Alveolar Ridge Augmentation
Conditions
Keywords
socket preservation, collagen sponge, collagen gel, Peptide
Brief 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.
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.
Interventions
DEVICEPeptide-loaded collagen sponge and collagen gel complex
A piece of peptide-loaded collagen sponge (Regenomer®) and collagen gel complex
DEVICECollagen sponge
Type 1 Collagen sponge (Regenomer)
Sponsors
NIBEC Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 19 to 75 years. 2. Systemically healthy or with mild systemic disease, classified as ASA I or II. 3. 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. 4. The extraction socket area must have more than 50% of the alveolar bone wall remaining. 5. Willing to maintain good oral hygiene during the clinical trial. 6. Voluntarily decided to participate in the trial and signed the informed consent form. 7. Willing to participate for the entire duration of the clinical trial and comply with trial procedures.
Exclusion criteria
1. Extensive alveolar bone absorption observed in the extraction socket area. 2. Severe periodontal disease or acute periodontal abscess. 3. Poor oral hygiene. 4. History of bone grafts or implants in the area of the medical device application. 5. Mucosal diseases due to autoimmune disorders. 6. History of hypersensitivity to collagen preparations. 7. Smoking more than 10 cigarettes per day. 8. Alcohol or drug addiction. \*The alcohol addiction screening will be conducted using AUDIT-K. 9. Use of drugs affecting bone formation within 2 weeks prior to screening (e.g., steroids, bisphosphonates). 10. Use of oral or injectable rheumatic medications, including immunosuppressants, within 2 weeks prior to screening. 11. History of or current use of oral or injectable bisphosphonates for osteoporosis for more than 12 weeks. 12. Uncontrolled bleeding disorders or use of medications affecting blood coagulation. 13. Uncontrolled diabetes or hypertension. 14. Clinically significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system diseases observed at screening. 15. Immune disorders including acquired immunodeficiency syndrome. 16. Pregnant or breastfeeding women 17. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the change in alveolar bone width at the 25% point of the extraction socket on CBCT images at 4 months compared to baseline | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant satisfaction evaluation | at 4 months compared to baseline | 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 |
| Assessment of alveolar bone healing | at 4 months compared to baseline | 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. |
Countries
South Korea
Contacts
Primary ContactPark Shin young
Outcome results
None listed