Measurement of Implant Stability by Resonance Frequency Analysis in Patients Treated for an Upper Aero-digestive Tract Cancer (STABICAN)
STABICAN : Measurement of Implant Stability by Analysis of the Resonance Frequency in Patients Treated for Cancer of the Upper Aero-digestive Tract
研究概览
详细说明
Oral implantology is widely used during prosthetic rehabilitation in healthy patients but also in patients presenting cancers of the upper aero-digestive tract.
Systems for measuring implant stability using resonance frequency analysis exist and are used clinically by some practitioners, such as the Ostell® system from W&H. These systems make it possible to determine the osseointegration of the implant, and thus the appropriate time to insert the implant, by comparing the value obtained with average values.
Implant survival rates are lower for implants placed in irradiated bone, with an implant stability quotient value identical to implant placement but lower after osseointegration. Only one study shows implant stability quotient values> 60 with a success rate of 100% at 41 months on implants placed in patients having received radiotherapy. However, no clinical study has investigated the kinetics of osseointegration and the stability of implants placed on a microanastomosis fibula flap as part of aesthetic and prosthetic reconstruction after cancer of the upper aero-digestive tract.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Ellen BLANC
- 电话号码:+33 4.78.78.2967
- 邮箱:ellen.blanc@lyon.unicancer.fr
研究联系人备份
- 姓名:Anne-Gaëlle CHAUX-BODARD, MD
- 电话号码:+33 4.78.78.29.59
- 邮箱:anne-gaelle.bodard@lyon.unicancer.fr
学习地点
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Lyon、法国、69008
- 招聘中
- Centre Léon Bérard
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接触:
- Anne-Gaëlle CHAUX-BODARD, MD
- 电话号码:+33 4.78.78.29.59
- 邮箱:anne-gaelle.bodard@lyon.unicancer.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patient with squamous cell carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx
- Patient having been treated by external radiotherapy and/or having benefited from a microanastomosis fibula flap
- Patient going to undergo a surgical intervention with placement of dental implant(s) in an irradiated area or in the microanastomosis fibula flap
- Non-opposition to the study
Exclusion Criteria:
- Patient having difficulties speaking and understanding French
- Patient under tutorship or curatorship
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Evolution of implant stability in patients treated for cancer of the upper aero-digestive tract between placement and 3 months after placement
大体时间:At 3 months after implant placement
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Measure with Osstell Beacon device (Implant Stability Quotient : value from 1 to 100)
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At 3 months after implant placement
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of the association between the type of bone (maxilla/mandible and fibula) and implant stability
大体时间:At 3 months after implant placement
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Correlation between the type of bone (maxilla / mandible and fibula) and implant stability
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At 3 months after implant placement
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Evaluation of the correlation between the irradiation dose received at the implant site and implant stability
大体时间:At 3 months after implant placement
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Correlation between the irradiation dose received at the implant site and implant stability
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At 3 months after implant placement
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合作者和调查者
调查人员
- 首席研究员:Anne-Gaëlle CHAUX-BODARD, MD、Centre Léon Bérard
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- STABICAN - ET20-099
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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