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DPBRN Persistent Pain and Root Canal Therapy

Sponsor
Dental Practice-Based Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT01201668
Collaborator
National Institute of Dental and Craniofacial Research (NIDCR) (NIH), HealthPartners Institute (Other), Kaiser Permanente (Other), Permanente Dental Associates Group, Oregon (Other), University of Copenhagen (Other), University of Florida (Other), University of Alabama at Birmingham (Other), University of Minnesota (Other)
500
Enrollment
8
Locations
13
Duration (Months)
62.5
Patients Per Site
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN "Peri-operative tooth pain" study. This study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the DPBRN "Peri-operative tooth pain" study.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Persistent Pain and Root Canal Therapy
    Study Start Date :
    Aug 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2011
    Actual Study Completion Date :
    Sep 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Persistent Tooth Pain

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      19 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:

      • 19-70 years old

      • Permanent adult tooth requiring its first non-surgical root canal therapy

      • patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure will be included to avoid problems of correlation within patients

      Exclusion Criteria:

      • evidence of prior root canal therapy, including iatrogenic, but not disease-induced pulp access of the tooth being considered

      • patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia,mental disability)

      • patients unable to return for 6 month follow-up

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Alabama at Birmingham Birmingham Alabama United States 35294-0007
      2 University of Florida College of Dentistry Gainesville Florida United States 32610
      3 Health Partners Dental Group Minneapolis Minnesota United States 55440-1309
      4 Health Partners Research Foundation Minneapolis Minnesota United States 55440-1524
      5 University of Minnesota Minneapolis Minnesota United States 55455
      6 Kaiser Permanente Center for Health Research Portland Oregon United States 97227
      7 Permanente Denrtal Associates Portland Oregon United States 97232
      8 University of Copenhagen Royal Dental College Copenhagen Denmark

      Sponsors and Collaborators

      • Dental Practice-Based Research Network
      • National Institute of Dental and Craniofacial Research (NIDCR)
      • HealthPartners Institute
      • Kaiser Permanente
      • Permanente Dental Associates Group, Oregon
      • University of Copenhagen
      • University of Florida
      • University of Alabama at Birmingham
      • University of Minnesota

      Investigators

      • Principal Investigator: Donald R Nixdorf, DDS, MS, University of Minnesota

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      Gregg H. Gilbert, DDS, MBA, FAAHD, Professor and Chair, Department of General Dental Sciences, Dental Practice-Based Research Network
      ClinicalTrials.gov Identifier:
      NCT01201668
      Other Study ID Numbers:
      • 133265
      • U01DE016747
      First Posted:
      Sep 14, 2010
      Last Update Posted:
      Sep 20, 2011
      Last Verified:
      Sep 1, 2011
      Keywords provided by Gregg H. Gilbert, DDS, MBA, FAAHD, Professor and Chair, Department of General Dental Sciences, Dental Practice-Based Research Network
      post-operative pain
      root canal therapy
      feasibility
      post-surgical persistent pain
      Additional relevant MeSH terms:
      Toothache

      Study Results

      No Results Posted as of Sep 20, 2011