跳至主要内容
临床试验/NCT02778503
NCT02778503已完成不适用

Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs: a Randomized Controlled Trial

Faculty Sao Leopoldo Mandic Campinas2 个研究点 分布在 1 个国家目标入组 574 人开始时间: 2016年4月1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
574
试验地点
2
主要终点
Restoration survival

研究概览

简要总结

Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental caries, applying the partial caries tissue removal philosophy using hand instruments, relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and avoiding local anesthesia. The chosen material for this study will be the High Viscosity Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its applicability in challenging clinical situations where other materials would not be adequate. Although there are substantial evidences regarding GIC properties, information about GIC (with different costs) longevity is still weak. Therefore, the objective of this study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated dentine carious lesions in primary and permanent molars. This will be a multicenter randomized controlled double-blind (patient and operator) clinical trial performed with 680 primary and/or permanent molars in children between 4 and 9 years old presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be considered as the unit sample, which will be randomly allocated to the groups through a generated random list numbers and distributed in dark sealed envelopes opened only by dental assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.

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
4 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with at least one primary and/or permanent molar with dentine carious lesion in the occlusal and/or occlusal-proximal surface.

排除标准

  • Special need patients, subjects under orthodontic treatment and/or systemically compromised.
  • Teeth with restorations, sealants, developmental defects, deep carious lesions with pulpal exposure risk, fistula and/or abscess, and those with history of spontaneous pain.

结局指标

主要结局

Restoration survival

时间窗: 12 months

The restoration will be classified according to the scores described by Frencken et al. (1994) and Roeleveld et al. (2006).

次要结局

  • Impact on children's quality of life(Baseline and 12 months)
  • Children self-reported discomfort(Baseline)
  • Caries lesions progression(Every 6 months up to 12 months)
  • Cost-effectiveness(Through study completion (12 months))

研究者

发起方
Faculty Sao Leopoldo Mandic Campinas
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Carlos P Imparato

PhD, Senior Lecturer

Faculty Sao Leopoldo Mandic Campinas

研究点 (2)

Loading locations...

相似试验