Root Canal TherapyNCT01201668
DPBRN Persistent Pain and Root Canal Therapy
An observational study of Root Canal Therapy and Persistent Tooth Pain, run by Dental Practice-Based Research Network at 8 sites in 2 countries.
Trial summary
The purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN "Peri-operative tooth pain" study. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Therapy, Persistent Tooth Pain
- How many people
- 500 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 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 the patients who have sought dental treament 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 its 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 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
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: Persistent Pain and Root Canal Therapy
The purpose of this study is to document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN "Peri-operative tooth pain" study. This study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the DPBRN "Peri-operative tooth pain" study.
- Conditions
- Root Canal Therapy, Persistent Tooth Pain
- Keywords
- post-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 |
|---|---|---|
| Persistent Tooth 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 startAug 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.
- Other trials for Root Canal TherapyStudies 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
- Cross-sectional
- 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 Copenhagen, University of Florida, 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
- NCT01201668
- Sponsor's protocol ID
- 133265
- 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
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
- Persistent Pain and Root Canal Therapy
- ClinicalTrials.gov ID
- NCT01201668
- Acronym / sponsor ID
- 133265
- Conditions
- Root Canal Therapy, Persistent Tooth Pain
- Keywords
- post-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 Copenhagen, University of Florida, University of Alabama at Birmingham, University of Minnesota
- Study start
- Aug 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 document by survey the occurence of tooth pain present 3 months and 6 months after root canal therapy in the patients recruited for the DPBRN "Peri-operative tooth pain" study. This study will access the feasibility of obtaining 3 month and 6 month follow-up data on the patient enrolled in the DPBRN "Peri-operative tooth pain" study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistent Tooth 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 the patients who have sought dental treament 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 its 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 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
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.
- Dental Practice-Based Research NetworkLink provided by the sponsor.
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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 Root Canal Therapy and Persistent Tooth Pain, 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?
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.