- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309971
DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions
February 14, 2014 updated by: Dental Practice-Based Research Network
Longitudinal Study of Questionable Occlusal Caries Lesions
The purpose of this study will allow us to observe and follow the subjects' treatment from DPBRN Prevalence of Questionable Occlusal Caries Lesions Study over a 24 month period.
Study Overview
Status
Completed
Conditions
Detailed Description
There have been very few studies regarding questionable lesions, virtually no clinical evaluations of the progression of questionable lesions over time, and no studies depicting the prevalence of these lesions.
Since carious lesions have the ability to arrest and possibly reverse, determining how often these lesions are being seen in practice and learning more about their characteristics and patient risk assessment are important steps in order to manage these lesions without unnecessary surgical intervention.
Study Type
Observational
Enrollment (Actual)
2624
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Copenhagen, Denmark
- University of Copenhagen Royal Dental College
-
-
-
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Alabama
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Birmingham, Alabama, United States, 35294-0007
- University of Alabama at Birmingham
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida College of Dentistry
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Minnesota
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Minneapolis, Minnesota, United States, 55440-1309
- Health Partners Dental Group
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Minneapolis, Minnesota, United States, 55440-1524
- Health Partners Research Foundation
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Oregon
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Portland, Oregon, United States, 97227
- Kaiser Permanente Center for Health Research
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Portland, Oregon, United States, 97232
- Permanente Denrtal Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The participants directly involved in this study were the patients who have sought dental treatment in the DPBRN practitioner-investigators' practices.
Description
Inclusion Criteria:
- patients needed to have at least one permanent tooth with a questionable lesion. This means that subjects were at least 6 years old because that is when the permanent first molar typically erupts.
Exclusion Criteria:
- patients under 6 years old
- patients 6 years old and older who do not have a questionable lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Questionable occlusal lesions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Questionable Caries
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
March 4, 2011
First Submitted That Met QC Criteria
March 4, 2011
First Posted (Estimate)
March 7, 2011
Study Record Updates
Last Update Posted (Estimate)
February 19, 2014
Last Update Submitted That Met QC Criteria
February 14, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 122012
- U01DE016747 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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