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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
Type 1 Collagen sponge (Regenomer)
Seoul National University Dental Hospital
Korea, Seoul, South Korea
RECRUITINGMeasure 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 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.
Time frame: 4 months, evaluation at each visit
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 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. 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.
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Time frame: at 4 months compared to baseline