DPBRN Prevalence of Questionable Occlusal Caries Lesions

Sponsor
Dental Practice-Based Research Network (Other)
Overall Status
Completed
CT.gov ID
NCT01201447
Collaborator
HealthPartners Institute (Other), Kaiser Permanente (Other), Permanente Dental Associates Group, Oregon (Other), National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
2,624
7
19
374.9
19.8

Study Details

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 Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    2624 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Prevalence of Questionable Occlusal Caries Lesions
    Study Start Date :
    Aug 1, 2008
    Actual Primary Completion Date :
    Mar 1, 2010
    Actual Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Questionable occlusal lesions

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      6 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 University of Alabama at Birmingham Birmingham Alabama United States 35294
      2 University of Florida College of Dentistry Gainesville Florida United States 32610
      3 Health Partners Dental Group Minneapolis Minnesota United States 55440-1309
      4 Health Partners Research Foundation Minneapolis Minnesota United States 55440-1524
      5 Kaiser Permanente Center for Health Research Portland Oregon United States 97227
      6 Permanente Denrtal Associates Portland Oregon United States 97232
      7 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01201447
      Other Study ID Numbers:
      • 119275
      • U01DE016747
      First Posted:
      Sep 14, 2010
      Last Update Posted:
      Mar 4, 2011
      Last Verified:
      Mar 1, 2011
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Mar 4, 2011