Sodium Channel Expression in Human Teeth

Dental Pulp Disease Clinical Trial

Official title:

Sodium Channel Expression in Human Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575263
• Other study ID #: HSC20060051H
• Status: Completed
• Phase: N/A
• First received: December 15, 2007
• Last updated: September 21, 2015
• Start date: January 2006
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dental Pulp Disease
• Dental Pulp Diseases

Locations

Country	Name	City	State
United States	University of Texas Health Science Center, San Antonio Dental School	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth.	Ex vivo lab bench study utilizing extracted human teeth.	Immediately following extration of the tooth.	No
Secondary	Vanilloid receptor subtype-1 (VR1) and cold-and menthol-sensitive receptor-1(CMR1) expression in normal vs diseased teeth.	Ex vivo bench lab study utilizing extracted human teeth.	Immediately following extraction of tooth.	No