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临床试验/NCT06058026
NCT06058026已完成不适用

Clinical Evaluation of Composite Resins in Class II Cavities

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Evaluation of class II restorative materials restored with different adhesives

研究概览

简要总结

Universal adhesive solutions have just entered the market, allowing dentists to choose an adhesive strategy based on the needs of patients and clinical situations. Theses adhesives contain a primer/adhesive resin mix in a single bottle for multi-mode etch-and-rinse or self-etch applications. The aim of this study was to evaluate the clinical performance of composite resins with diffent adesive agents on Class II cavities.

详细描述

This study was a double-blind (evaluator and patient) randomized controlled clinical study with six study groups with an equal allocation. Two composite materials with two universal and one two-step self-etch adhesives were compared in Class II restorations.

The treated patients were called back for controls after one week, six months, and eighteen months. Restorations were evaluated clinically according to modified FDI criteria. In terms of esthetic property, marginal discoloration; in terms of function properties, fracture and retention, and marginal adaptation; in terms of the biological characteristics, post-operative sensitivity, and secondary caries criteria were examined.

Clinical evaluation was performed by two qualified clinicians. Bite-wing radiographs were taken from the patients who were called for controls at 6-moth and 18-month to evaluate the formation of secondary caries.

Differences between adhesives at each time period were evaluated using Fisher's Exact test. The effect of time on restorations was evaluated using the Friedman test (p < 0.05).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Individuals without systemic disease
  • Individuals with good oral hygiene
  • Must be a minimum of one carious defect
  • Must be at least 18 years old
  • Must have vital teeth in antagonist and proximal contact.

排除标准

  • Pregnant or breastfeeding women
  • Receiving orthodontic treatment
  • Bruxism habit
  • Direct or indirect pulp coverage
  • Allergy to resin-based products

结局指标

主要结局

Evaluation of class II restorative materials restored with different adhesives

时间窗: Baseline

Restored teeth were evaluated according to FDI criteria.

次要结局

未报告次要终点

研究者

发起方
Recep Tayyip Erdogan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammet Karadaş

Assistan Professor

Recep Tayyip Erdogan University

研究点 (1)

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