Long-term Study to Evaluate Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants
2020年1月6日 更新者：Institut Straumann AG
Long-term, Prospective, Cohort Study to Evaluate Safety and Efficacy of Two Different Dental Implant Alloys in Straumann 3.3mm Diameter Bone Level Implants for Removable Prosthesis in Patients With Edentulous Mandibles
Patients with an edentulous mandible restored with implants who have participated in the core study CR 04/07 will be recruited for this extension study.
No further interventions will be made for this extension study other than a clinical follow-up examination and questionnaires.
Patients will not receive an investigational treatment in this study.
Patients will be followed at 5 to 10 years from the date of the original implant loading
研究概览
地位
完全的
条件
详细说明
The primary study objective is to compare implant survival with the Titanium Zirconium (Roxolid™) implant compared the Titanium grade IV (SLActive®) implant between baseline (surgery) and 10 years.
The following outcome parameters will be evaluated at 5 and 10 years post surgery for the two different implant types Straumann® Bone Level SLActive, diameter 3.3 mm, Titanium-Zirconium (Roxolid®) vs. Straumann® Bone Level SLActive implant, diameter 3.3 mm, Titanium Grade IV:
- Implant survival
- Implant success according to Buser et al. (1990)
- Crestal bone level change measured by Orthopantomogram (OPT)
- Soft tissue health
- Clinical measurements
- Prosthetic parts assessments: Success and maintenance
- Oral Health Related Quality of Life (OHRQoL)
- Product Safety (Adverse events and device deficiencies)
研究类型
观察性的
注册 (实际的)
49
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Geneva、瑞士、1211
- Frauke Müller
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Male or female patient ≥ 18 years of age who were provided with an implant supported over-denture in the mandible in the course of the core study (CR 04/07).
描述
Inclusion Criteria:
- Subjects must have voluntarily signed the informed consent form
- Patients must be committed to participate in the study until the ten year follow-up examinations
- Subjects must have received treatment in the CR 04/07 core study
- Subjects must have completed 3 year visit of core study
Exclusion Criteria:
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene or attend follow up visits
- Use of any investigational drug or device during the study
- Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Roxolid
Patient do not receive an intervention in the extension study.
Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant.
|
|
SLActive
Patient do not receive an intervention in the extension study.
Rather they are followed on the implant treatment from the core study which included a split-mouth design where all patients received both a Roxolid and SLActive implant.
|
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 |
|---|---|---|
|
Implant Survival
大体时间：10 years following implant procedure date
|
This is a long term follow up extension study including evaluations at 5 and 10 years after the implant procedure from the core study.
Implant survival will be assessed based on surviving implants for all patients at 10 years.
|
10 years following implant procedure date
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Crestal bone level change
大体时间：5 and 10 years
|
The change in crestal bone level will be measured on standard x-rays taken at 5 and 10 years as per standard of care.
An independent reviewer will evaluate all x-rays for the analysis.
|
5 and 10 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Frauke Müller, Prof.、University of Geneva
- 首席研究员：Bilal Al-Nawas, Prof.、Klinikum der Johannes - Gutenberg - Universität Mainz
- 首席研究员：Eugenio Romeo, Prof.、Università degli Studi di Milano, Dipartimento di Medicina, Chirurgia e Odontoiatria
- 首席研究员：Joke Duyck, Prof.、Department of Oral Health Sciences, Catholic University (KU) Leuven
- 首席研究员：Torsten E Reichert, Prof.、Klinikum der Universität Regensburg
- 首席研究员：Alessandro Perucchi, Prof.、Luzerner Kantonsspital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年6月1日
初级完成 (实际的)
2018年9月1日
研究完成 (实际的)
2018年9月1日
研究注册日期
首次提交
2013年4月29日
首先提交符合 QC 标准的
2013年6月13日
首次发布 (估计)
2013年6月14日
研究记录更新
最后更新发布 (实际的)
2020年1月7日
上次提交的符合 QC 标准的更新
2020年1月6日
最后验证
2020年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.