Clinical trial NCT01201681: DPBRN Peri-operative Pain and Root Canal Therapy
Official title: Peri-operative Pain and Root Canal Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-operative Tooth Pain
Root Canal Therapy
Keywords: Post-operative pain
intra-operative pain
root canal therapy
feasibility
post-surgical persistent pain
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: University of Florida
name: University of Copenhagen
name: University of Alabama at Birmingham
name: University of Minnesota
First posted: 2010-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
city: Minneapolis
country: United States
facility: Health Partners Dental Group
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Research Foundation
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: Permanente Denrtal Associates
state: Oregon
city: Copenhagen
country: Denmark
facility: University of Copenhagen Royal Dental College
Study officials:
affiliation: University of Minnesota
name: Donald R Nixdorf, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.