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临床试验/NCT00223366
NCT00223366已完成不适用

Studies on Normal and Inflamed Dental Pulp, NPY Regulation of Peripheral Human Nociceptors, Peripheral Mechanisms of Opioid Analgesia, Cannabinoid-induced Desensitization of TRPV1 Receptors Adrenergic Modulation of Trigeminal Nociceptors

The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 2,007 人开始时间: 2001年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,007
试验地点
1
主要终点
Effects of inflammation in periradicular tissues.

研究概览

简要总结

This protocol is for a number of in vitro studies using human surgical biopsies and evaluating the pharmacology and genetics of human nociceptors ("pain detecting") neurons

详细描述

Purpose/Objectives

a. Specific Aims Specific Aim 1: Characterize in humans the effects of inflammation and neuronal degeneration on peripheral levels of NPY, and related Y receptors (Y1, Y2, Y5) in periradicular tissue.

Specific Aim 2: Determine whether NPY inhibits neurosecretion from peripheral terminals of capsaicin-sensitive neurons innervating normal versus inflamed tissue.

Specific Aim 3: Determine whether peripheral administration of NPY is analgesic and/or anti-allodynic in patients experiencing spontaneous pain and mechanical allodynia in a clinical model of inflammation with associated neuronal degeneration.

Specific Aim 4: Evaluate whether population characteristics are associated with altered pain reports. First, we will determine whether patients with the C1128 single nucleotide polymorphism (SNP) of the PreProNPY gene, whose phenotype confers substantially augmented peripheral NPY neurosecretion, report less pain compared with patients without this genetic polymorphism. Second, we will determine whether ethnic/cultural factors associated with an underserved minority population (Hispanics in the San Antonio area) are associated with altered pain reports.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Willingness to participate; identified indication to have a tooth extraction; 16-90 years old; diagnosis of normal pulp; or diagnosis of irreversible pulpitis requiring a symptom of spontaneous pain and positive and lingering response to pulp vitality test.

排除标准

  • History of taking steroids within the last month; history of taking analgesics in the last four hours.

结局指标

主要结局

Effects of inflammation in periradicular tissues.

时间窗: Immediately following tooth extraction and dental pulp procurement.

Extracted human teeth are sectioned to obtain the crown dental pulp which is placed in a well plate. The pulp is moved every twenty minutes through proprietary substances for a total of 60 to 120 minutes depending on the specific experiment. After each 20 minute fraction, the buffer solution in each well plate is collected, labeled and placed in the -80 freezer along with the pulp sample.

次要结局

  • Altered pain reports.(24 hour post-tooth extraction.)

研究者

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

Kenneth Hargreaves

Chair, Dept. of Endodontics

The University of Texas Health Science Center at San Antonio

研究点 (1)

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