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DPBRN Persistent Pain and Root Canal Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01201668
First Posted: September 14, 2010
Last Update Posted: September 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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, MN
Information provided by (Responsible Party):
Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network
  Purpose
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
Root Canal Therapy Persistent Tooth Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Persistent Pain and Root Canal Therapy

Further study details as provided by Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network:

Estimated Enrollment: 500
Study Start Date: August 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Persistent Tooth Pain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The participants directly involved in this study are the patients who have sought dental treament in the practitioner-investigators' practices. The practitioner-investigators will be endodontists and general dentists.
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201668


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0007
United States, Florida
University of Florida College of Dentistry
Gainesville, Florida, United States, 32610
United States, Minnesota
Health Partners Dental Group
Minneapolis, Minnesota, United States, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55440-1524
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Permanente Denrtal Associates
Portland, Oregon, United States, 97232
Denmark
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, MN
Investigators
Principal Investigator: Donald R Nixdorf, DDS, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
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     History of Changes
Other Study ID Numbers: 133265
U01DE016747 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2010
First Posted: September 14, 2010
Last Update Posted: September 20, 2011
Last Verified: September 2011

Keywords provided by Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network:
post-operative pain
root canal therapy
feasibility
post-surgical persistent pain