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Cytokine Regulation of Periradicular Pain in Humans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00223470
First Posted: September 22, 2005
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis

Condition
Chronic Apical Periodontitis of Pulpal Origin

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cytokine Regulation of Periradicular Pain in Humans

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Biospecimen Retention:   Samples Without DNA
Sterile paper points are placed in the canal for 30 seconds

Enrollment: 9
Study Start Date: October 2002
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:
This study evaluates whether periradicular exudate concentrations of cytokines differ in patients experiencing pain and mechanical allodynia due to pulpal necrosis with an acute exacerbation of a chronic apical periodontitis, as compared to patients with pulpal necrosis with chronic apical periodontitis, but no pain or mechanical allodynia
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the Endodontics department with an indication for root canal treatment
Criteria

Inclusion Criteria:

  1. Patient must be at least 16 years of age.
  2. Clinical indication for Non-Surgical Root Canal Therapy (NSRCT).
  3. 1st or 2nd maxillary or mandibular molar
  4. Diagnosis must be Chronic Apical Periodontitis (CAP) with or without symptoms.
  5. Intact, mature apices.
  6. ASA I or II

Exclusion Criteria:

  1. Failure to meet any of the above
  2. Previous NSRCT
  3. Previous pulpotomy or pulpectomy
  4. Suppurative apical periodontitis
  5. Patients taking medications which can affect their pain rating or medications which effect their immune system ( such as glucocorticoids)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223470


Locations
United States, Texas
Univerity of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
National Institutes of Health (NIH)
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Asma A Khan, BDS, PhD The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223470     History of Changes
Other Study ID Numbers: 012-1904-455
K23DE014864-01A1S1 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 22, 2005
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by The University of Texas Health Science Center at San Antonio:
pain

Additional relevant MeSH terms:
Periodontitis
Periapical Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periapical Diseases
Jaw Diseases