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

Dentsply Sirona Implants and Consumables4 sites in 3 countries103 target enrollmentJuly 16, 2008

ConditionsPostmenopausal Osteoporosis Osteopenia Jaw, Edentulous, Partially

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Postmenopausal Osteoporosis
Sponsor: Dentsply Sirona Implants and Consumables
Enrollment: 103
Locations: 4
Primary Endpoint: Marginal Bone Level Alterations
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 16, 2008

End Date

November 15, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Dentsply Sirona Implants and Consumables

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

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).