NCT01707797|CompletedDMC
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Sponsor study identifier
Secondary identifiers
observational
1,326
1 country
3
Study Start
November 15, 2012
Actual (reported)Primary Completion
March 30, 2017
Actual (reported)Study Completion
March 30, 2017
Actual (reported)The study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). The aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for developing cavities.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 30, 2017
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 12, 2012
Actual (reported)October 16, 2012
Actual (reported)November 15, 2012
Actual (reported)March 30, 2017
Actual (reported)March 30, 2017
Actual (reported)Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
Outcomes will be defined at the participant level. 1. Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries). 2. Incidence (ICDAS ≥ 3, filling, or missing due to caries) and/or progression (change from ICDAS= 3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries) of any caries lesions at the follow-up examinations.
3 years
Presence of any caries at baseline
Baseline
Incidence and/or progression of any caries lesions at the follow-up examinations.
3 years
counts of the number of carious surfaces
3 years
Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.
Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.
Indiana University Oral Health Research Institute
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Duke Health Center
Durham, North Carolina, 27704, United States
Fontana M, Eckert GJ, Keels MA, Jackson R, Katz BP, Kemper AR, Levy BT, Levy SM, Yanca E, Kelly S, Daly JM, Patterson B, McKnight P. Predicting Caries in Medical Settings: Risk Factors in Diverse Infant Groups. J Dent Res. 2019 Jan;98(1):68-76. doi: 10.1177/0022034518799080. Epub 2018 Sep 11.
Fontana M, Eckert GJ, Keels MA, Jackson R, Katz B, Levy BT, Levy SM. Fluoride Use in Health Care Settings: Association with Children's Caries Risk. Adv Dent Res. 2018 Feb;29(1):24-34. doi: 10.1177/0022034517735297.
Margherita Fontana, DDS, PhD
University of Michigan
1,326 participants (actual enrollment reported by the registry).
First Submitted
October 12, 2012
First Posted
October 16, 2012
Study Start
November 15, 2012
Actual (reported)Use of Radiographic Contrast to Detect Dental Caries
Contact the study team to confirm eligibility.
Primary Completion
March 30, 2017
Actual (reported)Study Completion
March 30, 2017
Actual (reported)Last Updated
September 17, 2018
Record last verified: 2018-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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