Comparative Histological and Histomorphometric Results of Six Biomaterials Used in Two-stage Maxillary Sinus Augmentation Model After 6-month-healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 主要终点
- to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.
研究概览
简要总结
Objectives: The aim of the study was to compare histological and histomorphometric results of six bone substitute materials used as graft in two-stage maxillary sinus augmentation model, after 6-month-healing.
详细描述
Materials and Methods
A two-stage sinus augmentation was carried out in six patients using mineralized solvent-dehydrated bone allograft (MCBA), freeze-dried mineralized bone allograft (FDBA), anor-ganic bovine bone (ABB), equine-derived bone (EB); synthetic micromacroporous biphasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hydroxyap-atite (HA-β-TCP 30/70), or bioapatite-collagen (BC).
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participant, Investigator, Outcome Assessor
入排标准
- 年龄范围
- 33 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients healthy, absence of systemic pathologies (ASA class I), non-smokers, good oral hygiene, not pregnant or lactating, absence of painful symptoms and associated inflammatory or osteolytic pathologies, maxillary partial edentulism involving the premolar/molar areas, residual bone height between the sinus floor and alveolar ridge ranging from 2 to 4 mm, as measured on computerized tomography (CT) scan.
排除标准
- 未提供
研究组 & 干预措施
bone substitute material FDBA
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using freeze-dried mineralized bone allograft material.
干预措施: Sinus floor augmentation (Procedure)
bone substitute material MCBA
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using mineralized sol-vent-dehydrated bone allograft material.
干预措施: Sinus floor augmentation (Procedure)
bone substitute material ABB
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using anorganic bovine bone material.
干预措施: Sinus floor augmentation (Procedure)
bone substitute material EB
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using equine-derived bone material.
干预措施: Sinus floor augmentation (Procedure)
bone substitute material HA-β-TCP 30/70
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using synthetic micromacroporous bi-phasic calcium-phosphate block consisting of 70% beta-tricalcium phosphate and 30% hy-droxyapatite material.
干预措施: Sinus floor augmentation (Procedure)
bone substitute material BC
Sinus floor augmentation: a bony window was created along the lateral wall of the sinus, the sinus membrane was carefully elevated and the created space was augmented using bioapatite-collagen material.
干预措施: Sinus floor augmentation (Procedure)
结局指标
主要结局
to perform biopsies from each six augmented site using to compare, histologically and histomorphometrically, the percentages of newly formed bone, residual grafted material, and marrow spaces.
时间窗: 6 month-healing after surgery
After 6 months clinical and radiographic examinations were undertaken and each patient was reappointed for biopsy at the time of implant placement in the same location. Under local anesthesia, a full thickness flap was raised, a biopsy was performed using a 3.5 mm tre-phine bur under sterile saline solution irrigation, guided by the radiographic/surgical template in the selected implant site. A total of six bone samples was retrieved from the occlusal aspect to the alveolar crest, one from each augmented site to compare histologically and histomorphometrically the different materials.
次要结局
未报告次要终点
研究者
Maria Paola Cristalli
DDS PhD, Clinical Professor
University of Roma La Sapienza