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临床试验/NCT01066533
NCT01066533终止4 期

Histologic and Immunohistochemical Study of Fibronectin and Tenascin in Human Teeth Pulp Capped With MTA and NEC

Mashhad University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2009年10月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
终止
入组人数
32
试验地点
1
主要终点
histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer

研究概览

简要总结

The purpose of this study is to evaluate the response of human dental pulp to capping with MTA and NEC by histology and immunohistochemistry, using fibronectin and tenascin as markers, following 2 weeks and 8 weeks.

详细描述

Capping of the exposed pulp is indicated for reversible pulp tissue injury after physical or mechanical trauma in developing or mature teeth.The response to direct pulp capping with materials such as MTA or NEC is the formation of dentin barrier, resulting from the recruitment and proliferation of undifferentiated cells.

Different materials can be used to induce dentinal bridge formation.MTA has been introduced as a proper material to induce dentinal bridge formation,with greater mean thickness of dentinal bridge and less inflammation compared to traditional materials like calcium hydroxide. Although biocompatible, MTA has a poor handling characteristic, delay setting time, off-white color, and it is almost expensive.The Novel Endodontic Cement (NEC) has been introduced to combine reasonable characteristics of MTA with appropriate chemical properties, setting time, color, and handling characteristics.

The extracellular matrix (ECM) of pulp comprises a variety of proteins and polysaccharides, forming a neat network. The ECM components can induce either reactionary or reparative dentin formation. Fibronectin (FN) and tenascin (TNC) are the two major glycoproteins involved in wound healing and odontogenesis.

Fibronectins (FNs) are a class of high molecular weight adhesive proteins composed of two very large subunits. It has a variety of cell functions, such as adhesion, migration, growth, and differentiation. Furthermore FN may be involved in the polarization and migration of odontoblasts.

Tenascin is a large oligomeric glycoprotein of the ECM secreted by fibroblasts and glial cells in tissue cultures. It has also been identified in pulp and more prominent in dentinogenesis. TN has been shown to be important in the differentiation of odontoblasts. Therefore, it may be associated with secondary dentin formation, when pulp cells differentiate into odontoblasts in response to physiologic stimuli.

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 (Care Provider, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •patients 16-30 year-old
  • •patients with no systemic disease
  • •vital mature teeth with closed apex, no caries either clinically or radiographically, and without any restoration
  • •patients willing to participate in study

排除标准

  • •patients not in the range of 16-30 year-old
  • •patients with systemic disease
  • •nonvital teeth
  • •open apex teeth
  • •teeth with caries or restorations
  • •patients not willing to participate in study

研究组 & 干预措施

Mineral Trioxide Aggregate(MTA)

Experimental

MTA is a proper material for direct pulp capping,treatment of tooth perforations,root end filling.It is a safe and biocompatible material,which can induce cementum formation on root surface.In direct pulp capping, MTA can induce dentinal bridge formation on the expose surface to preserve pulp vitality.Although MTA has superior biocompatibility compared with the conventional materials,it has a delayed setting time, poor handling characteristics and off-white color

干预措施: direct pulp capping and covering the exposed pulp (Other)

NEC cement

Experimental

NEC cement is a proper material for direct pulp capping and treatment of tooth perforation. It is a new dental material that combines reasonable biocompatibility of MTA with appropriate setting time,handling characteristics,chemical properties and color.Like MTA, NEC cement can induce dentinal bridge formation in direct pulp capping to preserve pulp vitality.

干预措施: direct pulp capping and covering the exposed pulp (Other)

结局指标

主要结局

histologic study of: 1-mean thickness of formed dentinal bridge 2-morphology of formed dentinal bridge 3-intensity of pulp inflammation 4-odontoblastic layer

时间窗: 2 weeks and 8 weeks

次要结局

  • expression of Fibronectin and Tenascin by immunohistochemistry on a scale of 1 to 3: (a) 1 equals no staining; (b) 2 equals light-medium staining; (c) 3 equals medium-heavy staining for the marker(2 weeks and 8 weeks)

研究者

申办方类型
Other

研究点 (1)

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