PeptiCol EZgraft in the Extraction Socket Preservation Pr... | NCT06783660

NCT06783660

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
RS-2020-KD000091	Other Grant/Funding Number	The Korea Medical Device Development Fund

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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"	at 4 months compared to baseline
Assessment of alveolar bone healing

Eligibility Module

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.