 3. Planning to place implants in the maxilla or mandible after extraction, or having such plans for the future. If there are multiple extraction sockets, only one socket will be included in the trial, and other areas will follow spontaneous healing or treatment plans. 4. The extraction socket area must have more than 50% of the alveolar bone wall remaining. 5. Willing to maintain good oral hygiene during the clinical trial. 6. Voluntarily decided to participate in the trial and signed the informed consent form. 7. Willing to participate for the entire duration of the clinical trial and comply with trial procedures. Exclusion Criteria: 1. Extensive alveolar bone absorption observed in the extraction socket area. 2. Severe periodontal disease or acute periodontal abscess. 3. Poor oral hygiene. 4. History of bone grafts or implants in the area of the medical device application. 5. Mucosal diseases due to autoimmune disorders. 6. History of hypersensitivity to collagen preparations. 7. Smoking more than 10 cigarettes per day. 8. Alcohol or drug addiction. \*The alcohol addiction screening will be conducted using AUDIT-K. 9. Use of drugs affecting bone formation within 2 weeks prior to screening (e.g., steroids, bisphosphonates). 10. Use of oral or injectable rheumatic medications, including immunosuppressants, within 2 weeks prior to screening. 11. History of or current use of oral or injectable bisphosphonates for osteoporosis for more than 12 weeks. 12. Uncontrolled bleeding disorders or use of medications affecting blood coagulation. 13. Uncontrolled diabetes or hypertension. 14. Clinically significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system diseases observed at screening. 15. Immune disorders including acquired immunodeficiency syndrome. 16. Pregnant or breastfeeding women 17. During the clinical trial period, female and male participants who are of childbearing potential must agree to use appropriate contraception from the date of signing the informed consent form until the end of the clinical trial (16 weeks post-procedure). If a female participant becomes pregnant during the trial period, her participation will be discontinued.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06783660 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 75 Years, studying Alveolar Ridge Augmentation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783660 currently recruiting?
Yes, NCT06783660 is actively recruiting participants. Contact the research team at nalby99@snu.ac.kr for enrollment information.
Where is the NCT06783660 trial being conducted?
This trial is being conducted at Korea, South Korea.
Who is sponsoring the NCT06783660 clinical trial?
NCT06783660 is sponsored by NIBEC Co., Ltd.. The trial plans to enroll 114 participants.