Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis

Not Applicable

Completed

Conditions: Osteopenia
Postmenopausal Osteoporosis
Jaw, Edentulous, Partially

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 hypothesis is that there will be no difference in marginal bone level alterations between the two groups.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Group-B, Control	OsseoSpeed™	Control (non-osteoporotic/-osteopenic patients).
Group-A, Osteoporosis/osteopenia	OsseoSpeed™	Patients with osteoporosis/osteopenia.

Primary Outcome Measures

Name	Time	Method
Marginal Bone Level Alterations	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).

Secondary Outcome Measures

Name	Time	Method

Locations (4): Käkkirurgiska kliniken, Akademiska sjukhuset
🇸🇪
Uppsala, Sweden
Department of Oral and Maxillofacial Surgery, Gothenburg University
🇸🇪
Gothenburg, Sweden
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
🇧🇪
Leuven, Belgium
Zahnklinik
🇩🇪
Würzburg, Germany