KCT0001130已完成未知
Clinical experiment for evaluation of safety and efficacy of RAFUGENTM BMP2 DBM Gel
Cellumed0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Adult patients (aged 20 to 70) who need to have their maxillomandibular anterior and premolar teeth (limited to single rooted tooth) extracted.
- •(Bone grafting will be carried out on the wound of tooth extraction with RAFUGENTM BMP2 DBM Gel (a graft material containing rhBMP2) for the test group and RAFUGENTM DBM Gel (a graft material not containing rhBMP2) for the comparator group.
- •2) Patients whose bones surrounding the tooth at the target site of extraction and preservation (alveolar bones) procedures have been resorbed and decreased to 1/2 or less in a downward direction.
- •3) Patients who are strongly motivated for bone graft treatment.
- •4) Patients who have agreed to participate in the study and provided signed informed consent.
排除标准
- •1) Patients with serious periodontitis as in the case of those whose bones surrounding the tooth at the target site of extraction and preservation procedures (alveolar bones) have been resorbed and decreased to 1/2 or more in a downward direction, or patients with acute periodontitis although their alveolar bones have been resorbed and decreased to 1/2 or less in a downward direction.
- •2) Pregnant or lactating women, or women who are planning to become pregnant during the study and within 1 year after the study (women who do not agree to use contraception) or the elderly and infirm.
- •3) Patients with recent history of myocardial infarction attack.
- •4) Patients with uncontrolled bleeding diseases or other diseases that cannot allow minor operations.
- •5) Patients who have or are suspected of having mental diseases.
- •6) Patients with hypersensitivity reactions to bone graft materials.
- •7) Patients who are suspected of having insufficient liver function (AST/ALT = 2 X Upper Limit of Normal).
- •8) Patients with uncontrolled diabetes mellitus (Glucose> 200mg/dl).
- •9) Patients with history of alcohol or drug abuse.
- •10) Osteomyelitis or blood vessel damage at the site of operation.
- •11) Those excluded due to dental history (e.g., history of oral cancer, etc.).
- •12) Those on drugs that affect osteogenesis (e.g., steroids, bisphosphonates, etc.).
- •13) Smokers of 1/2 pack or more per day.
- •14) Renal disease or other systemic disease (uncontrolled diabetes mellitus, hyperthyroidism, abnormal bone metabolism, abnormal connective tissue metabolism, etc.).
- •15) Patients with HIV infection or those on immunosuppressants.
- •16) Inappropriate oral hygiene.
- •17) Administration of other investigational product within 30 days of study participation.
- •18) Patients, as judged by the principal investigator, who are not eligible for study participation due to ethical reasons or others that may affect the study results.
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