Using PeptiCol EZgraft for preserving tooth extraction sockets

A Multicenter, Open-label, Randomized, Independent Evaluation, Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of the Periodontal Tissue Inducing Photoresponsive PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction.

This study tests whether a new collagen treatment called PeptiCol EZgraft can better preserve tooth extraction sites compared to a standard treatment called Regenomer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 19 Years to 75 Years
• Sex: All
• Sponsor: NIBEC Co., Ltd. (industry)
• Locations: 1 site (Korea, Seoul)
• Trial ID: NCT06783660 on ClinicalTrials.gov

What this trial studies

This clinical trial compares the efficacy and safety of PeptiCol EZgraft against Regenomer in preserving extraction sockets after tooth removal. The study focuses on minimizing alveolar bone changes during the healing process. Participants will receive either PeptiCol EZgraft, a peptide-loaded collagen sponge and gel complex, or Regenomer to evaluate which treatment better reduces bone resorption. The trial aims to provide insights into the effectiveness of these materials in dental procedures.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 75 who are systemically healthy or have mild systemic diseases and plan to have dental implants after tooth extraction.

Not a fit: Patients with extensive alveolar bone absorption or severe periodontal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved outcomes in dental implant procedures by minimizing bone loss after tooth extractions.

How similar studies have performed: Other studies have shown promising results with similar approaches in socket preservation, indicating potential for success.

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.

Where this trial is running

Korea, Seoul

• Seoul National University Dental Hospital — Korea, Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Park Shin young

Conditions: Alveolar Ridge Augmentation, socket preservation, collagen sponge, collagen gel, Peptide