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Evaluation of the Survival of Inflamed Mature Single Rooted Teeth

2020年10月3日 更新者:Mostafa Omar Fahim、Cairo University

Short Term Success of Inflamed Mature Single Rooted Teeth With Symptomatic Apical Periodontitis Following Single Visit Regenerative Treatment Protocols (Randomized Clinical Trial)

The majority of articles present in literature concerning the enrollment of tissue engineering in the field of root canal treatment is concerned with the treatment of affected teeth with immature apex, after proper systematic search online, only 4 articles where found that are dealing with the treatment of teeth with mature apex. These 4 studies are case reports. None of these studies has been a randomized clinical trial, the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Since that the triad of regenerative endodontics are the key of success of any attempt to regenerate pulp, 2 different maneuvers shall be done in this study.

研究概览

地位

未知

条件

详细说明

Preservation of the natural dentition had always been a primary objective in endodontic practice. When the pulp is diseased or requires removal for restorative reasons, it is replaced with an artificial filling material during conventional root canal treatment. Root canal treatment has lots of drawbacks, starting with different iatrogenic errors during endodontic procedures, weakening of remaining tooth structure which might affect the tooth survival. Also Root canal treated teeth require the placement of a post and core, which itself is doubtful whether it increases fracture resistance of the tooth or it weakens it. The most important drawback is that the survival of affected pulp is hindered by the conventional root canal treatment. Thus a new treatment approach was introduced utilizing the body ability to regenerate, called Pulp Regeneration. Regeneration was first introduced in the dental field as a solution for immature apex treatment, due to difficulties encountered during its conventional root canal treatment. Here the Pulp regeneration shall be used on vital mature teeth to increase the survival rate of the affected teeth.

研究类型

介入性

注册 (预期的)

40

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

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

16年 至 25年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
  • Non-pregnant females
  • Single canalled teeth.
  • Patients having vital, mature, single rooted teeth, clinical evidence of pulpitis and apical periodontitis.
  • Positive patient/Guardian compliance for participation in the study.

Exclusion Criteria:

  • Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
  • Non-restorable coronal portion of teeth involved in the trial.
  • Non Vital teeth
  • Immature teeth
  • Traumatized teeth
  • Radiographic evidence of external or internal root resorption.
  • Single Rooted teeth with multiple canals.

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:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:conventional
Conventional blood clot technique
Conventional Blood Clot Technique
实验性的:PRF
Platelet Rich Fibrin Technique
Platelet Rich Fibrin Technique

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
Change of tooth Sensitivity
大体时间:1, 3, 6, 9, 12 Months
Electric Pulp Tester
1, 3, 6, 9, 12 Months

次要结果测量

结果测量
措施说明
大体时间
Survival
大体时间:1, 3, 6, 9, 12 Months
Clinical examination of tooth integrity
1, 3, 6, 9, 12 Months
Clinical Success
大体时间:1, 3, 6, 9, 12 Months
Clinical examination the signs & symptoms is present or absent
1, 3, 6, 9, 12 Months
Pericapical Status
大体时间:6, 9, 12 Months
CBCT assessment in Hounsfield unit
6, 9, 12 Months
Periapical Status
大体时间:1, 3, 6, 9, 12 Months
Digital Periapical Radiograph in pixels
1, 3, 6, 9, 12 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。

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12月1日

初级完成 (预期的)

2021年10月30日

研究完成 (预期的)

2021年12月30日

研究注册日期

首次提交

2018年10月28日

首先提交符合 QC 标准的

2018年10月29日

首次发布 (实际的)

2018年10月31日

研究记录更新

最后更新发布 (实际的)

2020年10月8日

上次提交的符合 QC 标准的更新

2020年10月3日

最后验证

2020年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • ENDO28

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

Participant data will be made available

IPD 共享时间框架

It will be available after finishing the study

IPD 共享访问标准

It will be uploaded on a folder on google drive to be accessed through this link URL: https://drive.google.com/open? id=1rZXDbSgsneWDO4xGz8KGkklEHHw2YYIX

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会

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.

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