Comparative Effectiveness of School-based Caries Prevention

Quality of Life Clinical Trial

Official title:

Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-income Minority Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03442309
• Other study ID #: i17-00578
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2023
• Source: NYU College of Dentistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7418
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Quality of Life

Intervention

Device:
• Silver Diamine Fluoride
Silver diamine fluoride (SDF)
• Fluoride Varnishes
Fluoride varnish (FV)
• Glass Ionomer
Glass Ionomer Sealants (GC Fuji IX)

Locations

Country	Name	City	State
United States	New York University College of Dentistry	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
NYU College of Dentistry	Boston University, New York City Department of Health and Mental Hygiene, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrest of dental caries as measured by clinical oral examination	For any untreated dental caries on teeth at baseline treated with SDF/FV or Glass ionomer/FV to arrest (control) the infection, what is the proportion of treated (arrested) caries that stayed arrested	Two years
Primary	Prevention of dental caries as measured by a clinical oral examination	For teeth without carious lesions (sound) treated with SDF/FV or Glass Ionomer/FV, what proportion of teeth stayed sound	5 years
Secondary	Oral Health-Related Quality of Life	Child oral health-related quality of life (e.g., functioning, social stigma, socio-emotional) as measured using the Child Oral Health Impact Profile - Short Form (COHIP-SF)	5 years
Secondary	Student achievement on standardized math and English exams	Student achievement on math and English standardized examinations conducted from grades 3-8 given by the New York City Department of Education	5 years
Secondary	School attendance	Annual school attendance per-participant as recorded by the New York City Department of Education	5 years