Mandibular Implants in Elderly Patients
2021年4月27日 更新者：Frauke Müller、University of Geneva, Switzerland
Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
The purpose of this study is to investigate denture satisfaction following the conversion of existing mandibular complete dentures to implant-overdentures (IOD) in very old edentulous patients who depend on help for activities of daily living (ADL) and evaluate secondary endpoints such as functional, structural, nutritional, cognitive and patient-centered outcome measures.
研究概览
研究类型
介入性
注册 (实际的)
45
阶段
- 不适用
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
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Geneva、瑞士、1205
- University of Geneva
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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
75年 及以上 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 75 years or older
- living institutionalized or receiving help for the ADL
- edentulous
- wearing complete dentures
- the lower denture had to cause discomfort to the degree that the patients were seeking treatment
Exclusion Criteria:
- severe clinical depression
- dementia
- poorly controlled diabetes
- immunosuppression
- treatment with bisphosphonates
- condition precluding the surgical intervention for implant placement
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
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：implant placement
insertion of 2 interforaminal mandibular implants and conversion of the lower complete denture to an implant-overdenture
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Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol.
The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
其他名称：
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有源比较器：denture reline
conventional reline of mandibular complete denture
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conventional reline of the existing mandibular complete denture
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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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Change from Baseline in Denture satisfaction
大体时间：at 3, 12, 24 and 36 months
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VAS-scale score to evaluate the subjective satisfaction with the denture
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at 3, 12, 24 and 36 months
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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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Change from Baseline in OHRQoL
大体时间：at 3, 12, 24 adn 36 months
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OHIP-Edent questionnaire, 20 questions
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at 3, 12, 24 adn 36 months
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Change from Baseline in cognitive function
大体时间：at 12, 24 and 36 months
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Mini-Mental State Examination, to evaluate cognitive function (Folstein et al. 1975) Trail-making test A and B Verbal fluency test
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at 12, 24 and 36 months
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Change from Baseline in Independence
大体时间：at 12, 24 and 36 months
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IADL Instrumental Activities of Daily Living Scale (Lawton and Brody, 1969) MIF Measure of functional independence
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at 12, 24 and 36 months
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Change from Baseline in MNA
大体时间：at 3, 12, 24 and 36 months
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Mini-nutritional Assessement questionnaire (Guigoz 1994)
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at 3, 12, 24 and 36 months
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Change from Baseline in Blood markers
大体时间：at 3, 12, 24 and 36 months
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Albumin, Folic acid, Vitamin B12 (VitB12), Hemoglobin (Hb), C-reactive protein (CRP)
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at 3, 12, 24 and 36 months
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Change from Baseline in BMI
大体时间：at 12, 24 and 36 months
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Body Mass Index kg/m2
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at 12, 24 and 36 months
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Change from Insertion in implant survival
大体时间：at 3, 12, 24 and 36 months
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inserted implants in vivo
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at 3, 12, 24 and 36 months
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Change from Insertion in Pocket depth
大体时间：at 3, 12, 24 and 36 months
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mesial and distal peri-implant probing depth
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at 3, 12, 24 and 36 months
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Change from Insertion in Plaque index
大体时间：at 3, 12, 24 and 36 months
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Plaque index on implants (Silness & Loe 1963) Denture plaque index
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at 3, 12, 24 and 36 months
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Change from Insertion in peri-implant bone loss
大体时间：at 3, 12, 24 and 36 months
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mesial and distal peri-implant bone loss, as evaluated on intraoral radiographs or OPTs
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at 3, 12, 24 and 36 months
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Change from Baseline in Chewing efficiency
大体时间：at Intervention, 3, 12, 24 and 36 months
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two color mixing test with bi-colored chewing gum (Schimmel et al 2007)
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at Intervention, 3, 12, 24 and 36 months
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Change from Baseline in Maximum bite force
大体时间：at Intervention, 3, 12, 24 and 36 months
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unilateral maximal bite force measured with force gauge
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at Intervention, 3, 12, 24 and 36 months
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Change from Baseline in Stimulated Saliva Flow Rate
大体时间：at Intervention, 3, 12, 24 and 36 months
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whole saliva collected after chewing wax for 2 minutes on one side
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at Intervention, 3, 12, 24 and 36 months
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Changes from Baseline in Masseter Muscle Thickness
大体时间：at 3, 12, 24 and 36 months
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ultrasound measurements of the masseter muscle thickness in contracted and relaxed state
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at 3, 12, 24 and 36 months
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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
- 首席研究员：Frauke Müller, Prof. Dr. med. dent.、University of Geneva
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。
一般刊物
- Muller F, Duvernay E, Loup A, Vazquez L, Herrmann FR, Schimmel M. Implant-supported mandibular overdentures in very old adults: a randomized controlled trial. J Dent Res. 2013 Dec;92(12 Suppl):154S-60S. doi: 10.1177/0022034513509630. Epub 2013 Oct 24.
- Maniewicz S, Duvernay E, Srinivasan M, Perneger T, Schimmel M, Muller F. Effect of implant-supported mandibular overdentures versus reline on masticatory performance and salivary flow rates in very old adults-A randomized clinical trial. Clin Oral Implants Res. 2019 Jan;30(1):59-67. doi: 10.1111/clr.13392. Epub 2018 Dec 30.
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
2007年9月1日
初级完成 (实际的)
2012年4月1日
研究完成 (实际的)
2019年4月1日
研究注册日期
首次提交
2013年8月16日
首先提交符合 QC 标准的
2013年8月20日
首次发布 (估计)
2013年8月23日
研究记录更新
最后更新发布 (实际的)
2021年4月30日
上次提交的符合 QC 标准的更新
2021年4月27日
最后验证
2021年4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.