Temporomandibular DisordersNCT01201512
CONDOR Temporomandibular Muscle and Joint Disorders (TMJD) Survey
An observational study of Temporomandibular Disorders, run by Dental Practice-Based Research Network at 1 site in United States.
Trial summary
The purpose of study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorders
- How many people
- 503 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 2010
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The questionnaire was administered to all enrolled DPBRN dentist practitoner-investigators (general dentists or specialists), defined as those who had completed a DPBRN Enrollment Questionnaire who were 22 years or older.
Who may be able to join
- DPBRN dentist practitioner-investigator (general dentists or specialists) who had completed a DPBRN Enrollment Questionnaire
- 22 years of age or older
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
About this study
Official title: Primary Care Management for TMJD Pain
The purpose of study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients.
Read the detailed description
The overall goal of this project was to collect data to be used in preparing an application for a Clinical Trial Planning Grant and then in designing a subsequent Phase III clinical trial. The ultimate goal of this series of research projects is to determine the most practical approach to conduct a randomized clinical trial (RCT) to evaluate initial intervention for patients with painful temporomandibular muscle and joint disorders (TMJD) using NIDCR's Collaboration of Networked Dental and Oral Health Research (CONDOR) group consisting of three dental Practice-Based Research Networks: The Dental Practice-Based Research Network (DPBNR), Northwest Practice-Based Research Collaborative in Evidence-based Dentistry (PRECEDENT), and Practitioners Engaged in Applied Research and Learning (PEARL).
- Conditions
- Temporomandibular Disorders
- Keywords
- TMJD pain, feasibility
- Medical subject headings
- Temporomandibular Joint Disorders
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 |
|---|---|---|
| Temporomandibular disorders | 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 startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies 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
- 503 participants (actual)
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
- Investigators
- Gregg H Gilbert, DDS, MBA, Principal investigator, The University of Alabama at BirminghamEric Schiffman, DDS, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201512
- Sponsor's protocol ID
- 129134
- Other IDs
- U01DE016747
- Status last verified
- Jun 2011
- First submitted
- 13 Sep 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Management for TMJD Pain
- ClinicalTrials.gov ID
- NCT01201512
- Acronym / sponsor ID
- 129134
- Conditions
- Temporomandibular Disorders
- Keywords
- TMJD pain, feasibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- 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
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (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 study was to characterize using an online questionnaire the feasibility of recruiting dentists in primary care dental practices in the practice-based research network and documenting their current initial care for their TMJD pain patients.
Detailed description
The overall goal of this project was to collect data to be used in preparing an application for a Clinical Trial Planning Grant and then in designing a subsequent Phase III clinical trial. The ultimate goal of this series of research projects is to determine the most practical approach to conduct a randomized clinical trial (RCT) to evaluate initial intervention for patients with painful temporomandibular muscle and joint disorders (TMJD) using NIDCR's Collaboration of Networked Dental and Oral Health Research (CONDOR) group consisting of three dental Practice-Based Research Networks: The Dental Practice-Based Research Network (DPBNR), Northwest Practice-Based Research Collaborative in Evidence-based Dentistry (PRECEDENT), and Practitioners Engaged in Applied Research and Learning (PEARL).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular disorders | – | – |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The questionnaire was administered to all enrolled DPBRN dentist practitoner-investigators (general dentists or specialists), defined as those who had completed a DPBRN Enrollment Questionnaire who were 22 years or older.
Key inclusion criteria (2 listed)
- DPBRN dentist practitioner-investigator (general dentists or specialists) who had completed a DPBRN Enrollment Questionnaire
- 22 years of age or older
Key exclusion criteria (0 listed)
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 16 Jun 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.
Gregg H Gilbert, DDS, MBA principal investigator
The University of Alabama at Birmingham
Eric Schiffman, DDS study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders, run by Dental Practice-Based Research Network at 1 site in United States.
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 2 inclusion and 0 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 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 16 Jun 2011.