CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

Caries,Dental Clinical Trial

Official title:

CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04632667
• Other study ID #: HSC-SPH-19-0838
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2022
• Est. completion date: April 30, 2026

Study information

• Verified date: June 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Shreela Sharma, PhD
• Phone: (713) 500-9344
• Email: Shreela.V.Sharma[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1066
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries,Dental
• Dental Caries

Intervention

Behavioral:
• Comparison 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.
• Intervention School Group
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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	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	Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)		Baseline(beginning of kindergarten)
Primary	Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)		end of year 1(Kindergarten)
Primary	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)
Primary	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	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.	Baseline
Secondary	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.	end of year 1 about 9 months form start of intervention
Secondary	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.	end of year 2 about 23 months from start of intervention
Secondary	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.	end of year 3 about 33 months form start of intervention
Secondary	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	Baseline
Secondary	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	end of year 1
Secondary	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	end of year 2
Secondary	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	end of year 3
Secondary	Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		Baseline
Secondary	Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		end of year 1 about 9 months from start of intervention
Secondary	Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys		End of year 2 about 23 months from start of intervention
Secondary	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
Secondary	Number of times a child brushes their teeth a day		Baseline
Secondary	Number of times a child brushes their teeth a day		end of year 1 about 9 months from start of intervention
Secondary	Number of times a child brushes their teeth a day		End of year 2 about 23 months from start of intervention
Secondary	Number of times a child brushes their teeth a day		End of year 3 about 33 months from start of intervention
Secondary	Change in Body Mass Index (BMI)	Child height and weight measured at the school using stadiometers and digital scales respectively.	baseline, end of Year 1, Year 2 and Year 3
Secondary	Change in Child Oral health quality of life measured using parent self-report surveys		baseline, end of Year 1, Year 2 and Year 3
Secondary	Frequency of flossing teeth for the child measured using parent self-report surveys		Baseline
Secondary	Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 1
Secondary	Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 2
Secondary	Frequency of flossing teeth for the child measured using parent self-report surveys		end of year 3