Alveolar Ridge AugmentationNCT06783660
PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction
A study testing Peptide-loaded collagen sponge and collagen gel complex and Collagen sponge in people with Alveolar Ridge Augmentation, run by NIBEC Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation
- What is being tested?
- Peptide-loaded collagen sponge and collagen gel complex and Collagen sponge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jan 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Dental Hospital
Korea, Seoul, 03080
Park Shin Young, +82-2-6256-3354, nalby99@snu.ac.kr
About this study
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.
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.
Read the 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.
- Conditions
- Alveolar Ridge Augmentation
- Being tested
- Peptide-loaded collagen sponge and collagen gel complex, Collagen sponge
- Keywords
- socket preservation, collagen sponge, collagen gel, Peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide-loaded collagen sponge and collagen gel complexDevice
A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
Collagen spongeDevice
Type 1 Collagen sponge (Regenomer)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Collagen sponge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 4 months, evaluation at each visit
Secondary outcomes (2)
Participant satisfaction evaluation
Participant evaluations such as satisfaction with the procedure and pain assessment were collected after the procedure. A survey was conducted using a 5-point scale from "very dissatisfied to very satisfied"
Measured: at 4 months compared to baseline
Assessment of alveolar bone healing
The goal is to measure the variables to observe the healing of alveolar bone based on CBCT at 4 months from baseline.
- Change in bone width Bone width at 50 and 75% of the alveolar bone apex at baseline and at 4 months with the investigational/control device was measured using CBCT scans taken with the reference stent in the oral cavity.
- Change in bone height D2 measured from line C as described by Fiorellini et al. at baseline to line C at 4 months after application of the test/control device, using CBCT images taken with the reference stent in the oral cavity.
Measured: at 4 months compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start8 Jan 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NIBEC Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783660
- Sponsor's protocol ID
- NIB-IND-(PTC)CTP
- Other IDs
- RS-2020-KD000091
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06783660
- Acronym / sponsor ID
- NIB-IND-(PTC)CTP
- Conditions
- Alveolar Ridge Augmentation
- Keywords
- socket preservation, collagen sponge, collagen gel, Peptide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- NIBEC Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peptide-loaded collagen sponge and collagen gel complex | Experimental | Device: Peptide-loaded collagen sponge and collagen gel complexA piece of peptide-loaded collagen sponge (Regenomer®) was placed in an extraction socket after tooth extraction and cover wound with collagen gel. |
| Collagen sponge | Active comparator | Device: Collagen spongeA piece of collagen sponge（Regenomer®）was placed in an extraction socket after tooth extraction. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide-loaded collagen sponge and collagen gel complexA piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex | Device | Peptide-loaded collagen sponge and collagen gel complex |
| Collagen spongeType 1 Collagen sponge (Regenomer) | Device | Collagen sponge |
Primary outcome
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
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.
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
* 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.
2 secondary outcomes
Participant satisfaction evaluation
Time frame: at 4 months compared to baseline
Assessment of alveolar bone healing
Time frame: at 4 months compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peptide-loaded collagen sponge and collagen gel complex and Collagen sponge in people with Alveolar Ridge Augmentation, run by NIBEC Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Park Shin young (82 + 262563354, nalby99@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.