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

1066 Participants Needed

Trial Summary

What is the purpose of this 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.

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 data supports the effectiveness of the treatment CATCH Healthy Smiles Program for preventing tooth decay in children?

The CATCH Healthy Smiles Program is based on the successful CATCH framework, which has shown long-term effectiveness in improving health behaviors and reducing obesity in children. Additionally, similar school-based dental programs have demonstrated significant reductions in tooth decay, with one study showing an 84% reduction in cavities among children receiving the treatment. ^{1 2 3 4 5}

Is the CATCH Healthy Smiles program safe for children?

The CATCH Healthy Smiles program is based on the CATCH framework, which has been tested in several studies and shown to be safe and effective in improving health behaviors among children. The program involves activities like supervised toothbrushing and dental health education, which are generally safe for children. ^{1 2 4 5 6}

How is the CATCH Healthy Smiles treatment different from other treatments for tooth decay?

CATCH Healthy Smiles is unique because it is a school-based program that focuses on teaching children healthy oral habits and behaviors to prevent tooth decay, rather than just treating it. It is part of a broader health initiative that has been successful in improving children's overall health behaviors, making it a novel approach compared to traditional dental treatments that focus on direct dental care. ^{1 2 3 5 7}

Research Team

Shreela Sharma, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Netherlands 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. [2023]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A school-based public health model to reduce oral health disparities. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

A combined approach to preventing dental caries in schoolchildren: caries reductions after one year. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Establishment of "Smiles": an innovative inclusive program for the promotion of oral health among preschool children. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Child involvement in oral health education interventions - a systematic review of randomised controlled studies. [2022]