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临床试验/NCT03476304
NCT03476304Unknown不适用

Comparison of Endocrowns Longevity and Post Retained Restorations: Randomized Clinical Trial

Federal University of Pelotas3 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
75
试验地点
3
主要终点
Survival

研究概览

简要总结

Caries disease is still the leading cause of severe tooth decay. Since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. Faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. It is known that an excellent restorative treatment with poor endodontic treatment and the inverse has a direct impact on the (in) success of the treatment. In this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. Acceptable restorations are those that provide adequate reestablishment of anatomy, function, proximal contacts, and occlusal stability. Traditionally, indirect restorations would be indicated in cases of extensive coronary destruction, because it was believed that they would present greater resistance and longevity when compared to direct restorations. However, contemporary dentistry admits that, thanks to adhesive and conservative principles, this difference between direct and indirect procedures in terms of longevity is not significant. The classic restorative procedure in cases of endodontically treated teeth with great loss of coronary structure involves the use of intraradicular retainers, followed by the creation of core and restoration through total crowns. Removal of healthy tissue for the use of posts can weaken the remaining dental structure and increase the risk of root perforations. In this sense, endocrown restorations show superiority when compared to those made with intraradicular retainers. Although the indications are favorable for the use of endocrown restorations, the clinical evidence available on the subject is still scarce. In this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will will be allocated to one of the three restorative groups available, being endocrown restoration in semi-direct composite resin, direct restoration in composite resin retained on the post and ceramic crown retained in the post. Patients will be monitored annually after completion of restorative treatment outcome. In addition to treatment longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact on quality of life and cost-effectiveness of the proposed treatments.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years old or more;
  • healthy volunteers;
  • molars or premolars with endodontic treatment and large coronal destruction;
  • at least 20 teeth;

排除标准

  • abutment of removable partial denture ;
  • tooth with mobility higher than 1;
  • more than 1/2 bone loss height;

研究组 & 干预措施

Post retained ceramic restoration

Active Comparator

干预措施: Post retained ceramic restoration (Device)

Post retained direct composite restoration

Active Comparator

干预措施: Post retained composite restoration (Device)

Semi-direct composite endocrown restorations

Experimental

干预措施: Endocrown restoration (Device)

结局指标

主要结局

Survival

时间窗: 2 years

Tooth will be annually followed until failure, but with a minimal follow-up of two years. They will be evaluated with FDI criteria for evaluation of direct and indirect restorations

次要结局

  • Satisfaction and quality of life improvement(2 years)
  • Cost-effectiveness(2 years)

研究者

发起方
Federal University of Pelotas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maximiliano Sergio Cenci

PhD

Federal University of Pelotas

研究点 (3)

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