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临床试验/NCT01680289
NCT01680289Unknown不适用

Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Resin Restorations in Primary Molars - Randomized Controlled Clinical Study.

Universidade Federal do Rio de Janeiro2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Survival rate

研究概览

简要总结

The aim of this study is to determinate the influence of an alternative adhesive application protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in primary molars.

详细描述

Adhesive systems based on total etch technique remains the most popular products among dental practitioners. These systems are based on the use of an acid conditioner to remove the smear layer and demineralize the enamel and dentin. After the removal of the conditioner by rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is applicated over the demineralized tissues. The polymerization of the adhesive monomers into microporosities created by acid conditioning forms the structure knowing as hybrid layer or resin-dentin interdifusion zone. A common problem related to total etch technique is the incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to enzymatic degradation. According to some laboratory studies, consecutive application of multiple adhesive coats results in quantitative and qualitative improvements in dental adhesion. In addition to increasing the values of bond strength to dentin, consecutive application of multiple adhesive layers enhances the infiltration of adehesive monomers through demineralized dentin, resulting in a more homogenous hybrid layer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • Presence of two or more pairs of caries lesions in occlusal or occluso-approximal surfaces of primary molars

排除标准

  • Systemic diseases in which dental treatment is a risk to patient's life
  • Orthodontic appliance
  • Absence of occlusal contact in eligible teeth
  • Signs and symptoms of pulp infflamation or necrosis

结局指标

主要结局

Survival rate

时间窗: 06, 12, 18, 24, 30 and 36 months

Survival rate considering failure of restorations due: partial or complete loss of restorative material; marginal ditching; superficial or marginal discoloration; secondary caries; pulpal complications; wear of restorative material; tooth fracture.

次要结局

  • Marginal adaptation(06, 12, 18, 24, 30 and 36 months)

研究者

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

Marlus Roberto Rodrigues Cajazeira

Assistant Professor

Universidade Federal do Rio de Janeiro

研究点 (2)

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