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

Osteopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745121
• Other study ID #: YA-OSS-0007
• Status: Completed
• Phase: N/A
• Start date: July 16, 2008
• Est. completion date: November 15, 2017

Study information

• Verified date: November 2019
• Source: Dentsply Sirona Implants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: November 15, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Jaw, Edentulous
• Jaw, Edentulous, Partially
• Osteopenia
• Osteoporosis
• Osteoporosis, Postmenopausal
• Postmenopausal Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Department of Periodontology, Faculty of Medicine, Catholic University of Leuven	Leuven
Germany	Zahnklinik	Würzburg
Sweden	Department of Oral and Maxillofacial Surgery, Gothenburg University	Gothenburg
Sweden	Käkkirurgiska kliniken, Akademiska sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Dentsply Sirona Implants

Countries where clinical trial is conducted

Belgium,  Germany,  Sweden, 

References & Publications (4)

Merheb J, Temmerman A, Coucke W, Rasmusson L, Kübler 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. — View Citation

Merheb J, Temmerman A, Rasmusson L, Kübler 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 — View Citation

Temmerman A, Rasmusson L, Kübler 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. d — View Citation

Temmerman A, Rasmusson L, Kübler 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. C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.