In Vitro Studies on Pharmacological Regulation and Genetic Risk Factors of Peripheral Human Nociceptors

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223366
• Other study ID #: HSC20020071H
• Secondary ID: R01NS058655
• Status: Completed
• Start date: October 2001
• Est. completion date: May 19, 2019

Study information

• Verified date: November 2020
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2007
• Est. completion date: May 19, 2019
• Est. primary completion date: May 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of inflammation in periradicular tissues.	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.	Immediately following tooth extraction and dental pulp procurement.
Secondary	Altered pain reports.	Patients provide perceived pain within the first 24 hours post-extraction via a take-home pain postcard. The postcard has a Visual Analog Scale pain graft that the patient marks and returns via mail.	24 hour post-tooth extraction.