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临床试验/NCT04307420
NCT04307420Unknown不适用

Postoperative Pain Following Restoration With Sonic Fill Versus Composite Resin in Children With Deep Carious First Permanent Molar: A Randomized Clinical Pilot Study

Cairo University0 个研究点目标入组 32 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
主要终点
Postoperative Pain

研究概览

简要总结

The aim of this study is to assess the postoperative pain following restoration with composite resin versus sonic fill in children with deep carious first permanent molar.

详细描述

For many years, composite resin restorations have been considered an acceptable treatment choice for anterior applications. Recent advances in composite resin mechanical properties and improved adhesive systems have broadened the application of these materials to include the restoration of posterior teeth. However, it is still generally accepted that posterior composite resin restorations have limitations and that there is no ideal material available. A volumetric shrinkage occurs when a composite resin material is cured. The shrinkage is the result of conversion of monomer molecules into a more dense polymer network, which leads to bulk contraction. A new nanohybrid composite activated by sonic energy has been recently introduced as a single-step, bulk-fill restorative material. This system utilizes the patented sonic-activation technology enabling a rapid flow of composite into the cavity for effortless placement and superior adaptation in one single layer, thereby, emphasizes its practical and efficient technique for placing posterior composites. The hand piece, designed by KaVo (Germany), delivers sonic energy at varying intensities, which is adjusted on the shank from low to high (1 to 5) to control rate of composite extrusion.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Asymptomatic First Permanent Molar
  • Age of the patient ranging from 6-9 years
  • Normal periodontal status
  • Teeth with no previous restorative treatment
  • Good oral health
  • Absences of pathological mobility

排除标准

  • Adverse medical history
  • Potential behavioral problems
  • Parents refusing participation of their children

结局指标

主要结局

Postoperative Pain

时间窗: Baseline

The primary outcome (postoperative pain) is evaluated the following day of the treatment performed by a phone call from the outcome assessor, a week and a month after to check in any pain.

次要结局

  • Clinical Evaluation of Restoration (Modified USPHS Criteria)(3 months, 6 months, 9 months)

研究者

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

Mennatallah Samy Mohamed Maklad

Principle Investigator

Cairo University

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