NCT01928004已完成不适用
Implant-supported Mandibular Overdentures in Very Old Adults - a Randomized Controlled Trial
University of Geneva, Switzerland2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change from Baseline in Denture satisfaction
研究概览
简要总结
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •severe clinical depression
- •poorly controlled diabetes
- •immunosuppression
- •treatment with bisphosphonates
- •condition precluding the surgical intervention for implant placement
结局指标
主要结局
Change from Baseline in Denture satisfaction
时间窗: at 3, 12, 24 and 36 months
VAS-scale score to evaluate the subjective satisfaction with the denture
次要结局
- Change from Insertion in implant survival(at 3, 12, 24 and 36 months)
- Change from Baseline in OHRQoL(at 3, 12, 24 adn 36 months)
- Change from Baseline in MNA(at 3, 12, 24 and 36 months)
- Change from Baseline in Blood markers(at 3, 12, 24 and 36 months)
- Change from Baseline in Maximum bite force(at Intervention, 3, 12, 24 and 36 months)
- Change from Baseline in Stimulated Saliva Flow Rate(at Intervention, 3, 12, 24 and 36 months)
- Change from Insertion in peri-implant bone loss(at 3, 12, 24 and 36 months)
- Changes from Baseline in Masseter Muscle Thickness(at 3, 12, 24 and 36 months)
- Change from Baseline in Independence(at 12, 24 and 36 months)
- Change from Insertion in Pocket depth(at 3, 12, 24 and 36 months)
- Change from Baseline in cognitive function(at 12, 24 and 36 months)
- Change from Baseline in BMI(at 12, 24 and 36 months)
- Change from Insertion in Plaque index(at 3, 12, 24 and 36 months)
- Change from Baseline in Chewing efficiency(at Intervention, 3, 12, 24 and 36 months)
研究者
Frauke Müller
Professor and Chair
University of Geneva, Switzerland
研究点 (2)
Loading locations...
相似试验
已完成
不适用
A Seven-year Follow-up Study of Patient Satisfaction With Three-Implant-Retained Mandibular OverdenturesPatient Satisfaction Using Implant Retained OverdenturesNCT04726540October University for Modern Sciences and Arts30
尚未招募
不适用
Patient Satisfaction and Adaptation of Dentures Printed at 0 Versus 45 DegreesEdentulous JawNCT06164366Cairo University10
Unknown
不适用
Patient Satisfaction and Retention in Implant Supported Telescopic Overdenture With Different CopingsImplant Supported Telescopic OverdentureNCT04032223Cairo University20
已完成
不适用
Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain ActivityImplant Supported OverdentureNCT05493579Al-Azhar University10
已完成
不适用
Implant-supported mandibular overdentures; a retrospective case series study in a daily dental practiceEdentulous mandibleNL-OMON22546one100