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Recruiting NCT06783660

PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction

No phase Interventional Alveolar Ridge Augmentation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peptide-loaded collagen sponge and collagen gel complex, Collagen sponge.
Who it may be relevant to
Registry conditions: Alveolar Ridge Augmentation. Basic parameters: 19 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Detailed description

The purpose of this clinical trial is to compare the efficacy and safety of using "PeptiCol EZgraft" in extraction socket preservation procedures against "Regenomer," specifically to evaluate whether PeptiCol EZgraft is more effective in reducing alveolar bone changes compared to Regenomer. The trial aims to assess both the effectiveness and safety of PeptiCol EZgraft in minimizing alveolar bone resorption during the healing process following tooth extraction.

Interventions

  • Device Peptide-loaded collagen sponge and collagen gel complex
    A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
  • Device Collagen sponge
    Type 1 Collagen sponge (Regenomer)

Primary outcome measures

  • Measure the change in alveolar bone width at the 25% point of the extraction socket on CBCT images at 4 months compared to baseline [Time frame: 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 [Time frame: 4 months, evaluation at each visit]
Secondary outcome measures (2)
  • Participant satisfaction evaluation [Time frame: at 4 months compared to baseline]
  • Assessment of alveolar bone healing [Time frame: at 4 months compared to baseline]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Immune disorders including acquired immunodeficiency syndrome.
  • Pregnant or breastfeeding women
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • Seoul National University Dental Hospital — Korea

Identifiers

NCT: NCT06783660 · NIB-IND-(PTC)CTP · RS-2020-KD000091

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗