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After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation.
Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties.
The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing.
The aim of the study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze-dried allograft bone block | Experimental | A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw. |
|
| Autogenous bone block | Active Comparator | An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone augmentation using an autologous bone block | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success of the bone augmentation | The bone augmentation surgery is successful if no inflammatory complications occur in the 3-month healing period and the bone volume is sufficient for dental implant placement. | 3 months |
| Success of the dental implants | According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. I. Success (optimum health)
II. Satisfactory survival
III. Compromised survival
IV. Failure (clinical or absolute failure) Any of the following:
| 3 months |
| Success of the implant-borne prostheses | Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Hisomorphometry: Percent of residual bone graft particles | The percentage of residual bone graft particle area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%) | 3-6 months |
| Hisomorphometry: Percent of newly formed bone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Csilla Szerencse, DMD, MDS | Contact | 003614591500 | 55890 | szerencse.csilla@semmelweis.hu |
| Márton Kivovics, DMD, MDS, PHD | Contact | 003614591500 | 55890 | kivovics.marton@semmelweis.hu |
| Name | Affiliation | Role |
|---|---|---|
| Csilla Szerencse, DMD, MDS | Department of Public Dental Health Semmelweis University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University Department of Public Dental Health | Recruiting | Budapest | Hungary | 1088 | Hungary |
Individual participant data that underlie the results published after de-identification.
Immediately after publication, no end date
Anyone who wishes access the data.
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|
| Bone augmentation using freeze-dried allograft block | Procedure |
|
|
| preoperative cone beam computed tomography (CBCT) | Diagnostic Test | • Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region. |
|
| post-operative cone beam computed tomography (CBCT) | Diagnostic Test | Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation. |
|
| Dental implant placement | Procedure | Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia. |
|
| Bone core biopsy | Diagnostic Test | At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis. |
|
| Fixed dental prosthesis (FDP) fabrication | Procedure | After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants. |
|
| Bone grafting | Device | Freeze-dried bone allograft block |
|
The percentage of newly formed bone area is measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%). |
| 3-6 months |
| Hisomorphometry: Percent of bone marrow | The percentage of bone marrow area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%) | 3-6 months |
| Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples | Relative volume of calcified tissue in the selected volume. Unit: none | 3-6 months |
| Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples | Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm | 3-6 months |
| Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples. | Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm. | 3-6 months |
| Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples. | Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm. | 3-6 months |
| Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples. | An indicator of the relation between convex and concave elements in the trabecular bone structure. Tb.Pf <0 when the trabecular bone is honeycomb-like and increases as the trabecular bone acquires a rod-like structure. Unit: none. | 3-6 months |
| Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples. | The estimator of the plate-versus rod-like characteristic of the trabecular bone structure, 0 for perfect plates, 3 for perfect rods, and 4 for perfect spheres. Unit: none. | 3-6 months |
| Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples. | Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%). | 3-6 months |
| Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples. | One useful and fast algorithm for calculating the Euler connectivity in 3D is the "Conneulor". It measures what might be called "redundant connectivity", the degree to which parts of the object are multiply connected. It is a measure of how many connections in a structure can be severed before the structure falls into two separate pieces. Unit: none. | 3-6 months |
| ID | Term |
|---|---|
| C020332 | formycin diphosphate |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |
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