Dental CariesNCT01309958
DPBRN Development of a Patient Based Provider Intervention for Early Caries Management
An observational study of Dental Caries, run by Dental Practice-Based Research Network at 7 sites in 2 countries.
Trial summary
This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 334 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jun 2008to Oct 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: ghg@uab.edu
Who may be able to join
- dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis \& Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces
Who cannot join
- patients under 19 years of age
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 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
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Permanente Denrtal Associates
Portland, Oregon, 97232
About this study
Official title: Development of a Patient Based Provider Intervention for Early Caries
This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.
Read the detailed description
Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment).
Phase 2 - field tested the patient brochure
Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Intervention, Non-invasive treatment for early caries
- Medical subject headings
- Dental Caries
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 |
|---|---|---|
| intervention | design instruments and test feasibility of an intervention aimed at increasing the proportion on non-invasive treatment for early caries |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startJun 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dental Practice-Based Research Network
- Sponsor type
- Research network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Gregg H. Gilbert, DDS, MBA, FAAHD, Dental Practice-Based Research Network
- Investigators
- Gregg H Gilbert, DDS, MBA, Principal investigator, National Dental PBRN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309958
- Sponsor's protocol ID
- 018592
- Other IDs
- U01DE016747
- Status last verified
- Aug 2015
- First submitted
- 4 Mar 2011
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Patient Based Provider Intervention for Early Caries
- ClinicalTrials.gov ID
- NCT01309958
- Acronym / sponsor ID
- 018592
- Conditions
- Dental Caries
- Keywords
- Dental Caries, Intervention, Non-invasive treatment for early caries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Dental Practice-Based Research NetworkResearch network
- Collaborators
- HealthPartners Institute, Kaiser Permanente, Permanente Dental Associates Group, Oregon, National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Jun 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Mar 2011 (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.
This study focused on improving the quality of dental care by fostering movement of the latest scientific advances into daily clinical practice.
Detailed description
Phase 1 - development of two instruments (a patient brochure that described non-invasive caries treatment and a patient questionnaire of satisfaction with non-invasive caries treatment).
Phase 2 - field tested the patient brochure
Phase 3 - pilot tested the patient brochure, quantifying patient satisfaction with non-invasive caries treatments and a feasibility study that will inform the design of a clinical trial in dental practices envisioned for a later study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | – | –design instruments and test feasibility of an intervention aimed at increasing the proportion on non-invasive treatment for early caries |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- ghg@uab.edu
Key inclusion criteria (1 listed)
- dentists enrolled in the Dental Practice-Based Research Network (DPBRN) who participated in DPBRN Assessment of Caries Diagnosis \& Caries Treatment and DBPRN Reasons for placing the First Restoration on Permanent Tooth Surfaces
Key exclusion criteria (1 listed)
- patients under 19 years of age
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 6 Aug 2015.
- 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
National Dental PBRN
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by Dental Practice-Based Research Network at 7 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 1 inclusion and 1 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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 6 Aug 2015.