Clinical trial NCT01309971: DPBRN Longitudinal Study of Questionable Occlusal Caries Lesions
Official title: Longitudinal Study of Questionable Occlusal Caries Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: Assessment
Questionable Caries
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2011-03-07
Enrollment: 2624
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
measure: Questionable Caries
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida College of Dentistry
state: Florida
city: Minneapolis
country: United States
facility: Health Partners Dental Group
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Research Foundation
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Portland
country: United States
facility: Permanente Denrtal Associates
state: Oregon
city: Copenhagen
country: Denmark
facility: University of Copenhagen Royal Dental College
Study officials:
affiliation: University of Alabama at Birmingham
name: Sonia K Makhija, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Makhija SK, Gilbert GH, Funkhouser E, Bader JD, Gordan VV, Rindal DB, Qvist V, Norrisgaard 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.