NCT01324778已完成不适用
An Open, Randomized, Prospective Multi Centre Study Comparing OsseoSpeedTM TX With OsseoSpeedTM in the Partially and Totally Edentulous Maxillae
Dentsply Sirona Implants and Consumables18 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2011年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 18
- 主要终点
- Marginal Bone Level
研究概览
简要总结
To compare marginal bone level alterations, implant stability and implant survival between OsseoSpeed och OsseoSpeed TX
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Female/male aged 18 years and over
- •History of edentulism in the study area of at least 3 months
- •In need for implant(s) replacing missing tooth/teeth in the maxilla
- •Deemed by the investigator to be suitable for one stage surgery
- •Deemed by the investigator to be suitable for loading after 10-12 weeks
- •Deemed by the investigator as likely to present an initially stable implant situation.
- •Deemed by the investigator to have a "functional" opposing dentition at the time of loading the implants.
排除标准
- •Unlikely to be able to comply with study procedures, as judged by the investigator
- •Uncontrolled pathological processes in the oral cavity
- •Known or suspected current malignancy
- •History of radiation therapy in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- •Uncontrolled diabetes mellitus
- •Corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
- •Present alcohol and/or drug abuse
- •Current need for bone grafting and/or augmentation in the planned implant area
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- •Previous enrolment in the present study.
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last 6 months.
结局指标
主要结局
Marginal Bone Level
时间窗: One year after loading
Marginal Bone Level will be determined from radiographs and expressed as the difference from a reference point on the implant to the most coronal bone-to-implant contact on the mesial and distal aspect of the implant. Marginal Bone Level expressed in millimeters at the 12 months follow-up visit will be compared to values obtained at delivery of permanent restoration i.e. loading (baseline).
次要结局
- Implant stability(At implant loading (10-12 weeks after implant placement))
- Implant survival(One year after loading)
研究者
研究点 (18)
Loading locations...
相似试验
招募中
不适用
Clinical and Radiographic Evaluation of Implant Stability in Healed Maxillary Posterior Sites Comparing Osteotome, Osseodensification and Conventional Drilling Implant Placement TechniquesImplant StabilityNCT06599112Cairo University36
已完成
不适用
4 vs 6 Implants in Totally Edentulous Patient in Maxilla With Ti. Cad-cam FrameworkEdentulous MaxillaNCT02405169Institute Franci56
已完成
不适用
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.Jaw, Edentulous, PartiallyNCT00746187Dentsply Sirona Implants and Consumables36
已完成
不适用
Multicenter Study Comparing OsseoSpeed TX With OsseoSpeed EV.Partial Edentulism in the Maxilla or in the MandibleNCT01528215Dentsply Sirona Implants and Consumables120
尚未招募
2 期
A clinical study to evaluate the marginal bone loss and implant stability by placing immediate and delayed implants in mandibular posterior region.CTRI/2021/08/035677chinta Anand