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临床试验/NCT02494193
NCT02494193已完成不适用

Indirect Pulp Capping With Resin Modified Glass Ionomer: a Randomized Controled Clinical Trial

Universidade Federal de Sergipe2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2015年6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
112
试验地点
2
主要终点
Tooth vitality - analysis for positive or negative response

研究概览

简要总结

In deep carious lesions, presenting risk of pulp exposition, a treatment option is the partial caries removal of carious tissue followed by provisional restoration, while this approach is called indirect pulp capping. The aim of this double-blinding controlled randomized clinical trial is to evaluate the success of indirect pulp capping using only resin-modified glass ionomer, while the additional layer of calcium hydroxide was used as control. The sample of 112 molars and/or premolars (n=56), presenting deep carious lesions, from patients with age between 15 and 30 years treated in dental clinic at Department of Dentistry of Federal University of Sergipe. The selected carious lesions must be reached 2/3 of dentin, observed in bite-wing radiography, without pulp involving and/or other factor that to compromise the evaluation. After detailed anamneses, the selected teeth will be radiographed e all carious tissue from surrounding walls will be removed. At the floor of cavity, the carious tissue will be partially removed using hand dentin excavators, remaining the caries-affected dentin and avoiding the pulp exposition. The removed carious tissue from the floor of cavity will be evaluated for presence of Lactobacilos e Estreptococos Mutans, while the remaining dentin will be evaluated for consistency, colour and humidity. Randomly, the cavity will be provisionally restored with: Control - dress and cement of calcium hydroxide followed resin-modified glass ionomer; or Experimental - only resin-modified glass ionomer. The distance between the base of restoration and the pulp cavity cap will be measured by bitw-wing radiography. The patients will be re-evaluated after 15 days, while the teeth with compromised pulp vitality will be excluded from the study. The remaining patients will be evaluated after 6 months. The distance between the base of restoration and the pulp cavity cap will be measured again, followed by provisional restoration removal. The remaining caries-affected dentin from floor of cavity will be fully removed and a bacteriological evaluation performed. The consistency, colour and humidity of this tissue will be evaluated too. Finally, the permanent restorations will performed.

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
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Molars and pre-molars presenting carious lesions involving 2/3 inner of dentin tissue.

排除标准

  • Teeth presenting signs of irreversible pulpits or necrose, cervical lesion and/or root exposition, or with carious lesion reaching the pulp.

结局指标

主要结局

Tooth vitality - analysis for positive or negative response

时间窗: 2 months after placement of provisional restoration

次要结局

  • Counting of Lactobacillus spp colonies - number of colony-forming units (CFUs)(Immediately after caries removal)
  • Coloration of dentin tissue - scores of 1 (clear yellow) to 5 (darkd)(Immediately after caries removal)
  • Consistency of dentin tissue - scores of 1 (softned) to 4 (hard)(Immediately after caries removal)
  • Counting of Streptococcus mutans colonies - number of colony-forming units (CFUs)(Immediately after caries removal)

研究者

发起方
Universidade Federal de Sergipe
申办方类型
Other
责任方
Principal Investigator
主要研究者

André Luis Faria e Silva

Dr.

Universidade Federal de Sergipe

研究点 (2)

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