NCT00575263

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

9.7 years

First QC Date

December 15, 2007

Last Update Submit

September 21, 2015

Conditions

Dental Pulp Disease

Keywords

Pain, Sodium Channel, Dental pulp

Outcome Measures

Primary Outcomes (1)

  • Sodium Channel (NaCh) expression in nerves of normal teeth compared to diseased teeth.

    Ex vivo lab bench study utilizing extracted human teeth.

    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.

    Immediately following extraction of tooth.

Study Arms (2)

Normal Teeth

Normal molar teeth

painful teeth

Painful molar teeth

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • individuals 16-80 years old
  • normal third molar(wisdom)teeth
  • painful, diseased teeth requiring extraction

You may not qualify if:

  • individuals under age 16 or above age 80
  • pregnant females
  • prisoners
  • nonvital painful teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center, San Antonio Dental School

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Extracted teeth including pulpal tissue

MeSH Terms

Conditions

Dental Pulp DiseasesPain

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael A. Henry, DDS, PhD

    University of Texas Health Science Center at San Antonio, TX

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Dept. of Endodontics

Study Record Dates

First Submitted

December 15, 2007

First Posted

December 18, 2007

Study Start

January 1, 2006

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

US(1)