Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

Completed

Conditions studied: Dental Caries

In brief

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.

Key facts

Study ID

NCT01707797

Run by

University of Michigan

People needed

1326

Starts

2012-11-15

Expected to finish

2017-03-30

Last updated by the study team

2018-09-17

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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