Status:
COMPLETED
Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis
Lead Sponsor:
Dentsply Sirona Implants and Consumables
Conditions:
Postmenopausal Osteoporosis
Osteopenia
Eligibility:
FEMALE
60+ years
Phase:
NA
Brief Summary
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 hy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 16 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 15 2017
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00745121
Start Date
July 16 2008
End Date
November 15 2017
Last Update
November 26 2019
Active Locations (4)
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1
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium, B-3000
2
Zahnklinik
Würzburg, Germany, DE-97070
3
Department of Oral and Maxillofacial Surgery, Gothenburg University
Gothenburg, Sweden, SE-405 30
4
Käkkirurgiska kliniken, Akademiska sjukhuset
Uppsala, Sweden, S-751 85