Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Margherita Fontana, DDS, PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01707797
First received: October 12, 2012
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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.


Condition
Dental Caries

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.


Secondary Outcome Measures:
  • Presence of any caries at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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)

  • Incidence and/or progression of any caries lesions at the follow-up examinations. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.


  • counts of the number of carious surfaces [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    1. Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 3 to define decayed surfaces.
    2. Counts of the number of carious surfaces (dmfs), using ICDAS > 0 to define decayed surfaces.
    3. Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 5 to define decayed surfaces


Estimated Enrollment: 1326
Study Start Date: November 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   9 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  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: NCT01707797

Contacts
Contact: Margherita Fontana, DDS 734-647-1225 mfontan@umich.edu
Contact: Emily Yanca 734-763-3988 emthorpe@umich.edu

Locations
United States, Indiana
Indiana University Oral Health Research Institute Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lorena Galvez    317-274-8838    logalvez@iu.edu   
Principal Investigator: Richard Jackson, DMD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jeanette Daly, PhD    319-384-8995    jeanette-daly@uiowa.edu   
Principal Investigator: Steven Levy, DDS, MPH         
United States, North Carolina
Duke Health Center Recruiting
Durham, North Carolina, United States, 27704
Contact: Brenda Pattison    919-668-1099    brenda.pattison@duke.edu   
Principal Investigator: Alex Kemper, MD, MPH, MS         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Margherita Fontana, DDS, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Margherita Fontana, DDS, PhD, Associate Professor Cariology Discipline Co-coordinator, University of Michigan
ClinicalTrials.gov Identifier: NCT01707797     History of Changes
Other Study ID Numbers: NIDCR 11-101, U01DE021412-01A1
Study First Received: October 12, 2012
Last Updated: September 5, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Michigan:
dental caries
high risk
dental cavities
children dental care

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

ClinicalTrials.gov processed this record on August 18, 2014