Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Tooth decay is a common problem for children in the United States. More than half of elementary school children have had cavities. One in five children with cavities do not get treatment. Children with untreated cavities miss more school, have a hard time paying attention in school, and have lower test scores than students with healthy teeth.

Children with fewer resources and Hispanic children are more likely to have tooth decay than other children. Visiting a dentist may be too costly or hard to get to. Previous research shows that school-based programs can improve oral health and reduce the number of cavities in children.

This study is comparing two school-based cavity prevention programs. The first program, which provides simple care, takes about five minutes per student and costs about $20 per student. In simple care, children receive a fluoride treatment. The second program, which provides complex care, takes about 20 minutes per student and costs about $80 per student. Complex care includes use of sealants and a fluoride treatment. The research team wants to know whether simple care works as well as complex care in preventing cavities.

Who can this research help?

Policy makers, school leaders, and parents can use findings from this study to inform decisions about school-based programs to prevent cavities in children.

What is the research team doing?

The research team is working with 60 elementary schools in New York City that serve children with fewer resources and Hispanic children. In the study’s first year, the research team is assigning 30 elementary schools by chance to receive either simple or complex care. The team is following the schools for four years. In the study’s second year, 30 more schools will receive either simple or complex care by chance. The team is following these schools for three years. All children receive their treatment twice per year.

The team is examining each child’s mouth for new cavities and cavities that stopped getting worse. In addition, the team is collecting information about children’s oral-health-related quality of life, such as their self-image and well-being and their school attendance and performance.

Parents, elementary school staff, community health workers, local and state officials, and dental health insurers worked with the research team to plan the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population Children with fewer resources and Hispanic children at 60 elementary schools in the Bronx, New York City
Interventions/
Comparators
  • Simple caries prevention: silver diamine fluoride plus fluoride varnish
  • Complex caries prevention: traditional and therapeutic sealants plus fluoride varnish
Outcomes

Primary: progress of existing caries, new caries

Secondary: quality of life, school attendance, academic performance

Timeframe 3- to 4-year follow-up for primary outcomes 

Project Information

Richard Niederman, DMD
New York University College of Dentistry
$13,343,026
Comparative Effectiveness of School-Based Caries Prevention Programs for Children in Underserved, Low-Income, Hispanic Communities

Key Dates

September 2017
March 2024
2017

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022