Radiographic, Histological and Immunohistochemical Evaluation of Allograft, Xenograft, and Combined Grafting in Maxillary Sinus Floor Augmentation: A Prospective Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Vertical Bone Height Gain
研究概览
简要总结
This prospective randomized clinical study evaluates and compares three different grafting approaches (allograft, xenograft, and combined grafting) used in lateral maxillary sinus augmentation prior to dental implant placement.
Patients with posterior maxillary bone deficiency (residual bone height ≤4 mm) undergoing sinus lift surgery were randomly assigned to one of three grafting groups. Cone-beam computed tomography (CBCT) was used to assess bone height before surgery, immediately after grafting, and at 6 months. During implant placement at 6 months, bone biopsy samples were collected from the grafted sites for histological and immunohistochemical evaluation.
The study aims to assess vertical bone gain, graft height stability, and biological bone healing using osteocalcin, osteopontin, and RUNX2 markers. The results are intended to provide clinically relevant information regarding the volumetric and biological behavior of different graft materials used in maxillary sinus augmentation.
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)
盲法说明
Histological and immunohistochemical evaluations were performed by a blinded examiner.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years.
- •Patients presenting with posterior maxillary edentulism requiring dental implant rehabilitation.
- •Residual alveolar bone height of 4 mm or less, indicating the need for lateral maxillary sinus augmentation.
- •Patients suitable for lateral sinus lift surgery based on clinical and radiographic evaluation.
- •Ability to provide written informed consent.
排除标准
- •Systemic conditions that could affect bone healing (e.g., uncontrolled diabetes, metabolic bone diseases).
- •History of radiotherapy or chemotherapy to the head and neck region.
- •Active sinus pathology or chronic sinusitis.
- •Heavy smoking (more than 10 cigarettes per day).
- •Pregnancy or lactation.
- •Use of medications known to affect bone metabolism.
研究组 & 干预措施
Control Group
Patients received dental implant placement without sinus augmentation. Bone biopsy samples were obtained during implant placement for histological and immunohistochemical evaluation.
干预措施: Dental Implant Placement Without Sinus Augmentation (Procedure)
Allograft Group
Patients underwent lateral maxillary sinus augmentation using allograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
干预措施: Lateral Maxillary Sinus Augmentation with Allograft (Procedure)
Xenograft Group
Patients underwent lateral maxillary sinus augmentation using xenograft material prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
干预措施: Lateral Maxillary Sinus Augmentation with Xenograft (Procedure)
Combined Graft Group
Patients underwent lateral maxillary sinus augmentation using a combination of allograft and xenograft materials prior to dental implant placement. Bone biopsies were obtained at implant placement for histological and immunohistochemical analyses.
干预措施: Lateral Maxillary Sinus Augmentation with Combined Graft (Procedure)
结局指标
主要结局
Vertical Bone Height Gain
时间窗: 6 months
Vertical bone height gain following lateral maxillary sinus augmentation, measured using cone-beam computed tomography (CBCT).
次要结局
- Graft Height Loss(6 months)
- Histological New Bone Formation(6 months)
- Immunohistochemical Expression of Osteogenic Markers(6 months)
研究者
Sefa Colak
Associate Professor
Tokat Gaziosmanpasa University