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临床试验/NCT06346756
NCT06346756已完成不适用

Clinical Evaluation of Class II Restorations Performed With High-fill Injectable Composite and Condensable Universal Composites

Selcuk University2 个研究点 分布在 2 个国家目标入组 71 人开始时间: 2023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
71
试验地点
2
主要终点
Retention

研究概览

简要总结

This study aims to evaluate the one-year clinical performance of Class II restorations made with high-filling injectable and condensable universal composite resins.

The study included 71 patients and 140 restorations. It used G-aenial Universal Injectable (GCI), G-aenial A'CHORD (GCA), Tetric Prime (TP), Filtek Ultimate (FU) composites, and the Clearfil SE Bond adhesive system. Restorations were evaluated and scored according to modified USPHS criteria at seven days, six months, and one year. Chi-square and Cochran Q tests were used for statistical analysis (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
Double (Participant, 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
  • proximal caries that are similar in size to premolar and molar teeth
  • vital 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
  • exposure of the pulp during cavity preparation
  • 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

次要结局

  • marginal adaptation(seventh day, sixth month, twelfth month)
  • anatomical form(seventh day, sixth month, twelfth month)
  • postoperative sensitivity(seventh day, sixth month, twelfth month)
  • surface texture(seventh day, sixth month, twelfth month)
  • color match(seventh day, sixth month, twelfth month)
  • marginal discoloration(seventh day, sixth month, twelfth month)
  • secondary caries(seventh day, sixth month, twelfth month)

研究者

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

Merve Gurses

Assistant Professor

Selcuk University

研究点 (2)

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