JPRN-UMIN000016561已完成未知
Assessment of the evaluating method for a spontaneous healing process at the extracted socket - Assessment of the evaluating method for a spontaneous healing process at the extracted socket
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 20years-old 至 50years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Issues affecting evaluation of safety Patient: 1 with traumatic bone defect 2 whose surgical treatment (GBR, implant, etc) is planned in 24 weeks after the extraction, or has been done in 24 weeks before, in the same jaw where the extraction is planned 3 with untreated severe periodontal disease or caries (moderate or severe in adult periodontitis, or C4 grade in caries) 2)Issues affecting patient safety Patient: 1 who was regularly smoking till 24 weeks before the extraction, or will possibly smoke during the follow-up term 2 of diabetes not under control 3 who has had an irradiation record at head and neck region 4 with severe metabolic bone disease (osteoporosis, osteomalacia, rachitis, etc) 5 who took drugs affecting bone metabolism (bis-phosphonate, calcitonine, etc) 3)Issues affecting evaluation of efficacy Patient: 1 who has an implant adjacent to the extraction site 2 whose teeth adjacent to the extraction site has a metal nail (screw post) 3 whose teeth adjacent to the extraction site has a metal prosthesis fully covering the crown down to alveolar bone 4 having metal subjects that might cause artifact in CT image up to the same level as extracted alveolar bone 4)General consideration Patient: 1 who has a history of infection disease, or is in danger of it 2 in pregnancy or of possible pregnancy, or seeking pregnant, or during breast-feeding 3 who has a history of autoimmune diseases 4 in unstable or fatal in clinical condition (that might require urgent treatment) 5 with clinically serious organ disorder (heart failure of NYHA Class IV, arrhythmia such as ventricle tachycardia, fibrillation and flutter, adult respiratory distress syndrome, and for kidney, blood, metabolic/electrolyte abnormality and circulatory, in grade 3 defined in the 80th notification by MHW issued on June 29, 1992. 6 who was using a investigational device or drugs within one year before participating this study 7 who was judged disqualified as the subject by a principal investigator or sub-investigators
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