Dental Pulp DiseaseNCT00575263
Sodium Channel Expression in Human Teeth
An observational study of Dental Pulp Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Pulp Disease
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- individuals 16-80 years old
- normal third molar(wisdom)teeth
- painful, diseased teeth requiring extraction
Who cannot join
- individuals under age 16 or above age 80
- pregnant females
- prisoners
- nonvital painful teeth
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center, San Antonio Dental School
San Antonio, Texas, 78229
About this study
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.
Read the 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
- Keywords
- Pain, Sodium Channel, Dental pulp
- Medical subject headings
- Dental Pulp Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Teeth | Normal molar teeth | |
| painful teeth | Painful molar teeth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth.
Ex vivo lab bench study utilizing extracted human teeth.
Measured: Immediately following extration of the tooth.
Secondary outcomes (1)
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.
Measured: Immediately following extraction of tooth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startJan 2006
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Henry, The University of Texas Health Science Center at San Antonio
- Investigators
- Michael A. Henry, DDS, PhD, Principal investigator, University of Texas Health Science Center at San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575263
- Sponsor's protocol ID
- HSC20060051H
- Status last verified
- Sep 2015
- First submitted
- 15 Dec 2007
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Channel Expression in Human Teeth
- ClinicalTrials.gov ID
- NCT00575263
- Acronym / sponsor ID
- HSC20060051H
- Conditions
- Dental Pulp Disease
- Keywords
- Pain, Sodium Channel, Dental pulp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Teeth | – | –Normal molar teeth |
| painful teeth | – | –Painful molar teeth |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- individuals 16-80 years old
- normal third molar(wisdom)teeth
- painful, diseased teeth requiring extraction
Key exclusion criteria (4 listed)
- individuals under age 16 or above age 80
- pregnant females
- prisoners
- nonvital painful teeth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Henry, DDS, PhD principal investigator
University of Texas Health Science Center at San Antonio, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Pulp Disease, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth. (time frame: Immediately following extration of the tooth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.