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Cytokine Regulation of Periradicular Pain in Humans

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ClinicalTrials.gov Identifier: NCT00223470
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 9, 2012
Sponsor:
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

Tracking Information
First Submitted Date September 13, 2005
First Posted Date September 22, 2005
Last Update Posted Date March 9, 2012
Study Start Date October 2002
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00223470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cytokine Regulation of Periradicular Pain in Humans
Official Title Cytokine Regulation of Periradicular Pain in Humans
Brief Summary This clinical trial evaluates the role of cytokines in patients needing root canal treatment with diagnosis of necrotic pulp and chronic apical periodontitis
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
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Sterile paper points are placed in the canal for 30 seconds
Sampling Method Non-Probability Sample
Study Population Patients presenting to the Endodontics department with an indication for root canal treatment
Condition Chronic Apical Periodontitis of Pulpal Origin
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 7, 2012)
9
Original Enrollment
 (submitted: September 13, 2005)
33
Actual Study Completion Date June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00223470
Other Study ID Numbers 012-1904-455
K23DE014864-01A1S1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The University of Texas Health Science Center at San Antonio
Study Sponsor The University of Texas Health Science Center at San Antonio
Collaborators
  • 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
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date March 2012