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临床试验/NCT06346795
NCT06346795尚未招募不适用

Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins

Selcuk University2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Retention

研究概览

简要总结

In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will 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
  • 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: 7th day, 6th month, 12th month.

No loss of restorative material

Color match

时间窗: 7th day, 6th month, 12th month.

The restoration matches the adjacent tooth structure in color and translucency

Marginal discoloration

时间窗: 7th day, 6th month, 12th month.

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

Surface texture

时间窗: 7th day, 6th month, 12th month.

The surface of the restoration does not have any defects

Marginal adaptation

时间窗: 7th day, 6th month, 12th month.

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

Secondary caries

时间窗: 7th day, 6th month, 12th month.

No evidence of secondary caries

Anatomical form

时间窗: 7th day, 6th month, 12th month.

The restoration is continuous with the existing anatomic form

Postoperative sensitivity

时间窗: 7th day, 6th month, 12th month.

No postoperative sensitivity, after the restorative procedure and during the study

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 (2)

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Class II Restorations With High-Filled Flowable... | 临床试验