CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial
- Conditions
- Caries,Dental
- Interventions
- Behavioral: Intervention School GroupBehavioral: Comparison School Group
- Registration Number
- NCT04632667
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1066
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
-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention School Group Intervention School Group - Comparison School Group Comparison School Group -
- Primary Outcome Measures
Name Time Method Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) end of year 2(first grade) number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) end of year 3( second grade)
- Secondary Outcome Measures
Name Time Method Number of children with good oral hygiene as measured by the child plaque index end of year 3 about 33 months form start of intervention The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
Child dietary intake as measured by the Block food frequency screener end of year 3 This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys End of year 3 about 33 months from start of intervention Frequency of flossing teeth for the child measured using parent self-report surveys end of year 3 Number of times a child brushes their teeth a day End of year 3 about 33 months from start of intervention Change in Body Mass Index (BMI) baseline, end of Year 1, Year 2 and Year 3 Child height and weight measured at the school using stadiometers and digital scales respectively.
Change in Child Oral health quality of life measured using parent self-report surveys baseline, end of Year 1, Year 2 and Year 3
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States