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临床试验/NCT05462808
NCT05462808已完成2 期

ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars

Esra Oz1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Hall technique

研究概览

简要总结

Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.

详细描述

Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.

The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.

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
Single (Participant)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children with no systemic disease,
  • children who had a Frankl Behavioral Scale score 2,
  • children who have no occlusal problems or bad habits,
  • children presenting between 2-5 caries lesion in primary molars.

排除标准

  • teeth with presence of radyolusens in furcation and/or periradicular areas,
  • teeth with pathologic resorption and internal/external resorption

研究组 & 干预措施

Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement

Experimental

Under cotton roll isolation, teeth were restored with EQUIA Forte cement. A layer of EQUIA Forte Coat was applied with a microbrush on surface and then light cured for 20 s

干预措施: High viscosity glass ionomer cement (Drug)

restorations with Hall technique

Experimental

In the Hall technique group, the deposits on the occlusal surface of the teeth were gently removed, SSC (3M ESPE, St. Paul, USA) was placed and were cemented using GIC. The crown was pressed tightly.

干预措施: Stainless steel crown (Device)

结局指标

主要结局

Hall technique

时间窗: up to 18 months

The restorations were scored as Alpha (A), clinically ideal restoration ''successful''; Bravo (B), clinically ''acceptable''; Charlie (C), clinically unacceptable restoration ''unsuccessful''. Outcomes criteria for assessment of the Hall Technique were made according to Innes et al.

次要结局

  • Atraumatic restorative treatment(up to 18 months)

研究者

发起方
Esra Oz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Esra Oz

Pediatric department

Suleyman Demirel University

研究点 (1)

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