Comparison of Bone Augmentation Techniques in the Mandibular Posterior Region: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Horizontal Bone Gain (mm) Measured by CBCT
研究概览
简要总结
This study will compare three methods to rebuild lost bone in the back part of the lower jaw (posterior mandible) before dental implant placement. Seventy-eight adults will be randomly assigned to receive one of three "cortical shell" techniques using either the patient's own bone (autogenous) or prefabricated bone plates from animal (xenogeneic) or human donors (allogeneic). In all groups, the space inside the shell will be filled with a mixture of small bone chips and bone substitute material. The main outcome is the increase in jawbone width measured on 3D cone-beam CT scans at 6 months after surgery. Additional scans and clinical assessments up to 12 months will evaluate healing, bone stability, and postoperative recovery.
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
- None (Participant, Investigator, Outcomes Assessor)
盲法说明
This is an open-label surgical trial. Due to the nature of the interventions, participants, surgeons, and investigators cannot be blinded. The statistician responsible for the primary analysis will remain blinded to group allocation until completion of the primary analysis.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Posterior mandibular edentulism requiring horizontal ridge augmentation (Cawood & Howell Classes IV-VI).
- •One or two eligible posterior mandibular sites suitable for cortical shell augmentation.
- •Adequate residual bone height to allow safe fixation above the mandibular canal.
- •Good general health (ASA I or II). Plaque index < 20% and absence of active periodontal infection. Ability and willingness to attend scheduled follow-up visits (up to 12 months). Written informed consent provided prior to any study-related procedure.
排除标准
- •Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus, immunosuppressive disorders).
- •Current heavy smoking (>5 cigarettes/day). Pregnancy or lactation. Current use of medications known to affect bone metabolism or healing (e.g., bisphosphonates, long-term corticosteroids, anticoagulants).
- •Active periodontal disease or untreated oral infection. History of chemotherapy or radiotherapy to the head and neck region.
研究组 & 干预措施
Autogenous Cortical Shell Graft
Thin cortical bone plates harvested from the mandibular ramus will be fixed to the recipient ridge with titanium microscrews to form a cortical shell. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft. This conventional technique represents the control group for comparison with xenogeneic and allogeneic materials.
干预措施: Cortical Shell Bone Grafting (Procedure)
Xenogeneic Cortical Shell Graft
Prefabricated bovine cortical laminae will be rehydrated, trimmed to contour, and fixed with titanium microscrews to the mandibular ridge. The enclosed space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft to promote bone regeneration.
干预措施: Cortical Shell Bone Grafting (Procedure)
Allogenic Cortical Shell Graft
A allogenic cortical sheets be rehydrated, adapted to the defect site, and fixed with titanium microscrews. The internal space will be filled with a 1:1 mixture of autogenous bone chips and xenogeneic particulate graft, following the same standardized protocol as the other groups.
干预措施: Cortical Shell Bone Grafting (Procedure)
结局指标
主要结局
Horizontal Bone Gain (mm) Measured by CBCT
时间窗: 6 after surgery
Participant-level horizontal bone gain at 6 months after surgery, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. When two eligible posterior mandibular sites are treated in the same participant, the participant-level mean will be used for the primary analysis.
Horizontal Bone Gain (mm) Measured by CBCT
时间窗: 3, 6, and 12 months after surgery
Linear horizontal bone gain at the grafted posterior mandibular ridge, measured on cone-beam computed tomography (CBCT) scans using standardized reference points. Measurements will be performed at 3, 6, and 12 months post-surgery by two calibrated, blinded examiners. Mean values per site will be compared among the three groups (autogenous, xenogeneic, allogeneic).
次要结局
- Relative Radiographic Density Using CBCT Gray Value Units(3, 6, and 12 months after surgery)
- Secondary Horizontal Bone Gain at 3 and 12 Months(3 and 12 months after surgery)
- Surgical Duration (minutes)(Day 0 (intraoperative measurement))
- Bone Density (Hounsfield Units) on CBCT(3, 6, and 12 months after surgery)
- Postoperative Inflammation (mm Facial Measurement)(Preoperative, immediate postoperative, days 3, 7, and 14)
- Volumetric Bone Gain (mm³)(3, 6, and 12 months after surgery)
- Morphometric Surface Deviation (mm)(3, 6, and 12 months after surgery)
研究者
Antonio Lanata Flores
Assistant Professor
Universidad de Especialidades Espiritu Santo