Actively Recruiting
Multicenter, Open-label, Randomized Trial Evaluating Safety and Efficacy of PeptiCol EZgraft in Extraction Socket Preservation After Tooth Extraction
Led by NIBEC Co., Ltd. · Updated on 2025-10-03
114
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of "PeptiCol EZgraft" compared to "Regenomer" in preserving the alveolar bone after tooth extraction. The study focuses on whether PeptiCol EZgraft better reduces bone changes during healing, aiming to minimize alveolar bone loss following the extraction procedure. Participants will receive either a peptide-loaded collagen sponge combined with collagen gel (PeptiCol EZgraft) or a collagen sponge (Regenomer) placed in the extraction socket after tooth removal. The trial is open-label and randomized, with treatment applied immediately after extraction to support bone preservation. During the 4-month study, participants will undergo CBCT imaging to measure changes in alveolar bone width and be monitored for any adverse events related to the devices used. Participant satisfaction and bone healing will also be evaluated. Safety assessments will occur at each visit, and the total participation lasts through the 4-month follow-up period.
CONDITIONS
Brief Title
PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 75 years
- Systemically healthy or with mild systemic disease (ASA I or II)
- Planning to place implants in the upper or lower jaw after extraction or planning for future implants
- Extraction socket with more than 50% of alveolar bone wall remaining
- Willing to maintain good oral hygiene during the trial
- Voluntarily agreed to participate and signed informed consent
- Willing to comply with trial procedures for the entire duration
You will not qualify if you...
- Extensive alveolar bone loss in the extraction socket area
- Severe periodontal disease or acute periodontal abscess
- Poor oral hygiene
- History of bone grafts or implants in the treatment area
- Mucosal diseases caused by autoimmune disorders
- History of allergic reaction to collagen products
- Smoking more than 10 cigarettes per day
- Alcohol or drug addiction (screened by AUDIT-K)
- Use of bone-affecting drugs 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
- Use of bisphosphonates for osteoporosis for more than 12 weeks
- Uncontrolled bleeding disorders or use of blood-thinning medications
- Uncontrolled diabetes or high blood pressure
- Significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system diseases
- Immune disorders including AIDS
- Pregnant or breastfeeding women
- Participants of childbearing potential must agree to contraception during the trial and for 16 weeks after; pregnancy during the trial will end participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 months
Participants receive extraction socket preservation with either a peptide-loaded collagen sponge and collagen gel complex or a collagen sponge after tooth extraction.
Visits at baseline and multiple follow-up visits during the 4 months
Trial Site Locations
Total: 1 location
1
Seoul National University Dental Hospital
Korea, Seoul, South Korea, 03080
Actively Recruiting
Research Team
P
Park Shin young
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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