DPBRN Peri-operative Pain and Root Canal Therapy

Peri-operative Pain and Root Canal Therapy

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.

Study Overview

• Status: Completed
• Conditions: Root Canal Therapy; Post-operative Tooth 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • University of Copenhagen Royal Dental College
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0007
      • University of Alabama at Birmingham
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida College of Dentistry
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55440-1309
      • Health Partners Dental Group
    • Minneapolis, Minnesota, United States, 55440-1524
      • Health Partners Research Foundation
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research
    • Portland, Oregon, United States, 97232
      • Permanente Denrtal Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Post-operativeTooth Pain

Collaborators and Investigators

• Sponsor: Dental Practice-Based Research Network
• Collaborators: University of Alabama at Birmingham; University of Copenhagen; University of Florida; National Institute of Dental and Craniofacial Research (NIDCR); University of Minnesota; HealthPartners Institute; Kaiser Permanente; Permanente Dental Associates Group, Oregon
• Investigators: Principal Investigator: Donald R Nixdorf, DDS, MS, University of Minnesota

Publications and helpful links

General Publications

• Nixdorf DR, Law AS, Lindquist K, Reams GJ, Cole E, Kanter K, Nguyen RHN, Harris DR; National Dental PBRN Collaborative Group. Frequency, impact, and predictors of persistent pain after root canal treatment: a national dental PBRN study. Pain. 2016 Jan;157(1):159-165. doi: 10.1097/j.pain.0000000000000343.
• Law AS, Nixdorf DR, Aguirre AM, Reams GJ, Tortomasi AJ, Manne BD, Harris DR; National Dental PBRN Collaborative Group. Predicting severe pain after root canal therapy in the National Dental PBRN. J Dent Res. 2015 Mar;94(3 Suppl):37S-43S. doi: 10.1177/0022034514555144. Epub 2014 Oct 29.
• Law AS, Nixdorf DR, Rabinowitz I, Reams GJ, Smith JA Jr, Torres AV, Harris DR; National Dental PBRN Collaborative Group. Root canal therapy reduces multiple dimensions of pain: a national dental practice-based research network study. J Endod. 2014 Nov;40(11):1738-45. doi: 10.1016/j.joen.2014.07.011. Epub 2014 Sep 1.

Helpful Links

• Dental Practice-Based Research Network

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): September 20, 2011
• Last Update Submitted That Met QC Criteria: September 16, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: feasibility; Post-operative pain; root canal therapy; intra-operative pain; post-surgical persistent pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache
• Other Study ID Numbers: 133266; U01DE016747 (U.S. NIH Grant/Contract)