DPBRN Reasons for Replacement or Repair of Dental Restorations
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| First Received Date ICMJE | September 13, 2010 | ||||||||
| Last Updated Date | June 14, 2011 | ||||||||
| Start Date ICMJE | November 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 NCT01201876 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 Reasons for Replacement or Repair of Dental Restorations | ||||||||
| Official Title ICMJE | Reasons for Replacement or Repair of Dental Restorations | ||||||||
| Brief Summary | The purpose of this study was to document the reasons for replacement or repair of defective restorations ("fillings") and to record the restorative material of the failed restoration and the material used in the replacement restoration on permanent ("adult") teeth. |
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| Detailed Description | The aims of this study were to (1) quantify the prevalence of reason(s) for replacing existing restorations in DPBRN practices; (2) quantify the percentages and types of restorative materials of failed restorations that are being replaced in DPBRN practices; (3) quantify the percentages and types of restorative materials used to replace or repair failed restorations in DPBRN practices; and (4) test the hypothesis that DPBRN practitioner-investigators who reported in a previous study that they treat enamel lesions operatively are more likely in actual patients as in this study to replace entire restorations rather than do repairs and are more likely to report the clinical diagnosis of secondary caries as a reason for replacement. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Practitioner investigators must have been enrolled in the DPBRN, completed the "Assessment of caries diagnosis & caries treatment" study; and do at least some restorative dentistry in their practices. The human subjects directly involved in this study were patients who had sought dental treatment in the DPBRN practitoners' practices. |
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| Condition ICMJE | Dental Caries | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| 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 | ||||||||
| Enrollment ICMJE | 6368 | ||||||||
| Completion Date | March 2010 | ||||||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion 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 | NCT01201876 | ||||||||
| Other Study ID Numbers ICMJE | 118680, U01DE016747 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Gregg H. Gilbert, DDS, MBA, Study Chair, University of Alabama at Birmingham | ||||||||
| 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 | June 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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