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Silver Diamine Fluoride Treatment Considerations in Children's Caries

Management Brief Communication and Commentary

Article  in  Pediatric dentistry · November 2016

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PEDIATRIC DENTISTRY V 38 / NO 7 NOV / DEC 16

BRIEF COMMUNICATION

Silver Diamine Fluoride Treatment Considerations in Children’s Caries Management

Yasmi O. Crystal, DDS1 • Richard Niederman, DMD2

Abstract: By arresting and preventing caries, silver diamine fluoride (SDF) offers an alternate care path for patients for whom traditional restor-
ative treatment is not immediately available. Current data from controlled clinical trials encompassing more than 3,900 children indicate that
biannual application of SDF reduces progression of current caries and risk of subsequent caries. The purpose of this paper was to highlight
the best evidence from systematic reviews and clinical trials for clinicians to consider the benefits, risks, and limitations as they implement
silver diamine fluoride therapy on young children. Pediatr Dent 2016;38(7):466-71) Received July 11, 2016 | Last Revision September 18, 2016
Accepted September 29, 2016
KEYWORDS: CARIES, SILVER DIAMINE FLUORIDE, CHILDREN

In the United States, children’s caries experience, 1 inequity, 2 tion to the clinical benefit for patients, application of SDF for
and cost of care3 have all increased significantly over the last 20 children with behavioral issues should reduce the clinician’s
years. This suggests that the health systems, current modes of potential legal risk.9
therapy, and/or barriers to care inhibit effective caries control To identify the current best evidence for using SDF in arrest-
and prevention. ing or preventing caries, we searched PubMed for randomized
Consider early childhood caries (ECC) as one example of controlled trials published in English using SDF in children. We
the challenges. Behavioral issues routinely complicate or prevent identified 10 clinical trials, carried out in six countries, exam-
restorative treatment of ECC in young children. Yet, if left ining the application of SDF in 3,904 children10-19 (Table 1).
untreated, the disease progresses, produces pain, has a negative Our commentary is based on their results and protocols. The
impact on the quality of life, and, in extreme cases, can be life methods differed between trials in terms of: teeth (primary
threatening. Further, because of the barriers to accessing dental or permanent; anterior or posterior); frequency of application
care, vulnerable populations go through life with untreated (one time, two times, or three times per year); SDF concentra-
disease.4 tion (10 percent to 38 percent); presence and extent of caries;
In developed countries, uncooperative children have the caries removal; residence time for SDF; children’s age; length
options of care delivered with conscious sedation or in an oper- of follow-up; geographic location of study; control groups;
ating room with general anesthesia. Both increase the risks and and outcome measured (caries arrest [assessed by hardened and
cost of treatment, and restorative care does not address the darkened dentin] and/or caries prevention [assessed by new
underlying bacterial infection. Consequently, there is a high caries]). Even with all this variability, in nine out of 10 studies
recurrence of lesions following restorative care.5 SDF performed better than controls in caries arrest and/or
Numerous systematic reviews of human randomized con- prevention. Finally, using the manufacturer’s MSDS data sheets,
trolled trials now suggest multiple preventive interventions as we calculated and compared the amount of fluoride delivered
alternates to the traditional methods of restorative care.4,6,7 One per dose for both SDF and fluoride varnish.
of these interventions, silver diamine fluoride (SDF), is unique
in both killing the bacteria and hardening the teeth, thus both Commentary
arresting and preventing caries. It appears to be almost twice The most effective treatment was 38 percent SDF twice per
as effective as fluoride varnish for caries arrest.6 The U.S. Food year, which led to nearly 80 percent reduction in both caries
and Drug Administration approved the use of SDF in 2014 as progression19 and subsequent caries on treated teeth,7 which is
a device for the treatment of dentin sensitivity in patients age twice that of fluoride varnish.10,11
21 and older. Consequently, use of SDF for caries prevention The results from randomized controlled trials (Table 1) can
or arrest is off-label, similar to fluoride varnish. serve as an initial foundation for clinical practice implementa-
Interestingly, a 2016 survey of pediatric training programs tion. The combined study results suggest that a reasonable pro-
indicated that, while greater than 90 percent of programs teach tocol for initial SDF use might be the following:
and use fluoride varnish, less than 30 percent of programs use • Twice yearly application of 38 percent SDF is a reason-
SDF.8 The purpose of this paper was to examine the applica- able starting point.
tion of a silver diamine fluoride for caries arrest and prevention • SDF is a viable treatment alternative for high-risk,
in children as a pathway to effective preventive care and provide high-need patients for whom cooperation is a concern.
a suggested protocol based on the current evidence. In addi- Use of a detailed informed consent to fully convey
the benefits and limitations of this therapy is recom-
1Dr. Crystal is a clinical associate professor of Pediatric Dentistry and 2Dr. Niederman is
mended. Clinicians might consider using clinical
a professor and chair, Department of Epidemiology and Health Promotion, New York
photographs with the informed consent.
University College of Dentistry, New York, N.Y., USA. • Thirty-eight percent SDF for arresting carious lesions
Correspond with Dr. Crystal at [email protected] and preventing new caries from forming in school

466 SDF TRE ATMENT IN PEDIATRIC DENTISTRY

 PEDIATRIC DENTISTRY V 38 / NO 7 NOV / DEC 16

Table 1. DESCRIPTION AND CLINICAL DETAILS OF RANDOMIZED CONTROL TRIALS OF SILVER DIAMINE FLUORIDE (SDF) ON CHILDREN

Study Chu et al. 200210 Yee et al. 2009 12 Zhi et al. 201214 Dos Santos et al. 201215 Duangthip et al. 201518

Location China Nepal China Brazil Hong Kong

Dentition Primary anterior only Primary Primary anterior and Primary Primary anterior and
studied posterior posterior
Caries effect Arrest Arrest Arrest Arrest Arrest
studied
Groups 1. SDF (38%) 1x/year 1. SDF (38%) 1x 1. SDF (30%) 1. SDF (30%) 1. SDF (30%) 1x/year
compared with caries removal followed by tannic 1x/year 1x 2. SDF (30%) 1x/
2. SDF (38%) 1x/year acid as reducing agent 2. SDF (30%) 2. ITR (Fuji IX) w/ week for 3 weeks
without caries removal 2.SDF (38%) 1x alone 2x/year conditioner 3. FV (5%) 1x/week
3. FV 5% 4x/year with 3. SDF (12%) 1x 3. GI (Fuji VII) w/condi- 1x for 3 weeks
caries removal alone tioner
4. FV 5% 4x/year 4. No treatment 1x/year
without caries removal
5. water control
Main 1. SDF was more 1. SDF was more 1. SDF and GI are equally 1. SDF was more 1. SDF 1x/year and
findings effective than FV or effective than controls effective (91% arrested effective than ITR SDF 3 consecutive
control (65% arrested (31% arrested lesions lesions for SDF 2x/year (67% arrested lesions weekly applications
lesions for SDF groups for SDF groups vs. vs. 79% SDF 1x/year vs. in SDF group vs. 39% were more effective
vs. 41% for FV groups 22% for SDF 12% 82% GI 1x/year) in control). than
vs. 34% for control). vs. 15% for control). 2. Increasing frequency of FV (40% arrested
2. Caries removal had 2. Tannic acid had no SDF (2x/year) increases lesions with SDF 1x/
no effect. effect. caries arrest. year vs. 35% with only
3. Control group 3. Arrest benefit 3. Anterior teeth and 3 consecutive SDF
developed more new decreases over time. buccal/lingual surfaces applications vs. 27%
caries than treatment are more likely to become with FV).
groups. arrested.

Additional 1. Arrested lesions 1. Single SDF applica- 1. GI provides a more 1. 43% of GIC fillings 1. Lesions in anterior
findings looked black without tion prevented half of esthetic outcome. were lost at 6 mos and teeth, buccal/lingual
changing parental arrested surfaces at 6 2. Only 3.5% retention dentin was soft. surfaces, and lesions
satisfaction (93% of mos from reverting of GI after 24 mos still 2. A higher rate of with no plaque had
parents didn’t mention to active lesions again provides caries arrest. failure was observed a higher chance to
a difference). over 24 mos. 3. 45% of parents in all when GIC involved become arrested.
2. No complaints from groups were satisfied with multiple surfaces.
parents or children to appearance.
SDF.
SDF Clinical *2 treated groups had *No caries removal *Minor excavation *No caries removal *No caries removal
Application caries removal and 2 *One drop of SDF *Doesn’t specify SDF *Doesn’t specify SDF *Doesn’t specify SDF
Protocol didn’t. applied for 2 min to amount used or time of amount used. amount used or kind
*Doesn’t specify SDF carious surfaces and exposure. *Cotton roll isolation, of isolation.
amount used or time dried with cotton *Eating or drinking for 30 Vaseline on gingiva, *SDF rubbed for 10
of exposure. pellet min after. SDF applied for 3 min sec. – no eating or
*No eating or drink- followed by rinse and drinking for 30 min
ing for 1 hr after spit after
*No eating or drink-
ing for 1 hr after
Adverse effects None None None None None
Duration of study 30 mos 24 mos 24 mos 12 mos 18 mos
Baseline caries 3.92 dmfs (active 6.8 dmfs (active 5.1 dmft (3 random teeth/ 3.8 dmft 4.4 dmft
anterior lesions) lesions) child) 6.7 dmfs
Background Low F exposure; Low F exposure; Low F exposure; low access Low F exposure; access F water;
F exposure reported use of F provided F toothpaste to F toothpaste to F toothpaste F toothpaste
toothpaste
No. of subjects 375 976 212 91 304
at baseline
No. of subjects 308 634 181 NA 275
at endpoint
Exams after Every 6 mos 1, 12, and 24 mos Every 6 mos Every 6 mos Every 6 mos
baseline

* Low F exposure=low F in the water, no other professionally applied fluorides nor fluoride supplements.

SDF TRE ATMENT IN PEDIATRIC DENTISTRY 467

PEDIATRIC DENTISTRY V 38 / NO 7 NOV / DEC 16

Table 1. CONTINUED

Fung et al. 201619 Llodra et al. 200511 Braga et al. 200913 Liu et al. 201216 Monse et al. 201217

China Cuba Brazil China Philippines

Primary anterior and Primary cuspids, molars, Permanent 1st molars Permanent 1st molars Permanent 1st molars
posterior and permanent 1st molars
Arrest Arrest and prevention Arrest Prevention Prevention
1. SDF (38%) 2x/year 1. SDF (38%) 2x/year 1. SDF (10%) 3x at 1. SDF (38%) 1x/year 1. SDF (38%) 1x on sound
2. SDF (38%) 1x/year 2. No treatment 1-week interval 2. Resin sealant and cavitated molars
3. SDF (12%) 2x/year 2. GI (Fuji III) sealant 1x 3. 5% NaF varnish 2x year 2. ART (high viscosity
4. SDF (12%) 1x/year 3. Cross tooth-brushing 4. Yearly placebo Ketac molar) on sound and
cavitated molars
Noncavitated carious Deep fissures or noncavi- 3. No treatment (NT)
lesions tated early lesions
Some schools had
On each child, one molar Each child got same toothbrushing programs,
was assigned to each group. treatment in all molars. and some didn’t.

1. SDF 38% 2x/year was 1. SDF 2x/year was more 1. SDF was more effective 1. The 3 active treatments 1. ART sealants were more
more effective than SDF effective for caries arrest than toothbrushing or GI are effective in caries effective than a single
38% 1x/year, SDF 12% than controls (85% at 3 and 6 mos. prevention (progression application of SDF
2x/year, or 1x/year arrested lesions with SDF 2. All were equally effective of caries into dentin was (caries increment in the
(74% arrested lesions vs. vs. 62% in control). in controlling initial 2.2% for SDF, 1.6% for brushing group was:
64%, 55%, and 50%, 2. SDF was effective for (noncavitated) occlusal sealant, 2.4% for FV vs. 0.08 for NT,
respectively). caries reduction in both caries at 30 mos. 4.6% for control). 0.09 for SDF, and
primary and permanent 2. Control group devel- 0.01 for sealants; in
teeth (0.29 surfaces with oped more dentin caries nonbrushing group:
new caries in SDF group vs than treatment groups. 0.17 for NT,
1.43 in control in primary 0.12 for SDF,
teeth and 0.37 vs 1.06 in 0.06 for sealants)
permanent molars). 2. Caries increment was
lower in tooth-brushing
group.

1. Lesion site was signifi- 1. SDF showed more 1. Retention rates for GI 1. Teeth with early caries at 1. Retention rate for
cant, with lower anteriors efficacy to arrest decay sealants were 32% at 6 baseline were more likely sealants was 58% after 18
having the highest rates of in primary teeth than mos and 9% at 30 mos. to develop dentin caries mos.
arrest followed by upper permanent teeth. 2. GI sealants were more after 24 mos
anteriors, lower posterior, time consuming that SDF 2. 46% sealant retention
and upper posterior. application.
2. Lesions with visible
plaque and large lesions
had a lower chance of
becoming arrested.

*Doesn’t specify SDF *Minor decay excavation on *No caries removal * Do e s n’t s p e c i f y S D F * Do e s n’t s p e c i f y S D F
amount used, time of permanent molars only * Do e s n’t s p e c i f y S D F amount used, time of expo- amount used. SDF rubbed
exposure, or kind of isola- * Do e s n’t s p e c i f y S D F amount used. sure, or whether it was for 1 min followed by tannic
tion. amount used. *Cotton roll isolation and rinsed or not acid, dried with cotton
*Cotton roll isolation, petroleum jelly on gingiva, *Cotton roll isolation pellet and covered with
SDF applied for 3 min and SDF applied for 3 min and *No eating or drinking for Vaseline
washed for 30 sec washed for 30 sec 30 min after *Cotton roll isolation
*No eating or drinking for
1 hr after
None 0.1% gingival irritation None None None
18 mos 36 mos 30 mos 24 mos 18 mos
3.84 dmft 3.2 dmft Noncavitated molar occlusal No cavitated lesions At least one sound perma-
5.15 dmfs nent molar
Low F exposure; Low F exposure; Low F exposure; Low F exposure; provided Low F exposure; provided
F toothpaste + 0.2% NaF rinse in school provided F toothpaste F toothpaste F toothpaste
every other week
888 425 22 children, 501 1,016
66 molars
831 373 NA 485 704
Every 6 mos Every 6 mos 3, 6, 12, 18 and 30 mos plus Every 6 mos 18 mos
X rays at 6, 12 and 30 mos

468 SDF TRE ATMENT IN PEDIATRIC DENTISTRY

 PEDIATRIC DENTISTRY V 38 / NO 7 NOV / DEC 16

children is effective in both primary and permanent treatment, due to behavioral or medical limitations,
dentitions (65.9 percent dentin caries arrest overall).11 are willing to accept the treatment. Studies are under
• No caries excavation or removal is necessary.10 How- way to formally explore parental acceptance.
ever, as direct contact of the solution with dentin is 2. Off-label use: More than 60 percent were concerned
required, surfaces clean of food debris are desirable. about off-label use. In fact, fluoride varnish, which
• Study application time ranged from 10 seconds to has become the gold standard of caries prevention for
three minutes with and without drying and with and children, has been used off-label for decades and is
without rinsing following the application. The manu- used in 100 percent of pediatric dental programs.
facturer’s recommendations of 30 to 60 seconds appli- 3. Standard of care: More than 60 percent were concerned
cation with air-drying is consistent with the best study that SDF use is not a standard of care. Based on the
results for caries arrest. human randomized controlled trials published in peer-
• Initial use on posterior pits, fissures, and caries might reviewed journals reported here, SDF meets the legal
be considered given concerns about anterior esthetics. standard of care in more than 34 states.9
• For anterior esthetics, SDF could be followed by glass 4. Evidence-based: More than 60 percent felt that the
ionomer prior to restorative treatment, further reducing evidence was insufficient. Skeptics might offer clarity
risk of caries reoccurrence. on protocols that would improve on those reported
• Posterior teeth and large cavities may have less chances here covering more than 3,900 children treated glo-
of arrest with one-time application. 14,19 However, bally under a variety of conditions.
in most clinical settings, individualized evaluation of 5. Reimbursement: More than 70 percent were con-
the caries and caries arrest on specific surfaces is fea- cerned about reimbursement. The American Dental
sible, so re-application can be tailored to the needs to Association billing code for interim caries arresting
each patient. A one-month follow-up to evaluate arrest medication application is D1354, and fees are dentist-
and need for re-application on active treated carious patient dependent.
surfaces should be advantageous, similar to a post-op 6. Resident training: More than 50 percent were con-
visit after restorative or surgical procedures cerned about training residents. With the wealth of
• The combination of SDF and fluoride varnish remains systematic reviews and human clinical trials, program
an open question. Fluoride varnish is used primarily to directors have a unique evidence-based dentistry teach-
prevent smooth surface caries and remineralize early ing opportunity.
enamel lesions. Conversely, SDF is used primarily for 7. Obtaining product: More than 50 percent were con-
frank carious lesions. Therefore, their combinatorial cerned about obtaining the product. Silver diamine
use may be additive or synergistic and remains to be fluoride (trade name Advantage Arrest) is available
determined. One potential solution is alternating their from Elevate Oral Care LLC (West Palm Beach,
use at three-month intervals. Fla., USA).
• Anterior teeth have higher rates of arrest.14,19 This 8. Cost: Nearly 60 percent were concerned about cost.
could be due to the fact that they are more easily clean- We estimate the material cost to be approximately
sable or that surfaces exposed to light may result in $0.91 per patient ($0.80 for the SDF for one drop of
more active silver precipitation. SDF sufficient to treat eight teeth, and $0.11 for the
micro brush).
Anecdotal evidence reports that, in clinical settings, the
use of a curing light after drying seems to improve arrest in pos- The U.S. Affordable Care Act’s triple aim calls for increa-
terior areas that are not exposed to natural light, as light-cured sing access, improving health, and reducing costs. SDF meets
surfaces immediately turn dark. Formal research is needed to all three aims. The most notable aspects of SDF are its efficacy,
investigate if the arrest in these lesions is at least as effective and ease of use, and low cost. SDF takes 30 seconds to apply, re-
sustainable as the rates reported in the clinical trials. duces caries progression and subsequent caries by 60 to 80
The foregoing would appear to meet the needs of pediatric percent in primary and permanent teeth, and we estimate that
program directors.8 More than 88 percent agree that SDF can the cost is less than $1 per child for supplies.
be used to arrest caries in high-risk patients in primary teeth SDF also meets the U.S. Institute of Medicines six quality
(87 percent agree) and permanent teeth (66 percent agree). aims20 of being: safe (e.g., without adverse events); effective
There is greater than 90 percent agreement that SDF will be
useful in treating patients who have difficulty receiving conven-
Table 2. FLUORIDE CONTENT IN SILVER DIAMINE FLUORIDE
tional treatment (e.g., precooperative, behavioral, or medically
(SDF) AND FLUORIDE VARNISH (FV) COMMERCIAL
fragile). Paradoxically, less than 50 percent agree that SDF will
UNIT DOSES*
be useful for caries prevention in incipient lesions.
The barriers to SDF use identified by program directors 8 Fluoride Unit dose Concentration F ion F ion
all appear to contradict the current best evidence identified here. product (ml) (ppm) mg/ml mg/dose
They include the following: SDF 38% 1 drop 44,800 44.8 2.24
1. Parental acceptance: Greater than 90 percent believe (0.05)
that parental acceptance is a concern. Where stud- 0.25 22,600 22.6 5.65
ied,10,12,14 parental concern about the staining was less FV
5% NaF 0.4 22,600 22.6 9.04
than seven percent, but we acknowledge the fact that
these studies took place in settings where esthetic con- 0.5 22,600 22.6 11.3
cerns may be different than U.S. standards. It is
our experience that parents with limited options for * Fluoride content equivalence (approximate): 2 drops SDF=small (.25 ml) FV.

SDF TRE ATMENT IN PEDIATRIC DENTISTRY 469

PEDIATRIC DENTISTRY V 38 / NO 7 NOV / DEC 16

Finally, there is some concern about potential adverse

events from SDF use. A primary concern is the child’s fluoride
dose. As indicated in Table 2, one drop of SDF, which is
enough to treat six teeth, contains approximately half the fluor-
ide level of the smallest unit dose used for a fluoride varnish
application. Clinicians are also concerned about parents’ response
to the tooth discoloration. Most parents in the trials studied
did not mind the staining associated with caries arrest in the
communities where it was tested. As seen in Figures 1 and 2,
the dentinal carious tissues change color from dark brown to
black. Porous incipient enamel lesions can darken as well. As
with all care, a detailed informed consent delineating the be-
nefits and potential esthetic limitations of this therapy are
needed. Clearly, the esthetic concern is paramount if one
applies SDF to noncavitated porous enamel lesions on anterior
teeth. Another concern is the pulpal or gingival reaction. In the
identified studies, no children exhibited negative reactions to
Figure 1. Anterior/posterior staining following application of silver diamine the treatment, no adverse pulpal responses were observed, and
fluoride - Esthetic restorations can be used at a future date when the caries only 0.1 percent of children noted slight gingival irritation.
process is under control, after the advantages provided by immediate arrest
have had an effect: reduced sensitivity, improved hygiene, improved gin-
gival health, enamel and dentin remineralization, tissue preservation. In summary, silver diamine fluoride appears to be a useful
immediate treatment for children who can’t receive traditional
restorative treatment for dental decay. It is effective for caries
arrest and prevention of new lesions on the teeth where it is
applied, and it is a minimal intervention treatment that is safe
and affordable. Considering the aforementioned information,
it might be expected that SDF will be widely implemented for
caries control to meet patient needs and the national goals of
both the Affordable Care Act and the Institute of Medicine’s
quality aims.

Acknowledgment
This work was supported in part by NIH/NIMHD U24
006964 and by the NYU CTSA grant 1UL1TR001445 from
the National Center for the Advancement of Translational Sci-
ence (NCATS), NIH.

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SDF TRE ATMENT IN PEDIATRIC DENTISTRY 471

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