Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings A Stratified (by Race, Ethnicity, and Medicaid Status) Study to Develop a Caries Risk Prediction Questionnaire

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries

Detailed Description

The duration of expected time to participate is 3 years (which includes 3 dental examinations).

• Study Type: Observational
• Enrollment (Actual): 1326

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Oral Health Research Institute
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Duke Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

Adults

• If Primary Caregiver is the Parent/Legal guardian: The parent/legal guardian must provide written informed consent for the child and her/himself (if s/he is the primary caregiver) prior to participation.
• If Primary Caregiver is not the Parent/Legal Guardian: If another individual is the primary caregiver, then this individual must provide written informed consent for her/himself prior to participation.
• The parent/legal guardian and the participating primary caregiver must each be at least 18 years old or an emancipated minor
• The parent/legal guardian must consent and allow examination of the oral cavity of her/his child. The primary caregiver must complete the caries risk assessment questionnaire.
• The primary caregiver must be willing to participate, anticipate being the child's primary caregiver during the study period, and anticipate being available for all examinations (baseline, 18 month follow up, and 36 month follow up), in addition to intermediate contacts in between examinations.

Children

• Child must be 9-15 months of age at the time of the baseline study visit.
• Child must be generally healthy (i.e., no current medical condition that makes it difficult for her/him to receive a dental examination).
• Child must allow examination of the oral cavity.

Exclusion Criteria:

Adults

• A participant pair (adult-child) who demonstrates an inability to comply with study protocol requirements will be excluded - this determination will be at the Site Primary Investigator's discretion.
• Non-English, non-Spanish reading/speaking individuals will be excluded, as they will not be able to comprehend the consent document or complete the risk questionnaire.

Children

• Children who are in foster care at study initiation will be excluded, due to the likelihood that their primary caregiver will change multiple times during the length of the study.
• Need for antibiotic and/or sedative premedication prior to dental exam.
• Uncontrolled epilepsy.
• Active cancer treatment.
• Unrepaired congenital heart defects that would require premedication prior to dental exam.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Healthy children aged 9-15 months; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.; Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries).; 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of any caries at baseline	Presence of any caries at baseline (defined as ICDAS > 0, which includes all early caries, filling, or missing due to caries). Presence of any caries at baseline (defined as ICDAS ≥ 5, which includes only frank cavitation, filling, or missing due to caries)	Baseline
Incidence and/or progression of any caries lesions at the follow-up examinations.	Incidence and/or progression of any caries lesions at the follow-up examinations. Progression is defined as change from ICDAS=0 to ICDAS=1 or higher, or filling, or missing due to caries; change from ICDAS=1 or 2 to ICDAS=3 or higher, or filling, or missing due to caries; or change from ICDAS=3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries. Incidence of any caries lesions at the follow-up examinations. Because only distinct cavitation is included at baseline, no progression outcomes from baseline to follow-up will be defined.	3 years
counts of the number of carious surfaces	Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 3 to define decayed surfaces.; Counts of the number of carious surfaces (dmfs), using ICDAS > 0 to define decayed surfaces.; Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 5 to define decayed surfaces	3 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Margherita Fontana, DDS, PhD, University of Michigan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2012
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: October 12, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 14, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: high risk; dental caries; dental cavities; children dental care
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: NIDCR 11-101; U01DE021412-01A1 (U.S. NIH Grant/Contract)