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CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Caries,Dental

Treatments

Behavioral: Comparison School Group
Behavioral: Intervention School Group

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04632667
HSC-SPH-19-0838

Details and patient eligibility

About

The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children,to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.

Enrollment

1,084 patients

Sex

All

Ages

5 to 9 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

For schools:

  • greater than 75% of the children enrolled in the dree/reduced school lunch program.
  • enrolling children in grade K in the 2021-2022 school year.
  • agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements

For parent and child to participate in the measures:

  • ability of the parent to speak and read in English or Spanish at the 4th grade level,
  • child enrolled in the participating school in grade K in the 2021-2022 school year
  • child ability to participate in the regular activities at the school

Exclusion criteria

-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,084 participants in 2 patient groups

Comparison School Group
Active Comparator group
Treatment:
Behavioral: Comparison School Group
Intervention School Group
Experimental group
Treatment:
Behavioral: Intervention School Group

Trial contacts and locations

1

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Central trial contact

Shreela Sharma, PhD; Ru-Jye Chuang, DrPH

Data sourced from clinicaltrials.gov

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