Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
- Conditions
- Edentulous Alveolar RidgeEdentulous Alveolar Ridge Atrophy
- Registration Number
- NCT07104370
- Lead Sponsor
- Semmelweis University
- Brief Summary
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 prior to or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for the reconstruction of 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:
* to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used,
* compare the micoarchitecture of the augmented bone depending on the bone graft material applied,
* to evalute the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- over 18 years old
- require lateral augmentation for implant rehabilitation
- Smoking
- Pregnancy
- Poor oral hygiene
- Failure to attend follow-up visits
- Therapeutic-dose irradiation to the head and neck region
- Local bone tumors, cysts, or inflammatory processes
- Decompensated systemic diseases contraindicating surgery
- Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
- Psychiatric disorders contraindicating implant rehabilitation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Success of the bone augmentation 3 months The bone augmentation surgery is successful if no inflammatory complications occur in the 3 months healing period and the bone volume is sufficient for dental implant placement.
Success of the dental implants 3 months According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference.
I. Success (optimum health)
1. No pain or tenderness upon function
2. 0 mobility
3. Less than 2 mm radiographic bone loss from initial surgery
4. No exudates in the patient's history
II. Satisfactory survival
1. No pain on function
2. 0 mobility
3. 2-4 mm radiographic bone loss
4. No exudates in the patient's history
III. Compromised survival
1. May have sensitivity on function
2. No mobility
3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body)
4. Probing depth more than 7 mm
5. May have exudates in the patient's history
IV. Failure (clinical or absolute failure)
Any of the following:
1. Pain on function
2. Mobility
3. Radiographic bone loss of more than 1/2 length of the implant
4. Uncontrolled exudate
5. Implant no longer in mouthSuccess of the implant borne prostheses 5 years Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
- Secondary Outcome Measures
Name Time Method Value of the trabecular bone pattern factor (Tb.Pf), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months 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
Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months 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
Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months Percent porosity is the volume of pores as a percent of the total volume of interest (VOI). Unit: percent (%)
Value of the Connectivity (Conn.), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months 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.
Hisomorphometry: Percent of residual bone graft particles 3-6 months The percentage of residual bone graft particle-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Hisomorphometry: Percent of newly formed bone 3-6 months The percentage of newly formed bone-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%).
Hisomorphometry: Percent of bone marrow 3-6 months The percentage of bone marrow-area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months Relative volume of calcified tissue in the selected volume. Unit: none
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months Ratio of the segmented bone surface to the total volume in the region of interest. Unit: 1/mm
Value of the trabecular thickness (Tb.Th.), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months Mean thickness of the trabeculae, assessed using direct 3D methods. Unit: mm
Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples 3-6 months Mean distance between the trabeculae, assessed using direct 3D methods. Unit: mm