Comparative Effectiveness of Treatments to Prevent Dental Caries

Dental Caries Clinical Trial

Official title:

Comparative Effectiveness of Treatments to Prevent Dental Caries Given to Rural Children in School-based Settings: Protocol for a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448107
• Other study ID #: i17-01221
• Secondary ID: R01MD011526
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• 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 Hampshire.

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 children enrolled in public elementary schools in New Hampshire from 2017-2023. The primary objective is to assess the non-inferiority of alternative agents in the arrest and prevention of dental caries. Caries arrest will be evaluated after two years, and caries prevention 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: 3345
• 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 with a previously employed caries prevention program operating in rural areas, with official Title 1 status, and located in a health professional shortage area. Within participating schools, all children are eligible to participate in the study. Those with informed consent and assent will receive care.

Exclusion Criteria:

• Children without informed consent or those with consent but without assent.

Related Conditions & MeSH terms

• Dental Caries

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 (2)

Lead Sponsor	Collaborator
NYU College of Dentistry	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrest of dental caries assessed based on a 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	Caries prevention	For teeth without carious lesions (sound teeth) treated with SDF/FV or Glass ionomer/FV, what proportion of teeth stayed sound	Five years