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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Jaw Diseases Jaw, Edentulous Jaw, Edentulous, Partially Metabolic Diseases Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteopenia Osteoporosis Osteoporosis, Postmenopausal Stomatognathic Diseases Tooth Diseases

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontology, Faculty of Medicine, Catholic University of Leuven, Leuven, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OsseoSpeed™

Device

ASTRA TECH Implant System, OsseoSpeed™ implants Ø 3.5, 4, 4.5, 5.0 mm in lengths of 8, 9, 11, 13, 15, 17 and 19 mm

Primary outcomes

Marginal Bone Level Alterations

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dentsply Sirona Implants and Consumables

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2017
Study completion: 2017
First posted: Sep 3, 2008
Registry last updated: Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed