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Completed

NCT Number: NCT04632667

CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

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.

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Key information

Conditions

Caries,Dental Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Comparison School Group

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

Secondary outcomes

  1. Number of children with good oral hygiene as measured by the child plaque index

    Time frame: Baseline

    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.

  2. Number of children with good oral hygiene as measured by the child plaque index

    Time frame: end of year 1 about 9 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.

  3. Number of children with good oral hygiene as measured by the child plaque index

    Time frame: end of year 2 about 23 months from 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.

  4. Number of children with good oral hygiene as measured by the child plaque index

    Time frame: 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.

  5. Child dietary intake as measured by the Block food frequency screener

    Time frame: Baseline

    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

  6. Child dietary intake as measured by the Block food frequency screener

    Time frame: end of year 1

    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

  7. Child dietary intake as measured by the Block food frequency screener

    Time frame: end of year 2

    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

  8. Child dietary intake as measured by the Block food frequency screener

    Time frame: 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

  9. Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys

    Time frame: Baseline

  10. 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

  11. 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

  12. 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

  13. Number of times a child brushes their teeth a day

    Time frame: Baseline

  14. Number of times a child brushes their teeth a day

    Time frame: end of year 1 about 9 months from start of intervention

  15. Number of times a child brushes their teeth a day

    Time frame: End of year 2 about 23 months from start of intervention

  16. Number of times a child brushes their teeth a day

    Time frame: End of year 3 about 33 months from start of intervention

  17. Change in Body Mass Index (BMI)

    Time frame: baseline, end of Year 1, Year 2 and Year 3

    Child height and weight measured at the school using stadiometers and digital scales respectively.

  18. 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

  19. Frequency of flossing teeth for the child measured using parent self-report surveys

    Time frame: Baseline

  20. Frequency of flossing teeth for the child measured using parent self-report surveys

    Time frame: end of year 1

  21. Frequency of flossing teeth for the child measured using parent self-report surveys

    Time frame: end of year 2

  22. Frequency of flossing teeth for the child measured using parent self-report surveys

    Time frame: end of year 3

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 17, 2020
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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