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临床试验/NCT06606379
NCT06606379尚未招募不适用

Impact of Different Separation Methods on Proximal Contact Tightness and Contour of Compound Class ii Nanohybrid Resin Composite Restorations: Randomized Clinical Trial

Cairo University0 个研究点目标入组 160 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
主要终点
Proximal Contact tightness (Success rate)

研究概览

简要总结

The aim of this study is to evaluate the interdental separation of various separation systems and their impact on the proximal contact tightness and contour in compound class II nanohybrid resin composite restorations.

详细描述

The target population consists of adult patients aged 25-40, with posterior compound proximal carious cavities (ICDS score 4 or 5) in molars. The interventions under investigation include three different separation systems: the Resin ring (DR-Resin ring, Egypt), Elliot separator (Pfingst & Co, USA), and Stainless Steel Metal ring (TOR VM ring, Russia). These systems will be compared to a Nickel titanium 3D-fusion ring (Garrison, USA). The primary outcomes assessed are proximal contact tightness and form/contour, measured visually according to FDI criteria, with scoring systems adapted from Hickel et al. (2023). Secondary outcomes, such as patient comfort (measured by a pain rating scale), and the emergence profile (assessed via bitewing radiographs), will also be considered. Data will be collected immediately postoperatively (T0), at 30 days (T1), and after 6 months (T2). The study will be conducted as a randomized clinical trial. The null hypothesis suggests that there will be no significant differences in proximal contact tightness or contour across the different separation systems used.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals with posterior compound proximal carious cavities in molars.
  • Age of (25-40) years.
  • Molars with compound proximal carious cavities score 4 or 5 ICDS.
  • Vital upper or lower posterior teeth with no signs of irreversible pulpitis.
  • Presence of adjacent and opposing teeth with normal occlusion

排除标准

  • Patients with major systemic disorders or xerostomia.
  • Patients with periodontal disease.
  • Patients with para-functional habits.
  • Presence of malocclusion or signs of pathological teeth wear
  • Non vital teeth or teeth with signs of pulpal pathology.
  • Teeth mobility or clinical attachment loss.

结局指标

主要结局

Proximal Contact tightness (Success rate)

时间窗: From enrollment to the end of treatment at 6 months

Visual examination and 25-/50-/100-µm blade according to FDI Criteria

次要结局

  • Form and Contour(From enrollment to the end of treatment at 6 months)
  • Patient Comfort(From enrollment to the end of treatment at 6 months)
  • Emergence profile(From enrollment to the end of treatment at 6 months)

研究者

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

Hadeer Hesham Mohamed

Dr. Hadeer Hesham

Cairo University

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