Post-operative Tooth PainNCT01201681
DPBRN Peri-operative Pain and Root Canal Therapy
An observational study of Post-operative Tooth Pain and Root Canal Therapy, run by Dental Practice-Based Research Network at 8 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Tooth Pain, Root Canal Therapy
- How many people
- 500 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Jul 2010to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
University of Florida College of Dentistry
Gainesville, Florida, 32610
Health Partners Dental Group
Minneapolis, Minnesota, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, 55440-1524
University of Minnesota
Minneapolis, Minnesota, 55455
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Permanente Denrtal Associates
Portland, Oregon, 97232
About this study
Official title: Peri-operative Pain and Root Canal Therapy
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.
Read the 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.
- Conditions
- Post-operative Tooth Pain, Root Canal Therapy
- Keywords
- Post-operative pain, intra-operative pain, root canal therapy, feasibility, post-surgical persistent pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Post-operativeTooth Pain | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-operative Tooth PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, University of Florida, University of Copenhagen, University of Alabama at Birmingham, University of Minnesota
- Responsible party
- Principal investigator, Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network
- Investigators
- Donald R Nixdorf, DDS, MS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201681
- Sponsor's protocol ID
- 133266
- Other IDs
- U01DE016747
- Status last verified
- Sep 2011
- First submitted
- 13 Sep 2010
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26335907Law 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.
PubMed 25355775Law 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.
PubMed 25190605
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Pain and Root Canal Therapy
- ClinicalTrials.gov ID
- NCT01201681
- Acronym / sponsor ID
- 133266
- Conditions
- Post-operative Tooth Pain, Root Canal Therapy
- Keywords
- Post-operative pain, intra-operative pain, root canal therapy, feasibility, post-surgical persistent pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, University of Florida, University of Copenhagen, University of Alabama at Birmingham, University of Minnesota
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-operativeTooth Pain | – | – |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
- Derived from this study: PubMed 26335907Nixdorf 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.
- Derived from this study: PubMed 25355775Law 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.
- Derived from this study: PubMed 25190605Law 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.
- Dental Practice-Based Research NetworkLink provided by the sponsor.
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald R Nixdorf, DDS, MS principal investigator
University of Minnesota
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Tooth Pain and Root Canal Therapy, run by Dental Practice-Based Research Network at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01201681, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.