跳至主要内容
临床试验/NCT04565860
NCT04565860已完成不适用

Erciyes University Clinical Research Ethics Committee

Nuh Naci Yazgan University1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
158
试验地点
1
主要终点
Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.

研究概览

简要总结

Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS).

详细描述

Composite resins have been widely used in the last years to restore teeth due to increases in patients' esthetic expectations. Therefore optical and mechanical properties of composite resins were being developed day by day. Composite resin restorations have the main advantages such as conservative cavity preparation, preserving healthy dental tissue, and strengthening the remaining tooth structure. Furthermore, according to clinical studies, high clinical performance and good longevity have been reported. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique. The incremental technique provides sufficient light penetration and monomer conversion. However, there are many disadvantages to the incremental technique. For instance, bonding failure, blood, or saliva contamination of between layers, the difficulty of application in limited access in small cavities, and to be time-consuming. Because of these, manufacturers have presented a "bulk-fill composites", which could be polymerized in a single layer up to 4-5 mm thick to the market. Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick. Bulk-fill composites that were introduced in recent years can be manipulated faster and more convenient in the cavity compared to conventional hybrid composites. In addition, these materials present good mechanical properties such as marginal adaptation, sealing properties, fracture strength, wear-resistance, and long-term clinical success. Clinical studies are required to clearly describe the clinical behavior of the materials. Although there have been many in vitro studies about bulk-fill composite in the literature, the number of clinical trials is insufficient. Therefore, the aim of this study was to evaluate the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental techniques) in Class II carious lesions using the criteria of the World Dental Federation (FDI) and the United States Public Health Service (USPHS)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 22 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • At least 4 Class-II caries lesions
  • Good health
  • Acceptable level of oral hygiene

排除标准

  • Did not have four caries lesions at least
  • Did not have Class-II caries lesions
  • Deep caries reaching the pulp
  • The patients are not 18-20 years old
  • Periodontal disease
  • Refused to participate

结局指标

主要结局

Evaluation of the clinical performance of bulk-fill composite about placement technique (bulk-filling and incremental) in Class II carious lesions using FDI and USPHS criteria.

时间窗: Four-year

FDI; The World Dental Federation. USPHS; The United States Public Health Service. The 4-year results of the restorations were evaluated with the FDI and USPHS criteria. Two calibrated observers who were blinded to the objective of this study performed the evaluations.

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

Nazire Nurdan Çakır

Assist. Prof Nurdan Çakır

Nuh Naci Yazgan University

研究点 (1)

Loading locations...

相似试验