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临床试验/NCT06612021
NCT06612021进行中(未招募)不适用

Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2023年7月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
64
试验地点
1
主要终点
marginal staining of restoration

研究概览

简要总结

The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.

详细描述

The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.

The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.

Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •of participants:
  • •Patients with occlusal caries in molars classified as ICDAS III or IV.
  • •19-35 years.
  • •Males or Females.
  • •Co-operative patients approving to participate in the trial.

排除标准

  • •of participants:
  • •Pregnancy.
  • •Disabilities.
  • •Systemic disease or severe medical complications.
  • •Allergic history concerning methacrylate.
  • •Rampant caries.
  • •Heavy smoking.
  • •Xerostomia.
  • •Lack of compliance.
  • •Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

研究组 & 干预措施

HEMA free universal adhesive group

Experimental

干预措施: Beautibond universal adhesive (Procedure)

HEMA containing universal adhesive group

Active Comparator

干预措施: Tetric N universal bond (Procedure)

结局指标

主要结局

marginal staining of restoration

时间窗: baseline ,6 months & 12 months

marginal staining using USPHS criteria Alpha: No staining in the margin Bravo: superficial staining on the margin Charlie: deep staining on the margin

次要结局

  • caries recurrence(baseline ,6 months ,12 months)
  • marginal adaptation of restoration(baseline ,6 months and 12 months)

研究者

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

Alaa Fathi Abdelsalam

lecturer of conservative dentistry

Cairo University

研究点 (1)

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