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DPBRN Peri-operative Pain and Root Canal Therapy

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ClinicalTrials.gov Identifier: NCT01201681
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to identify pre-operative factors that put patients at greater risk of developing severe tooth pain following root canal therapy, thereby providing evidence that will allow dentists to act preventively to lessen this risk, improve pain control, increase their patients' quality of life, and decrease the number of dental emergency interactions.

A parallel goal of this study is to assess the feasibility of recruiting dentists that provide root canal therapy and patients using the DPBRN.

Condition or disease
Post-operative Tooth Pain Root Canal Therapy

Detailed Description:

Goals for this study is to:

  • Assess the frequency and intensity of pre-operative pain
  • Evaluate the occurence and intensity of intra-operative pain
  • Evaluate the occurence and intensity of post-operative pain
  • Assess the interference of persistent tooth pain with daily life
  • Identify a limited set of risk factors related to the development of post-operative pain.

Study Design

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peri-operative Pain and Root Canal Therapy
Study Start Date : July 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011
Groups and Cohorts

Post-operativeTooth Pain

Outcome Measures

Eligibility Criteria

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 patients who have sought dental treatment in the practitioner-investigators' practices. The practitioner-investigators will be endodontists and general dentists.

Inclusion Criteria:

  • 19-70 years old
  • permanent adult tooth requiring it 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 performed 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, since another study plans to obtain data of these patients at that time (DPBRN Persistent Tooth Pain)
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): NCT01201681

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
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 Florida
University of Copenhagen
University of Alabama at Birmingham
University of Minnesota, MN
Principal Investigator: Donald R Nixdorf, DDS, MS University of Minnesota - Clinical and Translational Science Institute
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregg H. Gilbert, DDS, MBA, FAAHD, Professor and Chair, General Dental Sciences, Dental Practice-Based Research Network
ClinicalTrials.gov Identifier: NCT01201681     History of Changes
Other Study ID Numbers: 133266
U01DE016747 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2010    Key Record Dates
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
intra-operative pain
root canal therapy
post-surgical persistent pain