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临床试验/NCT04111003
NCT04111003已完成不适用

Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study

University of Turku0 个研究点目标入组 20 人开始时间: 2012年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Restoration failure detected at clinical follow-up examination

研究概览

简要总结

A short fiber reinforced composite base filling material has been shown to improve the strength of a direct composite filling significantly. It prevents fracture propagation and reduces shrinkage strain. These features are needed especially in endodontically treated molars, as root-canal treated teeth are structurally compromised and their restoration is associated with technical failures such as debonding and vertical root fractures.

Application on this core fiber-reinforced composite (FRC) material is simplified when compared to post and core techniques commonly used to restore endodontically treated teeth. Clinically, the use of core FRC offers a cost-effective way to restore endodontically treated molars without root canal involvement.

The purpose of this study is to compare the clinical performance of endodontically treated molars restored with either direct composite restorations with a FRC substructure, or with indirect full-ceramic onlay restorations, i.e. endo-crowns.

详细描述

INTRODUCTION

Composite resins are routinely used for restoring vital and non-vital posterior teeth by most practitioners in Finland. Various clinical studies have found that the three main reasons for failure of direct composite fillings are secondary caries, wear and fracture of composite resin especially at molar region (1, 2, 3). Non-vital (endodontically treated) teeth are structurally compromised and their restoration is associated with technical failures such as debonding and vertical root fractures (4). Techniques, like root canal post insertion, that are used to overcome these problems, are time consuming and may even further increase the risk for root fractures.

This study is a continuum on material development conducted at the the Department of Prosthetic Dentistry, Biomaterials Science and Turku Clinical Biomaterials Centre - TCBC, University of Turku, in collaboration with TEKES (Technology Development Center of Finland) and StickTech (Turku, Finland). The data obtained has shown that, the use of a bilayered structure consisting of a fiber-reinforced composite substructure (core FRC) combined with an upper layer of conventional restorative composite, increases the fracture load of a restoration significantly (5,6 and 7). This newly developed material has increased mechanical properties when compared to conventional materials, while maintaining its clinical applicability. Moreover, volumetric polymerization shrinkage of the core FRC is found to be lower than commercially available composites (<1.8% for the new FRC-material; 2.0% for a commercial composite Z250) (8). This may be expected to result in less marginal leakage and secondary caries in long term. With this backround a multidirectional short-fiber composite (everX, StickTech) has been introduced as a base material (FRC substructure) for large cavities in vital or non-vital teeth.

The investigators in vitro experiments have shown that the FRC substructure retains and significantly reinforces composite crowns in endodontically treated molars. Moreover, in case of failure, the presence of the FRC substructure seems to orient the fracture propagation and result in more easily restorable fractures. Application on the core FRC material is simplified when compared to post and core techniques commonly used to restore endodontically treated teeth. Clinically, the use of core FRC offers a cost-effective way to restore endodontically treated molars without root canal involvement. In a recently published clinical pilot study the investigators have reported successful 1 year results of this technique (9).

Ceramic onlay-restorations, so called "endo-crowns", are currently used to restore endodontically treated molars with similar indications (without root canal involvement). Case studies have reported good clinical results with this type of method (10). The use of an indirect technique (multiple patient visits), material and technical fabrication costs make this treatment modality, however, more costly and not in the reach of every patient.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • need for a restoration in a endodontically treated upper of lower molar tooth
  • adequate coronal tooth substance present for an adhesive restorative technique

排除标准

  • propable sleep bruxism
  • active periodontitis
  • disability to performs oral hygiene measures
  • periapical parodontitis in the study tooth
  • low quality of root canal obturation
  • fracture-line detected at cavity preparation
  • no enamel present
  • less than 2mm of coronal tissue present in average
  • no opposing tooth

研究组 & 干预措施

SFRC direct filling

Experimental

Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.

干预措施: local anesthesia (Procedure)

SFRC direct filling

Experimental

Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.

干预措施: Tooth restored using SFRC filling (Procedure)

CEREC endocrown

Active Comparator

Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.

干预措施: local anesthesia (Procedure)

CEREC endocrown

Active Comparator

Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.

干预措施: Tooth restored using Ceramic indirect endocrown (Procedure)

结局指标

主要结局

Restoration failure detected at clinical follow-up examination

时间窗: 5 years

Observer scores the restoration having a fracture or detachment that requires remaking of the restoration.

次要结局

  • Restoration fracture detected at clinical follow-up examination(5 years)
  • Restored tooth demonstrates with an endodontic complication needing removal of restoration or tooth. Clinical and radiographic examination requiered.(5 years)
  • Observer scores the restoration having with dental caries at clinical follow-up investigation(5 years)

研究者

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

Johanna Tanner

Associate professor, Department of Prosthetic Dentistry and Stomatognathic Physiology

University of Turku

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