School-Based Intervention for Tooth Decay

Overseen By Ru-Jye Chuang, DrPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Cleft palate, Enamel hypoplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a program called CATCH Healthy Smiles can reduce tooth decay in young children by promoting better dental habits. It focuses on kindergarten through 2nd-grade children from low-income, ethnically diverse backgrounds. The trial will compare children in schools using the program with those in schools that are not. Families with children enrolled in participating schools, who speak English or Spanish, and do not have congenital dental conditions are suitable candidates for this trial. As an unphased trial, it offers families the opportunity to contribute to important research that could enhance children's dental health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the CATCH Healthy Smiles program is safe for children?

Research has shown that the CATCH Healthy Smiles program is generally safe for children. Conducted in schools, the program aims to improve kids' oral health by teaching them about brushing their teeth and eating nutritious foods. Studies have tested the program's effectiveness, and no harmful effects or safety issues have been reported.

Previous studies examined the program's usability and found that young students manage it well. The program includes activities such as teaching proper brushing techniques and healthy eating habits, which are safe and beneficial for kids in kindergarten through 2nd grade. Overall, CATCH Healthy Smiles seeks to make dental care fun and educational without causing any harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CATCH Healthy Smiles program because it represents a novel approach to tackling tooth decay in children by implementing a school-based intervention. Unlike traditional methods that rely on individual dental visits and treatments like fluoride applications or dental sealants, CATCH Healthy Smiles integrates oral health education directly into the school environment. This approach not only aims to improve dental hygiene through better knowledge and habits but also makes oral health resources more accessible to children. By engaging kids in their everyday environment, this program has the potential to prevent tooth decay more effectively and sustainably.

What evidence suggests that the CATCH Healthy Smiles program is effective for reducing tooth decay in children?

This trial will compare the CATCH Healthy Smiles program with a Comparison School Group. Research has shown that CATCH Healthy Smiles successfully improves children's oral health in schools. Early results suggest that incorporating toothbrushing and nutrition lessons into school activities can reduce the risk of cavities in young children. A past survey revealed that many children—54% in kindergarten, 62% in grade 1, and 73% in grade 2—had cavities, underscoring the program's necessity. CATCH Healthy Smiles aims to educate parents and improve children's brushing habits. By focusing on both education and behavior, the program seeks to reduce cavities and enhance children's dental health. ^{1 2 3 4 6}

Who Is on the Research Team?

Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for children in kindergarten through 2nd grade at schools where most kids get free or reduced lunch. They should be able to do regular school activities and their parents must understand English or Spanish at a 4th-grade level. Kids with certain dental conditions like cleft palate, enamel issues, severe fluorosis, or those needing special dental care can't join.

Inclusion Criteria

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

My child was in kindergarten at the participating school during the 2021-2022 school year.

I agree to follow the CATCH Healthy Smiles program and participate in its evaluations.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the CATCH Healthy Smiles behavioral intervention in schools to reduce dental caries risk

3 years

Ongoing school-based activities

Follow-up

Participants are monitored for changes in oral health, dietary intake, and BMI

33 months

Annual assessments at school

What Are the Treatments Tested in This Trial?

Interventions

• CATCH Healthy Smiles

Trial Overview The study tests CATCH Healthy Smiles, a program aimed at reducing tooth decay by changing behavior in young students from low-income families. It compares results between schools that use the program (Intervention Group) and those that don't (Comparison Group).

How Is the Trial Designed?

Group I: Intervention School Group Experimental Treatment 1 Intervention

Group II: Comparison School Group Active Control 1 Intervention

CATCH Healthy Smiles is already approved in United States for the following indications:

Approved in United States as CATCH Healthy Smiles for:

• Prevention of dental caries in elementary school children

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

National Institute of Dental and Craniofacial Research (NIDCR)

Collaborator

Trials

312

Recruited

853,000+

Published Research Related to This Trial

School-based dental programs have been shown to be effective in reducing dental disease among children, based on evidence from a pilot program.

These programs are well accepted by both parents and children, provide quality care at a reasonable cost, and demonstrate the potential for broader implementation in the U.S.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of school-based primary and secondary preventive dental programs in the United States and other countries. Bagramian, RA.[2019]

In a study involving 125 children from grades K-2, the CATCH Healthy Smiles program showed high fidelity and acceptability, with all planned lessons successfully taught by trained teachers.

The study found that 54% of kindergarteners, 62% of first graders, and 73% of second graders had dental caries, with significant associations between caries experience and factors like higher body weight, increased consumption of sugary drinks, and lower dental care access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Feasibility Testing of CATCH Healthy Smiles, an Oral Health Promotion Intervention for Prevention of Dental Caries Among Elementary School Children. Sharma, SV., Kelder, S., Yamal, JM., et al.[2022]

A school-based oral health program in Los Angeles successfully screened and provided fluoride varnishing to 2,776 children, revealing that 66% had active dental disease, highlighting the need for preventive care in low-income urban areas.

After two years of participation, 56% of students showed improvement in their dental health with fewer or no visible caries, demonstrating the program's efficacy in reducing dental decay among children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A school-based public health model to reduce oral health disparities. Dudovitz, RN., Valiente, JE., Espinosa, G., et al.[2019]

The CATCH Healthy Smiles program is a school-based intervention designed to reduce dental caries among low-income, ethnically diverse children, involving 1020 kindergarteners across 30 schools over three years.

The study will evaluate the effectiveness of the program through dental assessments and parent surveys, aiming to provide a scalable model for improving oral health in schools if successful.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design for a cluster randomized controlled trial to evaluate the effects of the CATCH Healthy Smiles school-based oral health promotion intervention among elementary school children. Chuang, RJ., Byrd-Williams, C., Yamal, JM., et al.[2023]

A systematic review of 8 randomized controlled studies involving 3232 elementary school-aged children found that most oral health interventions were designed without input from the children themselves, indicating a lack of true participation.

The review suggests that future oral health interventions should incorporate children's perspectives and involve them as active participants in the research process to enhance the effectiveness and relevance of educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child involvement in oral health education interventions - a systematic review of randomised controlled studies. Hakojärvi, HR., Selänne, L., Salanterä, S.[2022]

A school-based dental program in a low-middle-income urban area showed a remarkable 84% reduction in dental caries on occlusal surfaces of permanent teeth in the treatment group after one year.

The program included multiple preventive measures such as fluoridated water, fluoride applications, sealants, and dental health education, demonstrating the effectiveness of a comprehensive approach to dental care in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined approach to preventing dental caries in schoolchildren: caries reductions after one year. Bagramian, RA., Graves, RC., Bhat, M.[2019]

The 'Smiles' program successfully engaged 5,311 preschool children across 180 kindergartens in Israel, achieving over 80% participation and high satisfaction ratings from teachers and parents, indicating strong community support for oral health promotion.

The program's focus on daily supervised toothbrushing and collaboration among educators, parents, and dental hygienists created a positive environment that encouraged children's oral health habits, suggesting its potential for long-term impact on dental hygiene in early childhood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of "Smiles": an innovative inclusive program for the promotion of oral health among preschool children. Vered, Y., Kynan Orenstein, M., Goldberg, H., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36387989/

Design for a cluster randomized controlled trial to evaluate ... The aim of this paper is to describe the design of the CATCH Healthy Smiles CRCT to determine the effectiveness of an oral health school-based ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422001508

Design for a cluster randomized controlled trial to evaluate ... The aim of this paper is to describe the design of the CATCH Healthy Smiles CRCT to determine the effectiveness of an oral health school-based behavioral ...

3. grantome.com grantome.com/grant/NIH/UG3-DE029213-01

CATCH Healthy Smiles: A cluster-RCT of an elementary ... Of the 113 children with dental assessments, 54% of children in Kindergarten, 62% in grade 1 and 73% in grade 2 had caries experience defined by any untreated ...

4. sph.uth.edu sph.uth.edu/news/story/catch-healthy-smiles

CATCH Healthy Smiles: Transforming Children's Oral Health ... By integrating toothbrushing and nutrition education into the curriculum, CATCH Healthy Smiles paves the way to improving oral health.

5. researchgate.net researchgate.net/figure/CATCH-Healthy-Smiles-intervention-logic-model_fig1_365133017

CATCH Healthy Smiles intervention logic model. This study assesses the relationship between parental oral health-related knowledge, self-efficacy, child dental caries, and OHQoL. This cross-sectional seco ...

6. researchgate.net researchgate.net/publication/356348889_Development_and_Feasibility_Testing_of_CATCH_Healthy_Smiles_an_Oral_Health_Promotion_Intervention_for_Prevention_of_Dental_Caries_Among_Elementary_School_Children

Development and Feasibility Testing of CATCH Healthy ... BACKGROUND We present results of the development and feasibility testing of CATCH Healthy Smiles, a school-based oral health program, ...