PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction

NCT06783660 | Recruiting DMC

• 2 other identifiers: NIB-IND-(PTC)CTPRS-2020-KD000091
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Augmentation

Keywords

socket preservation; collagen sponge; collagen gel; Peptide

Outcome Measures

Primary Outcomes (2)

• Measure the change in alveolar bone width at the 25% point of the extraction socket on CBCT images at 4 months compared to baseline

  To apply reproducible endpoints, a reference stent, was placed in the oral cavity before the procedure and CBCT images were taken at baseline and 4 months after the test/control device was placed to assess the change in alveolar bone width at the upper 25% of the alveolar bone between the test and control groups.

  at 4 months compared to baseline

• Evaluation of safety measures via occurrence of (S)AE ((serious) adverse events), DD (device deficiency) and medical device related events

  * List all anticipated side effects and adverse events with detailed descriptions. * Record the frequency of adverse events related and unrelated to the clinical trial device. * List all adverse events with detailed descriptions and record the frequency of events related and unrelated to the clinical trial device. * Compare the number of adverse events related to the clinical trial device across treatment groups. * Compare the number of adverse events related to the clinical trial medical device by each treatment group.

  4 months, evaluation at each visit

Secondary Outcomes (2)

• Participant satisfaction evaluation

  at 4 months compared to baseline

• Assessment of alveolar bone healing

  at 4 months compared to baseline

Study Arms (2)

Peptide-loaded collagen sponge and collagen gel complex

EXPERIMENTAL

A piece of peptide-loaded collagen sponge (Regenomer®) was placed in an extraction socket after tooth extraction and cover wound with collagen gel.

Device: Peptide-loaded collagen sponge and collagen gel complex

Collagen sponge

ACTIVE COMPARATOR

A piece of collagen sponge（Regenomer®）was placed in an extraction socket after tooth extraction.

Device: Collagen sponge

Interventions

Peptide-loaded collagen sponge and collagen gel complex DEVICE

A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex

Peptide-loaded collagen sponge and collagen gel complex

Collagen sponge DEVICE

Type 1 Collagen sponge (Regenomer)

Collagen sponge

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 19 to 75 years.
• Systemically healthy or with mild systemic disease, classified as ASA I or II.
• 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.
• The extraction socket area must have more than 50% of the alveolar bone wall remaining.
• Willing to maintain good oral hygiene during the clinical trial.
• Voluntarily decided to participate in the trial and signed the informed consent form.
• Willing to participate for the entire duration of the clinical trial and comply with trial procedures.

You may not qualify if:

• Extensive alveolar bone absorption observed in the extraction socket area.
• Severe periodontal disease or acute periodontal abscess.
• Poor oral hygiene.
• History of bone grafts or implants in the area of the medical device application.
• Mucosal diseases due to autoimmune disorders.
• History of hypersensitivity to collagen preparations.
• Smoking more than 10 cigarettes per day.
• Alcohol or drug addiction.
• \*The alcohol addiction screening will be conducted using AUDIT-K.
• Use of drugs affecting bone formation within 2 weeks prior to screening (e.g., steroids, bisphosphonates).
• Use of oral or injectable rheumatic medications, including immunosuppressants, within 2 weeks prior to screening.
• History of or current use of oral or injectable bisphosphonates for osteoporosis for more than 12 weeks.
• Uncontrolled bleeding disorders or use of medications affecting blood coagulation.
• Uncontrolled diabetes or hypertension.
• Clinically significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system diseases observed at screening.

Sponsors & Collaborators

• NIBEC Co., Ltd.: lead

Study Sites (1)

Seoul National University Dental Hospital

Korea, Seoul, 03080, South Korea

RECRUITING

Central Study Contacts

Park Shin young

CONTACT

82 + 262563354; nalby99@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 8, 2025
• Primary Completion: January 31, 2026
• Study Completion: February 28, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-01

Locations

KR (1)