NCT01201681

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

1.2 years

First QC Date

September 13, 2010

Last Update Submit

September 16, 2011

Conditions

Post-operative Tooth PainRoot Canal Therapy

Keywords

Post-operative painintra-operative painroot canal therapyfeasibilitypost-surgical persistent pain

Study Arms (1)

Post-operativeTooth Pain

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

University of Florida College of Dentistry

Gainesville, Florida, 32610, United States

Location

Health Partners Dental Group

Minneapolis, Minnesota, 55440-1309, United States

Location

Health Partners Research Foundation

Minneapolis, Minnesota, 55440-1524, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Kaiser Permanente Center for Health Research

Portland, Oregon, 97227, United States

Location

Permanente Denrtal Associates

Portland, Oregon, 97232, United States

Location

University of Copenhagen Royal Dental College

Copenhagen, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 26335907DERIVED

  • 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.

    PMID: 25355775DERIVED

  • 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.

    PMID: 25190605DERIVED

Related Links

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Donald R Nixdorf, DDS, MS

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, General Dental Sciences

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

July 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

DK(1)US(7)