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临床试验/NCT05500547
NCT05500547已完成不适用

Clinical Performance of One-shade Universal Dental Resin Composite as Posterior Restoration

Minia University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
USPSH criteria

研究概览

简要总结

This study is aimed to evaluate the clinical performance of new One-shade universal composite resin as posterior restoration using US Public Health Service "USPSH" criteria for color match, marginal adaptation, surface texture, retention, recurrent caries and others after 1, 3, 6 and 9 months.

详细描述

One operator will place all restorations under rubber-dam isolation. The patients will receive restorations with both materials, randomly after shade selection (The shade of single shade universal resin composite "Omnichroma" will be taken before and after placement into the cavity). During the referred period, only the two composites in study will be placed in posterior teeth in the dental office. The various materials' application procedure will be applied according to manufacturer's instructions.

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
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • They should have an acceptable oral hygiene level.
  • Presence of at least two occlusal carious lesions to be restored with two different types of composite.
  • The two studied materials restorations should be used in approximately the same sized lesions or within the same extension.
  • Age range between 25 and 45years.

排除标准

  • • Severe or active periodontal or carious disease and heavy bruxism or a traumatic occlusion
  • Patients with a compromised medical history, or had received therapeutic irradiation to the head and neck region.
  • Alcoholic and smoker patients.
  • Patients had participated in a clinical trial within 6 months before commencement of this trial.
  • Patients unable to return for recall appointment

结局指标

主要结局

USPSH criteria

时间窗: For 9 months

Alpha and Beta are clinically successful, Charlie and Delta are clinically failure

次要结局

未报告次要终点

研究者

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

Ruba Salah Anwar

Assistant Lecturer at Department of Operative Dentistry, Faculty of Dentistry

Minia University

研究点 (2)

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