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临床试验/NCT06346769
NCT06346769已完成不适用

Clinical Evaluation of Composite Restorations Performed by Placing Polyethylene Fiber in Endodontically Treated Posterior Teeth

Selcuk University4 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
68
试验地点
4
主要终点
Retention

研究概览

简要总结

This study aimed to evaluate the 12-month clinical performance of direct composite restorations by placing polyethylene fibers in different directions in endodontically treated posterior teeth. In this clinical study, Clearfil SE Bond (Kuraray/Japan) adhesive system, G-aenial Universal Injectable (GC/Tokyo, Japan), G-aenial A'chord (GC/Tokyo, Japan) composites, and polyethylene fiber (Ribbond, USA) were used. In the restoration of the teeth included in the study, polyethylene fiber was placed in different directions according to the amount of remaining tooth tissue and cavity preparation. The restorations were divided into three groups according to the direction of fiber placement ('O' shape, mesiodistal I shape, buccolingual I shape) (n=12). Restorations were evaluated according to modified USPHS criteria in 1st week and 6th months from the placement date. The Chi-square test was used for statistical analysis of the difference between the groups, and the Cochran Q test was used for the significance of the difference between time-dependent changes within each group (p<0.05).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • A patient presenting with;
  • over 18 years of age
  • a normal periodontal status and good general health
  • endodontically treated premolar and molar teeth
  • teeth in contact with the opposing tooth and subjected to normal occlusal forces
  • attend follow-up appointments

排除标准

  • poor oral hygiene status
  • those with severe or chronic periodontitis
  • absence of adjacent and antagonist teeth
  • potential behavioral problems (e.g. bruxism)
  • allergy to any product used in the study
  • systemically unhealthy
  • pregnant and lactating women

结局指标

主要结局

Retention

时间窗: Seventh day, sixth month, twelfth month

No loss of restorative material

Secondary caries

时间窗: Seventh day, sixth month, twelfth month

No evidence of secondary caries

Marginal adaptation

时间窗: Seventh day, sixth month, twelfth month

There is no visible evidence of a crevice along the margin into which the explorer will penetrate

Marginal Discoloration

时间窗: Seventh day, sixth month, twelfth month

There is no discoloration anywhere on the margin between the restoration and the tooth structure

Surface texture

时间窗: Seventh day, sixth month, twelfth month

The surface of the restoration does not have any defects

Color match

时间窗: Seventh day, sixth month, twelfth month

The restoration matches the adjacent tooth structure in color and translucency

Anatomical form

时间窗: Seventh day, sixth month, twelfth month

The restoration is continuous with the existing anatomic form

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

Merve Gurses

Assistant Proffesor

Selcuk University

研究点 (4)

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