Cytokine Regulation of Periradicular Pain in Humans

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00223470
First received: September 13, 2005
Last updated: March 7, 2012
Last verified: March 2012
  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

Ages Eligible for Study:   16 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Asma A Khan, BDS, PhD The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

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
Study First Received: September 13, 2005
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 30, 2014