PeptiCol EZgraft in the Extraction Socket Preservation Process After Tooth Extraction
ConditionAlveolar Ridge Augmentation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorNIBEC Co., Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Peptide-loaded collagen sponge and collagen gel complex
DeviceA piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
Collagen sponge
DeviceType 1 Collagen sponge (Regenomer)
Treatment groups
114 Participants
are divided into 2 treatment groupsGroup A: Peptide-loaded collagen sponge and collagen gel complexExperimental treatment 1 intervention
Group B: Collagen spongeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
at 4 months compared to baseline2
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.
Time frame
4 months, evaluation at each visitSecondary outcomes
1
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"
Time frame
at 4 months compared to baseline2
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. 1. 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. 2. 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.
Time frame
at 4 months compared to baselineLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Seoul National University Dental HospitalRecruiting03080, Korea, SeoulSouth Korea
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov