DPBRN Peri-operative Pain and Root Canal Therapy

This study has been completed.
Sponsor:
Collaborators:
HealthPartners Institute for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
University of Florida
University of Copenhagen
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network
ClinicalTrials.gov Identifier:
NCT01201681
First received: September 13, 2010
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

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
Post-operative Tooth Pain
Root Canal Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peri-operative Pain and Root Canal Therapy

Further study details as provided by Dental Practice-Based Research Network:

Estimated Enrollment: 500
Study Start Date: July 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post-operativeTooth Pain

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.
  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201681

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
HealthPartners Institute for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
University of Florida
University of Copenhagen
University of Alabama at Birmingham
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Donald R Nixdorf, DDS, MS University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
No publications provided

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
Study First Received: September 13, 2010
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Dental Practice-Based Research Network:
Post-operative pain
intra-operative pain
root canal therapy
feasibility
post-surgical persistent pain

ClinicalTrials.gov processed this record on September 18, 2014