Silver Diamine Fluoride: 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:    an8microbial     •  8%  ammonia:  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  den8n  hypersensi8vity  

SDF – how does it work? •  38% SDF contains ~44,800 ppm F and ~253,870 ppm Ag •  Sodium fluoride (NaF) & Silver nitrate (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 dentin demineralization, preserves collagen and inhibits collagen breakdown, increases dentin hardness

Caries  arrest  

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

Caries  preven8on  

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

How do you use it?

dry & apply, 2+ times per year

SDF  staining  

8me  0  

1  day  

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

1  week  

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   •  Pa8ents  without  access  to  care   •  Young  pa8ents  wait-­‐listed  for  OR-­‐based   dental  treatment  

Where  did  this  come  from?   •  Silver  Nitrate  used  globally  for  >1000  years.   –  Caries  arrest  case  series  &  protocols  in  1800s   –  1891:  87  of  142  treated  lesions  were  arrested   –  Founding  fathers  of  den8stry  had  protocols  

•  AgF  used  in  Japan  for  ~900  years   –  Cosme8c  blackening  of  teeth   –  Known  to  prevent  caries  

•  NH3+  added  >80  years  ago  =  SDF   –  Approved  &  monitored  by  Japan  

•  Available  in  Australia,  Brazil,  Argen8na,  Cuba,   China  since  1980s  or  before…   RosenblaK    et  al.    J  Dent  Res  2009;  88:116-­‐125  

GV Black

SDF  is  now  available  in  the  U.S.   •  •  •  • 

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

FDA  clearance  =  hypersensi8vity   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 fluorides, 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   •  Contraindica4on   –  Silver  allergy  

•  Rela8ve  contraindica8on   –  Significant  desquama8ve  processes    e.g.  ulcera8ve  gingivi8s,  stoma88s   →  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%  absorp8on  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  inflamma8on  

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 1 of 1

•  Permanent dark staining of clinic surfaces and clothes 6/3/15, 8:10 PM

1 of 1

–  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

6/3/15, 8:10 PM

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  preven8on   Dry  before  use   SDF  stains  the  crap  out  of  everything  

THANK YOU