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 人待定
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Diseases of the musculo-skeletal system and connective tissue
- 发起方
- Cellumed
- 入组人数
- 70
- 状态
- 已完成
- 最后更新
- 7年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
相似试验
已完成
不适用
Clinical investigation to evaluate safety and effectiveness of Geistlich TauroSept® used as adjunctive treatment in cancer patients with colonized or infected cathetersCatheter-associated infection/Catheter-associated bloodstream infection (CRBSI)Catheter dysfuntionDRKS00028535Centro di Riferimento Oncologico di Avioano (CRO)25
尚未招募
不适用
A clinical study to evaluate safety, in-use tolerability and efficacy of a toothpaste in adult subjects.Health Condition 1: K055- Other periodontal diseasesCTRI/2024/07/071276Patanjali Ayurved Ltd.
尚未招募
不适用
To evaluate safety, in-use tolerability and efficacy of a toothpaste in healthy subjects.Health Condition 1: K055- Other periodontal diseasesCTRI/2024/07/071277Patanjali Ayurved Ltd.
招募中
1 期
SHED for cerebral palsyJPRN-jRCTb040230042Sato Yoshiaki3
进行中（未招募）
不适用
Clinical study for the assessment of safety and efficacy of Bezafibrate as a drug therapy for patients suffering from an inborn muscular dysfunction characterized by intramuscular lack of energy supplymitochondrial disorderTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]EUCTR2012-002692-34-ATniv.-Klinik für Kinder- und Jugendheilkunde16