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临床试验/NCT05265559
NCT05265559招募中不适用

Multicenter Prospective Clinical Trial of Partial Ceramic Posterior Restorations Using Immediate Dentin Sealing - The Infuence of Operator Factors on Success and Survival

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年10月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Survival and Succes

研究概览

简要总结

Background: Nowadays, tissue preserving, aesthetically high-quality and sustainable dentistry is more and more becoming the standard way of treatment. To reach those standards, one of the treatment options is applying a partial indirect restoration made by glass ceramics using immediate dental sealing (IDS). Using IDS, a protocol is followed to applicate a dentin bonding agent to freshly cut dentin when it is exposed during tooth preparation for indirect restorations (inlays/onlays, crowns). The preparation made for partial restorations is minimal invasive. Glass ceramic restorations have very high survival rates (90 to 100% after five years) (Morimoto et al., 2016) and glass ceramic mimics the color and structure of the tooth very well.

This kind of treatment is gaining interest and increasingly applied however little information is available on the long-term effects when multiple general practitioners apply these restorations.

Objectives: The main goal of this study is to evaluate partial posterior ceramic restorations with the application of an immediate dentin sealing (IDS) performed by various practitioners.

Study design and population:

Twenty dental practitioners, who followed a course on making ceramic partial restorations using IDS, will be asked to include patients for this study. The dental practitioners are being asked to share their data (occlusal light photo's, impression and x-rays) of twenty-five restorations they make after having the course. Restorations of individuals with a minimum age of 18 will be included. The information from pictures and impressions will be evaluated.

Items to evaluate

The practitioners will be interviewed to get to know in what circumstances they do their treatment. Items that are discussed are:

  • using rubber dam;
  • using magnification by means of loupes/microscope;
  • scheduled time for the treatment;
  • number of restorations after following the course.

Initial data (gathered directly after treatment) will be evaluated looking at:

  • surface of preparation after IDS;
  • size of the prepared surface;
  • color.

Follow up data will be evaluated looking at:

  • tooth extraction
  • fracture restoration
  • fracture tooth
  • secondairy caries
  • de-bonding
  • endodontic problems

Outcome: Failures (fracture, de-bonding, secondairy cariës, endodontic problems) are the main outcome measurements.

Description and estimation of the load and risk for the subjects:

No extra intervention is performed. The dental practitioners will provide their data (i.e. impressions, occlusal light photo's) and these will be evaluated by the researchers. Follow up data will be gathered from X-rays already made for periodical oral examination (taking the caries risk into account). Summarizing, there is no extra load or risk for the patients.

Studie design Prospective practice-based research, multicenter.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Healthy individuals

排除标准

  • Periodontal unstable situation
  • Endodontic unstable situation
  • Allergies for one or more of the used products

结局指标

主要结局

Survival and Succes

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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