- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575263
Sodium Channel Expression in Human Teeth
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78229
- University of Texas Health Science Center, San Antonio Dental School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Normal Teeth
Normal molar teeth
|
painful teeth
Painful molar teeth
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately following extration of the tooth.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately following extraction of tooth.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael A. Henry, DDS, PhD, University of Texas Health Science Center at San Antonio, TX
Study record dates
Study Major Dates
Study Start
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 (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20060051H
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.
Clinical Trials on Dental Pulp Disease
-
University of SulaimaniCompletedPulp Disease, Dental | Pulp MummificationIraq
-
Hacettepe UniversityRecruitingPulp Disease, Dental | Dental Caries Extending to PulpTurkey
-
British University In EgyptRecruiting
-
Ain Shams UniversityNot yet recruitingPulp Disease, Dental
-
Universitat Internacional de CatalunyaRecruitingPulp Disease, DentalSpain
-
Minia UniversityActive, not recruiting
-
Minia UniversityNot yet recruitingPulp Disease, Dental
-
Cairo UniversityUnknownPulp Disease, DentalEgypt
-
Cairo UniversityCompleted
-
National University Health System, SingaporeCompletedPulpitis | Pulp Exposure, Dental | Pulp and Periapical Tissue Disease