DPBRN Peri-operative Pain and Root Canal Therapy

NCT ID: NCT01201681

Last Updated: 2011-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-operative Tooth Pain Root Canal Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-operativeTooth Pain

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

HealthPartners Institute

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

Permanente Dental Associates Group, Oregon

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

Dental Practice-Based Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Gregg H. Gilbert, DDS, MBA, FAAHD

Professor and Chair, General Dental Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald R Nixdorf, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

University of Florida College of Dentistry

Gainesville, Florida, United States

Site Status

Health Partners Dental Group

Minneapolis, Minnesota, United States

Site Status

Health Partners Research Foundation

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Kaiser Permanente Center for Health Research

Portland, Oregon, United States

Site Status

Permanente Denrtal Associates

Portland, Oregon, United States

Site Status

University of Copenhagen Royal Dental College

Copenhagen, , Denmark

Site Status

Countries

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United States Denmark

References

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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.

Reference Type DERIVED
PMID: 26335907 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25355775 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25190605 (View on PubMed)

Related Links

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http://DPBRN.org

Dental Practice-Based Research Network

Other Identifiers

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U01DE016747

Identifier Type: NIH

Identifier Source: secondary_id

View Link

133266

Identifier Type: -

Identifier Source: org_study_id

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