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临床试验/NCT06109987
NCT06109987已完成不适用

Clinical Evaluation of High-viscosity Glass-hybrid Systems Compared With a Bulk Fill Composite Resin in Different Cavity Type

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021年10月11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
160
试验地点
1
主要终点
Evaluation of different restorative materials

研究概览

简要总结

High-viscosity glass ionomer cements have been developed to improve the weak mechanical properties of glass ionomer cements, increase wear resistance and improve their limited indications. There are limited clinical studies on the use of high-viscosity glass ionomer cements in areas with large cavities bearing stress. The aim of this study is to compare the clinical performance of two different high-viscosity glass ionomer cements with a bulk-fill resin composite in different cavities.

详细描述

This study was a double-blind (evaluator and patient) randomized controlled clinical study with three study groups with an equal allocation. Three different restorative materials were compared in Class I, II, and V 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 marginal discoloration, fracture and retention, marginal adaptation, post-operative sensitivity, secondary caries, color match and difference criteria were examined.

Clinical evaluation was performed by one qualified clinicians using a mirror and probe under reflector light. 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 Wilcoxon Signed rank 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

  • Voluntarily agreed to participate in the study after being informed about the study.
  • Volunteer must not be under 18 years of age
  • No systemic disease
  • Having healthy oral hygiene
  • As a result of clinical and radiographic examination, there is a carious lesion at D1 and D2 levels according to the caries classification method.
  • The tooth to be restored is vital

排除标准

  • Refusal to participate in the study after being informed about the study
  • The patient has a history of teeth grinding
  • Volunteer must be under 18 years of age
  • The volunteer is undergoing or will begin orthodontic treatment
  • The volunteer has a serious systemic disease
  • The tooth to be restored has endodontic and periodontal problems
  • Volunteer's pregnancy status
  • Extraction of one of the teeth opposite or in contact with the tooth to be restored

结局指标

主要结局

Evaluation of different restorative materials

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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