Effectiveness of Silver Diamine Fluoride and Sodium Fluoride Varnish in Preventing New Carious Lesion in Preschoolers: A Randomized Clinical Trial

Deshpande, Anshula; Tailor, Brijesh; Jain, Arpit; Shah, Yatish T.; Jaiswal, Vidhi

doi:10.5005/jp-journals-10005-2488

Cited by 7 publications

(4 citation statements)

References 45 publications

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“…29,30 There is a reduced risk of new caries on surrounding sound denti-tion when existing lesions are treated, 31 and SDF is more effective than fluoride varnish in preventing new caries in early childhood. 32 However, prior short-term comparative assessments of SDF have yielded conflicting results on its superiority relative to glass ionomer sealants and atraumatic restorations. 33,34 These previous trials were also restricted to either 12 or 24 months of observation, and little long-term evidence exists.…”

Section: Discussionmentioning

confidence: 99%

Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence

Ruff,

Barry Godín,

Niederman

2024

JAMA Pediatr

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ImportanceDental caries is the world’s most prevalent noncommunicable disease and a source of health inequity; school dental sealant programs are a common preventive measure. Silver diamine fluoride (SDF) may provide an alternative therapy to prevent and control caries if shown to be noninferior to sealant treatment.ObjectiveTo determine whether school-based application of SDF is noninferior to dental sealants and atraumatic restorative treatment (ART) in the prevalence of dental caries.Design, Setting, and ParticipantsThe Silver Diamine Fluoride Versus Therapeutic Sealants for the Arrest and Prevention of Dental Caries in Low-Income Minority Children (CariedAway) study was a pragmatic noninferiority cluster-randomized clinical trial conducted from February 2018 to June 2023 to compare silver diamine fluoride vs therapeutic sealants for the arrest and prevention of dental caries. Children at primary schools in New York, New York, with at least 50% of the student population reporting as Black or Hispanic and at least 80% receiving free or reduced lunch were included. This population was selected as they are at the highest risk of caries in New York. Students were randomized to receive either SDF or sealant with ART; those aged 5 to 13 years were included in the analysis. Treatment was provided at every visit based on need, and the number of visits varied by child. Schools with preexisting oral health programs were excluded, as were children who did not speak English. Of 17 741 students assessed for eligibility, 7418 were randomized, and 4100 completed follow-up and were included in the final analysis.InterventionsParticipants were randomized at the school level to receive either a 38% concentration SDF solution or glass ionomer sealants and ART. Each participant also received fluoride varnish.Main Outcomes and MeasuresPrimary study outcomes were the prevalence and incidence of dental caries.ResultsA total of 7418 children (mean [SD] age, 7.58 [1.90] years; 4006 [54.0%] female; 125 [1.7%] Asian, 1246 [16.8%] Black, 3648 [49.2%] Hispanic, 153 [2.1%] White, 114 [1.5%] multiple races or ethnicities, 90 [1.2%] other [unspecified], 2042 [27.5%] unreported) were enrolled and randomized to receive either SDF (n = 3739) or sealants with ART (n = 3679). After initial treatment, 4100 participants (55.0%) completed at least 1 follow-up observation. The overall baseline prevalence of dental caries was approximately 27.2% (95% CI, 25.7-28.6). The odds of decay prevalence decreased longitudinally (odds ratio [OR], 0.79; 95% CI, 0.75-0.83) and SDF was noninferior compared to sealants and ART (OR, 0.94; 95% CI, 0.80-1.11). The crude incidence of dental caries in children treated with SDF was 10.2 per 1000 tooth-years vs 9.8 per 1000 tooth-years in children treated with sealants and ART (rate ratio, 1.05; 95% CI, 0.97-1.12).Conclusions and RelevanceIn this school-based pragmatic randomized clinical trial, application of SDF resulted in nearly identical caries incidence compared to dental sealants and ART and was noninferior in the longitudinal prevalence of caries. These findings suggest that SDF may provide an effective alternative for use in school caries prevention.Trial RegistrationClinicalTrials.gov Identifier: NCT03442309

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Section: Discussionmentioning

confidence: 99%

Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence

Ruff,

Barry Godín,

Niederman

2024

JAMA Pediatr

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“…Prior estimates of the incidence of caries in children treated with SDF ranges between 23% to 52% less than those receiving placebo 22 , compared to 65% to 70% less in those receiving dental sealants 22 . Similarly, a 2023 randomized trial concluded that SDF was more e=ective in preventing caries in primary teeth compared to fluoride varnish 29 , a review of SDF prevention studies estimated a preventive fraction of 61% for SDF compared to controls and a tooth number needed to treat of 4 and 12.1 for preventing caries in the primary dentition and first permanent molars, respectively 22 , and no di=erences were found between SDF, fluoride varnish, and resin sealants in the twoyear incidence of caries in permanent molars 30 . More recently, a large pragmatic trial conducted in predominantly low-income minority children living in urban areas reported nearly identical prevalence and incidence of caries over time in participants receiving SDF or dental sealants 23,31 .…”

Section: Discussionmentioning

confidence: 99%

School-based caries prevention using silver diamine fluoride: A pragmatic randomized trial in low-income rural children

Ruff,

Niederman

2024

Preprint

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BackgroundDental caries is the world’s most prevalent noncommunicable disease, disproportionately affecting children from low-income families and rural geographic areas.MethodsThe CariedAway 3.0 study was a cluster-randomized pragmatic non-inferiority trial comparing silver diamine fluoride (SDF) to sealants and atraumatic restorations (ART) for the prevention and control of dental caries. All participants also received fluoride varnish. Analysis consisted of mixed-effects logistic regression for caries prevalence and weighted least squares and mixed-effects negative binomial regression for caries incidence. A non-inferiority margin of 10% for the difference between groups was used. Dental caries was defined as an ICDAS score of four or greater.ResultsA total of 3345 children were enrolled across 35 schools; however there was a large proportion of children who were noncompliant and received external dental care over the course of the trial. In adjusted analyses of compliant participants (n=1083; 543 in the SDF group and 540 in the sealant and ART group), there was no difference in the weighted risk difference between treatment groups (B=0.003, 95% CI = -0.0001, 0.0008). The odds of caries prevalence was elevated in the SDF group in longitudinal analyses (OR = 1.35, 95% CI = 0.86, 2.11) but was not significant and was below the non-inferiority margin. There were no significant differences between groups for caries incidence in adjusted models (IRR = 1.19, 95% CI = 0.81, 1.74). Results for intent to treat analyses were similar to that of per-protocol.DiscussionIn this school-based clinical trial, the prevalence of dental caries in children treated with SDF and fluoride varnish was non-inferior compared to those treated with sealants, ART, and fluoride varnish, although the overall risk was slightly higher. Unfortunately, a high rate of dropout and participant noncompliance was observed, likely due to the impacts of COVID-19 on study procedures. As a result, observed effects may be unreliable beyond the short-term.Trial Registration:NCT03448107

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“…Although silver diamine fluoride is primarily used as a caries arresting agent, it is also effective in the prevention of new caries 31,32 . There is a reduced risk of new caries on surrounding sound dentition when existing lesions are treated 33 and SDF is more effective than fluoride varnish in preventing new caries in early childhood 34 . However, prior short term comparative assessments of SDF yields conflicting results on its superiority relative to glass ionomer sealants and atraumatic restorations.…”

Section: Discussionmentioning

confidence: 99%

“…Although silver diamine fluoride is primarily used as a caries arresting agent, it may also be effective in the prevention of new caries 29,30 . There is a reduced risk of new caries on surrounding sound dentition when existing lesions are treated 31 and SDF is more effective than fluoride varnish in preventing new caries in early childhood 32 . Other trials are ongoing 33,34 .…”

Section: Discussionmentioning

confidence: 99%

A school-based randomized clinical trial of silver diamine fluoride for dental caries incidence

Ruff,

Godín,

Niederman

2023

Preprint

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Background: Dental caries is a global health crisis. School-based sealant programs are effective strategies to increase access to care and reduce the risk of caries, but are limited by financial restraints and/or dental workforce barriers. The CariedAway trial was a study of alternative minimally-invasive treatments that can be used in a school-based caries prevention program. Methods: CariedAway was a longitudinal, cluster-randomized, single-blind, pragmatic non-inferiority trial comparing silver diamine fluoride (SDF) to glass ionomer sealants and atraumatic restorations (ART) for dental caries. All subjects also received fluoride varnish. Our subject population included children enrolled in New York City primary schools with a student population of at least 50% Hispanic/Latino or black and 80% from low-income families. Subjects were treated by dental hygienists or registered nurses under the supervision of a licensed pediatric dentist. We report on the four-year cumulative incidence and prevalence of caries. Results: We show that repeated application of a combinative therapy for dental caries consisting of SDF and fluoride varnish had similar effects compared to the standard of care sealants and atraumatic restorations over an approximate four year period. The crude incidence of caries in children treated with SDF was 9.2 per 1,000 tooth-years, versus 8.9 per 1,000 tooth-years in children treated with sealants and ART. The odds of decay prevalence decreased longitudinally (OR = 0.79, 95% CI = 0.753, 0.828) and SDF was non-inferior compared to sealants with ART (OR = 0.94, 90% CI = 0.795, 1.11). Conclusion: For high-risk, underserved populations, a minimally-invasive treatment of SDF with fluoride varnish resulted in similar caries prevalence and incidence compared to the standard of care over four years. Integration of silver diamine fluoride into school-based caries prevention may offer an attractive alternative to traditional school sealant programs.

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Effectiveness of Silver Diamine Fluoride and Sodium Fluoride Varnish in Preventing New Carious Lesion in Preschoolers: A Randomized Clinical Trial

Cited by 7 publications

References 45 publications

Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence

Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence

School-based caries prevention using silver diamine fluoride: A pragmatic randomized trial in low-income rural children

A school-based randomized clinical trial of silver diamine fluoride for dental caries incidence

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