A Randomized Clinical Trial to Assess Caries Arrest by Using Silver Diamine Fluoride in U.S. Children: Interim Findings

Margherita Fontana; Divya Khera; Steven Levy; George Eckert; Barry Katz; Emily Yanca; Carlos González-Cabezas; Amr Moursi

A Randomized Clinical Trial to Assess Caries Arrest by Using Silver Diamine Fluoride in U.S. Children: Interim Findings

Journal article

Peer reviewed

A Randomized Clinical Trial to Assess Caries Arrest by Using Silver Diamine Fluoride in U.S. Children: Interim Findings

Margherita Fontana, Divya Khera, Steven Levy, George Eckert, Barry Katz, Emily Yanca, Carlos González-Cabezas and Amr Moursi

Pediatric dentistry, Vol.46(1), pp.8-12

01/15/2024

PMCID: PMC10921985

PMID: 38449039

View Online

Abstract

Purpose: To assess the effectiveness of 38 percent silver diamine fluoride (SDF) in arresting cavitated caries lesions in young U.S. children. Methods: Children 12 to 71 months of age with severe early childhood caries participated in this phase three, multicenter, randomized, placebocontrolled trial. SDF was applied twice (at baseline and six months), and children were followed for eight months. A planned interim analysis of only the six-month primary outcome caries arrest data, for approximately half of the cohort (680 of 1,144 children), was conducted using a generalized estimating equation model, accounting for non-independence among carious lesions within a patient. Results: Five hundred ninety-nine of the 680 participants, with 1,413 lesions, completed the six-month exam. Lesions in the SDF group demonstrated 54 percent arrest versus 21 percent in the placebo (P<0.001). Conclusions: Silver diamine fluoride was effective at arresting active cavitated lesions in this population, leading to the early stop of the trial. Final analyses of all data and other outcomes are currently underway.

Cavitated Lesion

Children

Primary Teeth

Sdf

Severe Ecc

Details

Title: Subtitle: A Randomized Clinical Trial to Assess Caries Arrest by Using Silver Diamine Fluoride in U.S. Children: Interim Findings
Creators: Margherita Fontana - University of Michigan
Divya Khera - New York University
Steven Levy - University of Iowa
George Eckert - Indiana University Indianapolis
Barry Katz - Indiana University Indianapolis
Emily Yanca - University of Michigan
Carlos González-Cabezas - University of Michigan
Amr Moursi - New York University
Resource Type: Journal article
Publication Details: Pediatric dentistry, Vol.46(1), pp.8-12
PMID: 38449039
PMCID: PMC10921985
NLM abbreviation: Pediatr Dent
ISSN: 0164-1263
eISSN: 1942-5473
Publisher: American Academy of Pediatric Dentistry
Language: English
Date published: 01/15/2024
Academic Unit: Preventive and Community Dentistry; Epidemiology
Record Identifier: 9984567868702771

Metrics

18 Record Views