This trial is active, not recruiting.

Condition dental caries
Sponsor University of Michigan
Collaborator National Institute of Dental and Craniofacial Research (NIDCR)
Start date November 2012
End date May 2017
Trial size 1326 participants
Trial identifier NCT01707797, NIDCR 11-101, U01DE021412-01A1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
time frame: 3 years

Secondary Outcomes

Presence of any caries at baseline
time frame: Baseline
Incidence and/or progression of any caries lesions at the follow-up examinations.
time frame: 3 years
counts of the number of carious surfaces
time frame: 3 years

Eligibility Criteria

Male or female participants from 9 months up to 15 months old.

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.

Additional Information

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
Principal investigator Margherita Fontana, DDS, PhD
Description The duration of expected time to participate is 3 years (which includes 3 dental examinations).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Michigan.