Sodium Channel Expression in Human Teeth
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|ClinicalTrials.gov Identifier: NCT00575263|
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : September 22, 2015
|Condition or disease|
|Dental Pulp Disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||250 participants|
|Observational Model:||Case Control|
|Official Title:||Sodium Channel Expression in Human Teeth|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Normal molar teeth
Painful molar teeth
- Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth. [ Time Frame: Immediately following extration of the tooth. ]Ex vivo lab bench study utilizing extracted human teeth.
- 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. ]Ex vivo bench lab study utilizing extracted human teeth.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575263
|United States, Texas|
|University of Texas Health Science Center, San Antonio Dental School|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Michael A. Henry, DDS, PhD||University of Texas Health Science Center at San Antonio, TX|