Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings
Status: | Completed |
---|---|
Conditions: | Other Indications, Dental |
Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
Healthy: | No |
Age Range: | Any |
Updated: | 9/19/2018 |
Start Date: | November 15, 2012 |
End Date: | March 30, 2017 |
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
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.
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.
The duration of expected time to participate is 3 years (which includes 3 dental
examinations).
examinations).
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.
We found this trial at
3
sites
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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