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临床试验/NCT06485024
NCT06485024尚未招募不适用

Clinical Performance of Direct NanoHybrid Resin Composite Veneer Restorations Applied With or Without Modeling Resin:a Randomized Controlled Trial

Cairo University0 个研究点目标入组 25 人开始时间: 2024年7月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
主要终点
comparison of Color stability with and without the intervention

研究概览

简要总结

the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin

详细描述

ChatGPT This study aims to investigate the impact of modeling resin on the clinical performance of direct nanohybrid resin composite veneer restorations in anterior teeth. Resin composites are widely used in dental restorations due to their aesthetic qualities, but issues like discoloration and surface roughness can affect their longevity and patient satisfaction. Modeling resin, used to aid in composite placement and sculpting, has become common, but concerns exist regarding its effects on composite properties, particularly long-term color stability.

The research will employ a randomized controlled trial design with a two-arm parallel approach. Adult patients (18-45 years) with anterior tooth defects suitable for composite veneer restoration will be recruited. The intervention group will receive nanohybrid resin composite with modeling resin, while the comparator group will receive the composite without modeling resin. Outcomes will be assessed using modified USPHS criteria, including color stability, color match, anatomical form, marginal adaptation, marginal discoloration, retention rate, presence of secondary caries, and postoperative sensitivity, at baseline and at follow-up intervals of 1, 3, 6, and 12 months.

Statistical analysis will involve independent t-tests for intergroup comparisons and repeated measures ANOVA for intragroup comparisons, with a significance level set at 0.05. The study aims to determine if the use of modeling resin influences the clinical outcomes of resin composite veneer restorations. Ethics approval will be obtained, and confidentiality of participant data will be strictly maintained throughout the study period.

Overall, this research seeks to provide insights into optimizing the application of resin composites in dental practice to enhance patient outcomes and satisfaction

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Adults (18-45Ys) with anterior tooth defects indicated for direct composite veneer restoration.
  • Males or females.
  • Community-dwelling
  • Have all his/her anterior teeth with sufficient enamel structure
  • With ≥ 1 anterior tooth defect
  • Have sufficient cognitive ability to understand consent procedures
  • Anterior tooth defect indicated for direct composite veneer
  • Vital upper or lower anterior teeth with no signs or symptoms of irreversible pulpitis.
  • Mobility grade: no clinical mobility
  • Plaque index ≤ 2

排除标准

  • Patients younger than 18 or older than 45 years old • Disabilities.
  • Systemic diseases or severe medically compromised.
  • Lack of compliance.
  • Evidence of severe bruxism, clenching or temporomandibular joint disorders.
  • Cognitive impairment
  • Periapical pathosis or signs of pulpal pathology.
  • Malocclusion
  • Possible prosthodontic restoration within 1 year.
  • Non-vital tooth.
  • Endodontically treated tooth.
  • Severe periodontal affection or tooth indicated for extraction.

结局指标

主要结局

comparison of Color stability with and without the intervention

时间窗: baseline and after one year

by using Spectrophotometer to measure the color considering the intervention

次要结局

  • comparing the effect of the intervention on color match(baseline and after one year)
  • comparing the effect of the intervention on surface texture(baseline and after one year)
  • comparing the effect of the intervention on marginal adaptation(baseline and after one year)
  • comparing the effect of the intervention on recurrent caries(baseline and after one year)
  • comparing the effect of the intervention on postoperative sensitivity(baseline and after one year)
  • comparing the effect of the intervention on anatomical form(baseline and after one year)
  • comparing the effect of the intervention on marginal discoloration(baseline and after one year)
  • comparing the effect of the intervention on retention rate(baseline and after one year)

研究者

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

Sarah Azzazy ali

Master's student

Cairo University

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