Clinical trial NCT01707797: Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Caries
Keywords: dental caries
high risk
dental cavities
children dental care
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2012-10-16
Enrollment: 1326
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
timeFrame: 3 years
Secondary outcomes:
measure: Presence of any caries at baseline
timeFrame: Baseline
measure: Incidence and/or progression of any caries lesions at the follow-up examinations.
timeFrame: 3 years
measure: counts of the number of carious surfaces
timeFrame: 3 years
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Oral Health Research Institute
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Durham
country: United States
facility: Duke Health Center
state: North Carolina
Study officials:
affiliation: University of Michigan
name: Margherita Fontana, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.