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Clinical Trials/NCT00223366
NCT00223366
Completed
Not Applicable

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 site in 1 country2,007 target enrollmentOctober 2001
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
The University of Texas Health Science Center at San Antonio
Enrollment
2007
Locations
1
Primary Endpoint
Effects of inflammation in periradicular tissues.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
May 19, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kenneth Hargreaves

Chair, Dept. of Endodontics

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Effects of inflammation in periradicular tissues.

Time Frame: 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.

Secondary Outcomes

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

Study Sites (1)

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