DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions

This study has been completed.
Sponsor:
Collaborators:
HealthPartners Institute for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
Information provided by (Responsible Party):
Dental Practice-Based Research Network
ClinicalTrials.gov Identifier:
NCT01309971
First received: March 4, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition
Dental Caries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Longitudinal Study of Questionable Occlusal Caries Lesions

Resource links provided by NLM:


Further study details as provided by Dental Practice-Based Research Network:

Primary Outcome Measures:
  • Questionable Caries [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 2624
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Questionable occlusal lesions

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.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309971

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0007
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 for Education and Research
Kaiser Permanente
Permanente Dental Associates Group, Oregon
Investigators
Principal Investigator: Sonia K Makhija, DDS, MPH University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: Dental Practice-Based Research Network
ClinicalTrials.gov Identifier: NCT01309971     History of Changes
Other Study ID Numbers: 122012, U01DE016747
Study First Received: March 4, 2011
Last Updated: February 14, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 18, 2014