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临床试验/NCT04813744
NCT04813744已完成不适用

Investigation of Atraumatic Restorative Treatment by in Vivo and in Vitro Methods in Terms of the Microbiological, Marginal Adaptation and Microleakage

Istanbul University0 个研究点目标入组 25 人开始时间: 2009年5月9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
25
主要终点
Evaluation of microbiological parameters

研究概览

简要总结

Atraumatic Restorative Treatment (ART) was proposed as a new and effective method in the 1990s to provide conservative dental treatment to the people living in economically underdeveloped countries, due to lack of dental treatment facilities. In the technique, after the carious dentin is removed by excavation with hand instruments, the powder-liquid system conventional glass ionomer cement (GIC) which does not require special devices for mixing and hardening is used as a filling material. Because of these advantages of the treatment, the usage fields of ART have been expanded considering that it can be applied in the cases that working with rotary instruments is difficult or even impossible. But only a few research has been conducted on ART in adults and it must be investigated in terms of the clinical safety of ART by the studies focused on the counts and activities of the microorganisms in carious dentin left on the cavity floor. The purpose of this study is to investigate the reliability of ART in adult individuals related to the marginal adaptation of the restorations and the microbiological changes in the left carious dentin using in vitro and in vivo methods. In the in vivo part of the study, occlusal dentin carious of 25 participants at high risk of caries were removed with hand instruments and microorganisms of the last removed carious dentin were evaluated quantitatively concerning the bacterias playing a major role in caries lesions. The restorations of the teeth were carried out using ART technique with a GIC which has been proven its effectiveness in preventing the caries progression and recurrent caries in the practice of dentistry for many years. After six months, the microbiological assessment was repeated such as baseline. Marginal adaptation and the presence of the gaps in the ART restorations on the replicas created with the impression materials at the baseline and sixth month were investigated under scanning electron microscope. At the end of the study, the teeth were restored by the conventional methods and using composite material.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 19-35 years of age;
  • Good general health;
  • High risk of caries;
  • No evident signs of occlusal parafunctions.
  • Molar tooth;
  • 3-4 mm depth occlusal dentin caries;
  • In occlusion;
  • Proper tooth axes.

排除标准

  • Using regular medication;
  • Pregnancy or lactation;
  • Received radiotherapy or chemotherapy;
  • Tooth clenching, bruxism.
  • Spontaneous pain;
  • Radiographic alterations in the periapical region;
  • Presence of tooth mobility;
  • Previously restored;
  • Broken and/ or cracked.

结局指标

主要结局

Evaluation of microbiological parameters

时间窗: 6 months

Change at the counts of microorganisms

Microscopic analyses of the marginal gap formation

时间窗: 6 months

Change at the marginal integrity of restorations

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

Meltem Tekbas Atay

Project manager

Istanbul University

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