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Pediatr Dent. Author manuscript; available in PMC 2017 May 15. Published in final edited form as: Pediatr Dent. 2016 November 15; 38(7): 466–471.
Silver Diamine Fluoride Treatment Considerations in Children's Caries Management Brief Communication and Commentary Yasmi O Crystal, DDS [Clinical Associate Professor] and Pediatric Dentistry, New York University College of Dentistry, New York, NY, [email protected]
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Richard Niederman, DMD [Professor and Chair] Department of Epidemiology & Health Promotion, New York University College of Dentistry, New York, NY. [email protected]
Abstract By arresting and preventing caries, SDF offers an alternate care path for patients for whom traditional restorative treatment is not immediately available. Current data from controlled clinical trials encompassing more than 3900 children, indicates that biannual application of SDF reduces progression of current and risk of subsequent caries. This commentary highlights the best evidence from systematic reviews and clinical trials for clinicians to consider the benefits, risks and limitations as they implement SDF therapy on young children.
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Keywords caries; silver diamine fluoride; children
Background In the U.S., children's caries experience1, inequity2, and cost of care3 all increased significantly over the last 20 years. This suggests that the health systems, the current modes of therapy, and/or barriers to care inhibit effective caries control and prevention.
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Consider early childhood caries (ECC) as one example of the challenges. Behavioral issues routinely complicate or prevent restorative treatment of ECC in young children. Yet, if left untreated, the disease progresses producing pain, has a negative impact on the quality of life, and in extreme cases can be life threatening. Further, because of the barriers to accessing dental care, vulnerable populations go through life with untreated disease4. In developed countries, uncooperative children have the options of care delivered with conscious sedation, or in an operating room with general anesthesia. Both increase the risks and cost of treatment and restorative care does not address the underlying bacterial infection. Consequently, there is a high recurrence of lesions following restorative care5.
Disclosure: No conflicts of interest to disclose 1PubMed search strategy: (silver nitrate OR silver diamine fluoride OR silver fluoride) AND (caries OR tooth demineralization OR tooth decay)
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Numerous systematic reviews of human randomized controlled trials now suggest multiple preventive interventions as alternates to the traditional methods of restorative care.4, 6, 7 One of those interventions, silver diamine fluoride, is unique in both killing the bacteria and hardening the teeth, thus both arresting and preventing caries. It appears to be almost twice as effective as fluoride varnish for caries arrest 6. The U.S. Food and Drug Administration approved the use of SDF in 2014 as a device for the treatment of dentin sensitivity on patients 21 and older. Thus use of SDF for caries prevention or arrest is off-label, similar to fluoride varnish.
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Interestingly, a 2016 survey of pediatric training programs indicated that while greater than 90 percent of programs teach and use fluoride varnish, less than 30 percent of programs use SDF 8. Here we examine the application of SDF for caries arrest and prevention in children as a pathway to effective preventive care and provide a suggested protocol based on the current evidence. In addition to the clinical benefit for patients, application of SDF for children with behavioral issues should reduce the clinician's potential legal risk9.
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To identify the current best evidence for using SDF in arresting or preventing caries we searched PubMed for randomized controlled trials published in English using SDF in children. We identified 10 clinical trials, carried out in six countries, examining the application of SDF in 3,904 children10-19 (Table 1). Our commentary is based on their results and protocols. The methods differed between trials in terms of: teeth (primary or permanent; anterior or posterior); frequency of application (one time, two times, or three times per year); SDF concentration (10 percent to 38 percent); presence and extent of caries; caries removal; residence time for SDF; children's age; length of follow up; geographic location of study; control groups; and outcome measured: caries arrest (assessed by hardened and darkened dentin) and/or caries prevention (assessed by new caries). Even with all this variability, in nine out of 10 studies, SDF performed better than controls in caries arrest and/or prevention. Finally, using the manufacturer's MSDS data sheets we calculated and compared the amount of fluoride delivered per dose for both SDF and fluoride varnish.
Commentary The most effective treatment was 38 percent SDF twice per year, which lead to almost 80 percent reduction in both caries progression19 and subsequent caries on treated teeth7, which is twice that of fluoride varnish10, 11.
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The results from RCTs (Table 1) can serve as an initial foundation for clinical practice implementation. The combined study results suggest that a reasonable protocol for initial SDF use might be the following: •
Twice yearly application of SDF 38 percent is a reasonable starting point.
•
SDF is a viable treatment alternative for high-risk, high-need patients for whom cooperation is a concern.
•
Use of a detailed informed consent to fully convey the benefits and limitations of this therapy is recommended. Clinicians might consider using clinical photographs with the informed consent.
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•
Thirty-eight percent SDF for arresting caries lesions and preventing new caries from forming in school children is effective in both primary and permanent dentitions (65.9 percent dentine caries arrest overall 11).
•
No caries excavation or removal is necessary.10 However, as direct contact of the solution with dentin is required, surfaces clean of food debris are desirable.
•
Study application time ranged from 10 seconds to three minutes with and without drying and with and without rinsing following the application. The manufacturer's recommendations of 30 to 60 seconds application with air-drying is consistent with the best study results for caries arrest.
•
Initial use on posterior pits, fissures, and caries might be considered given concerns about anterior esthetics.
•
For anterior esthetics, SDF could be followed by glass ionomer prior to restorative treatment further reducing risk of caries re-occurrence.
•
Posterior teeth and large cavities may have less chances of arrest with one-time application14, 19. However, in most clinical settings, individualized evaluation of the caries and caries arrest on specific surfaces is feasible, so re-application can be tailored to the needs to each patient. A one-month follow-up to evaluate arrest and need for re-application on active treated carious surfaces should be advantageous, similar to a post-op visit after restorative or surgical procedures
•
The combination of SDF and fluoride varnish remains an open question. Fluoride varnish is used primarily to prevent smooth surface caries and remineralize early enamel lesions. Conversely, SDF is used primarily for frank carious lesions. Therefore, their combinatorial use may be additive or synergistic, and remains to be determined. One potential solution is alternating their use at three-month intervals.
•
Anterior teeth have higher rates of arrest.14, 19 This could be due to the fact that they are more easily cleansable, or that surfaces exposed to light may result in more active silver precipitation.
Anecdotal evidence reports that in clinical settings, the use of a curing light after drying seems to improve arrest in posterior areas that are not exposed to natural light, as light-cured surfaces immediately turn dark. Formal research is needed to investigate if the arrest in these lesions is at least as effective and sustainable as the rates reported in the clinical trials.
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The foregoing would appear to meet the needs of pediatric program directors8. More than 88 percent agree that SDF can be used to arrest caries in high-risk patients in primary (87 percent agree) and permanent (66 percent agree) teeth. There is greater than 90 percent agreement that SDF will be useful in treating patients who have difficulty receiving conventional treatment (e.g.: pre-cooperative, behavioral, or medically fragile). Paradoxically, less than 50 percent agree that SDF will be useful for caries prevention in incipient lesions.
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The barriers to SDF use identified by program directors8 all appear to contradict the current best evidence identified here. They include the following: (1) Parental acceptance: Greater than 90 percent believe that parental acceptance is a concern. Where studied10, 12, 14 parental concern to the staining was less than seven percent, but we acknowledge the fact that these studies took place in settings where esthetic concerns may be different than US standards. It is our experience that parents with limited options for treatment due to behavioral or medical limitations, are willing to accept the treatment. Studies are under way to formally explore parental acceptance. (2) Off label use: More than 60 percent were concerned about off label use. In fact, fluoride varnish, which has become the gold standard of caries prevention for children, has been used off label for decades, and is used in 100 percent of pediatric dental programs. (3) Standard of care: More than 60 percent were concerned that SDF use is not a standard of care. Based on the human randomized controlled trials, published in peer reviewed journals reported here, SDF meets the legal standard of care in more than 34 states9. (4) Evidence based: More than 60 percent felt that the evidence was insufficient. Skeptics might offer clarity on protocols that would improve on those reported here covering more than 3,900 children treated globally under a variety of conditions. (5) Reimbursement: More than 70 percent were concerned about reimbursement. The American Dental Association billing code for interim caries arresting medication application is D1354, and fees are dentist-patient dependent. (6) Resident training: More than 50 percent were concerned about training residents. With the wealth of systematic reviews and human clinical trials, program directors have a unique evidence-based dentistry teaching opportunity. (6) Obtaining product: More than 50 percent were concerned about obtaining the product. Silver diamine fluoride (trade name Advantage Arrest) is available from Elevate Oral Care LLC, Fla, US. (7) Cost: Almost 60 percent were concerned about cost. We estimate the material cost to be approximately $0.91 per patient ($0.80 for the SDF for one drop of SDF sufficient to treat eight teeth, and $0.11 for the micro brush). The U.S. Affordable Care Act's triple aim calls for: increasing access, improving health, and reducing costs. SDF meets all three aims. The most notable aspects of SDF are its efficacy, ease of use, and low cost. SDF takes 30 seconds to apply, reduces caries progression and subsequent caries by 60- 80 percent in primary and permanent teeth, and we estimate that the cost is less than one dollar per child for supplies.
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SDF also meets the U.S. Institute of Medicines six quality aims20 of: safe (e.g.: without adverse events), effective (e.g.: reduces caries progression and subsequent caries by almost 80 percent on treated teeth); efficient (e.g.: can be applied by health professional in any location where children learn, play, and pray), timely (e.g.: takes less than 30 seconds), patient centered (e.g.: meets immediate needs of child in one treatment); equitable (e.g.: is equally effective for all socioeconomic groups, races, ethnicities and cultures). Biologically, silver diamine fluoride is a bi-functional agent. The silver directly kills caries causing bacteria, while silver and fluoride interact synergistically to form fluorapatite, hardening the teeth preventing further demineralization6. More specifically, at the molecular level, silver ions interact with sulfhydryl groups of proteins and DNA altering hydrogen bonding, thus inhibiting respiratory processes, cell wall synthesis, and cell division.6 At the macro level, these interactions effect bacterial killing and inhibit biofilm formation.
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Simultaneously the silver precipitates onto the surface of the tissues creating the brownblack surface especially in dentin, which together with the hardening of the tissue are the clinical indications of “caries arrest”.
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Finally, there is some concern about the potential adverse events from SDF use. A primary concern is the child's fluoride dose. As indicated in Table 2, one drop of SDF, enough to treat six teeth, contains approximately half the fluoride 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 color changes from dark brown to black. Porous incipient enamel lesions can darken as well. As with all care, a detailed informed consent delineating the benefits and potential esthetic limitations of this therapy are needed. Clearly the esthetic concern is paramount if one applies SDF to non-cavitated porous enamel lesions on anterior teeth. Another concern is the pulpal or gingival reaction. In the identified studies, no children exhibited negative reactions to the treatment, no adverse pulpal responses, and only 0.1 percent of children noted slight gingival irritation.
Conclusions In summary, SDF 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 is a minimal intervention treatment that is safe and affordable.
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Given the foregoing, it might be expected that SDF will be widely implemented for caries control to meet our patient's needs, as well as national goals of both the Affordable Care Act's and the Institute of Medicine's quality aims.
Acknowledgements 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 Science (NCATS), NIH.
References
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1. Marcenes W, Kassebaum NJ, Bernabe E, et al. Global burden of oral conditions in 1990-2010: a systematic analysis. J Dent Res. 2013; 92(7):592–7. [PubMed: 23720570] 2. Capurro DA, Iafolla T, Kingman A, Chattopadhyay A, Garcia I. Trends in income-related inequality in untreated caries among children in the United States: findings from NHANES I, NHANES III, and NHANES 1999-2004. Community Dent Oral Epidemiol. 2015; 43(6):500–10. [PubMed: 26037290] 3. CMS National Health Expenditure Expenditures by type of service and sourc of funds. U.S. Department of Health and Human Services; 2015. CY 1960-2014. https://www.cms.gov/ResearchStatistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/ NationalHealthAccountsHistorical.html [7/11/2016] 4. Niederman, R., Feres, M., Ogunbodede, E. Dentistry.. In: Debas, HT.Donkor, P.Gawande, A.Jamison, DT.Kruk, ME., Mock, CN., editors. Essential Surgery: Disease Control Priorities. The 2015 International Bank for Reconstruction and Development / The World Bank; Washington (DC): 2015. p. 173-95.
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5. Berkowitz RJAA, et al. Dental Caries recurrence following clinical treatment for severe early childhood caries. Pediatr Dent. 2011; 33(7):510–14. [PubMed: 22353412] 6. Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries “silver-fluoride bullet”. J Dent Res. 2009; 88(2):116–25. [PubMed: 19278981] 7. Gao SS, Zhao IS, Hiraishi N, et al. Clinical Trials of Silver Diamine Fluoride in Arresting Caries among Children: A Systematic Review. JDR Clinical & Translational Research. 2016 8. Nelson T, Scott JM, Crystal YO, Berg JH, Milgrom P. Silver Diamine Fluoride in Pediatric Dentistry Training Programs: Survey of Graduate Program Directors. Pediatr Dent. 2016; 38(3):212–7. [PubMed: 27306245] 9. Niederman R, Richards D, Brands W. The changing standard of care. J Am Dent Assoc. 2012; 143(5):434–7. [PubMed: 22547707] 10. Chu CH, Lo ECM, Lin HC. Effectiveness of Silver Diamine Fluoride and Sodium Fluoride Varnish in Arresting Dentin Caries in Chinese Pre-school Children. J Dent Res. 2002; 81(11):767–70. [PubMed: 12407092] 11. Llodra JC, Rodriguez A, Ferrer B, et al. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005; 84(8):721–4. [PubMed: 16040729] 12. Yee R, Holmgren C, Mulder J, et al. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009; 88(7):644–7. [PubMed: 19641152] 13. Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009; 76(1):28–33. [PubMed: 19341576] 14. Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012; 40(11):962–7. [PubMed: 22892463] 15. Dos Santos VE Jr. de Vasconcelos FM, Ribeiro AG, Rosenblatt A. Paradigm shift in the effective treatment of caries in schoolchildren at risk. Int Dent J. 2012; 62(1):47–51. [PubMed: 22251037] 16. Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012; 91(8):753–8. [PubMed: 22736448] 17. Monse B, Heinrich-Weltzien R, Mulder J, Holmgren C, Helderman WHvP. Caries preventive efficacy of silver diammine fluoride (SDF) and ART sealants in a school-based daily fluoride toothbrushing program in the Philippines. BMC Oral Health. 2012:12. [PubMed: 22639910] 18. Duangthip D, Chu CH, Lo EC. A randomized clinical trial on arresting dentine caries in preschool children by topical fluorides-18 month results. J Dent. 2015 19. Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Arresting Dentine Caries with Different Concentration and Periodicity of Silver Diamine Fluoride. JDR Clinical & Translational Research. 2016; 1(2):143–52. 20. Atchison KA. Using information technology and community-based research to improve the dental health-care system. Adv Dent Res. 2003; 17:86–8. [PubMed: 15126215]
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FIGURE 1. anterior/posterior staining
Esthetic restorations can be used at a future date when the caries process is under control, after the advantages provided by immediate arrest have had an effect: reduced sensitivity, improved hygiene, improved gingival health, enamel and dentin remineralization, tissue preservation.
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FIGURE 2. Posterior staining
Esthetic restorations can be used at a future date when the caries process is under control, after the advantages provided by immediate arrest have had an effect: reduced sensitivity, improved hygiene, improved gingival health, enamel and dentin remineralization, tissue preservation.
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Yee et al 200912
Nepal
primary
Arrest
1. SDF (38%) 1x followed by tannic acid as reducing agent 2.SDF (38%) 1x alone 3.SDF (12%) 1x alone 4.no treatment
1.SDF was more effective than controls (31% arrested lesions for SDF groups vs. 22% for SDF 12% vs. 15% for control) 2.Tannic acid had no effect 3.Arrest benefit decreases over time.
1.single SDF application prevented half of arrested surfaces at 6 months from reverting to
Chu et al 200210
China
Primary anterior only
Arrest
1.SDF (38%) 1x/year with caries removal 2.SDF (38%) 1x/year without caries removal 3.FV 5% 4x year with caries removal 4.FV 5% 4x year without caries removal 5.water control
1.SDF was more effective than FV or control. . (65% arrested lesions for SDF groups vs. 41% for FV groups vs. 34% for control) 2.Caries removal had no effect. 3.Control group developed more new caries than treatment groups.
1. arrested lesions looked black without changing parental satisfaction (93% of parents didn't mention a difference)
Location
Dentition studied
Caries effect studied
Groups compared
Main findings
Additional findings
Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
1.GI provides a more esthetic outcome. 2.only 3.5% retention of GI after 24 months still
1.SDF and GI are equally effective. (91% arrested lesions for SDF 2x/ year vs. 79% SDF 1x/year, vs. 82% GI 1x/ year) 2.Increasing frequency of SDF (2x/year) increases caries arrest. 3.Anterior teeth and buccal/lingual surfaces are more likely to become arrested.
1.SDF (30%) 1x/year 2.SDF (30%) 2x/year 3.GI (Fuji VII) w/conditioner 1x/year
Arrest
Primary anterior and posterior
China
Zhi et al 201214
1.43% of GIC fillings were lost at 6 months and dentin was soft.
1. SDF was more effective than ITR. (67% arrested lesions in SDF group vs. 39% in control)
1.SDF(30%) 1x 2.ITR (Fuji IX) w/ conditioner 1x.
Arrest
Primary
Brazil
Dos Santos et al 201215
1. lesions in anterior teeth, buccal/lingual surfaces and lesions with no plaque had a
1. SDF 1x/year and SDF 3 consecutive weekly applications were more effective than FV. (40% arrested lesions with SDF 1x/ year vs.35% with only 3 consecutive SDF applications vs. 27% with FV)
1.SDF (30%) 1x/year 2.SDF (30%) 1x/week for 3 weeks 3.FV (5%) 1x/ week for 3 weeks
Arrest
Primary anterior and posterior
Hong Kong
Duangthip et al 201518
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Study
1.lesion site was significant, with lower anteriors having the highest rates of
1. SDF 38% 2x/year was more effective than SDF 38%1x/year, SDF12% 2x/ year or 1x/year (74% arrested lesions vs. 64%, 55% and 50% respectively)
1.SDF (38%) 2x/year 2.SDF (38%) 1x/year 3.SDF (12%) 2x/year 4.SDF (12%) 1x/year
Arrest
Primary anterior and posterior
China
Fung et al 201619
1. SDF showed more efficacy to arrest decay in deciduous teeth than permanent teeth.
1.SDF 2x/year was more effective for caries arrest than controls. (85% arrested lesions with SDF vs. 62% in control) 2.SDF was effective for caries reduction in both primary and permanent teeth. (0.29 surfaces with new caries in SDF group vs 1.43 in control in primary teeth and 0.37 vs 1.06 in permanent molars)
1.SDF (38%) 2x/year 2.No treatment
Arrest and prevention
Primary cuspids, molars and permanent 1rst molars
Cuba
Llodra et al 200511
1.retention rates for GI sealants were 32% at 6 months and 9% at 30 months 2.GI sealants were more time consuming that SDF application.
1.SDF was more effective than toothbrushing or GI at 3 and 6 months. 2.All equally effective in controlling initial (noncavitated) occlusal caries at 30 months.
1. SDF (10% ) 3x at 1 week interval 3. GI (Fuji III) sealant 1x 3. Cross tooth-brushing Non cavitated caries lesions On each child one molar was assigned to each group.
Arrest
Permanent 1st molars
Brazil
Braga et al 200913
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Description and Clinical Details of Randomized Control Trials on Children
1.teeth with early caries at baseline were more likely to develop dentin caries after 24 months 2.46% sealant retention
1.The 3 active treatments are effective in caries prevention. (progression of caries into dentin was 2.2% for SDF, 1.6% for sealant, 2.4% for FV vs. 4.6% for control) 2.Control group developed more dentin caries than treatment groups.
1.SDF (38%) 1x/year 2.Resin sealant 3.5% NaF varnish 2x year 4.yearly placebo Deep fissures or noncavitated early lesions. Each child got same tx. in all molars.
Prevention
Permanent 1st molars
China
Liu et al 201216
1. retention rate for sealants was 58% after 18 months.
1.ART sealants were more effective than a single application of SDF (caries increment in the brushing group was: .08 for NT .09 for SDF .01 for sealants in non brushing group: .17 for NT .12 for SDF .06 for sealants) 2.Caries increment was lower in tooth-brushing group.
1. SDF (38%) 1x on sound and cavitated molars. 2.ART (high viscosity Ketac molar) on sound and cavitated molars. 3.no treatment (NT) Some schools had toothbrushing programs and some didn't
Prevention
Permanent 1st molars
Philipinnes
Monse et al 201217
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Table 1 Crystal and Niederman Page 9
Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
24 months
6.8 dmfs (active lesions)
Low F exposure Provided F toothpaste
976
634
1,12 and 24 months
30 months
3.92 dmfs (active anterior lesions)
Low F exposure reported use of F toothpaste
375
308
X 6 months
Duration of study
Baseline caries
Background F exposure
# subjects at baseline
# subjects at endpoint
Exams after baseline
*
X 6 months
181
212
Low F exposure low access to F toothpaste
5.1 dmft (3 random teeth/ child)
24 months
None
* no eat or drink for 30 min after
X 6 months
?
91
Low F exposure access to F toothpaste
3.8 dmft
12 months
None
no eat or drink for 1 hr.
*
cotton roll isolation, Vaseline on gingiva, SDF applied for 3 min and rinse and spit
*
doesn't specify SDF amount used;
*
doesn't specify SDF amount used or time of exposure
no caries removal
*
minor excavation
*
2.higher rate of failure when GIC involved multiple surfaces.
Dos Santos et al 201215
low F exposure = low F in the water, no other professionally applied fluorides nor fluoride supplements.
*
None
no eat or drink for 1 hr after
*
one drop of SDF applied for 2 min to carious surfaces and dried with cotton pellet.
*
no caries removal
*
None
* doesn't specify SDF amount used or time of exposure
*
2 treated groups had caries removal and 2 didn't.
Adverse effects
SDF Clinical Application Protocol
provides caries arrest 3.45% of parents in all groups were satisfied with appearance.
active lesions again over 24 months. 2.no complaints from parents or children to SDF
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Zhi et al 201214
X 6 months
275
304
F water F toothpaste
4.4 dmft 6.7 dmfs
18 months
None
SDF rubbed for 10 sec. - no eat or drink for 30 min.
*
*
doesn't specify SDF amount used or kind of isolation.
no caries removal
*
higher chance to become arrested
Duangthip et al 201518
X 6 months
831
888
Low F exposure F toothpaste
3.84 dmft 5.15 dmfs
18 months
None
doesn't specify SDF amount used, time of exposure, or kind of isolation
*
arrest followed by upper anteriors, lower posterior and upper posterior. 2.Lesions with visible plaque and large lesions had lower chance of becoming arrested.
Fung et al 201619
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Yee et al 200912
X 6 months
373
425
Low F exposure + 0.2% NaF rinse in school every other week
3.2 dmft
36 months
0.1% Gingival irritation
cotton roll isolation, SDF applied for 3 min and wash for 30 sec.
*
doesn't specify SDF amount used
*
*
minor decay excavation on permanent molars only.
Llodra et al 200511
no caries removal
3, 6, 12, 18 and 30 months plus X rays at 6, 12 and 30 months
?
22 children, 66 molars
Low F exposure Provided F toothpaste
Non-cavitated molar occlusal
30 months
None
no eat or drink for 1 hr.
*
cotton roll isolation and petroleum jelly on gingiva, SDF applied for 3 min and wash for 30 seconds.
*
doesn't specify SDF amount used
*
*
Braga et al 200913
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Chu et al 200210
X 6 months
485
501
Low F exposure Provided F toothpaste
No cavitated lesions
24 months
None
no eat or drink for 30 min.
cotton roll isolation
*
*
doesn't specify SDF amount used, time of exposure, or whether it was rinsed or not
*
Liu et al 201216
18 months
704
1016
Low F exposure Provided F toothpaste
At least one sound permanent molar
18 months
None
cotton roll isolation
*
doesn't specify SDF amount used, SDF rubbed for 1 min. followed by tannic acid, dried with cotton pellet and covered with vaseline
*
Monse et al 201217
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Study
Crystal and Niederman Page 10
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Author Manuscript 22,600 PPM
0.5 ml
F content equivalence (aprox.): 2 drops SDF = small (.25 ml) FV
22,600 PPM
22,600 PPM
0.4 ml
0.25 ml
Fluoride Varnish 5% NaF
44,800 PPM
1 drop (0.05 ml)
SDF 38%
Concentration
Unit dose
Fluoride product
22.6
22.6
22.6
44.8
F ion mg/ml
Author Manuscript 11.3
9.04
5.65
2.24
F ion mg/dose
Fluoride content in SDF and Fluoride Varnish commercial unit doses
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Table 2 Crystal and Niederman Page 11
Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
Pediatr Dent. Author manuscript; available in PMC 2017 May 15. Published in final edited form as: Pediatr Dent. 2016 November 15; 38(7): 466–471.
Silver Diamine Fluoride Treatment Considerations in Children's Caries Management Brief Communication and Commentary Yasmi O Crystal, DDS [Clinical Associate Professor] and Pediatric Dentistry, New York University College of Dentistry, New York, NY, [email protected]
Author Manuscript
Richard Niederman, DMD [Professor and Chair] Department of Epidemiology & Health Promotion, New York University College of Dentistry, New York, NY. [email protected]
Abstract By arresting and preventing caries, SDF offers an alternate care path for patients for whom traditional restorative treatment is not immediately available. Current data from controlled clinical trials encompassing more than 3900 children, indicates that biannual application of SDF reduces progression of current and risk of subsequent caries. This commentary highlights the best evidence from systematic reviews and clinical trials for clinicians to consider the benefits, risks and limitations as they implement SDF therapy on young children.
Author Manuscript
Keywords caries; silver diamine fluoride; children
Background In the U.S., children's caries experience1, inequity2, and cost of care3 all increased significantly over the last 20 years. This suggests that the health systems, the current modes of therapy, and/or barriers to care inhibit effective caries control and prevention.
Author Manuscript
Consider early childhood caries (ECC) as one example of the challenges. Behavioral issues routinely complicate or prevent restorative treatment of ECC in young children. Yet, if left untreated, the disease progresses producing pain, has a negative impact on the quality of life, and in extreme cases can be life threatening. Further, because of the barriers to accessing dental care, vulnerable populations go through life with untreated disease4. In developed countries, uncooperative children have the options of care delivered with conscious sedation, or in an operating room with general anesthesia. Both increase the risks and cost of treatment and restorative care does not address the underlying bacterial infection. Consequently, there is a high recurrence of lesions following restorative care5.
Disclosure: No conflicts of interest to disclose 1PubMed search strategy: (silver nitrate OR silver diamine fluoride OR silver fluoride) AND (caries OR tooth demineralization OR tooth decay)
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Numerous systematic reviews of human randomized controlled trials now suggest multiple preventive interventions as alternates to the traditional methods of restorative care.4, 6, 7 One of those interventions, silver diamine fluoride, is unique in both killing the bacteria and hardening the teeth, thus both arresting and preventing caries. It appears to be almost twice as effective as fluoride varnish for caries arrest 6. The U.S. Food and Drug Administration approved the use of SDF in 2014 as a device for the treatment of dentin sensitivity on patients 21 and older. Thus use of SDF for caries prevention or arrest is off-label, similar to fluoride varnish.
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Interestingly, a 2016 survey of pediatric training programs indicated that while greater than 90 percent of programs teach and use fluoride varnish, less than 30 percent of programs use SDF 8. Here we examine the application of SDF for caries arrest and prevention in children as a pathway to effective preventive care and provide a suggested protocol based on the current evidence. In addition to the clinical benefit for patients, application of SDF for children with behavioral issues should reduce the clinician's potential legal risk9.
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To identify the current best evidence for using SDF in arresting or preventing caries we searched PubMed for randomized controlled trials published in English using SDF in children. We identified 10 clinical trials, carried out in six countries, examining the application of SDF in 3,904 children10-19 (Table 1). Our commentary is based on their results and protocols. The methods differed between trials in terms of: teeth (primary or permanent; anterior or posterior); frequency of application (one time, two times, or three times per year); SDF concentration (10 percent to 38 percent); presence and extent of caries; caries removal; residence time for SDF; children's age; length of follow up; geographic location of study; control groups; and outcome measured: caries arrest (assessed by hardened and darkened dentin) and/or caries prevention (assessed by new caries). Even with all this variability, in nine out of 10 studies, SDF performed better than controls in caries arrest and/or prevention. Finally, using the manufacturer's MSDS data sheets we calculated and compared the amount of fluoride delivered per dose for both SDF and fluoride varnish.
Commentary The most effective treatment was 38 percent SDF twice per year, which lead to almost 80 percent reduction in both caries progression19 and subsequent caries on treated teeth7, which is twice that of fluoride varnish10, 11.
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The results from RCTs (Table 1) can serve as an initial foundation for clinical practice implementation. The combined study results suggest that a reasonable protocol for initial SDF use might be the following: •
Twice yearly application of SDF 38 percent is a reasonable starting point.
•
SDF is a viable treatment alternative for high-risk, high-need patients for whom cooperation is a concern.
•
Use of a detailed informed consent to fully convey the benefits and limitations of this therapy is recommended. Clinicians might consider using clinical photographs with the informed consent.
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•
Thirty-eight percent SDF for arresting caries lesions and preventing new caries from forming in school children is effective in both primary and permanent dentitions (65.9 percent dentine caries arrest overall 11).
•
No caries excavation or removal is necessary.10 However, as direct contact of the solution with dentin is required, surfaces clean of food debris are desirable.
•
Study application time ranged from 10 seconds to three minutes with and without drying and with and without rinsing following the application. The manufacturer's recommendations of 30 to 60 seconds application with air-drying is consistent with the best study results for caries arrest.
•
Initial use on posterior pits, fissures, and caries might be considered given concerns about anterior esthetics.
•
For anterior esthetics, SDF could be followed by glass ionomer prior to restorative treatment further reducing risk of caries re-occurrence.
•
Posterior teeth and large cavities may have less chances of arrest with one-time application14, 19. However, in most clinical settings, individualized evaluation of the caries and caries arrest on specific surfaces is feasible, so re-application can be tailored to the needs to each patient. A one-month follow-up to evaluate arrest and need for re-application on active treated carious surfaces should be advantageous, similar to a post-op visit after restorative or surgical procedures
•
The combination of SDF and fluoride varnish remains an open question. Fluoride varnish is used primarily to prevent smooth surface caries and remineralize early enamel lesions. Conversely, SDF is used primarily for frank carious lesions. Therefore, their combinatorial use may be additive or synergistic, and remains to be determined. One potential solution is alternating their use at three-month intervals.
•
Anterior teeth have higher rates of arrest.14, 19 This could be due to the fact that they are more easily cleansable, or that surfaces exposed to light may result in more active silver precipitation.
Anecdotal evidence reports that in clinical settings, the use of a curing light after drying seems to improve arrest in posterior areas that are not exposed to natural light, as light-cured surfaces immediately turn dark. Formal research is needed to investigate if the arrest in these lesions is at least as effective and sustainable as the rates reported in the clinical trials.
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The foregoing would appear to meet the needs of pediatric program directors8. More than 88 percent agree that SDF can be used to arrest caries in high-risk patients in primary (87 percent agree) and permanent (66 percent agree) teeth. There is greater than 90 percent agreement that SDF will be useful in treating patients who have difficulty receiving conventional treatment (e.g.: pre-cooperative, behavioral, or medically fragile). Paradoxically, less than 50 percent agree that SDF will be useful for caries prevention in incipient lesions.
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The barriers to SDF use identified by program directors8 all appear to contradict the current best evidence identified here. They include the following: (1) Parental acceptance: Greater than 90 percent believe that parental acceptance is a concern. Where studied10, 12, 14 parental concern to the staining was less than seven percent, but we acknowledge the fact that these studies took place in settings where esthetic concerns may be different than US standards. It is our experience that parents with limited options for treatment due to behavioral or medical limitations, are willing to accept the treatment. Studies are under way to formally explore parental acceptance. (2) Off label use: More than 60 percent were concerned about off label use. In fact, fluoride varnish, which has become the gold standard of caries prevention for children, has been used off label for decades, and is used in 100 percent of pediatric dental programs. (3) Standard of care: More than 60 percent were concerned that SDF use is not a standard of care. Based on the human randomized controlled trials, published in peer reviewed journals reported here, SDF meets the legal standard of care in more than 34 states9. (4) Evidence based: More than 60 percent felt that the evidence was insufficient. Skeptics might offer clarity on protocols that would improve on those reported here covering more than 3,900 children treated globally under a variety of conditions. (5) Reimbursement: More than 70 percent were concerned about reimbursement. The American Dental Association billing code for interim caries arresting medication application is D1354, and fees are dentist-patient dependent. (6) Resident training: More than 50 percent were concerned about training residents. With the wealth of systematic reviews and human clinical trials, program directors have a unique evidence-based dentistry teaching opportunity. (6) Obtaining product: More than 50 percent were concerned about obtaining the product. Silver diamine fluoride (trade name Advantage Arrest) is available from Elevate Oral Care LLC, Fla, US. (7) Cost: Almost 60 percent were concerned about cost. We estimate the material cost to be approximately $0.91 per patient ($0.80 for the SDF for one drop of SDF sufficient to treat eight teeth, and $0.11 for the micro brush). The U.S. Affordable Care Act's triple aim calls for: increasing access, improving health, and reducing costs. SDF meets all three aims. The most notable aspects of SDF are its efficacy, ease of use, and low cost. SDF takes 30 seconds to apply, reduces caries progression and subsequent caries by 60- 80 percent in primary and permanent teeth, and we estimate that the cost is less than one dollar per child for supplies.
Author Manuscript
SDF also meets the U.S. Institute of Medicines six quality aims20 of: safe (e.g.: without adverse events), effective (e.g.: reduces caries progression and subsequent caries by almost 80 percent on treated teeth); efficient (e.g.: can be applied by health professional in any location where children learn, play, and pray), timely (e.g.: takes less than 30 seconds), patient centered (e.g.: meets immediate needs of child in one treatment); equitable (e.g.: is equally effective for all socioeconomic groups, races, ethnicities and cultures). Biologically, silver diamine fluoride is a bi-functional agent. The silver directly kills caries causing bacteria, while silver and fluoride interact synergistically to form fluorapatite, hardening the teeth preventing further demineralization6. More specifically, at the molecular level, silver ions interact with sulfhydryl groups of proteins and DNA altering hydrogen bonding, thus inhibiting respiratory processes, cell wall synthesis, and cell division.6 At the macro level, these interactions effect bacterial killing and inhibit biofilm formation.
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Simultaneously the silver precipitates onto the surface of the tissues creating the brownblack surface especially in dentin, which together with the hardening of the tissue are the clinical indications of “caries arrest”.
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Finally, there is some concern about the potential adverse events from SDF use. A primary concern is the child's fluoride dose. As indicated in Table 2, one drop of SDF, enough to treat six teeth, contains approximately half the fluoride 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 color changes from dark brown to black. Porous incipient enamel lesions can darken as well. As with all care, a detailed informed consent delineating the benefits and potential esthetic limitations of this therapy are needed. Clearly the esthetic concern is paramount if one applies SDF to non-cavitated porous enamel lesions on anterior teeth. Another concern is the pulpal or gingival reaction. In the identified studies, no children exhibited negative reactions to the treatment, no adverse pulpal responses, and only 0.1 percent of children noted slight gingival irritation.
Conclusions In summary, SDF 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 is a minimal intervention treatment that is safe and affordable.
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Given the foregoing, it might be expected that SDF will be widely implemented for caries control to meet our patient's needs, as well as national goals of both the Affordable Care Act's and the Institute of Medicine's quality aims.
Acknowledgements 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 Science (NCATS), NIH.
References
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1. Marcenes W, Kassebaum NJ, Bernabe E, et al. Global burden of oral conditions in 1990-2010: a systematic analysis. J Dent Res. 2013; 92(7):592–7. [PubMed: 23720570] 2. Capurro DA, Iafolla T, Kingman A, Chattopadhyay A, Garcia I. Trends in income-related inequality in untreated caries among children in the United States: findings from NHANES I, NHANES III, and NHANES 1999-2004. Community Dent Oral Epidemiol. 2015; 43(6):500–10. [PubMed: 26037290] 3. CMS National Health Expenditure Expenditures by type of service and sourc of funds. U.S. Department of Health and Human Services; 2015. CY 1960-2014. https://www.cms.gov/ResearchStatistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/ NationalHealthAccountsHistorical.html [7/11/2016] 4. Niederman, R., Feres, M., Ogunbodede, E. Dentistry.. In: Debas, HT.Donkor, P.Gawande, A.Jamison, DT.Kruk, ME., Mock, CN., editors. Essential Surgery: Disease Control Priorities. The 2015 International Bank for Reconstruction and Development / The World Bank; Washington (DC): 2015. p. 173-95.
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5. Berkowitz RJAA, et al. Dental Caries recurrence following clinical treatment for severe early childhood caries. Pediatr Dent. 2011; 33(7):510–14. [PubMed: 22353412] 6. Rosenblatt A, Stamford TC, Niederman R. Silver diamine fluoride: a caries “silver-fluoride bullet”. J Dent Res. 2009; 88(2):116–25. [PubMed: 19278981] 7. Gao SS, Zhao IS, Hiraishi N, et al. Clinical Trials of Silver Diamine Fluoride in Arresting Caries among Children: A Systematic Review. JDR Clinical & Translational Research. 2016 8. Nelson T, Scott JM, Crystal YO, Berg JH, Milgrom P. Silver Diamine Fluoride in Pediatric Dentistry Training Programs: Survey of Graduate Program Directors. Pediatr Dent. 2016; 38(3):212–7. [PubMed: 27306245] 9. Niederman R, Richards D, Brands W. The changing standard of care. J Am Dent Assoc. 2012; 143(5):434–7. [PubMed: 22547707] 10. Chu CH, Lo ECM, Lin HC. Effectiveness of Silver Diamine Fluoride and Sodium Fluoride Varnish in Arresting Dentin Caries in Chinese Pre-school Children. J Dent Res. 2002; 81(11):767–70. [PubMed: 12407092] 11. Llodra JC, Rodriguez A, Ferrer B, et al. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005; 84(8):721–4. [PubMed: 16040729] 12. Yee R, Holmgren C, Mulder J, et al. Efficacy of silver diamine fluoride for Arresting Caries Treatment. J Dent Res. 2009; 88(7):644–7. [PubMed: 19641152] 13. Braga MM, Mendes FM, De Benedetto MS, Imparato JC. Effect of silver diammine fluoride on incipient caries lesions in erupting permanent first molars: a pilot study. J Dent Child (Chic). 2009; 76(1):28–33. [PubMed: 19341576] 14. Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012; 40(11):962–7. [PubMed: 22892463] 15. Dos Santos VE Jr. de Vasconcelos FM, Ribeiro AG, Rosenblatt A. Paradigm shift in the effective treatment of caries in schoolchildren at risk. Int Dent J. 2012; 62(1):47–51. [PubMed: 22251037] 16. Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012; 91(8):753–8. [PubMed: 22736448] 17. Monse B, Heinrich-Weltzien R, Mulder J, Holmgren C, Helderman WHvP. Caries preventive efficacy of silver diammine fluoride (SDF) and ART sealants in a school-based daily fluoride toothbrushing program in the Philippines. BMC Oral Health. 2012:12. [PubMed: 22639910] 18. Duangthip D, Chu CH, Lo EC. A randomized clinical trial on arresting dentine caries in preschool children by topical fluorides-18 month results. J Dent. 2015 19. Fung MHT, Duangthip D, Wong MCM, Lo ECM, Chu CH. Arresting Dentine Caries with Different Concentration and Periodicity of Silver Diamine Fluoride. JDR Clinical & Translational Research. 2016; 1(2):143–52. 20. Atchison KA. Using information technology and community-based research to improve the dental health-care system. Adv Dent Res. 2003; 17:86–8. [PubMed: 15126215]
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FIGURE 1. anterior/posterior staining
Esthetic restorations can be used at a future date when the caries process is under control, after the advantages provided by immediate arrest have had an effect: reduced sensitivity, improved hygiene, improved gingival health, enamel and dentin remineralization, tissue preservation.
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FIGURE 2. Posterior staining
Esthetic restorations can be used at a future date when the caries process is under control, after the advantages provided by immediate arrest have had an effect: reduced sensitivity, improved hygiene, improved gingival health, enamel and dentin remineralization, tissue preservation.
Author Manuscript Author Manuscript Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
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Yee et al 200912
Nepal
primary
Arrest
1. SDF (38%) 1x followed by tannic acid as reducing agent 2.SDF (38%) 1x alone 3.SDF (12%) 1x alone 4.no treatment
1.SDF was more effective than controls (31% arrested lesions for SDF groups vs. 22% for SDF 12% vs. 15% for control) 2.Tannic acid had no effect 3.Arrest benefit decreases over time.
1.single SDF application prevented half of arrested surfaces at 6 months from reverting to
Chu et al 200210
China
Primary anterior only
Arrest
1.SDF (38%) 1x/year with caries removal 2.SDF (38%) 1x/year without caries removal 3.FV 5% 4x year with caries removal 4.FV 5% 4x year without caries removal 5.water control
1.SDF was more effective than FV or control. . (65% arrested lesions for SDF groups vs. 41% for FV groups vs. 34% for control) 2.Caries removal had no effect. 3.Control group developed more new caries than treatment groups.
1. arrested lesions looked black without changing parental satisfaction (93% of parents didn't mention a difference)
Location
Dentition studied
Caries effect studied
Groups compared
Main findings
Additional findings
Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
1.GI provides a more esthetic outcome. 2.only 3.5% retention of GI after 24 months still
1.SDF and GI are equally effective. (91% arrested lesions for SDF 2x/ year vs. 79% SDF 1x/year, vs. 82% GI 1x/ year) 2.Increasing frequency of SDF (2x/year) increases caries arrest. 3.Anterior teeth and buccal/lingual surfaces are more likely to become arrested.
1.SDF (30%) 1x/year 2.SDF (30%) 2x/year 3.GI (Fuji VII) w/conditioner 1x/year
Arrest
Primary anterior and posterior
China
Zhi et al 201214
1.43% of GIC fillings were lost at 6 months and dentin was soft.
1. SDF was more effective than ITR. (67% arrested lesions in SDF group vs. 39% in control)
1.SDF(30%) 1x 2.ITR (Fuji IX) w/ conditioner 1x.
Arrest
Primary
Brazil
Dos Santos et al 201215
1. lesions in anterior teeth, buccal/lingual surfaces and lesions with no plaque had a
1. SDF 1x/year and SDF 3 consecutive weekly applications were more effective than FV. (40% arrested lesions with SDF 1x/ year vs.35% with only 3 consecutive SDF applications vs. 27% with FV)
1.SDF (30%) 1x/year 2.SDF (30%) 1x/week for 3 weeks 3.FV (5%) 1x/ week for 3 weeks
Arrest
Primary anterior and posterior
Hong Kong
Duangthip et al 201518
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Study
1.lesion site was significant, with lower anteriors having the highest rates of
1. SDF 38% 2x/year was more effective than SDF 38%1x/year, SDF12% 2x/ year or 1x/year (74% arrested lesions vs. 64%, 55% and 50% respectively)
1.SDF (38%) 2x/year 2.SDF (38%) 1x/year 3.SDF (12%) 2x/year 4.SDF (12%) 1x/year
Arrest
Primary anterior and posterior
China
Fung et al 201619
1. SDF showed more efficacy to arrest decay in deciduous teeth than permanent teeth.
1.SDF 2x/year was more effective for caries arrest than controls. (85% arrested lesions with SDF vs. 62% in control) 2.SDF was effective for caries reduction in both primary and permanent teeth. (0.29 surfaces with new caries in SDF group vs 1.43 in control in primary teeth and 0.37 vs 1.06 in permanent molars)
1.SDF (38%) 2x/year 2.No treatment
Arrest and prevention
Primary cuspids, molars and permanent 1rst molars
Cuba
Llodra et al 200511
1.retention rates for GI sealants were 32% at 6 months and 9% at 30 months 2.GI sealants were more time consuming that SDF application.
1.SDF was more effective than toothbrushing or GI at 3 and 6 months. 2.All equally effective in controlling initial (noncavitated) occlusal caries at 30 months.
1. SDF (10% ) 3x at 1 week interval 3. GI (Fuji III) sealant 1x 3. Cross tooth-brushing Non cavitated caries lesions On each child one molar was assigned to each group.
Arrest
Permanent 1st molars
Brazil
Braga et al 200913
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Description and Clinical Details of Randomized Control Trials on Children
1.teeth with early caries at baseline were more likely to develop dentin caries after 24 months 2.46% sealant retention
1.The 3 active treatments are effective in caries prevention. (progression of caries into dentin was 2.2% for SDF, 1.6% for sealant, 2.4% for FV vs. 4.6% for control) 2.Control group developed more dentin caries than treatment groups.
1.SDF (38%) 1x/year 2.Resin sealant 3.5% NaF varnish 2x year 4.yearly placebo Deep fissures or noncavitated early lesions. Each child got same tx. in all molars.
Prevention
Permanent 1st molars
China
Liu et al 201216
1. retention rate for sealants was 58% after 18 months.
1.ART sealants were more effective than a single application of SDF (caries increment in the brushing group was: .08 for NT .09 for SDF .01 for sealants in non brushing group: .17 for NT .12 for SDF .06 for sealants) 2.Caries increment was lower in tooth-brushing group.
1. SDF (38%) 1x on sound and cavitated molars. 2.ART (high viscosity Ketac molar) on sound and cavitated molars. 3.no treatment (NT) Some schools had toothbrushing programs and some didn't
Prevention
Permanent 1st molars
Philipinnes
Monse et al 201217
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Table 1 Crystal and Niederman Page 9
Pediatr Dent. Author manuscript; available in PMC 2017 May 15.
24 months
6.8 dmfs (active lesions)
Low F exposure Provided F toothpaste
976
634
1,12 and 24 months
30 months
3.92 dmfs (active anterior lesions)
Low F exposure reported use of F toothpaste
375
308
X 6 months
Duration of study
Baseline caries
Background F exposure
# subjects at baseline
# subjects at endpoint
Exams after baseline
*
X 6 months
181
212
Low F exposure low access to F toothpaste
5.1 dmft (3 random teeth/ child)
24 months
None
* no eat or drink for 30 min after
X 6 months
?
91
Low F exposure access to F toothpaste
3.8 dmft
12 months
None
no eat or drink for 1 hr.
*
cotton roll isolation, Vaseline on gingiva, SDF applied for 3 min and rinse and spit
*
doesn't specify SDF amount used;
*
doesn't specify SDF amount used or time of exposure
no caries removal
*
minor excavation
*
2.higher rate of failure when GIC involved multiple surfaces.
Dos Santos et al 201215
low F exposure = low F in the water, no other professionally applied fluorides nor fluoride supplements.
*
None
no eat or drink for 1 hr after
*
one drop of SDF applied for 2 min to carious surfaces and dried with cotton pellet.
*
no caries removal
*
None
* doesn't specify SDF amount used or time of exposure
*
2 treated groups had caries removal and 2 didn't.
Adverse effects
SDF Clinical Application Protocol
provides caries arrest 3.45% of parents in all groups were satisfied with appearance.
active lesions again over 24 months. 2.no complaints from parents or children to SDF
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Zhi et al 201214
X 6 months
275
304
F water F toothpaste
4.4 dmft 6.7 dmfs
18 months
None
SDF rubbed for 10 sec. - no eat or drink for 30 min.
*
*
doesn't specify SDF amount used or kind of isolation.
no caries removal
*
higher chance to become arrested
Duangthip et al 201518
X 6 months
831
888
Low F exposure F toothpaste
3.84 dmft 5.15 dmfs
18 months
None
doesn't specify SDF amount used, time of exposure, or kind of isolation
*
arrest followed by upper anteriors, lower posterior and upper posterior. 2.Lesions with visible plaque and large lesions had lower chance of becoming arrested.
Fung et al 201619
Author Manuscript
Yee et al 200912
X 6 months
373
425
Low F exposure + 0.2% NaF rinse in school every other week
3.2 dmft
36 months
0.1% Gingival irritation
cotton roll isolation, SDF applied for 3 min and wash for 30 sec.
*
doesn't specify SDF amount used
*
*
minor decay excavation on permanent molars only.
Llodra et al 200511
no caries removal
3, 6, 12, 18 and 30 months plus X rays at 6, 12 and 30 months
?
22 children, 66 molars
Low F exposure Provided F toothpaste
Non-cavitated molar occlusal
30 months
None
no eat or drink for 1 hr.
*
cotton roll isolation and petroleum jelly on gingiva, SDF applied for 3 min and wash for 30 seconds.
*
doesn't specify SDF amount used
*
*
Braga et al 200913
Author Manuscript
Chu et al 200210
X 6 months
485
501
Low F exposure Provided F toothpaste
No cavitated lesions
24 months
None
no eat or drink for 30 min.
cotton roll isolation
*
*
doesn't specify SDF amount used, time of exposure, or whether it was rinsed or not
*
Liu et al 201216
18 months
704
1016
Low F exposure Provided F toothpaste
At least one sound permanent molar
18 months
None
cotton roll isolation
*
doesn't specify SDF amount used, SDF rubbed for 1 min. followed by tannic acid, dried with cotton pellet and covered with vaseline
*
Monse et al 201217
Author Manuscript
Study
Crystal and Niederman Page 10
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Author Manuscript 22,600 PPM
0.5 ml
F content equivalence (aprox.): 2 drops SDF = small (.25 ml) FV
22,600 PPM
22,600 PPM
0.4 ml
0.25 ml
Fluoride Varnish 5% NaF
44,800 PPM
1 drop (0.05 ml)
SDF 38%
Concentration
Unit dose
Fluoride product
22.6
22.6
22.6
44.8
F ion mg/ml
Author Manuscript 11.3
9.04
5.65
2.24
F ion mg/dose
Fluoride content in SDF and Fluoride Varnish commercial unit doses
Author Manuscript
Table 2 Crystal and Niederman Page 11
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