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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Measure the change in alveolar bone width at the 25% point of the extraction socket on CBCT images at 4 months compared to baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Measure the change in alveolar bone width at the 25% point of the extraction socket on CBCT images at 4 months compared to baseline
时间窗: 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
时间窗: 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.
次要结局
- Participant satisfaction evaluation(at 4 months compared to baseline)
- Assessment of alveolar bone healing(at 4 months compared to baseline)