An interventional study of Comparison School Group and Intervention School Group in Caries,Dental, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 5 Years to 9 Years. Per ClinicalTrials.gov, last updated 2025-07-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Prevention
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.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 1,084 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
Browse Dental Caries studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
For schools:
For parent and child to participate in the measures:
Exclusion Criteria:
-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Behavioral: Comparison School Group
Behavioral: Intervention School Group
All control schools will receive training and materials for the CATCH sun safety curriculum. Ray and the Sunbeatables®: A Sun Safety Curriculum is an evidence-based curriculum educates children, parents and teachers about sun protection and promotes sun safety behaviors in an effort to reduce children's lifetime risk of developing skin cancer. Training will be conducted with booster trainings yearly.
This intervention includes toothbrushing which will be implemented as a daily activity to develop skills and technique,classroom curriculum, which includes theory-based interactive lessons on oral health care,the physical education component consisting of an activity box containing different structured physical activities that will integrate the nutrition and oral health education messages, all cafeteria-based intervention materials including the "tooth friendly" Eat Smart guide, signage, nutrition labeling, menu planning and labeling using the tooth-friendly Go-Slow-Whoa CATCH terminology will be provided to the food service staff that is displayed across the cafeteria and sent home to parents and parents will be provided with tools and tips for maintaining oral health with website resources,parent-child homework activities, send-home infographics on dental care, parent-monitored tracking of child oral health,family fun nights in schools, and social media.
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time frame: Baseline(beginning of kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time frame: end of year 1(Kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Time frame: 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)
Time frame: end of year 3( second grade)
Number of children with good oral hygiene as measured by the child plaque index
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.
Time frame: Baseline
Number of children with good oral hygiene as measured by the child plaque index
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.
Time frame: end of year 1 about 9 months form start of intervention
Number of children with good oral hygiene as measured by the child plaque index
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.
Time frame: end of year 2 about 23 months from start of intervention
Number of children with good oral hygiene as measured by the child plaque index
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.
Time frame: end of year 3 about 33 months form start of intervention
Child dietary intake as measured by the Block food frequency screener
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
Time frame: Baseline
Child dietary intake as measured by the Block food frequency screener
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
Time frame: end of year 1
Child dietary intake as measured by the Block food frequency screener
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
Time frame: end of year 2
Child dietary intake as measured by the Block food frequency screener
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
Time frame: end of year 3
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time frame: Baseline
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time frame: end of year 1 about 9 months from start of intervention
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time frame: End of year 2 about 23 months from start of intervention
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time frame: End of year 3 about 33 months from start of intervention
Number of times a child brushes their teeth a day
Time frame: Baseline
Number of times a child brushes their teeth a day
Time frame: end of year 1 about 9 months from start of intervention
Number of times a child brushes their teeth a day
Time frame: End of year 2 about 23 months from start of intervention
Number of times a child brushes their teeth a day
Time frame: End of year 3 about 33 months from start of intervention
Change in Body Mass Index (BMI)
Child height and weight measured at the school using stadiometers and digital scales respectively.
Time frame: baseline, end of Year 1, Year 2 and Year 3
Change in Child Oral health quality of life measured using parent self-report surveys
Time frame: baseline, end of Year 1, Year 2 and Year 3
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: Baseline
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 1
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 2
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 3
Plan to share: No
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The University of Texas Health Science Center, Houston