ChiCTR2100047209CompletedEarly Phase 1
口腔种植手术导航定位系统临床使用的有效性和安全性临床试验
自筹1 site in 1 country81 target enrollmentStarted: July 31, 2020Last updated:
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- 导航定位达标率
Study Overview
Brief Summary
主要目的：评价北京柏惠维康科技有限公司生产的口腔种植手术导航定位系统临床应用的有效性和安全性。
Study Design
- Study Type
- 干预性研究
- Primary Purpose
- 单臂
- Masking
- N/a
Eligibility Criteria
- Ages
- 18 to 70 (—)
- Sex
- All
Inclusion Criteria
- •1.可进行人工牙科种植修复的牙缺失患者；
- •2.18~70 岁，男性或未孕未在哺乳期的女性；
- •3.自愿参加试验并签署知情同意书；
- •4.口腔软组织无明显炎症、病损；
- •5.能配合本研究方案，接受术后访视。
Exclusion Criteria
- •1.未来 1 年内有生育计划的女性患者；
- •2.全身状况及营养状况差的患者；
- •3.环游内分泌代谢性疾病、血液系统疾病及心血管疾病未控制者；
- •4.患有系统或局部的骨性疾病如骨软化、骨硬化、骨结核、骨炎、骨肿瘤等；
- •5.患有系统性免疫性疾病者；
- •6.长期服用特殊药物者如激素、抗凝药等；
- •7.妊娠及哺乳期女性；
- •8.精神病患者、有心里障碍者和有神经系统疾病者，如癫痫；
- •9.有颌骨和粘膜病变者；
- •11.舍格伦综合症患者；
- •12.有尚未控制的牙周病或口腔卫生极差者；
- •13.不良咬合习惯者如夜磨牙；
- •14.研究者认为其他不合适参加试验的情况。
Arms & Interventions
试验组
使用口腔种植导航定位系统植入种植体
Outcomes
Primary Outcomes
导航定位达标率
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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