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DPBRN Prevalence of Questionable Occlusal Caries Lesions

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ClinicalTrials.gov Identifier: NCT01201447
Recruitment Status : Completed
First Posted : September 14, 2010
Last Update Posted : March 4, 2011
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:
The purpose of this study was to investigate the process involved when making decisions about the diagnosis and treatment of questionable lesions, as well as determine if there is any association between lesions progression (or depth, if opened) and clinical characteristics and baseline risk assessment.

Condition or disease
Dental Caries

Detailed Description:

The term"questionable" is defined as a tooth with no cavitation (no continuity break in the enamel) and no radiographic radiolucencies, but the presence of caries is suspected due to roughness, surface opacities, or staining. The characteristics of these lesions and the patient's baseline caries risk were examined.

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 Design

Study Type : Observational
Estimated Enrollment : 2624 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Prevalence of Questionable Occlusal Caries Lesions
Study Start Date : August 2008
Primary Completion Date : March 2010
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Questionable occlusal lesions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01201447


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
University of Florida College of Dentistry
Gainesville, Florida, United States, 32610
United States, Minnesota
Health Partners Dental Group
Minneapolis, Minnesota, United States, 55440-1309
Health Partners Research Foundation
Minneapolis, Minnesota, United States, 55440-1524
United States, Oregon
Kaiser Permanente Center for Health Research
Portland, Oregon, United States, 97227
Permanente Denrtal Associates
Portland, Oregon, United States, 97232
Denmark
University of Copenhagen Royal Dental College
Copenhagen, Denmark
Sponsors and Collaborators
Dental Practice-Based Research Network
HealthPartners Institute
Kaiser Permanente
Permanente Dental Associates Group, Oregon
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Sonia K Makhija, DDS, MPH University of Alabama at Birmingham
More Information

Additional Information:
Responsible Party: Gregg H. Gilbert, DDS MBA, Study Chair, University of Alabama at Birmingahm
ClinicalTrials.gov Identifier: NCT01201447     History of Changes
Other Study ID Numbers: 119275
U01DE016747 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: March 4, 2011
Last Verified: March 2011

Keywords provided by Dental Practice-Based Research Network:
Assessment
Questionable Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents