Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

Sponsor

University of Michigan (Other)

Overall Status

Completed

CT.gov ID

NCT01707797

Collaborator

National Institute of Dental and Craniofacial Research (NIDCR) (NIH)

1,326

Enrollment

Locations

52.4

Actual Duration (Months)

442

Patients Per Site

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

1326 participants

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

Actual Study Start Date :

Nov 15, 2012

Actual Primary Completion Date :

Mar 30, 2017

Actual Study Completion Date :

Mar 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations [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 Outcome Measures

Presence of any caries at baseline [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)
Incidence and/or progression of any caries lesions at the follow-up examinations. [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.
counts of the number of carious surfaces [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Months to 15 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Oral Health Research Institute	Indianapolis	Indiana	United States	46202
2	University of Iowa	Iowa City	Iowa	United States	52242
3	Duke Health Center	Durham	North Carolina	United States	27704