Maxillary Sinus Lift With and Without Self Hardening Biphasic Calcium Phosphate and Simultaneous Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Radiographic Evaluation
研究概览
简要总结
This study was carried out to compare the outcome of sinus lift without grafting material, versus the use of moldable, self hardening calcium phosphate biomaterials with simultaneous implant placement.
详细描述
This study was designed as a randomized controlled clinical trial, the study population consisted of 20 patients with missing maxillary posterior teeth and residual bone height 5-7mm. The sample was selected conveniently according to a list of inclusion and exclusion criteria, the participants were allocated randomly into two equal groups. All patients had sinus lift using piezosurgery device with simultaneous implant placement. In group I, blood clot was the only filling material. In group II, moldable, self-hardening calcium phosphate was the filling material. Clinical and radiographic evaluations were done through 6 months postoperatively.
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
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients having missing posterior maxillary teeth
- •The vertical height between the floor of the maxillary sinus and the alveolar crest ranged between 5 and 7mm,
- •Free from maxillary sinus pathologies
- •Adequate oral hygiene
- •Acceptable interarch space for the prosthesis
排除标准
- •Patients with systemic diseases that directly affect the surgical procedure and/ or the healing of the bone
- •immunocompromised status
- •Alcoholism
- •psychiatric disorders
- •Parafunctional habits
结局指标
主要结局
Radiographic Evaluation
时间窗: 6 months
Cone beam computed tomography (CBCT) was done. The apparatus and the settings were kept the same during all the preoperative scans to evaluate the amount of vertical bone height gained, the change of bone density and the marginal bone loss postoperatively.
Pain Evaluation
时间窗: 1 week
Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Implant stability
时间窗: 6 months
Examining implant stability was done using Osstell (Osstell co. Swedan). It is a noninvasive and easy-to-use system to determine implant stability and to assess the process of osseointegration.
Wound healing
时间窗: 1 week
The presence of alveolar osteitis (dry socket) will be determined clinically using BLUM'S criteria. Wound healing was assessed and recorded depending on the absence or presence of dehiscence, every opening along the incision will be recorded as dehiscence , dental tweezers will be used to identify it.
次要结局
未报告次要终点
研究者
Nourhan M.Aly
Instructor of Dental Public Health
University of Alexandria