Cytokine Regulation of Periradicular Pain in Humans
This study has been completed.
Sponsor:
The University of Texas Health Science Center at San Antonio
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | March 7, 2012 | ||||
| Start Date ICMJE | October 2002 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00223470 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cytokine Regulation of Periradicular Pain in Humans | ||||
| Official Title ICMJE | 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 |
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| 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 |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Sterile paper points are placed in the canal for 30 seconds |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients presenting to the Endodontics department with an indication for root canal treatment |
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| Condition ICMJE | Chronic Apical Periodontitis of Pulpal Origin | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 9 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 16 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00223470 | ||||
| Other Study ID Numbers ICMJE | 012-1904-455, K23DE014864-01A1S1 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | The University of Texas Health Science Center at San Antonio | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center at San Antonio | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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