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

Primary Purpose

Postmenopausal Osteoporosis, Osteopenia, Jaw, Edentulous, Partially

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
OsseoSpeed™
Sponsored by
Dentsply Sirona Implants and Consumables
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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
  • 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.

Sites / Locations

  • Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
  • Zahnklinik
  • Department of Oral and Maxillofacial Surgery, Gothenburg University
  • Käkkirurgiska kliniken, Akademiska sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group-A, Osteoporosis/osteopenia

Group-B, Control

Arm Description

Patients with osteoporosis/osteopenia.

Control (non-osteoporotic/-osteopenic patients).

Outcomes

Primary Outcome Measures

Marginal Bone Level Alterations
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).

Secondary Outcome Measures

Full Information

First Posted
September 2, 2008
Last Updated
November 25, 2019
Sponsor
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT00745121
Brief Title
Study Evaluating ASTRA TECH Implant System, OsseoSpeed™ Implants in the Upper Jaw in Women With Osteoporosis
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 16, 2008 (undefined)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dentsply Sirona Implants and Consumables

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postmenopausal Osteoporosis, Osteopenia, Jaw, Edentulous, Partially

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-A, Osteoporosis/osteopenia
Arm Type
Experimental
Arm Description
Patients with osteoporosis/osteopenia.
Arm Title
Group-B, Control
Arm Type
Experimental
Arm Description
Control (non-osteoporotic/-osteopenic patients).
Intervention Type
Device
Intervention Name(s)
OsseoSpeed™
Intervention Description
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 Measure Information:
Title
Marginal Bone Level Alterations
Description
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).
Time Frame
Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Quirynen, Prof., Dr.
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Zahnklinik
City
Würzburg
ZIP/Postal Code
DE-97070
Country
Germany
Facility Name
Department of Oral and Maxillofacial Surgery, Gothenburg University
City
Gothenburg
ZIP/Postal Code
SE-405 30
Country
Sweden
Facility Name
Käkkirurgiska kliniken, Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
S-751 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24909074
Citation
Merheb J, Temmerman A, Coucke W, Rasmusson L, Kubler A, Thor A, Quirynen M. Relation between Spongy Bone Density in the Maxilla and Skeletal Bone Density. Clin Implant Dent Relat Res. 2015 Dec;17(6):1180-7. doi: 10.1111/cid.12228. Epub 2014 Jun 6.
Results Reference
result
PubMed Identifier
26864614
Citation
Merheb J, Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. Influence of Skeletal and Local Bone Density on Dental Implant Stability in Patients with Osteoporosis. Clin Implant Dent Relat Res. 2016 Apr;18(2):253-60. doi: 10.1111/cid.12290. Epub 2016 Feb 10.
Results Reference
result
PubMed Identifier
26744141
Citation
Temmerman A, Rasmusson L, Kubler A, Thor A, Quirynen M. An open, prospective, non-randomized, controlled, multicentre study to evaluate the clinical outcome of implant treatment in women over 60 years of age with osteoporosis/osteopenia: 1-year results. Clin Oral Implants Res. 2017 Jan;28(1):95-102. doi: 10.1111/clr.12766. Epub 2016 Jan 7.
Results Reference
result
PubMed Identifier
30205020
Citation
Temmerman A, Rasmusson L, Kubler A, Thor A, Merheb J, Quirynen M. A Prospective, Controlled, Multicenter Study to Evaluate the Clinical Outcome of Implant Treatment in Women with Osteoporosis/Osteopenia: 5-Year Results. J Dent Res. 2019 Jan;98(1):84-90. doi: 10.1177/0022034518798804. Epub 2018 Sep 11.
Results Reference
result

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

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