Clinical trial NCT03448107: Comparative Effectiveness of Treatments to Prevent Dental Caries
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: dental caries
caries arrest
caries prevention
silver diamine fluoride
sealants
interim therapeutic restorations
Lead sponsor: NYU College of Dentistry
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-02-27
Enrollment: 3345
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 Hampshire.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Arrested Dental Caries, Assessed Using a Clinical Oral Examination
timeFrame: Two years
measure: Caries Prevention
timeFrame: Five years
Secondary outcomes:
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, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruff RR, Niederman R. Comparative effectiveness of treatments to prevent dental caries given to rural children in school-based settings: protocol for a cluster randomised controlled trial. BMJ Open. 2018 Apr 13;8(4):e022646. doi: 10.1136/bmjopen-2018-022646.