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2/12/18 1 Silver Diamine Fluoride Rebecca L. Slayton, DDS, PhD February 2018 Objectives Learn the history of silver compounds in Dentistry What is Silver Diamine Fluoride (SDF)? What does SDF do? What are the indications/contraindications for using SDF? How do I use SDF with patients? Is there evidence to support its use? How do I bill for SDF? Used historically to treat colds, infections, tetanus and rheumatism Prior to invention of antibiotics, used to treat Gonorrhea Silver sulphadiazine used as topical agent to treat burns Peng JJ et al. J Dent. 2012 Jul;40(7):531-41 Paul Dirkes, DDS (Poarch Band of the Creek Indians) Silver compounds History of Silver Compounds Dr G.V. Black used multiple applications of silver nitrate solution to slow the progression of caries . 1920’s ammoniiacal silver nitrate used by Dr Howe for caries, the chemical precursor of SDF. Silver Nitrate Prior to FDA approval of silver diamine fluoride in the US, silver nitrate was combined with sodium fluoride varnish to reduce the need for hospital dentistry in EEC patients Silver Nitrate J Calif Dent Assoc. 2012;40(11):852-8. Dr Duffin reports on use of silver nitrate + fluoride varnish: 25% silver nitrate with 5% NaF varnish 5000 children over a five year period 7 of 578 teeth treated had to be extracted 98% of lesions remain inactive after 4 years Same magnitude expected in root caries Pulpitis is not an issue

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Silver DiamineFluorideRebeccaL.Slayton,DDS,PhD

February2018

Objectives• LearnthehistoryofsilvercompoundsinDentistry• WhatisSilverDiamine Fluoride(SDF)?• WhatdoesSDFdo?• Whataretheindications/contraindicationsforusingSDF?

• HowdoIuseSDFwithpatients?• Isthereevidencetosupportitsuse?• HowdoIbillforSDF?

• Usedhistoricallytotreatcolds,infections,tetanusandrheumatism

• Priortoinventionofantibiotics,usedtotreatGonorrhea• Silversulphadiazine usedastopicalagenttotreatburns

• Peng JJetal.JDent.2012Jul;40(7):531-41• PaulDirkes,DDS(PoarchBandoftheCreekIndians)

Silver compounds History of Silver Compounds• Dr G.V.Blackusedmultipleapplicationsofsilvernitratesolutiontoslowtheprogressionofcaries.

• 1920’sammoniiacal silvernitrateusedbyDrHoweforcaries,thechemicalprecursorofSDF.

Silver Nitrate• PriortoFDAapprovalofsilverdiamine fluorideintheUS,silvernitratewascombinedwithsodiumfluoridevarnishtoreducetheneedforhospitaldentistryinEECpatients

Silver Nitrate• J Calif Dent Assoc.2012;40(11):852-8.• Dr Duffin reportsonuseofsilvernitrate+fluoridevarnish:• 25%silvernitratewith5%NaF varnish• 5000childrenoverafiveyearperiod• 7of578teethtreatedhadtobeextracted• 98%oflesionsremaininactiveafter4years• Samemagnitudeexpectedinrootcaries• Pulpitisisnotanissue

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What is Silver DiamineFluoride?

• 24.4-28.8%(w/v)silverand5.0-5.9%fluoride(~44800ppm)

• Ammoniaandsilverfluoridecombinetoformadiamine silverioncomplex[Ag(NH3)2+]o Ammoniahelpsstabilizethesolutionataconstantconcentrationforlongertime

• pH10

• Silverandfluorideionspenetrate~25micronsintoenamel,and50-200micronsintodentin.

• Silverisantimicrobialandinhibitsenzymesthatbreakdowndentinorganicmatrix

• Fluorideaidsinremineralization oflesion

• Horstetal,JCalif DentAssoc.2016January;44(1):16–28

How it works• Formssilver-proteinconjugatesindecayedsurfaces• Increasesresistancetoaciddissolutionandenzymaticdigestion.

• Hydroxyapatiteandfluoroapatite formontheexposedorganicmatrix,alongwiththepresenceofsilverchlorideandmetallicsilver.

• Increasesinmineraldensityandhardnesswhilethelesiondepthdecreases.

• Inhibitstheproteinsthatbreakdowntheexposeddentinorganicmatrix:matrixmetalloproteinases;cathepsins;andbacterialcollagenases.

How it Works• Silverionsactdirectlyagainstbacteriainlesionsbybreakingmembranes,denaturingproteins,andinhibitingDNAreplication.

• Ionicsilverdeactivatesnearlyanymacromolecule.• Silverdiamine fluorideoutperformsotheranti-cariesmedicamentsinkillingcariogenicbacteriaindentinaltubules.

• Silverandfluorideionspenetrate~25micronsintoenamel,and50-200micronsintodentin.

• Fluoridepromotesremineralization,andsilverisavailableforantimicrobialactionuponreleasebyre-acidification.

SilverDiamine Fluoride• Effectivenessestablishedbasedona30-monthprospectivecontrolledclinicaltrial(Chuetal.,2002)o 376pre-schoolChinesechildrenwithcariesintheirmaxillaryprimaryanteriorteeth.

o Subjectsweresequentiallyassignedto:

• excavation+38%silverdiamine fluoride(SDF)appliedevery12months;

• SDFappliedevery12months(noexcavation)• excavation+5%NaF varnishappliedevery3months;• 5%NaF varnishappliedevery3months(noexcavation)• watercontrol

SilverDiamine Fluoride• AnnualapplicationofSDFwasmoreeffectiveinarrestingdentincariesthanapplicationoffluoridevarnishevery3months.

• TheremovalofcariestissuedidnotimprovetheeffectivenessofSDForfluoridevarnishtoarrestdentincaries.

• Forfluoridevarnishonly,cariesexcavationimprovedesthetics

Chuetal.,2002.JDentRes81:767-770

Silver Diamine Fluoride• Silverdiamine fluoridewasfoundtobeeffectiveinarrestingdentincariesinpermanentfirstmolarsinschool-agedchildren.

• Mechanismisthoughttobeanti-microbialactivityagainstS.mutans

• SDFrecentlyapprovedbyFDAfordentinsensitivity• AdvantageArrestgivendesignationas“breakthroughtherapy”

• J.C.Llodra,A.Rodriguez,B.Ferrer,V.Menardia,T.Ramos,andM.Morato.J.Dent.Res.,August 1, 2005;84(8):721- 724.

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Indications for Use• Highcariesrisk• Behavioralormedicalmanagementissues• Dentinalhypersensitivity• Cariesstabilization• Xerostomia fromcancertreatmentormedications• Difficulttotreatcarieslesions– crownmargin,furcation• Patientswithdentalphobia• Patientswithlimitedaccesstorestorativeservices• Physicalorcognitivedisabilities• Veryyoung/veryold

Contraindications• Silverallergy• Ulcerativegingivitis/stomatitis• Abscessedtoothneedingextraction• Irreversiblepulpitis

Side Effects• Metallictaste• Decayedteethturnblack• Transientgingivalirritation• Stainsclothes,skin,floor– mustusemeticuloustechnique

Advantages of silver solutions

• Controlspainbyarrestingcaries• Affordableforanycommunity• Procedureisfast• Minimalsupportinstafforequipmentneeded.• Non-invasiveandsafe

Informed Consent• Mayuseaseparateformorincorporateintoclinicconsentdocument

• PhotosshowinghowteethwilllookafterapplyingSDFmaybehelpful

• Parent,grandparent,otherfamilymembersmayhavestrongopinions

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Parental Perception• Crystaletal,JADA2017• Stainingonposteriorteethwasmoreacceptablethanonanteriorteeth

• MostparentspreferredstainingratherthantreatmentwithGAorsedation

Clinical Issues• Invitrostudiesshownoeffectonbondingtonon-cariousdentin(Quock etal,2012)

• BondingofacrowntoSDFtreateddentinmaybecompromised,sorecommendexcavationoftreateddentinpriortocementation(Soeno etal,2001)

• SDFeffectiveforsecondarycariespreventionwhenplacedunderamalgam(ShimizuandKawagoe,1976)

• 40%AgF placedondeepcariesinprimaryteethplannedforextraction;91%showedfavorablepulpresponse(Gotjamanos,1996)

Advantage Arrest Silver Diamine Fluoride 38%

Advantage Arrest• FDAclearedasadentinalhypersensitivitytreatment(similartofluoridevarnishes)

• 50+yearsofuseinJapan,China,India,NewZealand,AustraliaandmanyothersasCariesArrestingAgent

Breakthrough Therapy• Recently,FDAgaveAdvantageArrestthedesignationof‘breakthroughtherapy’

• ThebreakthroughtherapydesignationrepresentstheFDA’sefforttoexpeditethedevelopmentandreviewofdrugsthatareintendedtotreataseriouscondition;itisgrantedwhenpreliminaryclinicalevidenceindicatesthedrugmaydemonstratesubstantialimprovementoveravailabletherapies.

• FromDecisionsinDentistry.December2016.2(12):10.

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Toxicity• Onedropisapproximately25 μL andshouldbesufficienttotreat1-5teethandcontainsabout11.88mgofSDF. LDoforaladministrationisapproximately520mg/kgbodyweight;whileLDsubcutaneousadministrationis380mg/kgbodyweight. Achildof10kgwouldreceive1.185mg/kg.

• Ifyouusethe380mg/kgnumberbeingoverlycautious,thatisa400foldsafetymargin. TheEPAhasalsosetshortterm silver exposurelevelsindrinkingwaterat1.142mgperLfor1-10days.

• Typicalapplicationisonceperyear

Toxicity• Applicationsgreaterthanone

weekapartfallinlinewiththese

recommendations. TheEPA

longtermexposurelimitshave

beensetat1gramtosafely

avoidargyria.

• AccordingtoVasquezet.al,the

highestapplieddoseof2.37mg

wouldenable400+applications

overalifetime.

• Vasquezetal,BMCOralHealth.

2012Dec31;12:60.

Protocol• Covercountersandpatientwithplasticlinedbib/towel• UsestandardPPEforprovider,assistantandpatient• Place1dropofSDFintodisposableplasticdish• Forsingleuseampule,have2x2gauzeavailabletopreventsplashingwhenopening

• Usesalivaejectortoremovebulkofsaliva• Isolatetongueandcheekfromaffectedareawithgauzeorcottonrolls

• Iflesionisneargingiva,considerapplyingvaseline totissueinadvance

Protocol• Dryaffectedtoothsurface(s)withair/watersyringeorcottonpellet

• Dipapplicatorintodishandremoveexcessonsideofdish• ApplySDFtoaffectedtoothsurface• AllowSDFtoabsorbintotoothsurfacefor1minuteifpossible

• Removeexcesswithgauzeorcotton• Rinsewithwater• Discardallitemsinplasticbag

• LightcuringSDFisnot recommended• Itdoesspeedthedryingprocesssodarkstainisvisibleimmediately

• Lightcuringtakesfreesilverionsandcausesthemtooxidizerapidly.

• Onceoxidized,theyarenolongerabletobindwiththecollagenorphosphatesinthetooth,effectivelyweakeningtheSDF.

To Light Cure or Not? Advantage Arrest• Ifstainisanissue,canbecoveredwithGlassIonomer.• PotassiumIodidehasalsobeenusedtoreducethestaining

o ResearchisinconclusiveaboutKIreducingstain,orreducingefficacy

• Excesscanberinsedawayafterapplication• Canbereappliedatintervalsof>oneweek;oneapplicationperyearisnormallysufficient

• Clearliquid,LightSensitive• 10mlbottlefilledto8ml/alsoavailableasunitdose• 3yearshelflife

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• Beforeitdries,useanammoniabasedcleanersuchasWindex,orLysolwipes.

• FordriedandsetSDFstains,o Mr.CleanMagicErasero Bleacho BarKeepersFriendandComet

• Forskin,waterandsaltslurryaswellashydrogenperoxidehavebeeneffectivetosomeextent.

Oops, I spilled – Now what? Before and After SDF

Case #1• 16montholdchildpresentstoyourclinicwithECC• Childishealthybutparentsdon’thaveinsurancetopayforGAanddon’twantchildtobeasleepfortreatment

• Options:o Applyfluoridevarnishandputon3monthrecallo Attempttoplaceglassionomer restorationso PlaceSDF

Case #2• An8yearoldgirlwithalymphaticmalformationinvolvinghertongue,face,mediastinumandmandible

• Untilrecently,shewas100%G-tubefedbutnoweatsavarietyoffoodbymouth

• Anytraumatohertonguecausesexcessivebleeding• Shehasextensivecarieswithsomeprimaryteethandpermanentteethneedingtobeextracted

• Definitivetreatmentundergeneralanesthesiaisrecommendedwithpossibleadmissionforobservation

• ThecurrentbacklogfortheORfordentistryis1year

Case #2• Treatmentoptions:• SeeforfrequentrecallappointmentsandapplyFvarnish• Attempttoplaceglassionomer restorations• ApplySDFandexpediteORcase

• Inaddition:• Managediettodecreasesweetenedbeveragesandfoods• Regular2timesdailybrushingwithFtoothpaste

Case #3• 45yearoldmalewithahistoryofbisphosphonatetreatmentandnon-restorablemolar.Extractionnotrecommendedduetoriskforosteonecrosis.

• Optionstoconsider:o SDFapplicationo Decoronation andreplacementrootresorptiono RCTanddecoronationo Otherideas?

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Case #4• Frail,elderlypatientwithrootcarieswhoisunabletotraveltoclinicforroutinecare.

• Possibleoptions:o Glassionomer – ARTo SDFapplicationo Fvarnish

SDF + Glass ionomer =SMART

• Silvermodifiedatraumaticrestorativetreatment(SMART)• IfGIisplacedthesamedayasSDF,willhavestainingoftherestoration

• Someinsurancewon’tpayforSDFandGIdoneonthesameday

• SomeprovidersrecommendplacingGIoneortwoweekslater– maystillhaveadarkmarginduetoSDF

SMART• AfterplacingSDFfollowingpreviousprotocol• Cleanmarginsofthecavitated lesionwithslow-speedroundburorspoonexcavator

• Applyconditioner(20%polyacrylic acid)for10secondsandthenrinsefor10seconds

• Blotdrybutdon’tdessicate• MixGICandapplytolesion• Shapeandremoveexcess• Don’tlightcure• After2.5minutes,placeanatomy,adjustocclusionwithwaterspray

SDF use on proximal lesions• Noclinicalstudiestodate• SomeprovidersrecommendapplyingSDFusingsuperfloss• OtherproviderssuggestseparatingteethwithorthodonticelasticsandthenapplyingSDFdirectly

• Morestudiesneeded

Photo courtesy of Dr. JasonHirsch

SDF and GI• Bendit andYoung.SilverDiamineFluoride:Thenewesttoolinyourcariesmanagementtoolkit.CEcourseavailableat:o https://www.dentalacademyofce.com/

• CEcoursebyDr.JeanetteMacLeanandDentaltowno http://www.dentaltown.com/onlinece/details/803/silver-is-the-new-black-

improving-your-practice-with-silver-diamine-fluoride

Stains skin, clothes, floors, counters.

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Advantage Arrest• Perapplicationcost• $149=8mLbottle=250drops=$0.60/Drop• $11.25for100Applicators– $0.11perapp.

• Onedropapplication=$0.71perapplication• Twodropapplication=$1.42perapplication

• Unitdose=$4perapplication• EqualorlessthanFluorideVarnish

www.elevateoralcare.com/dentist/AdvantageArrest

Billing• In2016,newcodeestablished:D1354– interimcariesarrestingmedicamentapplication

• SomeMedicaidprogramsreimbursebutnotall• WashingtonHCAwillreimbursestartinginJanuary2018

Washington HCA• Theagencycoverssilverdiamine fluorideperapplicationasfollows:o Whenusedforstoppingtheprogressionofcariesonly;o Twotimesperclientpertoothinatwelve-monthperiod;ando Cannotbeperformedandbilledwithinterimtherapeuticrestorationonthesame

tooth.

• Providermusthavesignedinformedconsentthatincludes:o Benefitsandrisksofsilverdiamine fluorideapplication;o Alternativestosilverdiamine fluorideapplication;ando Colorphotographexamplethatdemonstratesthepost-procedureblackeningofa

toothwithsilverdiamine fluorideapplication.

• Reimbursement=$3.00/tooth• D1354codenowrequiresatoothnumber

Questions?• Ifunsureofbillingprotocol,contactHCA

o Dental-relatedservicesprogrambillingguide

• https://www.hca.wa.gov/assets/billers-and-providers/Dental-related-serv-bi-20181801.pdf

• MayalsocontactDr.JonGibbons(ADAtrusteeanda

pediatricdentist)o [email protected]

o Dr.RebeccaSlayton– [email protected]