Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Success of the bone augmentation
研究概览
简要总结
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:
- 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 microarchitecture of the augmented bone depending on the bone graft material applied,
- to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years old
- •require lateral augmentation for implant rehabilitation
排除标准
- •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 contraindicate surgery
- •Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
- •Psychiatric disorders contraindicate implant rehabilitation
研究组 & 干预措施
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: Bone augmentation using freeze-dried allograft block (Procedure)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: preoperative cone beam computed tomography (CBCT) (Diagnostic Test)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: post-operative cone beam computed tomography (CBCT) (Diagnostic Test)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: Dental implant placement (Procedure)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: Bone core biopsy (Diagnostic Test)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: Fixed dental prosthesis (FDP) fabrication (Procedure)
Freeze-dried allograft bone block
A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.
干预措施: Bone grafting (Device)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: Bone augmentation using an autologous bone block (Procedure)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: preoperative cone beam computed tomography (CBCT) (Diagnostic Test)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: post-operative cone beam computed tomography (CBCT) (Diagnostic Test)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: Dental implant placement (Procedure)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: Bone core biopsy (Diagnostic Test)
Autogenous bone block
An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.
干预措施: Fixed dental prosthesis (FDP) fabrication (Procedure)
结局指标
主要结局
Success of the bone augmentation
时间窗: 3 months
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.
Success of the dental implants
时间窗: 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 to the 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 the length of the implant 4. Uncontrolled exudate 5. Implant no longer in the mouth
Success of the bone augmentation
时间窗: 3 months
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.
Success of the dental implants
时间窗: 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 to the 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 the length of the implant 4. Uncontrolled exudate 5. Implant no longer in the mouth
Success of the implant-borne prostheses
时间窗: 5 years
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
次要结局
- Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples(3-6 months)
- Hisomorphometry: Percent of residual bone graft particles(3-6 months)
- Hisomorphometry: Percent of newly formed bone(3-6 months)
- Hisomorphometry: Percent of bone marrow(3-6 months)
- Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples(3-6 months)
- Hisomorphometry: Percent of bone marrow(3-6 months)
- Hisomorphometry: Percent of residual bone graft particles(3-6 months)
- Hisomorphometry: Percent of newly formed bone(3-6 months)
- Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples(3-6 months)
- Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples(3-6 months)
- Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples.(3-6 months)
- Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
- Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples.(3-6 months)
研究者
Dr. Szerencse Csilla
Dentist, oral surgeon
Semmelweis University