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临床试验/NCT01461239
NCT01461239Unknown3 期

Randomized Clinical Comparison of Endodontically Treated Teeth Restored With Fiber Posts or Cast Metal Posts

Federal University of Pelotas2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2009年7月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
200
试验地点
2
主要终点
Post and core survival

研究概览

简要总结

There are few randomized controlled trials comparing intraradicular posts used to restore endodontically treated teeth, especially considering cast posts and glass fiber posts. The investigators study will evaluate the clinical success rates of endodontically treated teeth restored with glass fiber posts or cast posts and metal ceramic crown. Individuals included in this study should present any tooth with endodontic treatment and need of intraradicular retention (post) on maxilla or mandible according to inclusion and exclusion criteria. Individuals will be randomly allocated into two groups: (1) endodontically treated teeth restored with fiber post and composite resin core and metal ceramic crown or (2) endodontically treated teeth restored with cast post and core and metal ceramic crown. A sample size calculation will be performed to establish the number of posts needed for comparison. All crowns and posts will be cemented with self-adhesive cement. Individuals will be examined by calibrated examiners, in years 1 to 3. The reason of failure will be categorized as root fracture, fracture of the post, post debonding, clinical and/or radiographical evidence of a gap between restoration and tooth or endodontic failure, tooth extraction, secondary caries, or marginal defects. The confidence level will be set in 95%.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with normal occlusion with at least one teeth endodontically treated needing restoration

排除标准

  • patients with malocclusion,
  • orthodontic devices,
  • temporomandibular disorders

结局指标

主要结局

Post and core survival

时间窗: 72 months

次要结局

  • quality of crowns and restorations (FDI criteria)(18 months)
  • endodontic success(18 months)
  • patient satisfaction with the treatment(18 months)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximiliano Sergio Cenci

PhD, Coordinator of Clinical Trials, Graduate Program in Dentistry

Federal University of Pelotas

研究点 (2)

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