Clinical and Radiographic Evaluation of Stability of Short Implants Versus Standard Blx Implants Placed With Internal Sinus Floor Elevation in Posterior Maxilla: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- crestal bone level
研究概览
简要总结
Implants in the maxillary posterior region are associated with compromised bone in both quantity - notably in vertical dimension- and quality. Along with the fact that the posterior teeth are subjected to higher occlusal forces than the anterior teeth (Marianne Morand & Tassos Irinakis, 2007). In order to overcome these shortcomings, various procedures have been advocated including open and closed sinus lift (Nkenke E & Stelzle F, 2009; Schropp et al, 2003). The use of short implants is a valid alternative for these procedures (Wallace SS & Froum SJ, 2003) sparing the need of applying augmentation techniques with the associated increased time, morbidity and complexity of such procedures.
详细描述
To overcome anatomical and physiological limitations, different sinus augmentation techniques with immediate or delayed (6-8 months post augmentation) implant placement have been proposed. The most common one is the sinus elevation with a lateral window approach. Although these protocols evoke a high level of success in augmenting the bone quantity (Nkenke E & Stelzle F, 2009; Schropp et al, 2003) many patients refuse them because of the invasiveness of the augmentative procedure, with obvious prolonged healing times and increased morbidity and costs (Fugazzotto, 2003; Bra¨gger et al, 2004; Toffler, 2004). An alternative therapy for restoring areas of limited bone dimension is the placement of short implants (Wallace SS & Froum SJ, 2003). ''Standard length implants'' are those of 10 mm in length and have been defined as the minimal length for anticipated success (Griffin TJ & Cheung WS, 2004).
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single edentuolous site at maxillary posterior region
- •The available bone height below the maxillary sinus should be 7-8mm
- •Patients ≥ 20 years old
- •Bucco-palatal bone width should be ≥6mm
- •Adequate interarch space
- •Bounded, single
排除标准
- •Patients with local pathological defects related to the area of interest.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits.
- •Inadequate inter-arch space for implant prosthetic part
- •pregnancy
研究组 & 干预措施
short implants
short 6 mm straumann blx implants
干预措施: surgery (Procedure)
regular length + internal sinus lift
regular length implant 10 mm, in addition to internal sinus lift procedure
干预措施: surgery (Procedure)
结局指标
主要结局
crestal bone level
时间窗: 1 year
crestal bone level will be assessed by periapical standardized radiographs
次要结局
未报告次要终点