Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707797
• Other study ID #: NIDCR 11-101
• Secondary ID: U01DE021412-01A1
• Status: Completed
• Start date: November 15, 2012
• Est. completion date: March 30, 2017

Study information

• Verified date: September 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1326
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 15 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Locations

Country	Name	City	State
United States	Duke Health Center	Durham	North Carolina
United States	Indiana University Oral Health Research Institute	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations	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.	3 years
Secondary	Presence of any caries at 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)	Baseline
Secondary	Incidence and/or progression of any caries lesions at the follow-up examinations.	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.	3 years
Secondary	counts of the number of carious surfaces	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	3 years