Diamine : A New, Old Approach to Dental Caries Management

Scott L. Tomar, DMD, DrPH University of Florida College of Dentistry [email protected]

AACDP Cincinnati, OH April 17, 2016 Disclosures

I have no financial interests in any silver diamine fluoride product Silver Diamine Fluoride (SDF) Outline • What is SDF? • How does SDF work? • Where does SDF come from? • When should I use SDF? • How do I use SDF? • What’s the evidence that SDF works? • What are the safety considerations? SDF – what is it?

• Colorless liquid • pH around 8.0 • 25% silver: anmicrobial • 8% : solvent • 5% fluoride: remineralization Fluoride • Promotes remineralization • Inhibits demineralization • Can inhibit plaque bacteria Silver

Silver Nitrate SDF - what does it do?

• Arrests dental caries • Prevents dental caries • directly & indirectly • Decreases denn hypersensivity SDF – how does it work?

• 38% SDF contains ~44,800 ppm F and ~253,870 ppm Ag

• (NaF) & (AgNO3)

• Reacts with hydroxyapatite producing calcium fluoride (CaF2) and silver phosphate (Ag3PO4)

Ø CaF2 – Reservoir of fluoride – Neutralizes imbalance in demineralization/mineralization

Ø Ag3PO4 – Crystal of low solubility in the oral environment – Yellowish color – darkened by sunlight or reducing agents Ø SDF inhibits demineralization, preserves and inhibits collagen breakdown, increases dentin hardness Caries arrest 2016; 44(1):16-28 44(1):16-28 2016; Horst et Dent al. J Calif Assoc

Caries prevenon 2016; 44(1):16-28 44(1):16-28 2016; Horst et Dent al. J Calif Assoc

How do you use it?

dry & apply, 2+ times per year SDF staining

me 0 1 day 1 week

Rosenbla et al. J Dent Res 2009; 88:116-125

Protocol v Prophylaxis v Vaseline – adjacent soft tissue v Relative isolation: cotton rolls /gauze v Suction / Drying v Application using a microbrush for ~2-3 min v Wash with water v No specification for number of applications Deep cavities = consider pulp effects When would you use SDF?

• Extreme caries risk (xerostomia, S-ECC) • Behavior or medical management challenges • More lesions than treatable at 1 visit • Difficult to treat lesions • Paents without access to care • Young paents wait-listed for OR-based dental treatment

Where did this come from?

• Silver Nitrate used globally for >1000 years. GV Black – Caries arrest case series & protocols in 1800s – 1891: 87 of 142 treated lesions were arrested – Founding fathers of denstry had protocols • AgF used in Japan for ~900 years – Cosmec blackening of teeth

– Known to prevent caries + • NH3 added >80 years ago = SDF – Approved & monitored by Japan • Available in Australia, Brazil, Argenna, Cuba, China since 1980s or before…

Rosenbla et al. J Dent Res 2009; 88:116-125 SDF is now available in the U.S.

• One manufacturer • $100/bole = ~250 drops • ~40¢/drop • 1 drop treats ~ 5 teeth

FDA clearance = hypersensivity Off label use = caries treatment This is the same as fluoride varnish SDF CDT Codes

D1208 -Topical application of fluoride “SDF is categorized as a fluoride and can be used to treat site-specific locations. Its application and effect is very different than most , but the off-Label indication is acceptable for this code use.” D9910 - Application of a desensitizing medicament, per visit “SDF is indicated for dentinal hypersensitivity treatment and can be used to treat site-specific locations.” D1999 - Unspecified preventive procedure by report New 2016 CDT code for the use of caries arresting medicaments, the off-label use of Advantage Arrest: D1354 - Interim caries arresting medicament application "Conservative treatment of an active, non-symptomatic carious lesion by topical application of a caries arresting or inhibiting medicament and without mechanical removal of sound tooth structure." Elevate Oral Care How safe is SDF?

• No adverse reports in >80 years of use in Japan • Contraindicaon – Silver allergy • Relave contraindicaon – Significant desquamave processes e.g. ulcerave gingivis, stomas → Protect by petroleum jelly • Side effects: – Small, white mucosal lesions • disappear in 48 hours – Will stain the lesion black How much can you use?

– FDA rat & mouse LD50 studies: • Oral LD50 = 520 mg/kg • Subcutaneous LD50 = 380 mg/kg – 100% absorpon of 20μL drop (9.5 mg SDF) in 10 kg child = 0.95 mg/kg • 400-fold LD50 safety margin. – No Observed Adverse Effect Level for 14 days of daily exposure = 1.3 mg/kg • Higher levels resulted in mild gastric inflammaon Recommended limit: 1 drop per 10 kg per visit 567px-Singapore_Road_Signs_-_Temporary_Sign_-_Caution.s... http://3.bp.blogspot.com/-VJvRwbauAzo/TxAnwGkM1aI/A... 567px-Singapore_Road_Signs_-_Temporary_Sign_-_Caution.s... http://3.bp.blogspot.com/-VJvRwbauAzo/TxAnwGkM1aI/A...

Person and Clinic Protection • Permanent dark staining of clinic surfaces 1 of 1 and6/3/15, 8:10 PMclothes 1 of 1 6/3/15, 8:10 PM – Does not come out after setting (exceptions) – Clean immediately with copious water, ethanol, or high pH solvents such as ammonia • Temporary staining of skin – Rinse – Will go away in days – No harm Combination with GIC sealants: Modified-ITRs (ITR=ART)

• Glass Ionomer Cements (GICs) add the benefit of sustained fluoride release and a seal • Protocol: SDF, then standard GIC protocol.

(they darken over time)

Photos courtesy of Dr. John Frachella SDF take-homes

• SDF arrests >90% caries when used 2/year • Powerful indirect prevenon • Dry before use • SDF stains the crap out of everything THANK YOU