Click here to load reader

Illumine Science EN - Dentsply Sirona

  • View
    0

  • Download
    0

Embed Size (px)

Text of Illumine Science EN - Dentsply Sirona

Illumine_Science_EN20 01 -0 9. 26 ( F or In di vi du al A tte nt io n O nl y)
TECHNICAL MANUAL
2.4 ToothDiscolorationDuetoAgeing ............................................................. 6
3TechniquesforToothWhitening .................................................... 7
3.1 VitalToothBleaching ................................................................................... 7
3.1.1 At-HomeWhitening...........................................................................................7
3.1.2 In-OfficeWhitening...........................................................................................8
3.2.1 WalkingBleachTechnique...............................................................................9
5AnOpenLegalSituationintheEuropeanCommunity? ............. 14
6 IlluminéToothWhiteningSystem.............................................. 16
6.1 IndicationsandContraindications ............................................................ 16
6.2 InteractionswithDentalMaterials ............................................................. 17
6.3 TrayManufacturing..................................................................................... 18
7.2 CompositionandWorkingMechanism..................................................... 21
7.3 ClinicalInvestigations ................................................................................ 22
7.3.1 ClinicalinvestigationofIlluminéhome10%bySwiftetalatUNC(1997) ..22
7.3.2 ClinicalinvestigationofIlluminéhome10%byBarnesetalatthe
UniversityofMaryland(1998) .....................................................................................24
7.3.3 ClinicalinvestigationofIlluminéhome10%and15%byKihnetalatthe
UniversityofMaryland(2000) .....................................................................................26
8.2 CompositionandWorkingMechanism..................................................... 31
8.3 In-VitroDataEvaluationoftheEnamelSurfaceMorphologyinTeeth
TreatedwithIlluminéofficebyShermanJ,DENTSPLYProfessional............ 32
8.3.1 Summary .........................................................................................................32
8.4 ClinicalInvestigations ................................................................................ 36
8.4.1 AClinicalStudyEvaluatingtheEfficacyofaNewChairsideandTake-
HomeBleachingSystem–FinalReport,January27,2000byBardwellD,
PapathanasiouA,TuftsUniversityDentalClinic.......................................................37
8.4.2 ClinicalEvaluationofa15%In-OfficeHydrogenPeroxideToothWhitening
TouchUpAgent-UpdatedReportApril24,2000byKihnPW,BarnesDM,Adachi
E,TheUniversityofMarylandDentalSchool ............................................................38
8.4.3 In-HouseWhiteningCaseStudyFP084–ReportFebruary4,2000by
ShermanJ,DENTSPLYPreventiveCare....................................................................40

Arangeofdevelopmentalabnormalities,acquireddiseases,anddegenerativechanges
resultintoothdiscolourationswhichcannotberemovedbysimplebrushingorprofessional
toothcleaninganduseofabrasives.Forthetreatmentofsuchstains,chemicalbleachingis
aconservative,toothsubstancesavingalternativetootherrestorativeproceduressuchas
veneeringortheplacementofcrowns.

Fortreatmentoftheabove-mentioneddiseasesbutalsoforpurecosmeticindications,the
DeTreyDivisionofDENTSPLYoffersunderthebrandIlluminéasystemofprofessional
toothwhiteningproducts.

Illuminéhome10%and15%arecarbamideperoxide-basedwhiteninggelsfordentist-
monitoredat-hometreatment.The15%fluoride-containingversionoffersafasterandmore
intensivewhiteningeffectthantheconventional10%version.

Illuminéofficemakesuseofanew,innovativechemicalconceptanddeliveryformforthe
controlledreleaseofhydrogenperoxide.Itlightensupto9shadesin30minuteswithout
heat,light,orgingivalisolation.Illuminéofficeisrecommendedasapre-treatmentboostto

TheIlluminéToothWhiteningproducts,theirpresentationsforms,andtheproduct
information(separatebookletsfordentist,patient,anddentaltechnician)havebeen
specificallydevelopedtomeettherequirementssetbytheEuropeanCommissionfor
MedicalDevices.
2ToothDiscoloration
Inthefieldofconservativeaestheticdentistry,toothbleachingmeetsthedemandofnon-
destructivetreatmentofdiscolouredteethinavarietyofindications.However,successand
efficiencyofthebleachingtreatment,andtheselectionofthemostsuitabletechniqueand
clinicalproceduredependuponseveralissuestobeconsidered.Onecharacteristicalltooth
bleachingprocedureshaveincommonistheoxidativeeliminationoratleastthedecreasein
dentalstains(pleaseseeChapter4fordetailsonthechemistryofthisprocess).Itisobvious
thatbleachingsuccessdependsonthenatureofthedentalstain.Toavoidmaskingof
pathologicalconditions,itismandatorythatthereasonforthediscolorationisunderstood
priortotreatment.
Theclinicallyperceivedshadesofunstainedteetharedeterminedbytheinherentdentine
andenamelshadesasillustratedinFigure1.Theoverallshadesofdiscolouredteetharea

Inherent toothcolor

Figure1 Theclinicallyperceivedshadeofunstainedteethisdetermined
bytheinherentdentineandenamelshades(Spouge1973;

Commonly,toothdiscolorationisclassifiedregardinglocationandaetiologyofthestain.In
general,dentaldiscolorationcanbegroupedintoextrinsicandintrinsicstaindependingon
3
thelocationofchromophorscausingstain.Extrinsicstainisconfinedtothetoothsurface
whereasintrinsicstain,i.e.discolorationofthedentalhardtissue,iscausedbycolouring
compoundsdepositedorpermeatedintodentineand/orenamel.Onageing,translucent
enamelgetsthinner;theapparenttoothcolouristhendeterminedbythedarkerdentine
shades.Structuralabnormalitiesofenamelordentinecountamongotherreasonsfortooth
discoloration.
2.1ExtrinsicStain
Extrinsicstainsarecausedbythedepositionofchromogenicmaterialonthetoothsurface
whereinadhesionofthechromogensonthetoothsurfaceplaysacriticalrole.Thetenacity
ofchromogenadhesionisdeterminedbytheinteractionforces,butthesemechanismsare
notyetfullyunderstood.However,inthecaseoftypicaltanninchromogenscausinge.g.
tea,coffeeandredwinestains,adhesionofchromogensviasalivaproteinsonthetooth
surfaceisassumedasoutlinedinFigure2(Nathoo,1997).Salivaproteinsareselectively
bondedviacalciumbridges,thusformingthepellicle.Attheearlystageofstaining,
chromogensthemselvesareassumedtointeractwiththepellicleviahydrogenbridges.At
thisstage,foodstainscanberemovedbytoothbrushingwithstandardtoothpastes.
However,foodandtobaccostainsareknowntodarkenandbecomemoretenaciousovera
longerperiodoftime.Especiallythecervicalportionsoftheteethadjacenttothegingival
marginsoftenbecomeyellowishorbrownish.Chemicalanalysisofagedstainsoffoodand
beveragesrevealedthepresenceoffurfuralsandfurfuraldehydederivatives.These
compoundsareproductsoftheMillardreaction(nonenzymaticbrowningreaction),whichisa
seriesofchemicalrearrangementsandreactionsbetweensugarsandaminoacids(Viscioet
al.2000).Ageingofextrinsicstainsisnotyetfullyunderstoodbutseemstoberelatedwith
thestrengtheningofthebondingofchromophorstothetoothsurface.Usually,theseaged
extrinsicstainscannotberemovedbytoothbrushing.Professionalcleaningwithabrasive
pastesorwhiteningwithableachingagentarenecessarytolightenteeth.Tenacioussurface
stainsarehighlyamenabletobleaching,althoughstainsaremoredifficulttoremovefrom

S.A.Nathoo.JADA1997;128:6S-10S
Figure2 Modeloftheinteractionoftanninswiththepellicle(Nathoo
1997).

Bindingofcolourlessmaterialstoteethwithsubsequentreactiontochromogensmayalso
resultinextrinsicstains.Forexample,colourlessstannousfluorideispronetoreductionto
tinbysulfuridylgroupsofpellicleproteinscausingdarkexternalmetallicstain.Another
exampleisbrownstaincausedbyredoxreactionsofchlorhexidine.Removingstainsof
antimicrobialagentsrequiresbleachingwithoxygenatingagents(Nathoo1997).
2.2IntrinsicStain
Unlikeextrinsicdiscoloration,intrinsicdiscolorationisduetochromogenicmateriallocated
withinthedentineorenamel.Aetiologyofintrinsicdiscolorationcanbepre-eruptiveand/or
post-eruptive.Intrinsicstainsarenotremovablebybrushingoranyabrasiveprocess,but
canbereducedbybleachingwithagentspenetratingenamelanddentinetodecolourisethe
chromogens.However,persistentintrinsicstainsmaybetreatedforalongerperiodthan
extrinsicdiscolorationtolightenteethandsometimesbleachingdoesnoteliminate
discolorationtotally.
Thedevastatingeffectofsomemedicamentationgivensystematically,especiallyduring
toothformation,isdisplayedbyteethofyoungpeoplewithyellow,brownorgreyintrinsic
stainsoftheantibiotictetracycline.Theseverityofstainsandspecificcolourdependsonthe
durationofadministrationoftetracyclineandthestageoftoothformationatthetimeofuse.
Teetharemostsusceptibletotetracyclinediscolorationinearlychildhoodduringtooth
5
developmentandevenpre-natally,beginningwiththesecondtrimesterofpregnancy.Itis
believedthattetracyclineisincorporatedintothetoothstructureduringcalcificationvia
complexationwithcalciumions.Thedyecausingthediscolorationresultsfroma
photochemicalreactionofthesecomplexeswhentetracyclineaffectedteethareexposedto
sunlight,whichiswhythelabialsurfacesoftheincisorstendtodarkenmorequicklytogrey
orbrownwhilethemolarsremainyellowforalongertime(Goldsteinetal.1995).Fully
formedteethinadultsmaybestainedfromtakingthetetracyclineMinocyclineforacne.This
discolorationcanbecausedfromdepositionoftetracyclineinsecondarydentineaswellas
fromsoakinginsaliva(Haywood2000).
Serioustetracyclinestainsareratherpersistentandusingbleaching,discolorationcanoften
onlybereduced(Glockneretal.1997;Haywood1997).However,onextendingtreatment
timeandconcentrationofactiveingredient,lighteningofevendarktetracyclinestainscan
beachieved(Leonard2000,Haywood2000).
Teethcanacquireintrinsicstainsaftereruptionduetotraumaontheteeth.Bloodpenetrates
intothedentinetubuliandthedegradationproductsandironcomplexescausediscoloration.
Forthesamereason,insomecasesendodonticallytreatednon-vitalteethexhibit
discolorationaftersometime.Thesediscolorationscanbereducedorevenremovedby
bleaching.However,withnon-vitalteeth,preferenceisusuallygiventointernalbleaching,
sinceinthiscaseitismoreefficientthananexternalbleachingprocedure(seeChapter3).
Intrinsicstainscausedbyblooddegradationproductsdepositedwithinthedentinecanalso
becausedbyhaematologicaldisorderssuchaserythroblastosisfetalis,thalassemia,and
sickle-cellanaemiabecauseoftheaffectedcoagulationsystem(Nathoo1997;Viscioetal.
2000).
Anothersourceofintrinsicstainsareageddentalmaterialslikerootfillingmaterials,zinc
oxideeugenolcements,oramalgam(Glockneretal.1997).
2.3ToothDiscolorationDuetoStructuralAbnormalities
Fluorosisisatypicaldiseaseresultinginabnormalstructureoftheenamel.Endemicenamel
fluorosisiscausedbyexcessiveintakeoffluorideduringenamelformationandcalcification,
resultingindiscolorationandsurfacedefects,socalled“mottledenamel”.Typically,affected
teethshowpaper-whiteflecks,areasofyellowtobrownorevendarkgreystains.Ifmottling
isseriousenough,enamelappearsopaque,chalkywithoutglazeandlustreofhealthyteeth.
Bleachingisviewedtobeusefultolowercontrastbetweenthesewhiteareasandthedark
stainstoimproveaesthetics.Bleachingcanalsobeanadjunctivetreatmentpreceding
6
veneering.However,iffluorosiscausedseverelackofenamelorbaredentine,bleaching
shouldnotbeusedatall(Goldsteinetal.1995).
2.4ToothDiscolorationDuetoAgeing
Changesintoothcolouralmostinevitablyaccompanyageing.Mostnewlyformedteeth
exhibitratherthick,evenenamelwhichmodifiestheinherentbasecolouroftheunderlying
dentineresultinginanmilkywhiteappearance–theaestheticidealintoday’ssociety.
Numerousgenetic,environmental,medical,anddentalcausesdescribedabovemoveaway
fromthisidealduetodentalstains.Asfoods,beverages,andnicotinehavecumulative
stainingeffect,teethusuallydarkenonageing.Additionally,stainsbecomemoretenacious
anddarkerduetochemicalreactions.Microcracksanddefectsintheenamelsurfaceenable
extrinsicchromophorstopenetrateintotheenamelthatresultsinintrinsicstain.Onageing,
thinningofenamelalsocausesashifttoadarkerapparentcolour.Atthesametimeasthe
enamelbecomesthinnersecondarydentineisdepositedwhichisanaturalprotective
mechanism.Thecombinationofallfactorscreatesanoldlookingtooth.Usually,unlessthe
enamelisbadlyworn,bleachingisanefficienttechniquetolightenteethofolderpatients
(Goldsteinetal.1995).
3TechniquesforToothWhitening
Techniquesfortoothwhiteningcanbeclassifiedanddescribedaccordingto:
a)Thevitalitystatusoftheteethtobetreated:
Vitalbleachingvs.non-vitalbleaching
b)Whereandbywhomthebleachingsubstanceisapplied:
In-officebleachingvs.at-homebleaching
3.1VitalToothBleaching
Vitalteetharebleachedbyapplicationofthewhiteningsubstanceontheexternalsurfaceof
theteeth.Thewhiteningprocedurecanbecarriedoutinthedentalsurgeryorathomeby
thepatientorbyacombinationofbothtechniques.
3.1.1At-HomeWhitening
[Synonyms:Nightguardvitalbleaching]
At-homewhiteninginvolvestheuseofa10–15%carbamideperoxidematerialappliedina
custom-madetrayforacertainnumberofhoursperdayorduringsleep.Treatmentis
carriedoutbythepatienthimself,buttheprocessismonitoredbythedentistduringrecall
appointments.
Advantages:
! Bleachingiscarriedoutwithlessaggressivechemicals.
! Theprolongedtreatmenttimemakesiteasytodeterminewhenthedesiredresultis
obtained.
Disadvantages:
8
CRAdata(Christensen,1997)showthatmostproductshavelost80%oftheiractive
ingredientwithin2hoursafterplacementinthemouth.All-nightbleachingistherefore
questionablefromthepointofviewofeffectiveness.However,somepatientspreferthis
scheduleasitdoesnotinterferewiththeirnormalactivities.
Inmostcases,thetreatmentperiodisbetween1and6weeks.
AccordingtoHaywood,1997,thetechniquewasfirstpublishedin1989andcanbetraced
backto1968.
GuidelinesbytheAmericanDentalAssociation,latestrevisionMay1998,recommend
suitableinvitroandclinicalteststoinvestigatesafetyandefficacy.
3.1.2In-OfficeWhitening
[Synonym:In-officebleaching]
Within-officebleaching,thewhiteningprocedureiscarriedoutinthedentalsurgerybythe
dentistorunderhissupervision.Theprocedureusuallytakes30to60minutes.Several
appointmentsmaybenecessarytoachievethedesiredresult.
Atpresent,hydrogenperoxideisconsideredtobethemosteffectivevitalbleachingagentfor
in-officeapplication.AccordingtoHaywood,1998,thistechniquewasalreadyappliedby
Harlanbackin1884.
Bleachingagentsvaryfromasolutionof35%hydrogenperoxidetovariousgelsofgreater
orlessercontent.Theprocesscanbeappliedtoanentirearchortoasingletoothonly.
Nowadays,itisbelievedthatanexternalenergysource(heat,light,laser)doesnotenhance
thewhiteningreaction.
! Thecompleteprocessisunderthecontrolofthedentist.
! Processisindependentfrompatientcompliance.
Disadvantages:
! Gingivalisolationbyrubberdamorarubberdamsubstituteisnecessary.
! Complexapplicationtechniqueanduseofpotentiallyharmful,highlyaggressive
chemicals.
! Highercostsincurredforthepatientduetoextendedchairtime.
! Severalappointmentsmaybenecessarytoachievethedesiredresult.
9
WithIlluminéoffice(seeChapter8.1),mostdisadvantagesofconventionalin-officesystems
areovercome.
[Synonyms:Internalbleaching]
Non-vitaltoothbleachingreferstothewhiteningoftoothdiscolorationscausedbytraumatic
damagesofthepulp,pulpnecrosis,orendodontictreatment.
Non-vitalteetharebleachedbyapplicationofthewhiteningsubstanceintothepreparedpulp
chamberandcoronalpartoftherootcanal.Inadditiontothisinternalbleaching,asuitable
whiteningsubstancemayalsobeappliedontotheexternalsurfacesofthetooth.
30%hydrogenperoxidesolutionaloneormixedwithsodiumperborate,orsodiumperborate
mixedwithwaterarecommonformulationsfornon-vitaltoothbleaching.Thewhitening
agentissuppliedintothepulpchamberin2differenttechniques:
3.2.1WalkingBleachTechnique
Thebleachingagent(sodiumperboratemixture)issealedinthepulpchambertoallowslow
activationoverseveraldays.
3.2.2ThermocatalyticTechnique
Thecompletetreatmentiscarriedoutinthesurgeryandinvolvestherepeatedapplicationof
a30%hydrogenperoxidesolutionwhichisactivatedbyheatoveraperiodofabout
30minutes.
4ChemistryofWhitening
Bleachingisachemicalprocesswhichiswidelyappliedforwhiteningmaterialsmostlyusing
oxidisingcompounds,e.g.hydrogenperoxide,chlorineorsodiumhypochlorit.Although
bleachingprocessesarecomplexsequencesofchemicalreactions,theunderlyingprinciple
ofthevastmajorityisthestepwiseoxidationofdyestodecolourisethem.Totaloxidationof
organicchromogensviaseveralintermediatesendsupinthefinalproductscarbondioxide
CO2andwaterH2O.Theextentandtherateofoxidationcanbecontrolledbythebleaching
conditions(e.g.oxygenatingagent,concentration,durationofbleaching,andtemperature).
Controlofchemicalbleachingisimportantforitsfeasibilityindentistrywithrespecttodental
healthandsafety.
Indentistry,modernbleachingmaterialscontainoxidisingperoxidecompounds,i.e.
hydrogenperoxideH2O2orcarbamideperoxide(CP).Carbamideperoxideisa1:1complex
ofureaandhydrogenperoxide.Hydrogenperoxideisstabilisedinthiscomplex.Inthe
presenceofcompoundspronetooxidation,hydrogenperoxideisreleased(Figure3).The
releasedhydrogenperoxide,butnotureahasanoxidisingcapacity.1.00gcarbamide

H2O2

Figure3 Carbamideperoxide(CP)isa1:1complexofureaandhydrogen
peroxide.Hydrogenperoxideisstabilisedinthiscomplex.Inthe
presenceofcompoundspronetooxidation,hydrogenperoxideis
released.

Themechanismofvitaltoothwhiteningwithperoxidecontainingbleachinggelsisillustrated
schematicallyinFigure4.Thebleachinggelisadministeredonthesurfaceofdiscoloured
teeth.Peroxideisreleasedfromthegelandcanpermeateintotheenamelanddentine.
Therefore,notonlyextrinsicstainingdyesbutalsointrinsicchromogenscanbeoxidisedto
colourlessproducts.
Penetrationofperoxide whichoxidizethe chromophors.
Decolorizeddentinand enamel.
Figure4 Schematicillustrationofthemechanismofbleachingwith
peroxides.Peroxideisreleasedfromthebleachinggel
administeredonthetoothsurfaceanddiffusedintotoothhard
tissues.Peroxideattacksextrinsicandintrinsicstaining
chromogenswhichresultsindecolourisingdyesviaanoxidation
mechanism.

Theoxidationprocessoforganiccompoundswithhydrogenperoxideisacomplexseriesof
reactions.Hydrogenperoxideisametastabileliquidwitharatherhightendencyto
decompositionintowaterandoxygenaccordingto
2H2O2 2H2O + O2
Thedecayofhydrogenperoxideisenhancedwithincreasingtemperatureandbyirradiation
withUVlight,andalsodependsonthepHvalue.Toreducebreakdownandtoextendshelf
life,hydrogenperoxideisusuallyavailableinacidicaqueoussolutionsandhastobestored
darkandrefrigerated.A30%aqueoussolutionofpurehydrogenperoxidehasroughlypH3.
AnelevatedpHacceleratesdecomposition.Inthepresenceofcatalysts,likeseveralmetal
ionsandmetaloxides,andnaturalenzymes,e.g.peroxidaseandcatalase,decompositionis
stronglyenhanced.Thehydrogenperoxidebreakdownisaradicalprocess.Thefirststepof
theradicalmechanismistheformationofthehydroxylradicalsHO·inducingachain
reaction.InthecourseofthereactiondioxygenylradicalsHOO·arealsoformed.Hydroxyl
anddioxygenylradicalsarehighlyreactiveandattackorganicmaterialtooxidiseit.
Especiallycompoundswithunsaturateddoublebondsarehighlypronetooxidationwith
theseradicals.Typically,stainingorganicchromogensarecharacterisedbyconjugated
doublebondsinthemolecule,whichisthestructuralreasonforthecolour.Viaseveral
13
intermediatesteps,theoxidationreactionofthedyemoleculesresultsincolourless
hydrophilicmoleculescomprisinghydroxylgroups(HO-groups).Thisisillustrated
schematicallyinFigure5.

Figure5 Schematicillustrationofthechemicaloxidationreactionofdye
moleculescomprisingunsaturateddoublebondswithhydrogen
peroxidetocolourlessmolecules.Afterconversionofallstainsto
colourlessproductthesaturationpointisreached.Further
bleachingwouldonlycausedegradationtocarbondioxideand
waterbutwouldnotincreasethewhiteningeffect
(overbleaching).
Asbleachingproceeds,teethcontinuallylighten.Whenallchromophorsareconvertedto
colourlessmolecules,theso-calledsaturationpointisreached.Furtherbleaching,i.e.
overbleaching,wouldcausefurtheroxidationresultingindegradationtocarbondioxideand
water,butwouldnotincreasethewhiteningeffect.Neitherdoesitimprovethebrightnessof
theteeth.Atthesaturationpoint,furtherlighteningofteethslowsdowndramatically.
Excessiveoverbleachingbearstherisktooxidiseproteinsoftheenamelanddentinewhich
maycausesignificantalterationoftheenamelanddentinestructure.Reductionofthetooth
structurebylossofenamelmaybetheconsequence(Goldsteinetal.1995).Therefore,itis
demandedthatin-officebleachingbecarriedoutbyadentistandthathome-bleachingbe
supervisedandregularlycontrolledbyadentist.Overbleachingwithover-the-counter
nightguardproductsandwithoutsupervisionbyadentistisofparticularconcern(Haymann
etal.1997).
5AnOpenLegalSituationintheEuropeanCommunity?
WhentoothwhiteningproductsstartedtoappearinEuropeatthebeginningofthenineties,
adisputehasarisenwhethertheseproductsarelegallydefinedascosmeticsorasmedical
devices.
ToothWhitenersasCosmeticProducts
On15thFebruary1996,Mrs.BoninoannouncedinthenameoftheCommissionofthe
EuropeanCommunitythatalltoothwhiteningproductsarecosmeticproductsasdefinedby
theCouncilDirective76/768/EEC.Theactivesubstanceoftoothwhiteningproducts,
hydrogenperoxide,isregulatedbytheDirective92/86/EEC.The15thadaptationofthis
Directiveof1stJuly1993,allowsamaximumconcentrationof0.1%hydrogenperoxide.As
thetoothwhiteningproductscommonlyusedcontainorreleaseatleast3%hydrogen
peroxide,Mrs.Boninoconcludedthattheuseofsuchproductsbydentistsandthepublic
wasnotpermitted.
TheScientificCommitteeonCosmeticProductsandNon-foodProductsintendedfor
Consumers(SCCNFP)reviewedthesafetyofhydrogenperoxideintooth-whiteningproducts
followingtherequesttoincreasethepermittedlevelinAnnex3ofDirective76/768/EECfrom
0.1to3.6%.Intheplenarymeetingof17thFebruary1999,theSCCNFPadoptedtheopinion
thatitwouldbeinappropriatetoprovideproductswithmorethan0.1%hydrogenperoxideas
cosmeticproducts.Thisdecisionwasduetothefactthatthecontra-indicationsand
warningsnecessaryforproductswithahigherconcentrationofhydrogenperoxidewere
foundincompatiblewiththenatureofacosmeticproduct.
Therefore,atpresenttooth-whitenerscontainingorreleasingmorethan0.1%hydrogen

ToothWhitenersasMedicalDevices
AccordingtoArticle1oftheCouncilDirective93/42/EECof14thJune1993,materials
intendedbythemanufacturertobeusedforthepurposeoftreatmentoralleviationof
diseaseandwhichdonotachievetheirprincipleintendedactionsbypharmaceutical,
immunologicalormetabolicmeansaremedicaldevices.Therefore,tooth-whiteningproducts
intendedbythemanufacturertobeusedfortoothdiscolourationscausedbydiseasesuch
15
aspulpnecrosisorbytetracyclinemedicamentationaremedicaldevices.Withthisasa
basis,itispossibletochallengeMrs.Bonino'sstatementthatalltooth-whiteningproducts
arecosmeticsbytakinglegalmeasuresagainstthelocalCompetentAuthorities.
ThisopinionisneithersharedbytheNotifiedBodies(institutionscertifyingcomplianceof
manufacturerswithECregulationsregardingaqualitymanagementsystemforthe
developmentandtheproductionofmedicaldevices)norbythelocalHealthAuthorities
whichhavetoadoptMrs.Bonino'sview.Thismayresultinfurthercourtactionssimilarto
thosealreadyongoing:
IntheUKin1998,theHighCourtruledthatatooth-whitenerproductisamedicaldeviceand
thattheDepartmentofTradeandIndustry(DTI)waswronginbanitsuse.TheDTIappealed
andon1stJuly1999,theCourtofAppealoverturnedthepreviousHighCourtruling.Leave
wasthenbeingthoughtfromtheHouseofLordstoappealagainstthelaterruling.In
summer2001,theHouseofLordsruledthatatooth-whitenerproductisacosmeticproduct.
ItcanthusnotbemarketedintheUKwithouttheriskoflegalaction.
InGermany,theVerwaltungsgerichtDüsseldorf(16K6063/99)ruledthatatoothwhiteneris
consideredamedicaldevice.TheCompetentAuthority(BezirksregierungDüsseldorf)
appealedandthedecisionwhichhadbeenexpectedforfall2001hasnowbeenpostponed
tospring2002.Bothpartiesofthisdisputeindicatedtoappealifnotsuccessful.
AslongastheEuropeanCommissiondonotreconsidertheirunfortunateandwrong
statementof1996,thedisputewillgoonuntiltheEuropeanCourtcomestoaruling.
16
6IlluminéToothWhiteningSystem
TheIlluminé™ToothWhiteningSystemisacompleteconceptforexternalbleachingthat
coversbothin-officeandat-homebleachingwithdifferentperoxideconcentrations(Figure6)
togainbestresultsaccordingindications,safety,andefficiency.

home carbamideperoxide(cp)
30–60min
Figure6 OverviewoftheIlluminé™ToothWhiteningSystem.
IlluminéhomeToothWhiteningGelsmaybeusedaloneorfollowingtreatmentwithanin-
officetoothwhitener.
IlluminéofficeIn-OfficeToothWhitenerisrecommendedasapre-treatmentboostto
IlluminéhomeToothWhiteningGelsorasastand-alonetreatmentcompletedin1to3office
visits.IfusedasaboosttoIlluminéhome,thetake-homeregimemaybeabbreviatedtoa
3-daytreatment.
TheIlluminéToothWhiteningproducts,theirpresentationforms,andtheproductinformation
(separatebookletsfordentist,patient,anddentaltechnician)havebeenspecifically
developedtomeettherequirementssetbytheEuropeanCommissionforMedicalDevices.
6.1IndicationsandContraindications
1.Toothdiscolourationcausedby:
! Stainingfromfoods,drinks,andtobaccowithpenetrationintothetoothsubstance
! Age-dependentdegenerativechanges
! Fluorosis,especiallybrownpigmentation
! Maskingofenamelmottling
! Geneticallydetermineddarkteeth
g.veneering

Thebestresultsarewithpatientswhoseteetharediscolouredtoyellow,orange,orlight
brown.
! Useduringpregnancyorlactation.
! Knownallergytohydrogenperoxideorotheringredientsoftheproducts.
! Extrinsicstainswhichcaneasilyberemovedbyprofessionaltoothcleaningandwhich
canbepreventedbythoroughoralhygiene.
! Useinheavysmokersunlesstheyrefrainfromsmokingwhilewearingthetray.
6.2InteractionswithDentalMaterials
Existingtoothcolouredrestorationsmaynotmatchthelightershadeofteethafterthe
treatmentandmayneedtobereplaced.
TheIlluminéproductsshouldbeusedbeforetheplacementofcomposites,veneersor
crowns,inordertomaintainaclosematchoftoothcolour.Wealsorecommendthatthe
patientwaitaminimumoftwoweeksafterthetreatmentforthetoothdiscolourationto
stabilisebeforeperforminganteriorrestorations.
18
Someoldrestorations(e.g.amalgams)mayleavedarkstainsinthetray.Thisisnormaland
harmless.
6.3TrayManufacturing
Awellfittingtraywithapropergingivalsealandmarginsjustawayfromthegingivais
essentialtoreduceirritationofthegingivaduringthewhiteningproceduretoaminimum.
Fortrayfabrication,informationonwhichteethareplannedtobetreatedaswellasthe
whiteningtechnique(hometreatmentonlyorofficetreatment)shouldbeavailable.For
communicationbetweenclinicianandtechnician,aform(Figure7)issuppliedonthelast
pageofthe"Instructionsfortrayfabrication"booklet.
ThetrayforIlluminéoffice(thegelreservoirofwhichislargerthanthatofthetraydesigned
forsolehomeapplication)mayalsobeusedforshort-termsubsequenttreatmentwith
Illuminéhome.
Pourthedisinfected,rinsedimpressionwithdentalstone.
Trimthestonecastsothatthebaseisparalleltotheocclusalplaneoftheposteriorteeth


CreatingtheReservoirs
1.Oncethestonemodelhasdriedtoaneffectivehardnessapplyanacrylicspacer(e.g.
Triad1Gel)totheteethonthemodel,thuscreatingreservoirsinthegeltray.
2.Applythespaceronlytoteethofaestheticvalue.
3.Stayapproximately1mmfromthegingivalmarginwhenapplyingthespacer.
4.Donotcoveranyinterproximalareas.
5.Donotapplyspacertoocclusalsurfacesorincisaledges.
6.Applyaspacertothefacialsurfacesoftheteethtobewhitened.
FortreatmentwithIlluminéhometoothwhiteninggelsalone,thethicknessofthespacer
isapprox.½to1mm.
FortreatmentwithIlluminéofficeoracombinationtreatmentwithIllumineofficeand
home,thethicknessofthespaceris3-4mm.
Note:Ifthetraywillbeusedforanin-officeprocedurealoneoranin-officeprocedurein
combinationwithshort-timetreatmentwithIlluminéhometoothwhiteninggels,the
thicknessofthespacerisincreasedaccordingtothedirectionsforuseoftherespective
product.
Waituntilspacerhassetorlight-curespacer,respectively.
7.Wipethecuredspacersurfaceswitha7.gauzedampenedwithalcoholtoremovethe

1.Useamediumthickheat/vacuumsheet2fortrayfabrication.
2.Placethevacuumsheet(pebblefinishtowardsthestonemodel)onaheat/vacuumtray-
formingmachine.
3.Softenthevacuumsheetuntilitsags2to5cmorasdirectedbytheManufacturer.
4.Engagethevacuum,andslowlylowertheheatedgeltrayontothestonemodeltoavoid
generatingwrinklesandfolds.
5.Allowthesheetampletimeundervacuumforgoodretentionanddefinition.
6.Allowthesheettocoolpriortotrimming.


2Erkodur(clear),0.8mmthickness,Reorder#521108(Erkodent®,D-Pfalzgrafenweiler)
20
2.Usingscissorstrimthetrayapproximately2-3mmbeyondtheteeth.
3.Trimandrefinetheremainingportionwithsmaller,precisionscissors(Scalloparoundthe
interdentalareas).
4.Trimthetrayapproximately1/4-½mmshortofthegingivalmargin.
5.Placethetrimmedtraybackontothestonemodeltoverifyextensions.
6.Finishmarginswithrotaryinstrumentsorslightlyflamepolishtrayedges.
7.Washanddisinfectthewhiteningtray.Drythoroughly.
8.Placeinstoragecaseorothersuitablecontaineranddelivertodentist.
21
7Illuminéhome
7.1ProductDescription
IlluminéhomeToothWhiteningGelsmaybeusedaloneorfollowingtreatmentwithanin-
officetoothwhitener.WhenusedasfollowingtreatmentthesametrayofthepriorIlluminé
officetreatmentcanbeused.

IlluminéhomeToothWhiteningGelscontaintheactiveingredientofcarbamideperoxide,

Illuminéhome10%ToothWhiteningGelcontains10%carbamideperoxide,releasingH2O2
inaconcentrationofabout3.6%.

Illuminéhome15%ToothWhiteningGelcontains15%carbamideperoxide,releasingH2O2
inaconcentrationofabout5.4%,andinadditionsodiumfluoride.
7.2CompositionandWorkingMechanism
Illuminéhome10%and15%arecolourlesstoothwhiteninggelsfornightguardorday-time
hometreatmentcomprisingcarbamideperoxideasactivebleachingingredient.The
compositionisshowninFigure8.

• GelatingagentCarbomer(modifiedpolyacrylicacid)
• SodiumhydroxidetobufferpHto5.7-6.5
• Illuminéhome 15%comprises0.22%sodiumfluoride
• Mintflavor
• Solventglycerine

ThegelatingagentusedwithinbothformulationsisCarbomerwhichismodifiedpolyacrylic
acid.ThepHofthispolyacidisbufferedto5.7–6.5withsodiumhydroxide.Theformulation
providesgoodadherenceofthegelonthetoothsurface.Peroxideisreleasedalmost
completelyaftertwohours(Christensen,2001).
Additionally,the15%formulationcomprisessodiumfluoridetoreducesensitivity.
7.3ClinicalInvestigations
Safetyandperformanceofthetwocarbamideperoxidebasedtoothwhiteninggelsfor
dentist-monitoredhomeapplication,marketedbyDENTSPLYDeTreyunderthebrand
Illuminéhome,wereinvestigatedin3separateformalinvestigations.
7.3.1 ClinicalinvestigationofIlluminéhome10%bySwiftetalatUNC(1997)
ThematerialusedintheinvestigationisidenticaltotheformulationofIlluminéhome10%.
Design,method,andmaterialoftheinvestigationaresummarisedinFigure9,thefindings
aresummarisedinFigure10andFigure11.

Theinvestigatorsconcludethatthetestmaterialwasaneffectiveagentforlighteningof
discolouredteeth.
Design Double-blindcontrolledinvestigation
Controlmaterials Placebogel
Method 50%ofpatientstreatedwithtestmaterial, 50%ofpatientstreatedwithplacebogelfor14days, thenswitchofregionandfurthertreatmentfor14days
Individualtrays
Thicknessofreservoir:0.5mm
ShadedeterminationwithVitaLuminguide,pre- treatment,2weeks,4weeks,3+ 6mthspost-treatment
Illumine™home10%: UNCClinicalInvestigation(1997)

Otherfindings
• Shadechangesinplacebogroupoccurredin35%ofthecases.
• Whiteningremainedefficaciousafter3monthsin97%ofthecasesand after6monthsin90%ofthecases.
• Transienttoothsensitivitywas17%inplacebogroupand7%with Illuminéhome10%.
"Effectiveagentforlighteningdiscolouredteeth


7.3.2 ClinicalinvestigationofIlluminéhome10%byBarnesetalattheUniversityof
Maryland(1998)
ThematerialusedintheinvestigationisidenticaltotheformulationofIlluminéhome10%.
Design,method,andmaterialoftheinvestigationaresummarisedinFigure12,thefindings
aresummarisedinFigure13andFigure14.

Theinvestigatorsconcludedthatthetestmaterialwhenadministeredunderthesupervision
ofadentistisaneffectivewhiteningagent.

Design Double-blindclinicaltrial
Controlmaterials placebogel
Method 50%ofpatientstreatedwithtestmaterial, 50%ofpatientstreatedwithplacebogelfor14days
Individualtrays
Thicknessofreservoir:0.5-1mm
ShadedeterminationwithVitaLuminguide,pre- treatment,14days,3and6monthspost-treatment
Illumine™home10%: UniversityofMarylandClinicalInvestigation(1998)

Otherfindings
• Whiteningremainedefficaciousat3monthsinatleast76%ofthecases andat6monthsinatleast64%ofthecases.
• Transienttoothsensitivityand/orgingivalsensitivityoccurredinapprox. 2/3ofthepatients.
• Nosignificantchangesingingivalcondition.
"Effectiveandsafetoothwhiteningsystem
Illumine™home10%: UniversityofMarylandClinicalInvestigation(1998)


7.3.3 ClinicalinvestigationofIlluminéhome10%and15%byKihnetalatthe
UniversityofMaryland(2000)
ThewhiteninggelsinvestigatedinthisclinicaltrialareidenticaltotheformulationsofIlluminé
home10%andIlluminéhome15%.
Design,materials,andmethodsusedintheinvestigationaresummarisedinFigure15,the
outcomeissummarisedinFigure16andFigure17.

Design Double-blindclinicaltrial
Numberofpatients 57patients
Method 50%ofpatientstreatedwith15%gel, 50%ofpatientstreatedwith10%gel
Individualtrays
Treatmenttime:14days(≥4h/d)
ShadedeterminationwithVitaLuminguide,pre- treatment,1week,2weeksafterbeginoftreatment, 2weekspost-treatment

Otherfindings
• Atoneweek,nosignificantdifferenceinshadechangewith10%and 15%gels.
• Withthe15%gel,asignificantlymoreintensewhiteningwasachieved after2weeksoftreatmentand14daysafterendoftreatment.
• Nosignificantdifferenceinleveloftoothsensitivitybetweenthetwo groups.
"Bothgelsofferaneffectivewhiteningtreatment. The15%geloffersamoreintensivecolourchange.



Brushandflossteeth priortowearingthe tray.

Fixapplicatorprovided onsyringe.
Illumine™home:Step-by-StepPatientInstructions

29
Openapplicatorby breakingofftip (retaintiptoclose applicatorafteruseof syringe.
Illumine™home:Step-by-StepPatientInstructions

Placesmallamountsofgel towardsfacialsideofteethto betreated.
Closeapplicatoronsyringe.

Insertgeltrayinthemouth overtheteeth
Wipeexcessmaterialfromthe gumsortissueswithfingeror toothbrush.
Illumine™home:Step-by-StepPatientInstructions

Wearthetray throughoutthenight orasdirected(a minimumof2hours issuggested).
Illumine™home:Step-by-StepPatientInstructions

Donoteatordrink anythingorsmoke whilewearingthe tray.
Illumine™home:Step-by-StepPatientInstructions

Aftertreatment,removetray. Rinseyourteeth.Brushawayany remaininggel.
Illumine™home:Step-by-StepPatientInstructions

Cleanthegeltraywithwarm waterandatoothbrush.
Drytraythoroughlyand storeintrayholder.
Illumine™home:Step-by-StepPatientInstructions



8Illuminéoffice
8.1ProductDescription
Illuminéofficeisuniqueinbothtechniqueandformulationandmakesuseofanewchemical
conceptforthecontrolledreleaseofhydrogenperoxide.

Illuminéofficeisa15%hydrogenperoxide-basedtreatmentwhichwillprovidewith
significantlynoticeablewhiteningresultsin30minutes.Theprocessrequiresnolightorheat
activation.

Illuminéofficeisrecommendedasapre-treatment“boost”toIlluminéhomeToothWhitening
Gel,orasastand-alonetreatment,completedin1to3officevisits.Ifusedasaboostto

Eachkitcontainstwo(2)syringesetsandanapplicatortipforeach.Eachsyringeset
comprisesonesyringecontaininga30%hydrogenperoxidesolution(syringeA)andone
powdersyringe(syringeB)withanattachedstopcock.Eachsyringesetcontainsenough
materialtowhiten1arch.

Thehydrogenperoxidesolutionandthegelatingpowderareseparatedintwosyringesto
maintainstabilityduringstorage.ThecontentsofthesyringesA(hydrogenperoxide)andB
(powder)aremixedaccordingtothestep-by-stepinstructionsdirectlybeforeadministration.
Themixed15%hydrogenperoxidebleachinggelisappliedinthecustom-fittedtray.After
settingofthegeltoarubberysemi-solid(settingtime:30to60seconds)thetrayisseated
ontheteeth.Duetothesemi-solidconsistencyandthegoodadherenceonthetoothsurface
migrationofthematerialcanbeavoided.Therefore,gingivalisolationshouldnotberequired
iftheinstructionsarefollowed,andawell-fittingbleachingtrayhasbeenpreparedwith
adequate(3–4mmdepth)reservoirsforeachtoothtobebleached.
31
SyringeAcontains:30%hydrogenperoxide
SyringeBcontains:Poly(MethylVinylEther/MaleicAnhydride)mixedcalcium/sodiumsalts,
titaniumdioxide

Illuminéofficehasanuniquerubberysemi-solidconsistencywhichallowssafe
administrationwithoutgingivalisolation,andimprovescomfortandeconomyofin-office
bleaching.Theadvantageousconsistencyisachievedwithmixedsodium/calciumsaltsof
poly(methylvinylether/maleicanhydride)whichisacopolymer(PVM/MA-copolymer)and
exhibitsgelatingproperties.ThiscopolymerispartofthepowderinsyringeB.Whenmixed
withthehydrogenperoxidesolutionthatcontains70%water,thecopolymerabsorbsthe
waterandswells.Settingtothesemi-solidisduetothehydrationreaction.Itisnotpossible
tocombinethepowderwiththehydrogenperoxideaheadoftimeasthemixedmaterialwill
formaskinandcannolongerbeextrudedfromthesyringe.Themixtureprogressively

Additionally,thePVM/MA-copolymerbuffersthepHofthehydrogenperoxidesolution(pH3)
tobebetween5.6and5.9inthemixedmaterial.Anenamelsurfacestudywasconductedby
scanningelectronmicroscopywhichindicatesthatexposuretothefinalmixedproductforup
32
to90minuteswillNOTdemineralisetheenamelandeffectthetoothsurfacestructure(see
In-vitrodata,Chapter8.3).

ThePVM/MA-copolymerprovidesthegoodadherenceoftherubberysemi-solidtothetooth
surfacewhichisnecessaryforoptimalreleaseofthehydrogenperoxidetothetoothand
bestbleachingefficiency.

Titaniumdioxide(TiO2)causestheopaquewhitecolourofthemixedgelwhichmakes
opticalcontrolofproperseatingofthegelontheteethmorecomfortable.
8.3 In-VitroData
withIlluminéofficebyShermanJ,DENTSPLYProfessional
8.3.1Summary
ThestudywasconductedtodetermineiftheIlluminéofficeIn-OfficeToothWhitenerhas
anyeffectontoothsurfacemorphologywhenplaceddirectlyonthetoothsurfacefor
designatedperiodsoftime.Mixedproductwasplaceddirectlyonthesurfaceofextracted
humanteethfor30minutes,60minutes,90minutes,oraseriesofthree30-minute
treatments.Scanningelectronmicroscopywasusedtoevaluatedsurfacemorphology
changespost-treatmentcomparedtountreatedtoothsurface.Theresultsofthestudy
suggestthatIlluminéofficedoesnotproducesignificantmorphologicalchangesinthe
surfaceofatoothwhenadministeredforupto90minutesorwhenadministeredforatotalof
90minutesthroughthreeindividual30-minutetreatmentsinaninvitroenvironment.
8.3.2Methods
ApplicationofIlluminéoffice
Extractedhumanincisorsweretreatedonthelongitudinalhalfoftheanteriorsurfacewith
themixedbleachinggel.Thematerialwasplaceddirectlyonthetoothsurfaceandallowed
tosetup.AdabofTriadGelwasplacedontheposteriorofeachtoothandlight-curedto
designatethetreatedsideofthetooth.Theremaininghalfofeachtoothservedasan
33
untreatedcontrolforthetooth.Theteethwerepartiallyandintermittentlysubmersedin
deionisedwaterandmaintainedat37°Cforthedurationofthetreatment.Treatmenttimes
were30minutes,60minutes,90minutesoraseriesofthree30-minutetreatmentsat24
hourintervals.Thematerialwasgentlyremovedwithgauzeandtheteethwereplacedin
labelledcontainersofdeionisedwater.
Positivecontrol
Etchinggelwasappliedtothesurfaceofonetoothfortwominutes.Thetoothwasthen
placedinalabelledcontainerofdeionisedwater.
Evaluation
Uponcompletionoftreatment,theteethweresenttoDENTSPLYCaulkforsurface
morphologyexaminationbyscanningelectronmicroscopy(SEM).Treatedanduntreated
areasofeachtoothwerevisuallyexaminedandphotographedatmagnificationratiosof
2500:1and5000:1.
8.3.3Results
TheSEMphotographssuggestthatIlluminéofficedoesnotproducesignificant
morphologicalchangesinthesurfaceofatoothwhenadministeredforupto90minutesor
whenadministeredforatotalof90minutesthroughthreeindividual30-minutetreatmentsin
aninvitroenvironment(Figure19-Figure22).IndifferencetothetreatmentwithIlluminé
office,afteretchingteethofthepositivecontrolgroupexhibittypicaletchingpatternofthe
enamelsurface(Figure23).


2 5 0 0X 2500X
5000X 5000X

2500X 2500X
5000X 5000X

2 5 0 0 X 2 5 0 0 X
5 0 0 0 X 5 0 0 0 X
1In terva lo f2 4h
Figure22 Scanningelectronmicroscopyphotographsofuntreatedteeth
andofteethtreatedwithIlluminéofficefor3x30minwithan
intervalof24h.
andpositivecontrolafteretchingfor2min.

8.3.4Conclusion
Underinvitroconditionsthemorphologyoftheenamelsurfaceisnotsignificantlyaltered
whentreatedwithIlluminéofficeupto90min.
8.4ClinicalInvestigations
Safetyandperformanceoftheprofessionalin-officetooth-whiteningproductmarketedby
DENTSPLYDeTreyunderthebrandIlluminéofficewasinvestigatedintwoseparateformal
clinicalinvestigationsandoneinternaluserevaluation.Whenusedasastand-alone
treatmentandforanapplicationtimeof30minutes,theaveragewhiteningeffectachievedin
theinvestigationsreferredtowas3.4vs.5.8vs.7.2shades(measuredattheVitaLumin
shadescale).
37
8.4.1AClinicalStudyEvaluatingtheEfficacyofaNewChairsideandTake-Home
BleachingSystem–FinalReport,January27,2000byBardwellD,PapathanasiouA,
TuftsUniversityDentalClinic
Objectives:Toevaluatetheeffectivenessandsafetyofa15%hydrogenperoxidein-office
whiteningproductfollowedupbyhomeapplicationofa10%carbamideperoxidewhitening
gel.
MaterialsandMethod:Theupperanteriorteethof24patientswithashadenolighterthan
A3wereselected.ShadeswereassessedusingaVitaLuminShadeGuide.Thein-office
whiteningproduct(usedfor30,45,and60minutes)andthehomewhiteninggelwere
appliedincustom-madetrays.Shaderecordingwasdonepriortoapplication,immediately
afterin-officetreatment,24hoursafterin-officetreatmentand24hours,72hours,and7
daysafterhometreatment.
Results:Whiteningcouldbeattainedquicklywiththein-officesystemandwasenhancedby
subsequenthomeapplicationofthe10%carbamidegel.
Thefinalresultwasslightlydifferentforthe30-minute,45and60-minutein-officetreatment
(Table1).
30minutes officeapplication
B1 A1 B2 D2 A2 C1 C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C4
Officeonly, 24hafter
Office+ Home, 7daysafter
C ha ng e in S ha de In cr em en ts
5.8


50%ofthepatientstreatedexperiencedtoothsensitivitywhichimprovedfastanddidnot
returnforanypatientsatcompletionoftheinvestigation.
38
8.4.2ClinicalEvaluationofa15%In-OfficeHydrogenPeroxideToothWhitening
TouchUpAgent-UpdatedReportApril24,2000byKihnPW,BarnesDM,AdachiE,
TheUniversityofMarylandDentalSchool
Objectives:Toinvestigatetheperformancewhenusedasa"touchup"treatmentfor
previouslywhitenedteeth
MaterialsandMethods:31patientswithpreviouslywhitenedteethweretreatedwith
Illuminéofficeappliedinacustom-madetray(whereavailable,theexistingwhiteningtrays
wereused).For10patients,theapplicationtimewas30minutes,for11patientsitwas
45minutes,andforanother10patientsitwas60minutes.Shadedeterminationwascarried
outwithaVitaLuminshadeguideandwasdocumentedbycolourtransparenciesat
1:1magnification:
72hrspost-application.
Results:Ofthe31patientswhobeganthestudy,2didnotreturnforthe72-hourrecalland
wereexcludedfromtheanalysisaswere2patientspresentingwithshadeslighterthanB1.

Shadechanges72hoursaftertreatment
80
60
40
20
0
100
Changeinshadeincrements
B1 A1 B2 D2 A2 C1 C2 D4 A3 D3 B3 A3.5 B4 C3 A4 C4
30minutes
45minutes
60minutes
Pe rc en ta ge o f Pa tie nt s
75 70
20 12.5

TheaverageshadechangesaregiveninTable3.Theshadechangeforthe30-minute
treatmentwas3.4at72hourspost-treatment.
39
Table3

Toothsensitivityoccurredinthemajorityofallcases(Table4),buttherewasonly1case
withlingeringtoothsensitivityatthe72-hourrecall.

Table4

7patientsexperiencedmildgingivalburns,i.e.awhiteningofthetissue,whichleftbehind
anerythematousareafromcontactwiththebleachingmaterial.In6ofthesecases,the
problemwasassociatedwithanill-manufacturedtray.
6ofthepatientsreportedaburningsensationofthegingivaduringtreatmentwhich
disappearedaftertrayremoval.
Conclusions:
! Thetestmaterialprovedtobeanefficientagentforrewhitening.
! Propertrayfabricationisimportantforthepreventionofgingivalburns.
40
! Sideeffectsweremildandmanageablebyboththeclinicianandthepatient.
8.4.3In-HouseWhiteningCaseStudyFP084–ReportFebruary4,2000byShermanJ,
DENTSPLYPreventiveCare
Objectives:ToevaluatetheeffectivenessofIlluminéofficeforwhiteningteethwhenapplied
for15or30minutes
MaterialsandMethods:12subjectsweredividedin2treatmentgroups(1for15-minute,
1for30-minuteapplicationtimes).ShadeevaluationwithVitaLuminShadeGuidewas
carriedoutpriortoapplication,immediatelyafterapplication,and24hoursafterapplication.
Thein-officewhiteningproductwasappliedincustom-madetrays.
Results:Boththe15-minuteandthe30-minutetreatmentswereeffectivetowhitenteeth.

Treatmenttime Change
Nopatientcomplainedofsensitivityduringtreatment.Onepatientreportedsignificantpost-
treatmentsensitivity,butbythe24-hourrecallthesensitivitywasgone.5patients
experiencedisolatedminorgingivalirritationthathadresolvedbythe24-hourrecall.
Conclusions:SignificanttoothwhiteningcanbeachievedwithIlluminéofficeasastand-
alonetreatment.
1.Reviewthepatient'smedicalanddentalhistory.
2.Performanintraoralexaminationofthe,softtissue,periodontal,andteethhealth.
41
3.Informthepatientthatdependingonthenatureofthestain,anextendedtreatmentmay
berequiredtoattainthedesiredeffect.
4.Afullprophylaxis(usingNuproProphyPaste)andfluoridetreatmentisrecommended
beforestartingthebleachingprocess.
5.Thecompleteprocedureshouldbediscussedwiththepatient,reviewinganypotential
problemsandsideeffects.
6.Informthepatientthatanyexistingtoothcolouredrestorationsmaynotmatchthelighter
shadeofteethafterthetreatmentandmayneedtobereplaced.
7.Useasuitableshadeguide,e.g.Biodent3orVita4LuminVacuumshadeguide,tomake

TakeImpression
Makeanalginateorelastomerimpressionofthearchtobetreated(Itishighly
recommendedthattheteethbetreatedonearchatatime,sothatthepatientcanseethe
changes.)
seeChapter6.2
GingivalIsolation
Gingivalisolationshouldnotberequirediftheinstructionsarefollowed,and:
! awell-fittingbleachingtrayhasbeenpreparedwithadequate(2-4mmdepth)reservoirs
foreachtoothtobebleached
! theIlluminématerialhasbeenallowedtoproperlyset,assuringthatitwilladheretothe
toothsurfaceandnotmigrate,and
! carehasbeentakenduringplacementinthemouthtoassurethatthematerialhasnot
contactedthegingiva.
If,however,theinstructionscannotbefollowed,orifedentulousorinterdentalgingival

42
questionbeprotectedviaapetrolatumjellysuchasVaseline®,anisolationresin(paint-on
rubberdam),oraconventionalrubberdam.



Step1:

Illumine™office:Step-by-StepInstructions
MixfromsyringeAto syringeB3-5times.
Mixedmaterialmust endinsyringeA.
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
Illumine™office:Step-by-StepInstructions
1.AmericanDentalAssociation(1998).Home-usetoothwhiteningproducts.Acceptance
ProgramGuidelines1-10.
2.AttinT(2001).DieAufhellungverfärbter,avitalerZähnemitder"Walking-bleach-
Technik".DZZ56:2;78-89.
3.AttinT(1998).SicherheitundAnwendungvoncarbamidperoxidhaltigenGelenbei
Bleichtherapien.DZZ53:1;11-16.
4.AttinT,BurgmaierGMetal(2001).NeueszurZahnaufhellungmit
carbamidperoxidhaltigenGelen.ZM91:5;32-36.
5.AttinT,HickelRetal(2001).BleichenvonverfärbtenZähnen.Gemeinsame
StellungnahmederDGZMKundderDGZ.DZZ56:2;72-73.
6.BardwellD,PapathanasiouA(2000).AClinicalStudyEvaluatingtheEfficacyofaNew
ChairsideandTake-HomeBleachingSystem–FinalinternalreporttoDENTSPLY.
January27,2000.
7.BarnesDM,KihnPW,RombergE,GeorgeD,DePaolaL,MedinaE(1998).Clinical
evaluationofanew10%carbamideperoxidetooth-whiteningagent.CompendContin
EducDent19:10;968-972,977-978.
8.ChristensenGJ(2001).Athometoothbleaching,state-of-art2001.CRA,9:4.
9.ClinicalResearchAssociates(1997).BleichenvonZähnen,State-of-the-Art'97.CRA
News(D)5:1-3.
10.ClinicalResearchAssociates(2000).BleichungvitalerZähneinderzahnärztlichen
Praxis.CRANews(D)8:6;1-3.
11.ClinicalResearchAssociates(1997).Toothbleaching,state-of-art'97.CRANews
21:4;1-3.
12.ErnstCP,WillershausenB,KöttgenC(2000).Bleaching-thestateoftheart.Submitted
forpublication.
13.FloydRA(1997).Theeffectofperoxidesandfreeradicalsonbodytissues.JADA
128:4;37S-40S.
45
128:51S-55S.
15.GlocknerK,EbelesederK,StädtlerP(1997).DasBleichenvonverfärbtenFrontzähnen.
SchweizMonatsschrZahnmed107:5;413-420.
16.GoldsteinRE,GarberDA(1995).Completedentalbleaching.QuintessencePublishing
Co,Inc.Chicago.
17.GropperG(2000).EinneuesMaterialfürdasHome-Bleaching.DS20:6;28-30.
18.HaywoodVB(2000).Currentstatusofnightguardvitalbleaching.CompendContinEduc
Dent21:Suppl28;S10-S17.
19.HaywoodVB(1997).Nightguardvitalbleaching:currentconceptsandresearch.JADA
128:4;19S-25S.
20.HeymannHO,GoldsteinRE,HaywoodVB,FreedmanG(1997).Bleachingofvitalteeth.
QuintessenceInt28:6;420-427.
21.KihnPW,BarnesDM,AdachiE(2000).ClinicalEvaluationofa15%In-OfficeHydrogen
PeroxideToothWhiteningTouchUpAgent-UpdatedInternalReporttoDENTSPLY.
April24,2000.
22.KihnPW,BarnesDM,RombergE,PetersonK(2000).Aclinicalevaluationof10percent
vs.15percentcarbamideperoxidetooth-whiteningagents.JADA131:10;1478-1484.
23.LeonardJrRH(2000).Nightguardvitalbleaching:Darkstainsandlong-termresults.
CompendContinEducDent21:Suppl28;S18-S27.
24.LiY(1997).Toxicologicalconsiderationsoftoothbleachingusingperoxide-containing
agents.JADA128:4;31S-36S.
25.LiY(2000).Peroxide-containingtoothwhiteners:Anupdateonsafety.CompendContin
EducDent21:Suppl28;S4-S9.
26.MatisBA,CochranMA,EckertG,CarlsonTJ(1998).WirksamkeitundSicherheiteines
GelszumBleichenvitalerZähne.Quintessenz49:10;979-987.
27.MatisBA,CochranMA,EckertG,CarlsonTJ(1998).Theefficacyandsafetyofa10%
carbamideperoxidebleachinggel.QuintessenceInt29:9;555-563.
28.MüllerP(1901).FrühkindlicheZahnverfärbungenauspädiatrischerSicht.ZM91:11;32-
34.
29.NathooSA(1997).Thechemistryandmechanismsofextrinsicandintrinsic
discoloration.JADA128:6S-10S.
30.PriceRBT,SedarousM,HiltzGS(2000).ThepHoftooth-whiteningproducts.JCan
46
DentAssoc66:8;421-462.
31.ShermanJ(2000).In-HouseWhiteningCaseStudyFP084–InternalReport.February
4,2000.
32.SmidtA,WellerD,RomanI,GedaliaI(1998).Effectofbleachingagentson
microhardnessandsurfacemorphologyoftoothenamel.AmJDent11:2;83-85.
33.SpougeJD(1973).OralPathology.TheC.V.MosbyCompany.
34.SwiftJrEJ,MayJrKN,WilderJrAD,HeymannHO,WilderRS,BayneSC(1997).Six-
monthclinicalevaluationofatoothwhiteningsystemusinganinnovativeexperimental
design.JEsthDent9:5;265-274.
35.ViscioD,GaffarA,Fakhry-SmithS,XuT(2000).Presentandfuturetechnologiesof
toothwhitening.Compendium21:Suppl.28;S36-S43.