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Completed

NCT Number: NCT01707797

Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

9 month–15 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Indiana University Oral Health Research Institute, Indianapolis, Indiana, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations

    Time frame: 3 years

    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.

Secondary outcomes

  1. Presence of any caries at baseline

    Time frame: 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)

  2. Incidence and/or progression of any caries lesions at the follow-up examinations.

    Time frame: 3 years

    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. counts of the number of carious surfaces

    Time frame: 3 years

    • 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2012
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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