Osteogenic Effects of Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach With Simultaneous Implant Placement: a Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 主要终点
- Excellent and good rate of bone repair
研究概览
简要总结
To investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation.
详细描述
Maxillary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxillary posterior region. Bone transplantation is considered to be a prerequisite for the success of maxillary sinus floor elevation. Platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. However, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Loss of one or more maxillary molars in the posterior maxillary region
- •Occlusogingival distance of > 4 mm
- •Residual bone height of 2-5 mm in the posterior maxillary region, no obvious maxillary sinus separation
- •No problems with the lungs, heart, or brain
- •Normal liver and kidney function
- •Normal coagulation function
- •Adequate prosthetic space
- •No history of bruxism or temporomandibular joint disorders
- •No tumors, cysts and polyps in maxillary sinus
- •No acute or chronic maxillary sinusitis
- •No acute periodontitis
- •No oral mucosal disease
- •Age 20-45 years
- •Able to tolerate the stress of anesthesia and surgery
排除标准
- •Residual bone height of < 1 mm in the posterior maxillary region or presence of maxillary sinus mucosa rupture
- •Poor control of complex periodontal disease
- •Local inflammation or poor oral hygiene
- •Poorly treated maxillary disease
- •With severe bruxism
- •With temporomandibular joint disorders
- •Alcohol consumption and cigarette smoking (20 cigarettes/d)
- •Have a history of chemotherapy and radiation therapy in face and neck
- •With coagulation disorders
- •With autoimmune disease
- •With severe osteoporosis
- •With acute maxillary sinusitis
- •Unable to tolerate simple surgery because of systemic diseases including severe diabetes mellitus and heart disease
- •Unable to provide informed consent
结局指标
主要结局
Excellent and good rate of bone repair
时间窗: changes of month 1, month 3 and month 6 after surgery
X-ray examination was performed to evaluate bone repair as per excellent and good rate.
次要结局
- Bone density at bone defect sites(changes of month 1, month 3 and month 6 after surgery)
研究者
Yang Cheng
Attending Physician
Deyang Stomatological Hospital