NCT00745121

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 26, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

9.3 years

First QC Date

September 2, 2008

Results QC Date

November 4, 2019

Last Update Submit

November 25, 2019

Conditions

Postmenopausal OsteoporosisOsteopeniaJaw, Edentulous, Partially

Outcome Measures

Primary Outcomes (1)

  • 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).

    Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.

Study Arms (2)

Group-A, Osteoporosis/osteopenia

EXPERIMENTAL

Patients with osteoporosis/osteopenia.

Device: OsseoSpeed™

Group-B, Control

EXPERIMENTAL

Control (non-osteoporotic/-osteopenic patients).

Device: OsseoSpeed™

Interventions

OsseoSpeed™DEVICE

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

Group-A, Osteoporosis/osteopeniaGroup-B, Control

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Leuven, B-3000, Belgium

Location

Zahnklinik

Würzburg, DE-97070, Germany

Location

Department of Oral and Maxillofacial Surgery, Gothenburg University

Gothenburg, SE-405 30, Sweden

Location

Käkkirurgiska kliniken, Akademiska sjukhuset

Uppsala, S-751 85, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 24909074RESULT

  • 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.

    PMID: 26864614RESULT

  • 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.

    PMID: 26744141RESULT

  • 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.

    PMID: 30205020RESULT

MeSH Terms

Conditions

Osteoporosis, PostmenopausalBone Diseases, MetabolicJaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

OsteoporosisBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesJaw, EdentulousJaw DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Manager Global Clinical Research
Organization
Dentsply Sirona Implants, Mölndal, SWEDEN
ClinicalResearchMolndal@dentsplysirona.com
0046313763500

Study Officials

  • Marc Quirynen, Prof., Dr.

    KU Leuven

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

July 16, 2008

Primary Completion

November 1, 2017

Study Completion

November 15, 2017

Last Updated

November 26, 2019

Results First Posted

November 26, 2019

Record last verified: 2019-11

Locations

SE(2)BE(1)DE(1)