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| ID | Type | Description | Link |
|---|---|---|---|
| 1638-2021 | Other Grant/Funding Number | ITI Foundation |
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The aim of this study is to determine whether jawbone augmentations using allogeneic and autogenous bone blocks lead to comparable three-dimensional clinical and radiological outcomes.
In addition, the study seeks to investigate whether there are differences regarding safety, biocompatibility, complications, and PROMs.
Furthermore, it aims to clarify whether differences exist between the two groups with respect to implant condition (one year after implantation and during annual follow-ups for up to five years).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| individualized allogenic bone block alveolar ridge augmentation | Experimental |
| |
| autologous bone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alveolar socket preservation with graft and flap surgery | Procedure | Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width <5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position will be included. In the control group, the blocks will be adapted to the defect site morphology. With a small drill, holes for fixation will be prepared and the bone blocks will be immobilized with one or two screws. Subsequently, a layer of bone particles will be applied if needed to cover the autogenous bone and to fill up voids. |
| Measure | Description | Time Frame |
|---|---|---|
| ridge width gain in mm |
| at screening after augementation (= day 0) 180 days past augmentation (=implantation) 1 year after 2nd stage surgery 2 years after 2nd stage surgery 3 years after 2nd stage surgery 4 years after 2nd stage surgery 5 years after 2nd stage surgery |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Payer, Assoz.Prof. | Contact | +4331638580659 | mi.payer@medunigraz.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics, Medical University of Graz | Recruiting | Graz | Styria | 8010 | Austria |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2024 | Feb 15, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D014180 | Transplantation |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| allogenic bone block augmentation | Procedure | Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width <5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position. Based on CT/CBCT scans of the patient, the allogenic bone block has already been virtually designed using 3D CAD/CAM technology prior to surgery. The individually milled bone graft Botiss maxgraft® bonebuilder (allogenic bone block), optional addition of MinerOss® A (allogenic bone granules) will then be covered with Argonaut® (porcine collagenbased membrane). |
|
| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |