Immediate vs Delayed Placement of Straumann BLX Implants in Molar Extraction Sockets
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Osstell Value Assessment
研究概览
简要总结
The aim of this study is to clinically and radiographically compare the success and survival of implants immediately placed in molar fresh extraction socket to delayed implant placement at least 12 weeks post molar extraction. The secondary aim is to evaluate the peri-implant tissue response around implants with immediate vs. delayed placement.
详细描述
Study Population To be included in the study, the subjects must be 22 years of age or older and in good general health. They must have at least one nonrestorable more indicated for extraction and immediate or delayed implant placement. Subjects who are unable to undergo oral surgery procedures, smokers, and women who are (or become) pregnant (or are breastfeeding) will be excluded from this study. Additionally, subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use) will not be included in this clinical study.
15 implants in each group are necessary to provide 90% power with a type I error of 0.05. Each subject will be randomly assigned into one of two treatment groups:
Test Group (n=15):
The test group will receive immediate molar implant placement in fresh extraction socket with nonocclusal loading immediate provisionalization (Straumann BLX 6.5mm).
Control Group (n=15):
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
- 22 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •22 years of age or older
- •good general health.
- •at least one nonrestorable more indicated for extraction and immediate or delayed implant placement
排除标准
- •undergo oral surgery procedures
- •women who are (or become) pregnant (or are breastfeeding)
- •subjects with bone infections or compromised health that may affect the ability of the patients' tissues to heal (e.g., uncontrolled diabetes, bisphosphonate use, current glucocorticoid use)
结局指标
主要结局
Osstell Value Assessment
时间窗: 12 months
Osstell® RFA (Resonance Frequency Analysis) values will be recorded immediately after implant placement, 3 months, and 12 months follow up visits to report implant stability during the healing time. RFA values for each implant will be statistically analyzed and compared between and within groups utilizing SPSS software.
3D Printed Models Assessment
时间窗: 12 months
3D printed models will be generated from intraoral scan prior to baseline extraction visit and 3, 12 months follow up. Volumetric changes will be measured and analyzed digitally with compare software.
Photographic Documentation
时间窗: 12 months
Photographic documentation will be made using a digital camera for each visit to clinically evaluate the peri-implant tissue healing response around implants with immediate vs. early placements.
Clinical Examination: Implant Success and Failure Criteria
时间窗: 12 months
Implant success is defined by clinical and radiographic parameters. The success criteria for the implants will be (1) no radiolucency around the implant, (2) no mobility, and (3) no suppuration, pain, or ongoing pathologic process. Implants that do not meet the above criteria fall under the implant failure category. Success rate percentage will be based on clinical and radiographic assessment per implant site.
Radiographic Examination
时间窗: 12 months
Regional Cone Beam CT scan imaging for implant sites will be made for research purposes at baseline after implant placement, and 12 months follow up visits. These images are the only way to provide 3 dimensional view of bone around implants (Mesial-Distal, Buccal-Lingual). Marginal bone level changes will be recorded on the mid-mesial, mid-distal, mid-labial, and mid-lingual sites for each implant from the reference line (RL) of the implant platform immediately after implant placement and 12 months follow up visits. All measurements will be made utilizing a coDiagnostiX software used at University of Kentucky College of Dentistry. Marginal bone changes around implants for each site (i.e., Mesial, Distal, Buccal, and Lingual) will be digitally analyzed using the software and statistically analyzed and compared between groups utilizing SPSS software.
次要结局
未报告次要终点
研究者
Ahmad Kutkut
Associate Professor
University of Kentucky