An observational study in Dental Pulp Disease, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 16 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-22.
Sponsored by The University of Texas Health Science Center at San Antonio · Observational
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.
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.
125 studies on the registry are indexed under Dental Pulp Diseases; 38 are open to participants now.
This study's enrollment of 250 is above the median of 128 across 20 observational studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
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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.
Exclusion Criteria:
Normal molar teeth
Painful molar teeth
Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth.
Ex vivo lab bench study utilizing extracted human teeth.
Time frame: Immediately following extration of the tooth.
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.
Time frame: Immediately following extraction of tooth.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio