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临床试验/NCT03242291
NCT03242291Unknown不适用

Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial

Cairo University0 个研究点目标入组 26 人开始时间: 2017年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
26
主要终点
marginal integrity of both restorations

研究概览

简要总结

This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over a one year period.

详细描述

A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be divided into two groups according to type of flowable composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed with conventional resin-based flowable composite. Each restoration will be assessed after one week, six and twelve months Both materials will be applied according to manufacturer's instructions where teeth should be cleaned to remove surface stains, then select appropriate shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and rinse adhesive system is applied, where acid etching will be applied for 15 seconds then rinse and dry followed by application of adhesive then light cure 10 seconds, then place and cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition layer after light cure with slurry of pumice or polishing paste All restorations were reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material used for the restorations. All restorations were be evaluated by calibrated examiners following the FDI criteria

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients should be over 18 Years old.
  • Patient should have good oral hygiene and general health
  • With at least 2 non-cavitated initial occlusal carious lesion first and/or Second molar teeth in each quadrant of maxilla or mandible

排除标准

  • Known allergy to any of the resins used,
  • Clinically detectable caries,
  • Previously placed sealants or restorations,
  • Bruxism or malocclusion

研究组 & 干预措施

conventional resin-based flowable composite

Active Comparator

干预措施: Conventional resin-based flowable composite (Other)

conventional resin-based flowable composite

Active Comparator

干预措施: Hydroxyapatite Nanofiber reinforced flowable composite (Other)

Hydroxyapatite Nanofiber reinforced flowable composite

Other

干预措施: Conventional resin-based flowable composite (Other)

Hydroxyapatite Nanofiber reinforced flowable composite

Other

干预措施: Hydroxyapatite Nanofiber reinforced flowable composite (Other)

结局指标

主要结局

marginal integrity of both restorations

时间窗: 12 months

restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.

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

donia elshafey

internal resident

Cairo University

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