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.

Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]

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. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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

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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:

9 Months to 15 Months

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

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.

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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707797