Clinical Question: In children with primary dentition, to what extent does an application of 38% Silver Diamine Fluoride (SDF) every 3-6 months results in carious lesions arrest (non-cavitated and cavitated) compared to other currently available treatments (i.e., fluorides) within a 30 months period?
Clinical Bottom Line: The evidence from selected clinical practice guideline and systematic review based on meta-analysis with four RCTs collectively support the following conclusion: the application of 38% SDF is more effective than other atraumatic treatments or non-treatments in arresting active cavitated carious lesions in primary dentition within 12-30 months. The results from both evidence sources are clinically meaningful and clinically decisive. Limitations of the evidence include inconsistent diagnostic criteria for caries lesion activity and inability to blind outcome assessors. 38% SDF can be considered as a treatment option as long as the dentists consult and explain benefits/harms and also consider individual circumstances, preferences and values of the patient, as is the case for conditional recommendations.
("Dental Caries/therapy"[Mesh] OR "Dental Caries/prevention and control"[Mesh] OR “caries” [tw]) AND ("silver diamine fluoride"[All Fields] OR "silver diamine fluoride" [Supplementary Concept]). Filters activated: Child: birth-18 years.
PubMed yield: 62 evidence sources. Additional sources of evidence: ADA, EBD, nature.com/ ebd. 71 evidence sources found in total.
|Author, year||Source of evidence||Population Characteristics||Methods|
Crystal, YO et al., 2017.
Practice guideline based on systematic review and meta-analysis (3 RCTs, 1 controlled clinical trial)
Population: children, including those with special care needs, aged 3-6 years old; primary dentition.
Sample size, total: n= 976 (subjects); n=8410 (teeth)
Location/Setting: Nepal, China, Cuba; setting unspecified
Search: PubMed/Medline, Embase, Cochrane Central Register of Controlled Trials, gray literature
Intervention: SDF 38% once or twice per year
Primary Outcome: Caries arrest in primary teeth
Follow up: 24 or 30 months and over
Measurements: mean # of arrested carious teeth/mean # of new decayed surfaces/caries arrest rate/mean # of arrested surfaces
The panel made a conditional recommendation regarding the use of SDF for the arrest of cavitated caries lesions in primary teeth as part of a comprehensive caries management program, based on low-quality evidence. 3 RCTs and 1 CCT was used to formulate this guideline, Publication years -2002 to 2012.
Based on the pooled estimates of SDF group, appx 68 % (95% CI 9.7 to 97.7) of cavitated caries lesions in primary teeth would be expected to be arrested two years after SDF application (with once or twice a year application). Using data with longest follow up time (at least 30 months follow up and N=2567 surfaces) SDF had 48 % higher (95% CI 32 to 66) success rate in caries lesion arrest compared to the controls (76% percent versus 51 %arrested lesions).
The cavitated caries lesions arrest in primary teeth in the 38% SDF groups is 1.48 times (48%) more likely to occur in comparison with the control intervention group (95% CI = 32 to 66) within 30 month follow-up. RD = 29% (95% CI 19%; 40%). Assuming a clinically meaningful threshold of 10% and caries prevalence of 60%, the intervention is deemed to be clinically meaningful as well as clinically decisive.
The panel determined the overall quality of the evidence for this comparison was low or very low, owing to serious issues of risk of bias (small number of RCTs evaluating SDF, unclear method for randomization, selective reporting) and high heterogeneity of the included studies.
Limitations: The systematic review and supporting literature have weaknesses that permeate into the guideline: lack of evidence of agreement for examiners assessing clinical outcomes and unclear definitions or inconsistent criteria for caries lesion activity; possibility of misclassification bias (cannot blind the assessors to the group allocation), lack of evidence pertaining to other age groups.
Strengths: clear research question, no language restriction, RCT and CCT study designs, GRADE quality rating system, no conflict of interests, evidence to decision framework used, updated literature search, discussion, debate and consensus seeking methods were used. Benefits and harms discussed, and financial aspect were taken into account.
Perspectives: A well designed RCT should be done to compare outcome of SDF to other treatment options for arrest of caries lesions in primary and permanent teeth. More studies need to be done to evaluate health effects in humans as a result of exposure to water or food containing specific levels of silver and to determine the amount of fluoride and silver in one drop of SDF which as of now it is determined by the specific gravity of the liquid and the dropper used.
|Author, year||Source of evidence||Population Characteristics||Methods|
Chibinski YC et al., 2017.
Systematic Review and Meta-analysis
(11 studies included in qualitative synthesis)
Population: Children, mean age 8± 0.5. With primary dentition (8 studies), permanent teeth (2 studies), or both teeth (1 study). Setting and gender in selected studies not specified.
Sample size: n=4328 individuals (ranging from 60 to 1016 per trial)
Location/Setting: Setting in selected studies not specified.
Search: PubMed, Scopus, Web of Science, LILACS, BBO, Cochrane Library, grey literature, dissertation and theses, unpublished and ongoing trials, Cochrane Collaboration tool.
Intervention: Most common is SDF at 38%; 30%, 12% and nanosilver fluoride 34% also used; 1 application at baseline to every 6 months
Comparison: fluoride varnish/ART restorations/saline solution/no treatment
Primary Outcome: Caries lesion arrestment
Follow up: ranged 12 months to 36 months
Measurements: # of inactive carious surface/# of active carious surface/dmf-t index/# teeth with new carious lesions/# of inactive carious lesions in first permanent molars
19 RCTs assessed for eligibility, 11 RCTs included in SR, 4 RCTs included in meta-analyses. Publication years: 2002 to 2015.
Specifically, subgroup analysis shows (1) SDF is 66% more effective in controlling/arresting caries than active treatment (atraumatic restoration and fluoride varnish), with RR = 1.66 and 95% CI = (1.41, 1.96)(2) SDF is 154% more effective in controlling/arresting caries than placebo or no treatment, RR= 2.54, 95% CI = (1.67, 3.85) (3) SDF is overall 89% more effective in control/arresting caries than other treatments or no treatment, RR=1.89, 95% CI = (1.49, 2.38).
Limitations: High heterogeneity of measured outcomes of the 11 studies included in the SR, only 4 RCTs could be retained for meta-analysis, introducing selection bias. Publication bias of the 11 studies selected is not assessed (ie. no funnel plot shown). Only 2 studies included in the sub-analyses of the meta-analysis, which reduces precision effect of the systematic review. Pooling of the 2 sub-analysis into 1 meta-analysis raises risk ratio in favor of SDF, and having different comparator groups (control treatment and placebo) makes the percentage of caries arrest due to SDF compared to other treatment/no treatment uninterpretable. It also lacks blinding of outcome assessors because SDF stains teeth.
Strengths: clear research question and eligibility criteria, 5 databases and grey literature, MeSH terms and key words, 2 independent reviewers, Cochrane Collaboration tool for risk of bias assessment, GRADE approach for evidence assessment, PRISMA diagram, meta-analysis, no restrictions on publication date or languages, heterogeneity among the 4 studies included in the meta-analysis is low.
Dental caries represent a major oral health problem that is especially prevalent in preschool-age children, the decayed teeth being the main component in the dmft. Socio-economic status, access to water fluoridation and fluoride toothpaste greatly compound the situation. After taking into consideration the low cost of treatment and disease burden of caries, panel members were confident that benefits of SDF application in the target populations outweigh its possible undesirable effects. However, this is a conditional recommendation, wherein dentists will need more time to consult and explain benefits/harms and also to consider individual circumstances, preferences and values before applying the recommended intervention. When formulating recommendations, potential harms were considered together with the benefits. But it’s not clear if these factors are pertinent to patients. For example, while choosing this guideline for a patient in clinic, maybe cost and esthetics are not the only factors the patient is concerned about; perhaps time of action, taste, etc. would concern the patient more. We can question the extent to which the panel and stakeholders are knowledgeable about our concerned population’s (children and adolescents also including special needs) values and preferences. Other demographic factors within the studies are not explored, making it difficult to judge the generalizability of the study population to the population that we would be exposed to. The application of SDF does not require complex infrastructure or instrumentation or trained skills beyond that of any practicing dentist or dental assistant. Therefore, this treatment can be provided widely and universally, from dental clinics to more inaccessible areas and communities (perhaps within a school setting). The follow-up periods ranged from 12 to 36 months. We deem this to be adequately appropriate, as it follows the general time sequence of the progression of carious disease for the average population.
Authors: Aimy Le Duc, Yen-Chau Nguyen, Amanpreet Sohal, Frances Wang (DMD3 students)
Faculty mentor(s): Dr. D. Taqi, Dr. S. Tikhonova, Dr. I. Fried
Acknowledgments: Martin Morris
Date: April 18th, 2020