PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction
NCT ID: NCT06783660
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
114 participants
INTERVENTIONAL
2025-01-08
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Peptide-loaded collagen sponge and collagen gel complex
A piece of peptide-loaded collagen sponge (Regenomer®) was placed in an extraction socket after tooth extraction and cover wound with collagen gel.
Peptide-loaded collagen sponge and collagen gel complex
A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
Collagen sponge
A piece of collagen sponge（Regenomer®）was placed in an extraction socket after tooth extraction.
Collagen sponge
Type 1 Collagen sponge (Regenomer)
Interventions
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Peptide-loaded collagen sponge and collagen gel complex
A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
Collagen sponge
Type 1 Collagen sponge (Regenomer)
Eligibility Criteria
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Inclusion Criteria
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
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.
19 Years
75 Years
ALL
Yes
Sponsors
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NIBEC Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Seoul National University Dental Hospital
Korea, Seoul, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RS-2020-KD000091
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
NIB-IND-(PTC)CTP
Identifier Type: -
Identifier Source: org_study_id
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