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

This study is currently recruiting participants.
Verified January 2014 by The University of Texas Health Science Center at San Antonio
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Kenneth Hargreaves, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223366
First received: September 13, 2005
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Effects of inflammation in periradicular tissues. [ Time Frame: Immediately following tooth extraction and dental pulp procurement. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Altered pain reports. [ Time Frame: 24 hour post-tooth extraction. ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

Whole blood, serum, sputum, oral mucosa tissue, teeth


Estimated Enrollment: 2000
Study Start Date: October 2001
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy volunteers between ages 16-90 y.o. presenting to the dental clinics within the University Health Science Center San Antonio for extraction of teeth.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00223366

Contacts
Contact: Kenneth M. Hargreaves, DDS, PhD 210-567-3385 Hargreaves@uthscsa.edu
Contact: Erin Locke, RN, BSN 210-567-0895 Locke@uthascsa.edu

Locations
United States, Texas
The University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Kenneth M. Hargreaves, DDS, PhD    210-567-3385    Hargreaves@uthscsa.edu   
Contact: Erin Locke, RN, BSN    210-567-0895    Locke@uthscsa.edu   
Principal Investigator: Kenneth M. Hargreaves, DDS, PhD         
Sub-Investigator: Karl Keiser, DDS, MS         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Kenneth M. Hargreaves, DDS, PhD University of Texas Health Science Center at San Antonio, Texas
  More Information

No publications provided

Responsible Party: Kenneth Hargreaves, Chair, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223366     History of Changes
Other Study ID Numbers: HSC20020071H, R01NS058655
Study First Received: September 13, 2005
Last Updated: January 31, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Pain in teeth

ClinicalTrials.gov processed this record on April 16, 2014