Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis
This trial is active, not recruiting.
|Conditions||postmenopausal osteoporosis, osteopenia, jaw, edentulous, partially|
|Start date||August 2008|
|End date||December 2017|
|Trial size||58 participants|
|Trial identifier||NCT00745121, YA-OSS-0007|
The overall objective of the study is to compare treatment with the ATRA 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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Leuven, Belgium||Department of Periodontology, Faculty of Medicine, Catholic University of Leuven||no longer recruiting|
|Würzburg, Germany||Zahnklinik||no longer recruiting|
|Gothenburg, Sweden||Department of Oral and Maxillofacial Surgery, Gothenburg University||no longer recruiting|
|Uppsala, Sweden||Käkkirurgiska kliniken, Akademiska sjukhuset||no longer recruiting|
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Marginal bone level alterations
time frame: 6, 12, 24, 36, 48 and 60 months after insertion of permanent prosthesis
Female participants at least 60 years old.
- 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 BMD value suitable either for group A or group B:
- Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations below mean peak bone density of young adults for the spine and total hip (T-score = -2SD 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 = -1SD or more). Absolute values (g/cm2) will be used.
- 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.
|Official title||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|
|Principal investigator||Marc Quirynen, Prof., Dr.|
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