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

Dentsply

Status

Completed

Conditions

Osteopenia

Postmenopausal Osteoporosis

Jaw, Edentulous, Partially

Treatments

Device: OsseoSpeed™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00745121

YA-OSS-0007

Details and patient eligibility

About

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.

Enrollment

103 patients

Sex

Female

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.