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

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ClinicalTrials.gov Identifier: NCT00745121
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Dentsply Sirona Implants

Brief 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.

Condition or disease Intervention/treatment
Postmenopausal Osteoporosis Osteopenia Jaw, Edentulous, Partially Device: OsseoSpeed™

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 16, 2008
Primary Completion Date : November 1, 2017
Study Completion Date : November 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Patients with osteoporosis/osteopenia.
Device: 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: B
Control (non-osteoporotic/-osteopenic patients).
Device: 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 Outcome Measures :
  1. Marginal bone level alterations [ Time Frame: 6, 12, 24, 36, 48 and 60 months after insertion of permanent prosthesis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745121


Locations
Belgium
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
Leuven, Belgium, B-3000
Germany
Zahnklinik
Würzburg, Germany, DE-97070
Sweden
Department of Oral and Maxillofacial Surgery, Gothenburg University
Gothenburg, Sweden, SE-405 30
Käkkirurgiska kliniken, Akademiska sjukhuset
Uppsala, Sweden, S-751 85
Sponsors and Collaborators
Dentsply Sirona Implants
Investigators
Principal Investigator: Marc Quirynen, Prof., Dr. Katholieke Universiteit Leuven