The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics: Multicentric RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 5
- 主要终点
- Marginal Bone remodeling around the implant
研究概览
简要总结
The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy patients, with edentulous maxillary or mandibular ridge, requiring rehabilitation with two adjacent implants;
- •at least 6 month after extraction;
排除标准
- •post-extractive implants;
- •sites requiring bone regeneration or maxillary sinus lift;
- •general health problems that contraindicate implant treatment.
结局指标
主要结局
Marginal Bone remodeling around the implant
时间窗: 0-4-12 months after implant placement
The marginal bone remodeling will be evaluated by Radiographic examination. Periapical radiographs will be performed using paralleling technique with a Rinn-type positioner, customized for each patient at implant placement (T0), prosthetic restoration delivery (T1), and after 12 months (T2).Peri-implant bone levels will be measured at each time point as the linear distance (in mm) between implant platform and bone crest at mesial and distal aspects of each implant. A positive value will be assigned if the bone crest is coronal to the implant platform, whereas a negative value will be assigned if the first bone-to implant contact is apical to the implant platform. All measurements will be performed by two examiners, using measuring software (Image J). Each measurement will be performed three times at three different points.
次要结局
- Periodontal indexes: Probing Depth(The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.)
- Implant Stability evaluation(0-4 months.)
- Suppuration on probing(The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.)
- Bleeding on Probing(The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.)
- Plaque index of peri-implant tissues(The measurements will be performed at 4 (T1) and 12 (T2) months after implant placement.)
研究者
Khrystyna Zhurakivska
Researcher
University of Foggia