DPBRN Peri-operative Pain and Root Canal Therapy

Sponsor

Dental Practice-Based Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT01201681

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR) (NIH), HealthPartners Institute (Other), Kaiser Permanente (Other), Permanente Dental Associates Group, Oregon (Other), University of Florida (Other), University of Copenhagen (Other), University of Alabama at Birmingham (Other), University of Minnesota (Other)

500

Enrollment

Locations

Duration (Months)

62.5

Patients Per Site

4.5

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Peri-operative Pain and Root Canal Therapy

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Post-operativeTooth Pain

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-0007
2	University of Florida College of Dentistry	Gainesville	Florida	United States	32610
3	Health Partners Dental Group	Minneapolis	Minnesota	United States	55440-1309
4	Health Partners Research Foundation	Minneapolis	Minnesota	United States	55440-1524
5	University of Minnesota	Minneapolis	Minnesota	United States	55455
6	Kaiser Permanente Center for Health Research	Portland	Oregon	United States	97227
7	Permanente Denrtal Associates	Portland	Oregon	United States	97232
8	University of Copenhagen Royal Dental College	Copenhagen		Denmark