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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dentsply Implants
ClinicalTrials.gov Identifier:
NCT00745121
First received: September 2, 2008
Last updated: March 13, 2014
Last verified: March 2014
  Purpose

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 Intervention
Postmenopausal Osteoporosis
Osteopenia
Jaw, Edentulous, Partially
Device: OsseoSpeed™

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Dentsply Implants:

Primary Outcome Measures:
  • Marginal bone level alterations [ Time Frame: 6, 12, 24, 36, 48 and 60 months after insertion of permanent prosthesis ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: August 2008
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Implants
Investigators
Principal Investigator: Marc Quirynen, Prof., Dr. Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: Dentsply Implants
ClinicalTrials.gov Identifier: NCT00745121     History of Changes
Other Study ID Numbers: YA-OSS-0007
Study First Received: September 2, 2008
Last Updated: March 13, 2014
Health Authority: Belgium: Institutional Review Board
Germany: Ethics Commission
Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw, Edentulous, Partially
Mouth, Edentulous
Bone Diseases, Metabolic
Osteoporosis
Osteoporosis, Postmenopausal
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth Diseases
Tooth Diseases
Bone Diseases

ClinicalTrials.gov processed this record on April 17, 2014