SDF, SMART -Medical Management of Caries -Preventive Strategies inPediatric Dentistry and Public Health.

Dr. Vinod MiriyalaDDS, MPH, CAGSFeb.28th , 2017

Silver Diamine Fluoride -SDF The traditional treatment for a cavitated tooth

involves mechanical excavation of infected, irreversibly demineralized tooth structure and replacement with a restorative material. Treatment of dental caries can be challenging requiring advanced skill of the clinician and high cost of instrumentation and materials as well as good cooperation from patient. Especially when dental caries present in very young children because of their limited coping ability.

Aqueous sliver diamine Fluoride{ (Ag (NH3)}2 F SDF has been used for decades by dentists in Japan and other countries to arrest dental caries.

Peng et al., 2012

Evidence Based High level of evidence Systematic reviews Meta analysis studies Randomized control studies Decades of use in many countries FDA approval for caries arresting

medication

Advantage Arrest Silver Diamine Fluoride 38%

Advantage Arrest FDA cleared as a dentinal hypersensitivity

treatment (similar to fluoride varnishes) For use in adults over the age of 21. Increases Dentinal Hardness Painless, Blocks dentinal tubules

50+ years of use in Japan, China, India, New Zealand, Australia and many others as Caries Arresting Agent

Quick, Affordable for Patients, and Cost Effective for the Clinic

Mechanism of Action -SDF Forms silver-protein conjugates in decayed surfaces

Increases resistance to acid dissolution and enzymatic digestion.

Hydroxyapatite and fluoroapatite form on the exposed organic matrix, along with the presence of silver chloride and metallic silver.

Increases in mineral density and hardness while the lesion depth decreases.

Inhibits the proteins that break down the exposed dentin organic matrix: matrix metalloproteinases; cathepsins; and bacterial collagenases.

Silver ions act directly against bacteria in lesions by breaking membranes, denaturing proteins, and inhibiting DNA replication.

Ionic silver deactivates nearly any macromolecule.

Silver diamine fluoride outperforms other anti-caries medicaments in killing cariogenic bacteria in dentinal tubules.

Silver and fluoride ions penetrate ~25 microns into enamel, and 50-200 microns into dentin.17 Fluoride promotes remineralization, and silver is available for antimicrobial action upon release by re-acidification.

Mechanism of action -SDF

SDF - Toxicity One drop is approximately 25 L and should be sufficient to

treat 1-5 teeth and contains about 11.88 mg of SDF. LD of oral administration is approximately 520 mg/kg body weight; while LD subcutaneous administration is 380 mg/kg body weight. A child of 10 kg would receive 1.185 mg/kg.

If we use the 380mg/kg number being overly cautious, that is a 400 fold safety margin. The EPA has also set short term silver exposure levels in drinking water at 1.142 mg per L for 1-10 days.

Applications greater than one week apart fall in line with these recommendations. The EPA long term exposure limits have been set at 1 gram to safely avoid argyria.

According to Vasquez et. al. in the study below, the highest applied dose of 2.37 mg would enable 400+ applications over a lifetime. http://www.biomedcentral.com/content/pdf/1472-6831-12-60.pdf

http://www.biomedcentral.com/content/pdf/1472-6831-12-60.pdf

SDF The main downside is aesthetic: Silver diamine

fluoride blackens the brownish decay on a tooth. That may not matter on a back molar or a baby tooth that will fall out, but some patients are likely to be deterred by the prospect of a dark spot on a visible tooth.

The noninvasive treatment may be ideal for the indigent, nursing home residents and others who have trouble finding care. And many anxious dental patients want to dodge the drill.

SDF Silver diamine fluoride is already used in

hundreds of dental offices. Medicaid patients in Oregon are receiving the treatment.

19 (26%) Residency programs in Pediatric dentistry are currently using SDF. However SDF and silver nitrate were more frequently taught in didactic coursework than in clinical practice.

https://na01.safelinks.protection.outlook.com/?url=http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics/medicaid/index.html?inline%3dnyt-classifier&data=01|01|dental-public-health@list.pitt.edu|1cd63e1430c249423d0c08d3ab12b3bc|9ef9f489e0a04eeb87cc3a526112fd0d|1&sdata=6X1ihtBE6xw2Bon99DOLptQEzFDUoOs0C1KLjssBkew%3d

SDF But the liquid may be especially useful for

children. Nearly a quarter of 2- to 5-year-olds have cavities, according to the Centers for Disease Control and Prevention.

Some preschoolers with severe cavities must be treated in a hospital under general anesthesia, even though it may pose risks to the developing brain (under 3 years of age, FDA black box warning).

https://na01.safelinks.protection.outlook.com/?url=http://well.blogs.nytimes.com/2015/03/05/untreated-dental-decay-is-falling-among-children/&data=01|01|dental-public-health@list.pitt.edu|1cd63e1430c249423d0c08d3ab12b3bc|9ef9f489e0a04eeb87cc3a526112fd0d|1&sdata=9SpmZAuaW4o%2bLJ%2bSmhMuN%2bJcUhRClilRdDqAbD/Qiog%3dhttps://na01.safelinks.protection.outlook.com/?url=http://www.nytimes.com/2012/03/06/health/rise-in-preschool-cavities-prompts-anesthesia-use.html&data=01|01|dental-public-health@list.pitt.edu|1cd63e1430c249423d0c08d3ab12b3bc|9ef9f489e0a04eeb87cc3a526112fd0d|1&sdata=Z%2bjHx7rs3DzCvS3VYBrKBDsWs4GRLJY4RQspbOrEG6U%3d

SDF Silver diamine fluoride has another advantage

over traditional treatment: It kills the bacteria that cause decay. A second treatment applied six to 18 months after the first markedly arrests cavities, studies have shown(~90% caries arrest with twice annual application).

Still, silver diamine fluoride is no silver bullet. Patients with mouth sores or a silver allergy cant use it. Severe cavities huge holes that trap food and plaque still require fillings.

90% caries arresting activity in primary teeth in children and 60% in permanent teeth.

SDF 38% (44,800 ppm fluoride) SDF solution is commonly

used to arrest caries and to reduce hypersensitivity in primary and permanent teeth. Application of SDF to arrest dental caries is a non-invasive procedure that is quick and simple to use.

Reports of available studies found no severe pulpal damage after SDF application. However, it has drawbacks like black discoloration of the carious teeth and an unpleasant metallic taste. But, the low cost of SDF and its simplicity in application suggest that SDF is an appropriate therapeutic agent for use in community dental health projects.

The availability of a safe, effective, efficient, and equitable caries preventive agent like SDF appears to meet the criteria of both the WHO Millennium Goals and the US Institute of Medicines criteria for 21st century medical care.

Indications and Contraindications of SDFIndications: Carious lesions in Primary and permanent teeth, white spot lesions Children of pre cooperative age Difficult behavior Medically fragile patients Logistic challengesContraindications: Patients with ulcerative gingivitis or stomatitis known sensitivity to silver or other heavy-metal ions Patients with more than six affected sites Patients having had full mouth gingivectomies and

patients showing abnormal skin sensitization in daily circumstances are recommended for exclusion.

SDF Advantages: Low cost Ease of application Minimal cooperation of the patient Caries arrest and prevention (primary and

secondary caries) Disadvantages: Metallic taste Dark discoloration of the carious lesion Discoloration of tooth colored crowns and

resin fillings Can stain skin, mucosa, saliva, etc

Staining due to SDF SDF can stain the skin of the body and clothes. The stain caused

by SDF on the skin, though not causing any pain, cannot be washed away, and it takes a long time for it to be removed. If the skin or clothes have been stained the following procedure is suggested for removing the stain:

- Wash out with running water, soap, or ammonia water, if immediately after staining.

- If the discoloration is not removed and persists, apply the solution of sodium hypochlorite or a bleaching powder (with caution in dyed cloth).

SDF solution also has a metallic taste which is unpleasant. Furthermore, gingival and mucosal irritation can occur. In most cases, the damage is transient and the tissue affected turns white, but it will heal within 12 days.

When the solution is to be applied to the lesions very close to the gingiva protect the gingiva with Vaseline or cocoa butter.

SDF clinical photos Dr.Miriyala

SDF clinical photos Dr.Miriyala

Before SDF After SDF + KI

Before and After SDF

SDF + Activa

Dr. Josh Wren

SDF + Activa

Dr. Josh Wren

SDF Application

SDF + GI

SDF

Dr. John Frachella

SDF

Dr. John Frachella

Post SDF Application Round bur w/o LA, acid etch, bond agent, light cured resin opaquer, light cured Majesty flowable composite

Super floss- Interproximal Tx

Advantage Arrest by Elevate Oral Care

Advantage Arrest Silver Diamine Fluoride 38% - Bottle Each bottle contains 8 mL

Quantity Price1 $149.002 $141.503 11 $134.5012 + $119.00

11

http://www.elevateoralcare.com/dentist/AdvantageArrest/Advantage-Arrest-Silver-Diamine-Fluoride-38http://www.elevateoralcare.com/dentist/AdvantageArrest/Advantage-Arrest-Silver-Diamine-Fluoride-38

Advantage Arrest by Elevate Oral Care

Advantage Arrest Silver Diamine Fluoride 38% - Unit-Dose Ampule Box of 30 Ampules plus 30 each small and large applicators

Quantity Price1 $119.952 $109.953 + $99.95

Advantage Arrest

Per application cost $149 = 8 mL bottle = 250 drops = $0.59/Drop $11.25 for 100 Applicators $0.1125 per app. One drop application = $0.70 per application Two drop application = $1.40 per application Equal or less than Fluoride Varnish

Bonding Strength after SDF application Evidence suggests that there is no decrease

in the bond strength after SDF use It is recommended to etch the SDF treated

lesion before placement of resin based restorations

It is recommended to remove the SDF treated lesions before placement of resin based cement for cementation of a crown

Potassium Iodide KI The dark staining of SDF carious lesions

can be lessened by an application of potassium Iodide using an applicator brush or micro brush.

KI can be applied after the activation of SDF (dark discoloration appears).

Limited evidence in literature of effectiveness of SDF after KI application.

Tincture of Iodine can also be used.

SMART S Silver Diamine Fluoride M- Modified ART Atraumatic Restorative Treatment(SMART- Use of Silver Diamine Fluoride with a modified Atraumatic Restorative Treatment)Silver Diamine Fluoride application, followed by Glass Ionomer application.- Light cure treated lesion for precipitation /activation of silver ions

SDF clinical photos Dr.Miriyala

After removing dental caries, before SDF

After SDF, KI and GI fill

SDF- Application videos

BEFORE AFTER

BEFORE AFTER

BEFORE AFTER

Michigan Medicaid SDF coverage

D1354-Interim Caries Arresting Medicament Application is billable once per date of service regardless of the number of teeth treated up to a maximum of 5 teeth per visit.

D1354 has a maximum lifetime limit of 6 applications as medically necessary in the treatment of active caries when traditional treatments are not available or are contraindicated.

SDF cannot be billed on the same date of service as other fluoride applications.

Michigan Medicaid SDF coverage SDF is a covered benefit for all ages. It is billable

once per date of service regardless of the number of teeth, with a maximum of 6 applications per lifetime.

Advantage Arrest by Elevate Oral Care is currently the only FDA approved SDF for use in the United States.

Direct application to the tooth is required to arrest active carious lesions, however application to sound teeth is not necessary for the additional anti-caries benefit.

Application of SDF has an antimicrobial effect on the entire oral cavity in addition to the teeth being treated for caries arrest.

MSA 16-38 Bulletin, Interim Caries Arresting Medicament Application, November 30, 2016

Medicaid Reimbursement Currently about 9 states Medicaid pay for

SDF application. Private dental insurance companies are

also reimbursing for SDF application in certain states.

Ohio Medicaid is currently looking at reimbursing for SDF application.

SDF Use in Ohio Educational Programs

OSU College of Dentistry Undergrad Didactic Nationwide Childrens Hospital Didactic, Clinical University of Cincinnati Didactic, Clinical CWRU School of Dentistry Undergrad Didactic University of Toledo Didactic, Clinical

SDF Q&A1. Does the application technique differ between the label indication of relief of

dentinal hypersensitivity and the off label indication of caries control? No

2. Is there a recommended frequency of application of silver diamine fluoride for caries control?6 months to one year

3. Does the application of silver diamine fluoride to a lesion cause discoloration?Yes

4. Can Advantage Arrest be used on a prepared tooth just prior to restoration cementation?Yes

5. Are there any contraindications for the use of silver diamine fluoride for the control of caries? Silver diamine fluoride should not be placed on exposed pulps. Other topical fluorides (e.g. fluoride varnish) should not be used in the same appointment. Studies have shown that 38% silver diamine fluoride conveys more effective protection against decay in other teeth than fluoride varnish with reduced overall fluoride exposure.

6. Is there evidence of caries prevention benefit to non-application sites following Advantage Arrest use for a patient?

Treating carious areas with silver diamine fluoride 38% acts as a whole mouth fluoride treatment. It can also be used in place of sealants in grooves. A protective effect has been shown to non-treated teeth and surfaces. These findings come from high quality randomized clinical trials.

7. Are there any post appointment instructions for the patient or the caregivers/guardians? There are no postoperative limitations. Patients may eat or drink immediately. Patients may

brush their teeth with fluoridated toothpaste on their regular schedule.

SDF Q&A8. Does silver diamine fluoride stain skin, countertops, instruments etc.

Yes9. A contraindication in the Advantage Arrest Package Insert states that patients with more than six affected sites are

recommended for exclusion. What are the safety implications for application of Advantage Arrest for a patient that has more than six sites to be treated?

The Margin of Safety for the volume of product needed to treat six sites is within 130 times the NOAEL (no-observed-adverse-effect- level). Treating more sites in one visit will likely have little practical impact on patient safety; like protocols for fluoride varnish application, the suspension for several days of fluoride supplements is advised.

11. How does an arrested lesion treated with Advantage Arrest look like on radiographs?Arrested lesions look like a scar on radiographs. You will observe radio-opacity as the mineralization of the

previously softened dentin increases. Ultimately the best test of arrest is still the color change and tactile hardness of the dentin surface. It is advised that you educate your referring dentist about your use of Advantage Arrest since the appearance of a treated lesion might be new and confusing for many practitioners.

12. How can Advantage Arrest be coded using CDT?D1208 - Topical application of fluoride D 9910 - Application of a desensitizing medicament, per visitD1999 - Unspecified preventive procedure by reportIn 2016 there will be a new CDT code specifically for the use of caries arresting medicaments; the off-label use

of Advantage Arrest.Code D1354 - Interim caries arresting medicament application

13. Can Advantage Arrest be used as a cavity Liner?Yes, Silver Diamine Fluoride (SDF) is cleared in the same FDA category as cavity liners. Although there are no

head to head clinical trials comparing SDF as a cavity liner, it has been used successfully in this way. Silver Diamine Fluoride will not discolor intact enamel or dentin. SDF can discolor demineralized tooth structure brown/black. Some of this discoloration may shadow a restoration and can create less than optimal esthetic restorations.

References:

http://mmclibrary.com Silver Diamine Fluoride: A review and

current applications. Shah et.al., J AdvOral Res/ Jan-Apr 2014/ Vol. 5 No. ,25-35

Provided on request

http://www.mmclibrary.com/

Acknowledgments

Pediatric patients who have challenged us to find quality affordable care

Margherita Fontana, DDS, PhD University of Michigan

Dr. Jeremy Horst, DDS, PhD UCSF Elevate Oral Care Unsung heros in public health and

dentistry

SDF, SMART - Medical Management of Caries - Preventive Strategies inPediatric Dentistry and Public Health.Silver Diamine Fluoride -SDFSlide Number 3Evidence BasedSlide Number 5Slide Number 6Advantage Arrest Silver Diamine Fluoride 38%Advantage ArrestMechanism of Action -SDFMechanism of action -SDFSDF - ToxicitySDFSDFSDFSDFSDFIndications and Contraindications of SDFSDFStaining due to SDFSlide Number 20SDF clinical photos Dr.MiriyalaSDF clinical photos Dr.MiriyalaBefore and After SDFSDF + ActivaSDF + ActivaSDF ApplicationSDF + GI SDFSDFSuper floss- Interproximal TxAdvantage Arrest by Elevate Oral CareAdvantage Arrest by Elevate Oral CareAdvantage ArrestBonding Strength after SDF applicationPotassium Iodide KISMARTSDF clinical photos Dr.MiriyalaSDF- Application videosSlide Number 39Michigan Medicaid SDF coverageMichigan Medicaid SDF coverageMedicaid ReimbursementSDF Use in Ohio Educational ProgramsSDF Q&ASDF Q&AReferences:Acknowledgments