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临床试验/NCT07289022
NCT07289022尚未招募不适用

Evaluation of the Color Matching Ability and Clinical Success of Flowable Monochromatic and Polychromatic Composite Resins in Posterior Restorations

Istanbul University0 个研究点目标入组 30 人开始时间: 2026年1月5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
30
主要终点
Clinical acceptability of restorations according to FDI criteria

研究概览

简要总结

This clinical study aims to investigate whether a single flowable composite resin system can achieve adequate color matching in posterior restorations and to compare it with a polychromatic composite system, which will serve as a control group. Clinical success will also be assessed using data obtained from the initial, six month, one-year, two-year, three-year, four-year, and five-year recall checks of the four different composite resin systems used in the study over a five-year period. L, a, and b parameters will be determined using the Vita Easyshade Compact (VITA Zahnfabrik, Bad Sackingen, Germany) Spectrophotometer device used in the study at the initial, half-year, one-year, two-year, three-year, four-year, and five-year intervals. Based on the obtained data, intraoral color changes will be determined using the CIEDE2000 color system. Each patient will be scanned with an intraoral scanner at each session. The hypothesis tested was that color matching and long-term clinical follow-up would be successful for all composite materials used in the study.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must be over 18 years of age and have no systemic disease.
  • Participants must have acceptable oral hygiene and at least 20 teeth in occlusion.
  • Participants must have at least four Class I-II carious lesions requiring treatment.
  • Lesions must involve both enamel and dentin, and the involved teeth must be vital and non-mobile.
  • All participants must read and sign an informed consent form prior to enrollment.

排除标准

  • Presence of any general health problem (systemic disease).
  • Periodontal disease or poor oral hygiene.
  • Tooth mobility or non-vital teeth in the target teeth.
  • Bruxism or uncontrolled parafunction

结局指标

主要结局

Clinical acceptability of restorations according to FDI criteria

时间窗: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Restorations will be evaluated by a blinded assessor using the World Dental Federation (FDI) criteria across functional, esthetic, and biological domains. Clinical acceptability is defined as FDI scores 1-3. The primary analysis will report the proportion of clinically acceptable restorations and the trajectory of scores over time.

次要结局

  • Color difference (ΔE00) using the CIEDE2000 system(1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years)

研究者

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

Safa Tuncer

Prof. Dr.

Istanbul University

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