The Materials

Ledermix Paste and Ledermix Cement

Tried Tested Trusted

2 3

The Materials

Table of Contents

Introduction .........................................................................................3

The LEDERMIX Materials ......................................................................5

How do the LEDERMIX Materials Work? ..............................................7

PharmacokineticsoftheLEDERMIXMaterials................................... 8

Indications for Use ............................................................................13

Ledermixpaste............................................................................. 13

Ledermixcement.......................................................................... 15

Directions for Use ..............................................................................16

Ledermixpaste............................................................................. 16

TimeofUse................................................................................. 18

Ledermixcement.......................................................................... 19

References .........................................................................................21

Introduction

Oneof themostcommonreasons forpatients to seekdental care is thepresenceofpain.Therecanbemanyreasonsfororalanddentalpainbutthemostcommonpainconditionsingeneraldentalpracticeareusuallyrelatedtopulpandperiapicaldiseases.These conditions have a variety of clinical presentations depending on the particulardiseasecondition.1,2Thepaincanrangefrombeingaverymild,occasionalachetoaspontaneous,veryintense,severeandcontinuouspain.

Acute reversible pulpitisisacommonalthoughnotverypainfulcondition.Itisgenerallycharacterizedbyreactionstoextremetemperaturechangesinthemouthsuchasthosecausedbyeatingordrinkingveryhotorverycoldfoodsanddrinkstypicalexamplesareicecreamandhotcoffeeortea.Thepainistypicallyshortandsharpinnature,anditdisappearsalmostimmediatelyafterthestimulusisremovedfromthetoothinquestion.1Reversiblepulpitis isusuallyaresultofbacterial invasionof the toothsuch invasiontypicallyoccursviacaries,breakdownofarestoration,cracksinthetooth,fractureofthetoothorrestoration.1

Acute irreversible pulpitis isoneof themostseveredentalpainconditionsandit ischaracterizedbyasharpintensepain(typicallyassociatedwithmildtemperaturechangessuchastapwater)whichthenbecomesadulllingeringpain.Thetoothmaybesoretobiteonorevenjusttolighttouch.Thepaincanbespontaneous,maybeworsewhenthepatientislyingdownanditmaywakethematnight.1Acuteirreversiblepulpitisisusuallya result of bacterial invasion of the tooth such invasion typically occurs via caries,breakdownofarestoration,cracksinthetooth,fractureofthetoothorrestoration.1

Acute apical periodontitis isan inflammatoryconditionwithin theperiapical tissuesanditisusuallyaresultofeitherinflammationinthepulp(i.e.pulpitis)oraninfectionwithin the root canal system. Infected root canal systems can occur when there is anecroticpulp,whenthetoothispulplessorwhenthetoothhashadpreviousendodontictreatment.2Theinfectionwithintherootcanalsystemisaresultofbacterialinvasionofthetoothandthiscanoccurviathesamepathwaysmentionedaboveforpulpitis.1,2Inaddition,theinfectionmaybearesultofbacteriathathavesurvivedpreviousendodontictreatmentprocedures.Thepainassociatedwithacuteapicalperiodontitisischaracterizedbythetoothbeingverysoretobiteon.Occasionally,theremaybesomeswellingoftheoverlyingmucosa.2

Acute apical abscessescanalsocauseseverepain.Suchteethareextremely tendertoevenjustlightbitingpressure.Therewillbeswellingwhichistendertopalpationand

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The Materials

thepatientmayfeelgenerallyunwellwithincreasedbodytemperatureandlymphnodeinvolvement.Anapicalabscessisasequeltoaninfectedrootcanalsystemandapicalperiodontitissothesamepathwaysforbacterialinvasionaretheoriginalcauseofthediseaseprocess.Apicalabscessescanprogresstobecomefacialcellulitissothisconditionrequiresimmediateandcomprehensivemanagementtoavoidfurthercomplications.2

Managementoftheaboveconditionsrequiresathoroughandaccuratediagnosisofthediseaseconditionsandanevaluationofwhathascausedthesediseases.Thecausemustbeidentifiedsoitcanberemovedasthefirststageoftreatingthepatient.3Attemptstomanagethepainjustwithanalgesicsand/orantibioticsarenotappropriateandusuallyhavelittleeffect.4

Allteethwithpulpandperiapicaldiseaseshouldbecarefullyevaluatedduringtheinitialexaminationandearlytreatmentphasestodeterminewhetherthetoothissuitableforfurther restoration3 - if there is insufficient tooth structure remaining and the tooth isnot suitable for further restoration, then extraction should be considered.Otherwise,conservativepulptherapyorendodontictreatmentshouldbeconsidered.

Teethwithreversiblepulpitiscanusuallybemanagedbyremovingtheirritantfromthetoothandrestoring it tonormal functionalthough theadjunctiveuseofa therapeuticmaterialonexposedpulpand/ordentinecanbeadvantageousinrelievingpainforthepatient.1

Teethwith irreversiblepulpitis shouldalsobemanagedby removing thecauseof thediseasesaswellasbyremovingtheinflamedpulp.1Thistreatmentcanbeenhancedbyplacinganintracanalmedicamenttoensureeffectiveandrapidpainrelief.5,6

Teethwithinfectedrootcanalsystemsshouldbemanagedbydebridementofthedebrisfromwithintherootcanalfollowedbytheplacementofanintracanalmedicamentwhichwill lead to effective and rapid pain relief.2,5-8 Previously root-filled teethwill requireremovaloftherootfillingbeforedebridementcanbedone.

As outlined above, an intracanal medicament should be used as an adjunct to themechanical phases of root canal treatment.5,6,9 There are two major functions ofmedicamentsnamely,anti-inflammatoryactionandantimicrobialaction.6,9Thesetwoactionsaddress theprimaryproblemsencounteredwithpulpandperiapical diseaseswhich helps to ensure effective and rapid pain relief for patients. Other functionsof medicaments include the inhibition of clastic cells that are responsible for rootresorption,10,11andthestimulationofhardtissuerepair(suchasboneandcementum).5,6,9

The Materials

The LEDERMIX materials were developed in 1960 by Prof. Andre Schroeder fromSwitzerland.There isapaste formandacement formof thismaterial.Bothof thesematerials have beenwidely researchedand used extensively in clinical practice sincebecomingcommerciallyavailablein1962.Awiderangeofresearchersandclinicianshaveinvestigatedandreportedtheuseofthesematerials.Apartiallistofthesearticlesisincludedinthisbooklet7,8,10-27andreadersshouldbeawarethattherearenumerousotherarticlesinthedentalliteraturewhichsupporttheuseofthesematerials.

Although the two forms of Ledermix have different uses in Dentistry, they have twocommon active components, triamcinolone (a corticosteroid) and demeclocycline (atetracyclineantibiotic).Thebasesinwhichthesecomponentsarepresenteddictatethewayeachmaterialisusedandtheirindicationsforuse.

LEDERMIX Pasteisformulatedtobeusedasanintracanalmedicamentwithawater-solublepastebase.18Itispresentedasasinglepasteinatubesothereisnoneedtomixthismaterialpriortouse.28

LEDERMIX Cementisahard-settingmaterialforuseondentineasalining,asapulpcappingagentandasapulpotomyagent.16Thismaterialispresentedasapowderandaliquidthatmustbemixedimmediatelypriortouseinatooth.28Therearetwoformsoftheliquidcomponentafast-settingformulationandanormalsettingformulationandthemajorityoftheliquidiseugenol(85%).27,28Thepowdercomponentcontainszincoxide(47.2%)andcalciumhydroxidewiththelattermakingup33.4%ofthepowder.27Oncethepowderandliquidaremixed,thecementisazincoxide-eugenolcementcontainingtriamcinolone,demeclocyclineandcalciumhydroxideasitsactiveingredients.27

Triamcinolone is used in the LEDERMIX materials because of its anti-inflammatoryactionwhichassistswithrapidpainrelieffollowingthecommencementoftreatment.Italso inhibitsclasticcells (osteoclasts,cementoclastsanddentinoclasts)andtherefore itcanbeusedtomanagerootresorption.6,10,11ThetriamcinoloneispresentinLEDERMIX Pasteataconcentrationof1.0%9,18andinLEDERMIX Cementataconcentrationof0.67%.16,27

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The Materials

Demeclocyclineisusedforitsantimicrobialactionanditalsohassomelimitedabilitytoinhibittheclasticcellsinvolvedinrootresorption.6,10,11ItispresentinLEDERMIX Paste ataconcentrationof3.21%9,18andinLEDERMIX Cementataconcentrationof2.0%.16,27

ThepurposeofthismanualistoprovidedentistswithinformationanddirectionstoassistthemintheirendodontictreatmentthroughtheuseofLEDERMIX Paste.

How do the Materials Work?

Ingeneral,LEDERMIX Pastehastwomaintherapeuticactionsasaresultofitstwoactivecomponentsonereduces inflammationwhilst theotherreduces theviablemicrobialflorawithintherootcanalsystem.5,6,9Afurthertherapeuticactionisbyinhibitionofclasticcellswhenmanaginginflammatoryrootresorption.10,11

The pain associatedwith pulp and periapical diseases is a result of inflammation ofthepulpand/orperiapical tissues.1,2 Hence, inorder to reduce thepatientspain, itis essential to remove the cause of the inflammation.6 In addition, reduction of theinflammatoryreactionwillhelptoreducepainmorerapidly.5,6

Themanagementofacute irreversible pulpitiscanbegreatlyenhancedbyplacingLEDERMIX Pasteintherootcanalsystemaftertheinflamedpulphasbeenremoved.6The LEDERMIX Pastecanthenworkbythedirectcontactandanti-inflammatoryactionofthetriamcinolonecomponentonanyremainingpulptissue.Itcanalsoactbydiffusingthroughtheapical foramenof therootcanal to theperiapical tissueswhichmayalsobeinflamed.18Directactionbythetriamcinolonecomponentonthesetissuescanhelptoreducetheinflammationthatispresent.Furthermore,thedemeclocyclinecomponentcanprovidesomeusefulantimicrobialactioninpulpitiscasesastheremaybebacteriawithintheinflamedpulp(althoughinsufficientforthepulptohavenecrosedandbecomeinfected).

Themanagement of pain associatedwith infected root canal systems can also beenhancedbyplacingLEDERMIX Pasteintherootcanalfollowinginitialdebridementofthecanals.6,7,8Inthesecases,theLEDERMIX Pastehasdualfunctions.Thefirstfunctionissimilartothedirectactiondescribedaboveforpulpitiscaseswherethetriamcinolonediffusesthroughtheapicalforamentotheinflamedperiapicaltissuestohelpreducetheinflammation there.18Thesecond function is the inhibitionofbacteriawithin the rootcanalsystem.9

Periapicaldiseasesareusuallyaresultofbacterial invasionof therootcanalsystem.2Initially,thepulpmaybecomeinflamedthroughdirectbacterialinvasionofthepulporasareactiontothebacterialmetabolicby-productsandendotoxinsdiffusingthroughthedentinaltubulestoirritatethepulp.1Oncethebacteriahaveinvadedthepulpspace,theyprogressthroughtheentiretoothrootandrootcanalsystem.Therootcanalsystemisaverycomplexmazeofplaceswherebacteriacanestablishcolonies.Therootcanalsystemconsistsoftherootcanalsthemselves,lateralcanals,accessorycanals,interconnectionsbetweenthemaincanals,fins,anddentinaltubules.9Hence,thebacteriacanexistin

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The Materials

all partsof the tooth root,manyofwhichare inaccessible tomechanical endodonticproceduressuchasfilingandirrigation.9

Antimicrobial irrigantsmay reach some of the bacteria beyond themain canals butirrigantsaretypicallyonlyusedforashortperiodoftimeandthereforetheireffectivenessis somewhat limited.9 Inorder to reachallareasof the rootcanal system,adequatetime is required fordiffusionof theantimicrobial substance though thedentine thisrequiresatleastseveralhoursbutdaysandevenweeksformostmaterialstoreachtheirfullpotentialandtobeeffective.18Studieshaveshownthat themajorcomponentsofLEDERMIX Pastewilldiffusethroughthetoothrootwhenthepasteisplacedintherootcanalasamedicament.Thisdiffusioncanpersist forup tosixweeks inadult teeth.18

StudiesofLEDERMIX Cementhavealsoshownthatthetriamcinolonecandiffuseintothepulpspacewhenplacedinacoronalcavity.16,27

Pharmacokinetics of the LEDERMIX Materials

The active components of LEDERMIX Paste, triamcinolone and demeclocycline, arereleasedfromthepreparationfollowingplacementintherootcanal.18Theythendiffusethroughthemainrootcanalsthemselves,lateralcanals,accessorycanals,interconnectionsbetweenthemaincanals,fins,anddentinaltubules.18Thesecomponentsexitthetoothrootviaanyopeningssuchastheapicalforaminaorlateralcanalforamina,aswellasviadiffusionthroughthecementum.20Therateofdiffusionisaffectedbyfactorssuchasthepresenceofsmearlayeronthecanalwalls,thepresenceofcementum,thepermeabilityofthedentineandcementum,thesizeandstructureofthemoleculesthatarediffusing,theinitialamountofpasteusedandtheconcentrationsofthecomponents.18,20

Themajorityofbothactivecomponentsarereleasedwithinthefirstfewdays18-20andthisensuresrapidactionandparticularlypainreliefforthepatient.Diffusionwillcontinueataprogressivelyreducingrateandtherapeuticamountsarereleasedforuptoaboutsixweeksinadultteeth,basedonanin vitrostudy.18Inthatstudy,afterapplicationofradioactively-marked LEDERMIX Paste into prepared root canals of freshly extractedteeth,releaseanddiffusionofdemeclocyclineandtriamcinolonethroughdentinecouldbedetectedafteronehour (Fig.1).The triamcinolonehadaslight increase in releaseand diffusion over the next seven hours and then it decreased gradually until aboutsixweekswhen it couldno longerbedetectedat therapeutically-usefulamounts.Thedemeclocyclinehadamuchgreaterinitialrateofreleaseanddiffusion,andthisreducedsteadilyover thefirstdaybeforeslowing toagradualdecreaseforup to14weeks.18

Thedifferentpatternofreleaseanddiffusionofdemeclocyclineislikelytobearesultof

thehigherinitialconcentrationinthepaste(3.21%comparedto1%fortriamcinolone)and the effects of the tetracycline bindingwith the calciumof the dentine. This lattereffect helps tomaintain thedrug in thedentine for a longer periodof timewhich isadvantageousandprovidessomeantimicrobialsubstantivity.18,29

Inthesamestudy,18theconcentrationofdemeclocyclinewithintherootdentinewasalsomeasured.Bytheendofthefirstday,aconcentrationof200g/mlwasfoundinthedentineclosetotherootcanal.Aconcentrationgradientoccurredacrossthedentinewithconcentrationsof21g/mlinthemiddlelayerofdentineand17g/mlinthedentineadjacenttothecementum.Afteroneweek,theseconcentrationsreducedbyafactorofaboutteninalllevelsofthedentine.Theconcentrationofdemeclocyclineinthedentineishighenoughtoinhibitmostendodonticbacteriainthedentineimmediatelyadjacentto the root canal in the first fewdays.However, the levels reached furtherout in thedentineandoverlongerperiodswasnotsufficienttoinhibitmostbacteriathatarelikelytobepresent.18Hence,furtherantimicrobialstrategies(e.g.theuseofcalciumhydroxide)shouldbeemployed toensurecompletedisinfectionof the rootcanal systemprior toplacementoftherootcanalfilling.6

LEDERMIX Pastecanalsobeusedinacoronalcavityasasedativedressingunderatemporaryrestorationincasesofreversiblepulpitis.Thetriamcinoloneanddemeclocycline

260

Demeclocycline

Triamcinolone100

50

01h 3h 8h 1 Day 3 Days 10 Days 31 Days 14 Weeks

pmol/m

in

Fig. 1 -Meanratesofreleaseanddiffusion(pmol/min)throughhumantoothrootsoftheactivecomponentsofLEDERMIX Paste(fromAbbottetal18)

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The Materials

havebeenshowntobereleasedanddiffusethroughcoronaldentinetoreachthepulpspace.19 Thedemeclocycline release reached its peak rate after twohours and thendroppedthroughouttheremainderofthefirstdaytoaratethatwasmaintainedforatleast8days(Fig.2).Thetriamcinolonereacheditsmaximumreleaserateintheperiodbetween2to8hoursandthendroppedoverthenexttwodaysandhadalmostbeencompletelyeliminatedbytheendoftheeighthday.19

As outlinedabove,LEDERMIX Cement is a hard-settingmaterial. It canbe usedasa sedative dressing or lining under temporary or definitive restorations in teeth withreversiblepulpitiswithorwithoutpulpexposures.16,27,28Asitisahard-settingcement,itispreferredforthissituationratherthanusingthepasteform.LEDERMIX Cementhasbeenshowntoreleasetriamcinolonewhichthendiffusesthroughthedentinetoreachthepulpspace.16Approximately70%ofthetriamcinoloneisreleasedbytheendofthefirstdayandtheremainderisreleasedbytheendofthethirddayfollowingapplicationtoacavityfloor(Fig3).16Theresultsofthisin vitrostudyareconsistentwithaclinicalstudy27oftheuseofLedermixcementasanindirectpulpcappingorliningmaterialin85teethwithreversiblepulpitisduetothepresenceofcracksintheteeth.Afterremovalof

80

60

40

20

0

1h 2h 4h 8h 1 Day 2 Days 4 Days 8 Days

Demeclocycline

Triamcinolone

pmol/m

in

Fig. 2-Meanratesofreleaseanddiffusion(pmol/min)throughcoronal dentine of the active components of LEDERMIX Paste(fromAbbottetal19)

thecrackandcariesfollowedbytheplacementofLedermixcementandaninterimglassionomerrestoration,completeresolutionofsymptomsoccurredimmediatelyin71%ofthepatients.Afurther21%ofcaseshadresolutionofthesymptomswithin1day,6%took2daysand3%took3days.Onfollow-upafterthreemonths,98%oftheteethshowedsignsofthepulpitishavingcompletelyresolvedandthepulpshadreturnedtoaclinicallynormalstate(Fig4).27

After the triamcinolone is released from LEDERMIX Cement, the remaining cementis essentially a zinc oxide-eugenol material with calcium hydroxide. Both of thesecomponentshavewellknownandresearchedtherapeuticeffectsonthepulp.Calciumhydroxide has beneficial effects on the healing of dental pulps and the formation ofreactionary/reparativedentine30,31whilsttheeugenolcanbebothanti-inflammatoryandanti-bacterial,32-34dependingontheconcentrationreachingthedentineandpulpasitisreleasedbyprogressivehydrolysisoccurringatthecavityfloor.

100

Percen

t of R

elea

se

75

50

A B C

25

01h 4h 24h 2 Days 28 Days

Control

Fig. 3-PercentagereleaseanddiffusionthroughcoronaldentineoftriamcinolonefromLEDERMIX Cementinthreeexperimentalteeth(A,B,C)andonecontroltooth(withnoLedermixcement)(AdaptedfromHume&Kenney16)

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The Materials

Indications for Use

LEDERMIX PASTE

LEDERMIX Paste is indicatedforuseasanintracanalmedicamentinteethundergoingrootcanal treatment5,6 inthefollowingsituations:

Acuteirreversiblepulpitis.

Acuteapicalperiodontitisduetoaninfectedrootcanalsystem.Othermedicamentsthenneed tobeusedas subsequent dressings (e.g. calciumhydroxide) to ensuremaximumdisinfectionsincethedemeclocyclinehasalimitedantibacterialspectrumofactivity.

Inflammatory root resorption - both internal and external - as the initial dressingwhen the resorption is established.Othermedicaments then need to be used assubsequentdressings(e.g.calciumhydroxide)topromotehardtissuerepair.

Toprevent thedevelopmentof inflammatory resorption10,11,35 followingavulsionoffullydevelopedteethandotherinjuries(e.g.intrusionoffullydevelopedteeth)wherethistypeofresorptionislikelytooccur.Itsuseinthesesituationsmayalsoreducetheamountofreplacementresorptionthatcanoccurfollowingtheseinjuries.35

Toreducepost-operativepainbyreducingtheperiapicalinflammation.7,8Ifthepainisassociatedwithaninfectedrootcanalsystem,thenothermedicamentsthenneedto be used as subsequent dressings (e.g. calciumhydroxide) to ensuremaximumdisinfectionsincethedemeclocyclinehasalimitedantibacterialspectrumofactivity.

To inhibit & reduce the number of bacteria within infected root canals. Othermedicamentsthenneedtobeusedassubsequentdressings(e.g.calciumhydroxide)toensuremaximumdisinfectionsincethedemeclocyclinehasalimitedantibacterialspectrumofactivity.

LEDERMIX Paste canalsobeusedasapulpotomyagentintheemergencymanagementof acute irreversible pulpitis5,6 - in these cases, it should only be used as an interimpain reliefmeasure thatmustbe followedbymorecomprehensive treatment suchaspulpectomyandrootcanaltherapy.

Fig. 4-97.6%ofteethtreatedwithLedermixCementhadtheirReversiblePulpitisresolved.Pulpstatusatthethree-monthreviewfor85teeththathadconservativepulptreatmentwithLedermixcement.(AdaptedfromAbbott&Leow27)

Pulpitisresolved83teeth

Pulpitiscontinued1toothPulpnecrosis

1tooth

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The Materials

LEDERMIX Paste canbeused inbothdeciduousandpermanent teeth for theabovepurposes.

NOTE: LEDERMIX Paste canbeusedinconjunctionwithcalciumhydroxideinordertoimprovetheoveralldisinfectionoftherootcanalsystem.36,37Asmentionedabove,theantibacterialspectrumofdemeclocycline is limited,particularly in theperipheralpartsoftherootdentineandovertime.CalciumhydroxidecanbemixedwiththeLEDERMIX Paste (as an approximate 50:50 mixture)5,6,36,37 or it can be used as a separatesubsequentdressing in thecanal.5,6 If thecalciumhydroxide isbeingmixedwith theLEDERMIX Paste,thentheformulationofcalciumhydroxidewilldictatehowthisshouldbedone,5,6asfollows:

Calciumhydroxide inasaline-basedpasteapproximatelyequalamountsof theLEDERMIX Pasteandthecalciumhydroxidepastecanbemixedonaglassslaboronamixingpad.ThemixturecanthenbeinsertedintothecanalinthesamemanneraswhenplacingLEDERMIX Pastealone.

Calciumhydroxideinamethylcellulose-basedpastetheLEDERMIX Pasteshouldbeplacedintotherootcanalbyitselfwiththespiralfillerorhandfile(asdescribedabovealthoughlesswillberequired).Then,thecalciumhydroxidepasteshouldbeplacedintothecanalinthesamewayandwhilstdoingso,thetwopastesaremixedtogetherinsidethecanal.Thismethodisrecommendedbecausethemethylcellulosebase in these pastes causes the mixture to become quite thick or gluggy andthereforeitisdifficulttoinserttothefulllengthoftherootcanalasitdoesnotfloweasily.

Calciumhydroxidepowder thepowdercanbemixed into theLEDERMIX Paste priortoinsertionofthemixtureintotherootcanal.Thepowderwillcausethepastetobecomethickerandthereforeitmaybemoredifficulttospindownthecanalwithaspiralfillerasitwillnotflowaseasily.

LEDERMIX CEMENT

NOTE:LEDERMIX CementisNOTsuitableforuseinteethwithirreversiblepulpitis-suchteethrequirepulpectomyandrootcanaltherapy,orextraction.Hence,anaccuratediagnosis is essentialandshouldbebasedonathoroughhistory,clinicalexamination,pulpsensibilitytestsandperiapicalradiograph(s).

LEDERMIX Cement isindicatedforuse15,16,27,38-44inthefollowingsituations:

For themanagementof reversible pulpitis inbothdeciduousandpermanentteethbyindirectpulpcappingthatis,wheretherehasnotbeenapulpexposure.

For themanagementof reversible pulpitis inbothdeciduousandpermanent teethbydirectpulpcappingorasapulpotomyagentwherethepulphasbeenexposed.Inthissituation,theclinicianmustdecidewhethertoperformadirectpulpcaporapulpotomy-thiswilldependonmanyfactorsincludingtheageofthepatient,statusofthetooth,thesizeoftheexposure,thetypeofrestorationrequired,whichtoothisbeingtreatedanditsstrategicvalue,financialconsiderations,etc.

Useasaliningor indirectpulpcappingmaterial inasymptomatic teethwithdeepcariouscavitiespriortoplacingarestorationinordertoreducetheinflammationthatmayhavebeenpresentduetothecariesandalsotoreducetheinflammatoryeffectsoftheoperativeprocedures.

Use to cement interim crowns following preparation of the tooth for a crownrestorationinordertoreducetheinflammatoryeffectsoftheoperativeprocedures.

Useasarootfillingmaterialindeciduousteethwithirreversiblepulpitisoraninfectedrootcanalsystemfollowingthoroughcanalcleaningandpreparation.

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The Materials

Directions for Use

LEDERMIX PASTE

Whenusedasanintracanalmedicament,LEDERMIX Pastecanbeplacedintothecanalintwoways.Themethodchosenwilldependonthesizeofthecanalandwhetherithasbeenenlargedatall.5,6Theaimistofillasmuchoftherootcanalspaceaspossiblewiththepastesothemaximumamountpossibleisplaced.Thepasteneedstobeincontactwiththedentinewallsoftherootcanaltoensurediffusionthroughthedentine.5,6,18,20

ItisextremelyimportanttoensurethatNONEofthepastetouchestheaccesscavitywallsorremainsinthecoronalpartofthetoothasthiscanleadtodiscolourationofthetoothstructure45,46withresultantaestheticcomplicationsforthepatient.Althoughtetracyclinestaining can be removed via internal bleaching following endodontic treatment, it ishighlydesirableandadvantageoustoavoiddiscolourationbyverycarefulplacementofthepaste.Thepasteonlyneedstobeintherootcanalandnotinthepulpchamberinordertoachieveitstherapeuticeffects.

ThetwomethodsofapplicationofLEDERMIX Pasteareasfollows:

1. For narrow or unprepared canals useasmallhandfiletoplacethepaste(e.g.atanemergencyappointmentforpainreliefwhentherehasbeeninsufficienttimeavailabletoenlarge/biomechanicallypreparethecanals).5,6

o PlaceaverysmallamountofLEDERMIX Pasteonasmallfile(e.g.size10or15Hedstrmfile)andinsertthefileintothecanalasfaraspossiblewithoutforcingtheinstrument.Useaslightanti-clockwiserotationaction(approximatelyone-eighthturnmaximum)andaninandoutverticalpumpingaction(i.e.movethefile2-3mmvertically).Theslightrotationwipessomeofthepasteoffthefilebycontactwiththecanalwallwhilsttheverticalmovementhelpstodistributethepasteoverthecanalwall.Removethefileandrepeatthisprocesswithanotherverysmallamountofpasteonthefile.

2. For large canals and canals that have been biomechanically prepared/enlargeduseaspiralfillerrotatinginalow-speedhandpiecetoinsertthepaste.5,6

o Place a very small amount of the paste on the end of the spiral filler only2-3mmofthespiralfillerneedstobecoveredwiththepaste.

o Insertthespiralfillerintothecanalandthenstartthehandpiecespinningintheforward(i.e.clockwise)direction.Thespiralfillershouldnotberotateduntilithasbeenfullyinsertedintothecanalinordertoavoidthepastebeingplacedinthepulpchamberofthetooth.

o Thespiralfillershouldbekept3-4mmshortofthecanalsWorkingLengthandavery low speedisrecommended.

o Usethespiralfillerwithaninandoutpumpingactionthatis,moveitupanddowninsidethecanalbutonlymoveit2-3mmverticallyeachtime.Atthesametime,keepspinningitintheforwarddirection.

o Keepspinningthespiralfilleratalowspeedasyouremoveitfromthecanalsoitkeepspushingthepastematerialdownintothecanalsanditdoesnotdrawthepastebackoutofthecanalwiththeinstrument.Thiswillminimisethepossibilityofthepastebeingplacedinthepulpchamber,andsubsequentdiscolourationofthetooth.

o Ifanyexcesspasteis inadvertently left inthepulpchamber,removeitwithanexcavatorandthenwipethepulpchambercleanwithadrysterilecottonpellet.

LEDERMIXPasteintherootcanal

Apicalperiodontitis

Temporaryfilling

Cottonwoolpellet

18 19

The Materials

Time of Use

SinceLEDERMIX Paste releases itsactivecomponentsoveraperiodof time, ithasalimitedtimeoftherapeuticuse.5,6,18,20ThisappliesinallofthesituationswhereLEDERMIX Pasteisindicatedforuse.Thereareminimumandmaximumtimesthatthispasteshouldbeusedfor.

MINIMUM TIME OF USE: Although most of the release and diffusion of thecomponentsoccurswithinthefirstfewdays,18theminimumtimeofuseshouldbeTWO WEEKSsinceinflamedtissueneedsatleast10-14daysfortheinflammationtoresolveandforthetissuestohealinitially.5

MAXIMUM TIME OF USE:ThemaximumtimeofeffectiveuseofLEDERMIX Pasteinadult teethisaboutSIX WEEKS.After this, theremainingconcentrationsof theactivecomponentsarevery lowand insufficient toprovidea therapeuticeffect. Inyoungteethwithwiderdentinaltubulesandopenapicalforamina,ashorterperiodoftimeofactionshouldbeexpected.5,18

IDEAL TIME OF USE:TheidealtimeofuseofLEDERMIX PasteisbetweenFOUR and SIX WEEKSsincebonerepaircantakelongerthantwoweeks.5,6

SPECIFIC TIMES RECOMMENDED5,6 FOR SPECIFIC INDICATIONS -

o Asanintracanalmedicamentforacuteirreversiblepulpitis:4-6 weeks.

o Asanintracanalmedicamentforacuteapicalperiodontitisduetoaninfectedrootcanalsystem:4-6 weeks.

o Asan intracanalmedicament for inflammatory root resorption-both internalandexternal-astheinitialdressingwhentheresorptionisestablished:6 weeks followed by a further application of fresh paste for another 6 weeks.

o As an intracanal medicament to prevent the development of inflammatoryresorption following avulsion of fully developed teeth and other injuries (e.g.intrusionoffullydevelopedteeth)wherethistypeofresorptionislikelytooccur:6 weeks followed by a further application of fresh paste for another 6 weeks.

o As an intracanal medicament to reduce post-operative pain by reducing theperiapicalinflammation:4-6 weeks.

o Asanintracanalmedicamenttoinhibit&reducethenumberofbacteriawithininfectedrootcanals:4-6 weeks.

o As a pulpotomy agent in the emergency management of acute irreversiblepulpitis:4-6 weeks.

LEDERMIX CEMENT

ThepowderandliquidcomponentsofLEDERMIX Cementmustbemixedimmediatelypriortouse.28ThepowdercanbemixedwitheithertheNormalSetortheFastSetliquid,accordingtothedentistspreferencesandtheclinicalsituation.Thesettingtimewithbothformsofliquidwillbedependentonthethicknessofthemixi.e.themorepowderthatisused,thefasterthesettingtime.28Thepowder:liquidratioisnotcriticaltotheperformanceof thematerialandgenerallyacreamy-likeconsistencyshouldbeused.Therearenospecialmixingrequirementsalthoughitisadvisabletoprogressivelyaddsmallamountsofpowderinordertogaugethethicknessofthemixtureasitisbeingmixed.Thiswillavoidwastagethatcanoccuriftoomuchpowderisaddedatonetime.

MethodsofapplicationforLEDERMIX Cementare:

1. For the management of reversible pulpitis in both deciduous and permanent teeth by indirect pulp cappingthatis,wheretherehasnotbeenapulpexposure.

Mix thepowderand liquid to formacreamypaste-likemixture.Place thismixonthedentineandallowit tosethard.Thenplaceasuitablerestorationasrequiredfortheparticulartooth.Insomecases,thedentistmaychoosetoplaceaninterimor temporary restoration for a period of time to reassess the tooth and the pulpresponse. In all cases, the pulp status should be reviewed after 3-6 months todeterminewhetherithashealedadequately.

LEDERMIXCementTemporaryfilling

Pulp

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The Materials

2. For the management of reversible pulpitis in both deciduous and permanent teeth by direct pulp capping or as a pulpotomy agent where the pulp has been exposed.

Mixthepowderandliquidtoformacreamypaste-likemixture.Placethismixontheexposedpulpandadjacentdentineandallowittosethard.Thenplaceasuitablerestorationasrequiredfortheparticulartooth.Insomecases,thedentistmaychoosetoplaceaninterimortemporaryrestorationforaperiodoftimetoreassessthetoothand thepulp response. Inall cases, thepulpstatus shouldbe reviewedafter3-6monthstodeterminewhetherithashealedadequately.

3. Use as a lining or indirect pulp capping material in asymptomatic teeth with deep carious cavities prior to placing a restoration.

Mixthepowderandliquidtoformacreamypaste-likemixture.Placethismixonthedentineinthedeepestpartof thecavityfloorandonanypulpwallsof thecavity.Then place a base using a glass ionomer cement or other hard settingmaterialfollowedbythefinalrestorationasrequiredfortheparticulartooth.Insomecases,thedentistmaychoosetoplaceaninterimortemporaryrestorationforaperiodoftimetoreassessthetoothandthepulpresponse.Inallcases,thepulpstatusshouldbereviewedafter3-6monthstodeterminewhetherithashealedadequately.

4. Use to cement interim crowns following preparation of the tooth for a crown. Mix the powder and liquid to form a creamy paste-likemixture. Coat the fitting

surfaceoftheinterimcrownwiththismixture,seatthecrownonthetoothwithlightpressuretoensurecompleteseating.Allowthecementtosethardandthencleananyexcesscementawayfromthemarginswithasuitablehandinstrument(e.g.scalerorprobe).Reviewthepulpstatuspriortofittingandcementingthedefinitivecrownatasubsequentappointment.

5. Use as a root filling material in deciduous teeth with irreversible pulpitis or an infected root canal system following thorough canal cleaning and preparation.

Mix thepowderand liquid to formacreamypaste-likemixture.Place themixtureintotherootcanalsystemusingaspiralfiller(asdescribedaboveforLedermixPaste)orotherappropriatemethod(e.g.handfile)andallowittosethard.Thenplaceasuitable restorationas required for theparticular tooth. Review the toothand theperiapicalhealingresponseafter6-12months.

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