Clinical trial NCT00745121: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Osteoporosis
Osteopenia
Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 103
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Marginal Bone Level Alterations
timeFrame: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Periodontology, Faculty of Medicine, Catholic University of Leuven
city: Würzburg
country: Germany
facility: Zahnklinik
city: Gothenburg
country: Sweden
facility: Department of Oral and Maxillofacial Surgery, Gothenburg University
city: Uppsala
country: Sweden
facility: Käkkirurgiska kliniken, Akademiska sjukhuset
Study officials:
affiliation: KU Leuven
name: Marc Quirynen, Prof., Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.