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Survival of Root Canal Treated Teeth Restored With Ceramic Onlays

2020年12月2日 更新者:Professor Francesco Mannocci、King's College London

The Success and Survival of Teeth and Restoration Following Root Canal Treatment With Varying Degrees of Tooth Structure Loss Restored With CAD CAM Restorations.

Advances in digital dentistry coupled with increased demand for aesthetic restorations have led to developments in CAD CAM( Computer Aided Design and Computer Aided manufacturing)systems for manufacturing tooth restorations. CAD CAM restorations have the added benefit of digital impressions which eliminate the need to take conventional impressions, something patients find difficult to tolerate. CAD CAM restorations are now part of routine dental care. However there are no clinical studies evaluating these restorations on root canal treated teeth

This study aims to compare the success and survival of root canal treated teeth and/or restoration with varying degrees of tooth structure loss restored using CAD CAM restorations.

Null Hypothesis:- The amount of residual coronal dentin has no effect on the survival of root canal treated teeth and/or restoration.

研究概览

地位

完全的

条件

详细说明

This study will be carried out at KCL Dental Institute at Guy's Hospital and will form part of the routine dental treatment done at the endodontic postgraduate unit. Potential volunteers will be given written information about the process and be given time to consider participation. Once any questions have been answered, fully informed written consent will be obtained if they are interested in taking part. Patients requiring endodontic treatment with varying degrees of tooth structure loss will be detected, diagnosed and treated by endodontic MClinDent postgraduate students at Guy's hospital using suitable clinical techniques. The teeth will then be restored using CAD CAM restorations. Dental periapical radiograph and cone beam computed tomography (CBCT)scans (Morita Accuitomo) will be taken at baseline, 12 months and 24 months. Clinical assessment and radiographical evaluation will be carried out immediately after endodontic treatments have been accomplished and 1 and 2 years post treatment and will be assessed independently by a group of examiners. It is hoped that data analysed from this study will provide a definitive clinical evidence base for the success and survival of endodontically teeth and/or restorations.

研究类型

观察性的

注册 (实际的)

125

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

      • London、英国、SE19RT
        • Guy's Hospital

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 至 64年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Routine patients requiring root canal treatment at Guy's Hospital, London

描述

Inclusion Criteria:

  1. Patients either male or female over the age of 18 (who can consent for themselves) in good general health.
  2. The selected teeth needed to be in occlusal function with a natural tooth and in interproximal contact with two adjacent natural teeth.
  3. Molar or premolar teeth with suspected endodontic problems that require root canal treatment.
  4. Teeth should not be mobile and must be restorable.

Exclusion Criteria:

  1. Pregnant women, in view of requirements for radiographs (or if they could possibly be pregnant). To be confirmed by the Medical History Questionnaire.
  2. Patients younger than 18.
  3. Patients unable to give consent.
  4. Teeth with probing periodontal depths greater than 5 mm.
  5. Non-restorable teeth.
  6. Not involving patients from prisons.
  7. Not involving patients who cannot read, write or understand English

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
干预/治疗
Less than 33% Tooth Structure remaining
Root canal treatment followed by CAD CAM restoration
Root Canal Treatment followed by Ceramic Onlay restoration
33%-50% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Root Canal Treatment followed by Ceramic Onlay restoration
50% -66% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Root Canal Treatment followed by Ceramic Onlay restoration
More than 66% tooth structure remaining
Root canal treatment followed by CAD CAM restoration
Root Canal Treatment followed by Ceramic Onlay restoration

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
Success of root canal treatment
大体时间:Upto 24 months
Outcome of root canal treatment assessed using CBCT
Upto 24 months
Survival of Ceramic Onlays
大体时间:Upto 24 months
Survival of ceramic onlays assessed using modified USPHS criteria
Upto 24 months

次要结果测量

结果测量
措施说明
大体时间
Main types of failure of restoration.
大体时间:Upto 24 months
Modified USPHS criteria will be used to identify the main types of failure of these restorations.
Upto 24 months

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:Francesco Mannocci、Professor of Endodontology

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)

2018年1月1日

初级完成 (实际的)

2020年11月1日

研究完成 (实际的)

2020年11月1日

研究注册日期

首次提交

2017年12月5日

首先提交符合 QC 标准的

2017年12月19日

首次发布 (实际的)

2017年12月20日

研究记录更新

最后更新发布 (实际的)

2020年12月3日

上次提交的符合 QC 标准的更新

2020年12月2日

最后验证

2020年12月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRAS Project ID: 224248

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

De-identified individual data for all primary and secondary outcome measurements will be made available

IPD 共享时间框架

Data will be available within 6 months of study completion

IPD 共享访问标准

Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Root canal treatment的临床试验

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