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临床试验/NCT04249726
NCT04249726进行中(未招募)不适用

The Restoration of Minimally Destructed Posterior Endodontically Treated Teeth Using Indirect Full Coverage Restorations Compared to Direct Composite Resin Restorations: A Randomised Clinical Trial.

University of Jordan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年1月25日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
2
主要终点
Survival

研究概览

简要总结

The use of full cuspal coverage restoration for the management root treated teeth was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for a root treated tooth with good amount of remaining tooth structure such as direct restorations.

The aims of this randomized clinical trial is to compare the survival and success of root treated teeth with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.

详细描述

The management of posterior endodontically treated teeth (ETT) is still to this day considered a controversial topic.The use of full cuspal coverage restoration for the management ETT was advocated by many clinical studies and supported by systematic reviews. However, most of the studies did not take into account the amount of tooth structure remaining before providing cuspal coverage. An ETT tooth with an MOD cavity will be at a higher risk of fracture than an ETT tooth with just an occlusal cavity. Managing both with cuspal coverage could be considered an overtreatment and an unnecessary removal of tooth structure. The strength and fracture resistance of the tooth has been shown to be positively correlated with the amount of tooth structure remaining. A more conservative treatment option could be selected for an ETT with good amount of remaining tooth structure such as direct restorations.

The aims of this randomized clinical trial is to compare the survival and success of ETT with occlusal cavities and at least three intact axial walls, when restored through the use of indirect full cuspal coverage restorations vs direct composite resin restorations.

The groups are:

Group 1: Managed with direct intracoronal composite resin restoration. Group 2: Managed with a direct composite resin restoration, followed by an indirect full coverage restoration.

Patients will be recalled at 1 year, 3 years and 5 years.

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

入选标准

  • To have at least one posterior tooth in need for root canal treatment and restoration.
  • The tooth structure loss of the tooth should be limited to an occlusal cavity with at least three remaining axial walls (>2mm thickness).
  • The tooth should be opposed by a natural tooth or a fixed partial denture.
  • The tooth should not be serving as an abutment for a removal or fixed partial denture.

排除标准

  • Patients under 18

结局指标

主要结局

Survival

时间窗: 5 years

Survival of the tooth and restoration

Complications

时间窗: 5 years

Complications that affect the restoration

Success

时间窗: 5 years

Success of the restoration without complications: to be assessed based on modified USPHS criteria (margin integrity, color, surface texture)

Patient reported satisfaction

时间窗: 5 years

Patients' reported satisfaction with the restoration provided regarding: appearance, function, ease of cleaning and cost using the visual analog scale.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Motasum Abu-Awwad

Assistant Professor

University of Jordan

研究点 (2)

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