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临床试验/NCT05173753
NCT05173753Unknown不适用

Novel Self-Adhesive Composite Hybrid Versus Conventional Composite in Restoration of Carious Primary Teeth. A Split Mouth Randomized Clinical Trial

Cairo University0 个研究点目标入组 60 人开始时间: 2022年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
clinical effectiveness

研究概览

简要总结

The clinical trial aim to evaluate clinical effectiveness of self-adhesive composite hybrid (Surefil one) versus conventional composite(VOCO Grandio) as restorative material for carious primary teeth.

详细描述

Composite resin is a continuous improving material as its full fill many requirements seeking in dental restorative materials, but is the new introducing composite resin material is always better than the previous one? This randomized clinical trial is performed to discus and assess that hypothesis. A total of 120 class I restoration(60 Surefil one novel self-adhesive composite hybrid & 60 VOCO Grandio conventional composite resin) will be placed in posterior teeth of 60 volunteers(splint mouth design) following the manufacturer instruction. age between 4-7 years. The restorations will then be evaluate clinically at baseline, 3, and 6 month intervene. Both the procedure and follow up will done in the out-patient clinic, Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Cairo, Egypt.

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
4 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Unable to attend follow-up visits. Refusal of participation.
  • Symptom tooth. Periapical Pathosis. Mobile primary tooth.

结局指标

主要结局

clinical effectiveness

时间窗: 6 month intervene

The two materials will be evaluated using the FDI World Federation criteria.

次要结局

  • Duration of procedure(6 month intervene)
  • The cost effectiveness(6 month intervene)
  • Child cooperation(6 month intervene)

研究者

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

Fatima Elfadil Rabie

Principal investigator

Cairo University

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