DPBRN Prevalence of Questionable Occlusal Caries Lesions
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2010 | ||||
| Last Updated Date | March 3, 2011 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01201447 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | DPBRN Prevalence of Questionable Occlusal Caries Lesions | ||||
| Official Title ICMJE | Prevalence of Questionable Occlusal Caries Lesions | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Dental Caries | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Questionable occlusal lesions | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 2624 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 6 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01201447 | ||||
| Other Study ID Numbers ICMJE | 119275, U01DE016747 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gregg H. Gilbert, DDS MBA, Study Chair, University of Alabama at Birmingahm | ||||
| Study Sponsor ICMJE | Dental Practice-Based Research Network | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Dental Practice-Based Research Network | ||||
| Verification Date | March 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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