NCT00745121已完成不适用
An Open, Prospective, Non-randomized, Controlled, Multicenter Study to Evaluate Clinical Outcome of the ASTRA TECH Implant System, OsseoSpeed™ Implant in Women Over 60 Years of Age With Osteoporosis/Osteopenia
Dentsply Sirona Implants and Consumables8 个研究点 分布在 3 个国家目标入组 103 人开始时间: 2008年7月16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
- 103
- 试验地点
- 8
- 主要终点
- Marginal Bone Level Alterations
研究概览
简要总结
The overall objective of the study is to compare treatment with the ASTRA TECH Implant System, OsseoSpeed™ implant in the maxilla of postmenopausal women with and without systemic osteoporosis. The hypothesis is that there will be no difference in marginal bone level alterations between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Postmenopausal women aged 60 years and over
- •In need of 2-8 implants in maxilla
- •A history of edentulism in the area of implant treatment of at least 6 months.
- •A Bone Mineral Density (BMD) value suitable either for group A or group B:
- •Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations (SD) below mean peak bone density of young adults for the spine and total hip (T-score = -2 SD or less). Absolute values (g/cm2) will be used.
- •Group B (Control): BMD not more than 1 standard deviation below mean peak bone density of young adults for the spine and total hip (T-score = -1 SD or more). Absolute values (g/cm2) will be used.
排除标准
- •Unlikely to be able to comply with study procedures, as judged by the investigator.
- •Untreated, uncontrolled caries and/or periodontal disease
- •Known or suspected current malignancy
- •History of chemotherapy within 5 years prior to surgery
- •History of radiation in the head and neck region
- •History of other metabolic bone diseases, e.g. Paget's disease, hyperparathyroidism, fibrous dysplasia or osteomalacia
- •A medical history that makes implant insertion unfavourable
- •Need for systemic corticosteroids
- •Current or previous use of intravenous bisphosphonates (esp. zoledronic acid)
- •Current or previous use of oral bisphosphonates
- •History of bone grafting and/or sinus lift in the planned implant area
- •Current need for bone grafting and/or sinus lift in the planned implant area
- •Present alcohol and/or drug abuse
- •Involvement in the planning and conduct of the study (applies to both Astra Tech AB staff or staff at the study site)
- •Previous enrolment in the present study.
- •Participation in a clinical study during the last 6 months.
结局指标
主要结局
Marginal Bone Level Alterations
时间窗: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.
Marginal Bone Level 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 5 year follow-up visit compared to values obtained at time of loading of the permanent restoration (baseline).
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
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