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临床试验/NCT01924611
NCT01924611已完成不适用

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.

Federal University of Paraíba2 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2004年9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
232
试验地点
2
主要终点
Number of teeth with fractured restorations.

研究概览

简要总结

AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

详细描述

To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Children of both genders enrolled in school,
  • Children aged between 6 and 7 years,
  • having cavity with access to ART hand instruments,
  • cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
  • proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

排除标准

  • Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
  • Children out of the age range,

结局指标

主要结局

Number of teeth with fractured restorations.

时间窗: 2 years

The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

次要结局

未报告次要终点

研究者

发起方
Federal University of Paraíba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thiago Saads Carvalho

Principal Investigator

Federal University of Paraíba

研究点 (2)

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