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Cytokine Regulation of Periradicular Pain in Humans

This study is ongoing, but not recruiting participants.

Sponsored by: The University of Texas Health Science Center at San Antonio
Information provided by: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00223470
  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

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, 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

Biospecimen Description:

Sterile paper points are placed in the canal for 30 seconds


Estimated Enrollment:   33
Study Start Date:   October 2002
Estimated Study Completion Date:   June 2008

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

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     University of Texas    
  More Information


Responsible Party:   University of Texas Health Science Center San Antonio ( Asma Khan, DDS, PhD )
Study ID Numbers:   012-1904-455, DE 14864-01A1S1
First Received:   September 13, 2005
Last Updated:   December 15, 2007
ClinicalTrials.gov Identifier:   NCT00223470
Health Authority:   United States: Food and Drug Administration

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

Study placed in the following topic categories:
Mouth Diseases
Periodontal Diseases
Periodontitis
Periapical Diseases
Pain
Stomatognathic Diseases
Periapical Periodontitis

Additional relevant MeSH terms:
Jaw Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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