- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223366
In Vitro Studies on Pharmacological Regulation and Genetic Risk Factors of Peripheral Human Nociceptors
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of inflammation in periradicular tissues.
Time Frame: Immediately following tooth extraction and dental pulp procurement.
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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.
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Immediately following tooth extraction and dental pulp procurement.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Altered pain reports.
Time Frame: 24 hour post-tooth extraction.
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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.
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24 hour post-tooth extraction.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kenneth M. Hargreaves, DDS, PhD, University of Texas Health Science Center at San Antonio, Texas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC20020071H
- R01NS058655 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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