Clinical trial NCT03442309: Comparative Effectiveness of School-based Caries Prevention
Official title: Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Quality of Life
Keywords: dental caries
caries arrest
caries prevention
quality of life
silver diamine fluoride
sealants
interim therapeutic restorations
student achievement
school attendance
Lead sponsor: NYU College of Dentistry
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Boston University
name: New York City Department of Health and Mental Hygiene
First posted: 2018-02-22
Enrollment: 7418
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, parallel, non-inferiority cluster randomized trial
Primary purpose: PREVENTION

Brief summary: Dental caries (tooth decay) is the most prevalent childhood disease in the world. Multiple interventions are available to treat and prevent caries. The aim of the proposed study is to compare the benefit of silver diamine fluoride (SDF) and fluoride varnish versus fluoride varnish and glass ionomer sealants. This study is a five-year, cluster randomized, pragmatic controlled trial conducted in public elementary schools in New York City.

Detailed description: Dental caries is the most prevalent childhood disease in the world and can lead to infection, pain, reduced quality of life, and negative educational outcomes. Multiple prevention agents are available to arrest and prevent dental caries, however little is known of the comparative effectiveness of combined treatments in pragmatic settings. The aim of the presented study is to compare the benefit of silver diamine fluoride and fluoride varnish versus fluoride varnish and glass ionomer therapeutic sealants in the arrest and prevention of dental caries.

This is a longitudinal, pragmatic, cluster randomized, single-blind, non-inferiority trial to be conducted in low-income minority children enrolled in public elementary schools in New York City, New York, United States, from 2018-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Secondary objectives are to assess oral health-related quality of life and educational outcomes. Caries arrest will be evaluated after two years, and caries prevention and secondary outcomes will be assessed at the completion of the study. Data analysis will follow intent to treat, and statistical analyses will be conducted using a two-sided significance level of 0.05.

Notably, the standard of care for dental caries is office-based surgery, which presents multiple barriers to care including cost, fear, and geographic isolation. The simplicity and affordability of silver diamine fluoride may be a viable alternative for the arrest and prevention of dental caries in high-risk children.

Eligibility criteria: Inclusion Criteria:

* Any primary school in New York City with a Hispanic/Latino student population greater than 50% and,
* A low-income population (defined as a student receiving free or reduced price lunch) of at least 80%.
* Within participating schools, all children are eligible to participate in the study.

Exclusion Criteria:

* Schools that already have a pre-existing school-based dental health program.
* Within participating schools, exclusion criteria for children include those without informed consent or those with consent but without assent.

Primary outcomes:
measure: Proportion of Subjects With All Caries Arrested
timeFrame: Two years
measure: Prevalence of Dental Caries as Measured by a Clinical Oral Examination
timeFrame: Participants were evaluated biannually over a total of four years or until lost to follow-up, whichever occurred first.
Secondary outcomes:
measure: Oral Health-Related Quality of Life
timeFrame: Six months after initial treatment.
measure: School Attendance
timeFrame: 4 years after initial baseline observation
measure: Academic Performance
timeFrame: 4 years after initial baseline observation
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University College of Dentistry
state: New York
Study officials:
affiliation: NYU Langone Health
name: Richard Niederman, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Ryan R Ruff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruff RR, Niederman R. Silver diamine fluoride versus therapeutic sealants for the arrest and prevention of dental caries in low-income minority children: study protocol for a cluster randomized controlled trial. Trials. 2018 Sep 26;19(1):523. doi: 10.1186/s13063-018-2891-1.