Jaw, Edentulous, Partially, Osteopenia, Postmenopausal Osteoporosis
Conditions
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.
Interventions
DEVICEOsseoSpeed™
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
Sponsors
Dentsply Sirona Implants and Consumables
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Bone Level Alterations | Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading. | 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). |
Countries
Belgium, Germany, Sweden
Participant flow
Recruitment details
A total of 103 participants were enrolled in the study (provided written informed consent).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Group-A, Osteoporosis/Osteopenia Patients with osteoporosis/osteopenia. | 20 |
| Group-A, Osteoporosis/Osteopenia Patients with osteoporosis/osteopenia. | 63 |
| Group-B, Control Control (non-osteoporotic/-osteopenic patients). | 28 |
| Group-B, Control Control (non-osteoporotic/-osteopenic patients). | 85 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 3 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Group-B, Control | Total | Group-A, Osteoporosis/Osteopenia |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 4.1 | 66.8 years STANDARD_DEVIATION 5.47 | 69.4 years STANDARD_DEVIATION 6.18 |
| Race/Ethnicity, Customized Caucasian | 28 Participants | 47 Participants | 19 Participants |
| Race/Ethnicity, Customized South American Indian (Chile) | 0 Participants | 1 Participants | 1 Participants |
| Region of Enrollment Belgium | 13 participants | 18 participants | 5 participants |
| Region of Enrollment Germany | 6 participants | 11 participants | 5 participants |
| Region of Enrollment Sweden | 9 participants | 19 participants | 10 participants |
| Sex: Female, Male Female | 28 Participants | 48 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 20 | 0 / 28 |
| other Total, other adverse events | 2 / 20 | 2 / 28 |
| serious Total, serious adverse events | 6 / 20 | 5 / 28 |
Outcome results
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).
Time frame: Evaluated at time of loading of the permanent restoration and at the 5 years follow-up after loading.
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group-A, Osteoporosis/Osteopenia | Marginal Bone Level Alterations | -0.15 millimeter | Standard Deviation 0.5 |
| Group-B, Control | Marginal Bone Level Alterations | -0.06 millimeter | Standard Deviation 0.89 |