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DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions

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ClinicalTrials.gov Identifier: NCT01309971
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : February 19, 2014
Sponsor:
Collaborators:
HealthPartners Institute
Kaiser Permanente
Permanente Dental Associates Group, Oregon
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Dental Practice-Based Research Network

Tracking Information
First Submitted Date March 4, 2011
First Posted Date March 7, 2011
Last Update Posted Date February 19, 2014
Study Start Date August 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2014)
Questionable Caries [ Time Frame: 24 months ]
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01309971 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions
Official Title Longitudinal Study of Questionable Occlusal Caries Lesions
Brief Summary 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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
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.
Condition Dental Caries
Intervention Not Provided
Study Groups/Cohorts Questionable occlusal lesions
Publications * Makhija SK, Gilbert GH, Funkhouser E, Bader JD, Gordan VV, Rindal DB, Qvist V, Nørrisgaard P; National Dental PBRN Collaborative Group. Twenty-month follow-up of occlusal caries lesions deemed questionable at baseline: findings from the National Dental Practice-Based Research Network. J Am Dent Assoc. 2014 Nov;145(11):1112-8. doi: 10.14219/jada.2014.82.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 4, 2011)
2624
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01309971
Other Study ID Numbers 122012
U01DE016747 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dental Practice-Based Research Network
Study Sponsor Dental Practice-Based Research Network
Collaborators
  • 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
PRS Account Dental Practice-Based Research Network
Verification Date February 2014