Sodium Channel Expression in Human Teeth

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by The University of Texas Health Science Center at San Antonio
Sponsor:
Information provided by (Responsible Party):
Michael Henry, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00575263
First received: December 15, 2007
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

The human tooth pulp has many nerve fibers and is a common source of pain. This study examines nerve fibers within normal and painful samples and identifies changes that can contribute to the generation of pain.


Condition
Dental Pulp Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sodium Channel Expression in Human Teeth

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

Primary Outcome Measures:
  • Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth. [ Time Frame: Immediately following extration of the tooth. ] [ Designated as safety issue: No ]
    Ex vivo lab bench study utilizing extracted human teeth.


Secondary Outcome Measures:
  • Vanilloid receptor subtype-1 (VR1) and cold-and menthol-sensitive receptor-1(CMR1) expression in normal vs diseased teeth. [ Time Frame: Immediately following extraction of tooth. ] [ Designated as safety issue: No ]
    Ex vivo bench lab study utilizing extracted human teeth.


Biospecimen Retention:   Samples Without DNA

Extracted teeth including pulpal tissue


Estimated Enrollment: 500
Study Start Date: January 2006
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal Teeth
Normal molar teeth
painful teeth
Painful molar teeth

Detailed Description:

The human tooth pulp is a rich source of pain fibers and is a common site of pathology that is often accompanied by spontaneous and stimulus-induced lingering pain. A common treatment modality includes the extraction of the offending tooth diagnosed with irreversible pulpitis. Extracted teeth represent an abundant source of normal and diseased human nociceptors and the evaluation of these tissues represents a powerful model to study human pain mechanisms since the character of pain, pain levels, and response to stimuli can be documented prior to extraction.

The overall objective of this study is to correlate changes in the expression of Sodium Channels (NaCh) with clinical responses to hot and cold thermal stimuli, and the expression of the associated receptors/transducers responsible for receiving that stimulus in extracted teeth with severe and spontaneous pain. Teeth requiring extraction in the clinical setting will be used for this study.

The research questions are: 1.) To evaluate quantitatively the overall NaCh and Nav 1.3, 1.6, 1.7, 1.8 1.9 isoform expressions in nerves of normal teeth as compared to diseased teeth 2.) To evaluate quantitatively hot/cold VR1 and CMR1 receptor expression in nerves of normal teeth as compared to the nerves in the modality-specific pain groups of diseased teeth 3.) To investigate the ultrastructural localization of NaCh isoforms in different fiber types and at sites that may be involved in pain generation.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy patients presenting to the dental clinic with an indication for extraction of their normal third molar(wisdom) teeth or diseased teeth that are associated with pain.

Criteria

Inclusion Criteria:

  • individuals 16-80 years old
  • normal third molar(wisdom)teeth
  • painful, diseased teeth requiring extraction

Exclusion Criteria:

  • individuals under age 16 or above age 80
  • pregnant females
  • prisoners
  • nonvital painful teeth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575263

Contacts
Contact: Michael A Henry, DDS, PhD 210-567-0877 henrym2@uthscsa.edu
Contact: Erin Locke, RN,BSN 210-567-0895 locke@uthscsa.edu

Locations
United States, Texas
University of Texas Health Science Center, San Antonio Dental School Recruiting
San Antonio, Texas, United States, 78229
Contact: Michael A Henry, DDS,PhD    210-567-0877    henrya2@uthscsa.edu   
Contact: Lola Miranda    210-567-0873    MirandaM4@uthscsa.edu   
Principal Investigator: Michael A Henry, DDS, PhD         
Sub-Investigator: Erin Locke, BSN, RN         
Sub-Investigator: Rock Levinson, PhD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Michael A. Henry, DDS, PhD University of Texas Health Science Center at San Antonio, TX
  More Information

No publications provided

Responsible Party: Michael Henry, Professor, Dept. of Endodontics, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00575263     History of Changes
Other Study ID Numbers: HSC20060051H
Study First Received: December 15, 2007
Last Updated: August 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center at San Antonio:
Pain, Sodium Channel, Dental pulp

Additional relevant MeSH terms:
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 19, 2014