Overview

This trial is active, not recruiting.

Conditions postmenopausal osteoporosis, osteopenia, jaw, edentulous, partially
Treatment osseospeed™
Sponsor Dentsply Implants
Start date August 2008
End date December 2017
Trial size 58 participants
Trial identifier NCT00745121, YA-OSS-0007

Summary

The overall objective of the study is to compare treatment with the ATRA 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients with osteoporosis/osteopenia.
osseospeed™
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
(Experimental)
Control (non-osteoporotic/-osteopenic patients).
osseospeed™
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

Measure
Marginal bone level alterations
time frame: 6, 12, 24, 36, 48 and 60 months after insertion of permanent prosthesis

Eligibility Criteria

Female participants at least 60 years old.

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 BMD value suitable either for group A or group B: - Group A (Osteoporosis/osteopenia): BMD at least 2 standard deviations below mean peak bone density of young adults for the spine and total hip (T-score = -2SD 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 = -1SD 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.

Additional Information

Official 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
Principal investigator Marc Quirynen, Prof., Dr.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Dentsply Implants.