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Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT00745121•Dentsply Sirona Implants and Consumables

View on ClinicalTrials.gov

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.

Eligibility

Age

60 - No limit years

Sex

FEMALE

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
+6 more criteria

Locations (4)

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

Leuven, Belgium

Zahnklinik

Würzburg, Germany

Department of Oral and Maxillofacial Surgery, Gothenburg University

Gothenburg, Sweden

Käkkirurgiska kliniken, Akademiska sjukhuset

Uppsala, Sweden

Key Dates

Start Date

July 16, 2008

Primary Completion Date

November 1, 2017

Completion Date

November 15, 2017

Last Updated

November 26, 2019

Enrollment

103

ACTUAL participants

Conditions

Postmenopausal OsteoporosisOsteopeniaJaw, Edentulous, Partially

Interventions

OsseoSpeed™

DEVICE

Clinical Study to Estimate Bone Mineral Density With the POROUS Ultrasound Device

NCT07187518

HealthyOsteopenia+1 more

View study

RECRUITINGNA

Vibration Applications After Total Knee Arthroplasty in Osteopenic Women

NCT06988033

OsteopeniaTotal Knee Arthroplasty

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 26, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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