DPBRN Peri-operative Pain and Root Canal Therapy

Root Canal Therapy Clinical Trial

Official title:

Peri-operative Pain and Root Canal Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201681
• Other study ID #: 133266
• Secondary ID: U01DE016747
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: September 16, 2011
• Start date: July 2010
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Dental Practice-Based Research Network
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Post-operative Tooth Pain
• Root Canal Therapy

Locations

Country	Name	City	State
Denmark	University of Copenhagen Royal Dental College	Copenhagen
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Florida College of Dentistry	Gainesville	Florida
United States	Health Partners Dental Group	Minneapolis	Minnesota
United States	Health Partners Research Foundation	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Kaiser Permanente Center for Health Research	Portland	Oregon
United States	Permanente Denrtal Associates	Portland	Oregon

Sponsors (9)

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

Countries where clinical trial is conducted

United States,  Denmark, 

External Links

•   Dental Practice-Based Research Network
•   Dental Practice-Based Research Network