Sodium Channel Expression in Human Teeth

NCT ID: NCT00575263

Last Updated: 2015-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2015-09-30

Brief 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.

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.

Conditions

Dental Pulp Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Normal Teeth

Normal molar teeth

No interventions assigned to this group

painful teeth

Painful molar teeth

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Michael Henry

Professor, Dept. of Endodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael A. Henry, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center at San Antonio, TX

Locations

University of Texas Health Science Center, San Antonio Dental School

San Antonio, Texas, United States

Countries

United States

Other Identifiers

HSC20060051H

Identifier Type: -

Identifier Source: org_study_id