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临床试验/NCT03785769
NCT03785769撤回不适用

Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement

Universidade Ibirapuera2 个研究点 分布在 1 个国家开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Survival of restorations

研究概览

简要总结

The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques

入排标准

年龄范围
4 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with carious lesion of occlusoproximais in primary molars

排除标准

  • Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
  • Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

结局指标

主要结局

Survival of restorations

时间窗: 24 months

Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.

次要结局

  • Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration(Immediately after the restoration and 24 months)
  • Cost-efficacy(24 months.)
  • Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale(Immediately after the treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tamara Kerber Tedesco

Principal investigator

Universidade Ibirapuera

研究点 (2)

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