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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-A, Osteoporosis/osteopenia | Experimental | Patients with osteoporosis/osteopenia. |
|
| Group-B, Control | Experimental | Control (non-osteoporotic/-osteopenic patients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Quirynen, Prof., Dr. | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontology, Faculty of Medicine, Catholic University of Leuven | Leuven | B-3000 | Belgium | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24909074 | Result | 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. | |
| 26864614 | Result | 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. |
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55 of the enrolled participants became screening failures and were excluded from the study before implant installation.
The baseline population consist of all participants that had at least one implant installed, a total of 48 participants.
A total of 103 participants were enrolled in the study (provided written informed consent).
| ID | Title | Description |
|---|---|---|
| FG000 | Group-A, Osteoporosis/Osteopenia | Patients with osteoporosis/osteopenia. Receiving 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 |
| FG001 | Group-B, Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2010 |
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| Zahnklinik |
| Würzburg |
| DE-97070 |
| Germany |
| Department of Oral and Maxillofacial Surgery, Gothenburg University | Gothenburg | SE-405 30 | Sweden |
| Käkkirurgiska kliniken, Akademiska sjukhuset | Uppsala | S-751 85 | Sweden |
| 26744141 | Result | 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. |
| 30205020 | Result | 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. |
Control (non-osteoporotic/-osteopenic patients). Receiving 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
A total of 103 participants were enrolled in the study (provided written informed consent).
55 of those participants became screening failures and were excluded from the study before implant installation.
The baseline population consist of all participants that had at least one implant installed, a total of 48 participants.
| ID | Title | Description |
|---|---|---|
| BG000 | Group-A, Osteoporosis/Osteopenia | Patients with osteoporosis/osteopenia. |
| BG001 | Group-B, Control | Control (non-osteoporotic/-osteopenic patients). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Implants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | In group A, 11 subjects (38 implants) completed the 5-year follow-up visit. In group B, 26 subjects (79 implants) completed the 5-year follow-up visit. Three radiographs were not possible to evaluate, giving an overall number of 37 subjects (114 implants) as basis for the analysis of Marginal Bone Level Change. | Posted | Mean | Standard Deviation | millimeter | Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading. | Implants | Implants |
|
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5 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group-A, Osteoporosis/Osteopenia | Patients with osteoporosis/osteopenia. | 3 | 20 | 6 | 20 | 2 | 20 |
| EG001 | Group-B, Control | Control (non-osteoporotic/-osteopenic patients). | 0 | 28 | 5 | 28 | 2 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death, reason unknown | General disorders | Systematic Assessment |
| ||
| Stroke | Vascular disorders | Systematic Assessment |
| ||
| Pancreatic cancer | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cerebral colloid cyst | Nervous system disorders | Systematic Assessment |
| ||
| Removal of gall bladder (gallstone related) | Hepatobiliary disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Knee injury (due to a fall) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Operation (artificial shoulder joint) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Breast surgery | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental bridge loose | Product Issues | Systematic Assessment | the dental bridge screws connecting the implant abutment to the restoration coming loose |
| |
| Fracture connecting bar | Product Issues | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager Global Clinical Research | Dentsply Sirona Implants, Mölndal, SWEDEN | 0046313763500 | ClinicalResearchMolndal@dentsplysirona.com |
| Nov 4, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D001851 | Bone Diseases, Metabolic |
| D007576 | Jaw, Edentulous, Partially |
| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007575 | Jaw, Edentulous |
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D009066 | Mouth, Edentulous |
| D009059 | Mouth Diseases |
| D014076 | Tooth Diseases |
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| Male |
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| South American Indian (Chile) |
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| Belgium |
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| Germany |
|