Clinical Evaluation of Laser Microtexturing百好瑞激光蚀刻技(2)

Safetyendpoints.Thesafetyend-pointsareplaqueindexandsulcularbleedingindex.Eachoftheseend-pointsaremeasuredatthemesialanddistallocationsoftheimplantona4-pointscale,withthecategoriesof0(noplaquedetected),1(plaquewasnotedonlybyrunningaprobeacrossthesmoothmarginalsurfaceoftheimplant),2(plaquecouldbeseenbythenakedeye),and3(anabundanceofsoftmatter)fortheplaqueindexand0(nobleedingwhenaperiodontalprobewaspassedalongthegingivalmarginadjacenttotheimplant),1(onlyisolatedbleedingwasvisible),2(bloodformedaconfluentredlineonthemargin),and3(presenceofheavyorprofusebleeding)forthesulcularbleedingindex.Thescoresassignedtothe2measurementswereaveragedtocreateanumericscore.

Allmeasurementswereinitiatedat1-monthpostoperative,aftersofttissuehealingandweredoneat2-monthintervalsupto37months.

inFigure2fora44-year-oldmale.Thecrestalboneseemstobere-tainedaroundtheSilhouettewithla-sersurfacetreatment(LL),whereasthereisnoticeablebonelossevidentaroundtheimplantwithoutlasersur-facetreatment(controlimplant).

The2primaryeffectivenessend-pointsareprobingdepthandcrestalboneloss.ThedifferencesbetweentheLLandcontrolimplantsweretestedateachstudyvisitbyapairedttest.

AsseeninFigure3,theLLtreatmentyieldedconsistentlylowerprobingdepthateachvisitwithsignificanceforalltimeperiods(P?0.001).AsseeninFigure4,LLwasnumericallysuperiortocontrolimplantincrestalbonelossateachmonthaftermonth1,andachievednominalsta-tisticalsignificanceatmonth7(P?0.003),andeachmonththereafter(P?0.001).Thisdifferenceisseentoincreasenumericallyateachsuccessivevisit.

All20implantpairswereincludedinanalysesupto7months,andonly19pairsatmonths9through37.ThisisbecausetheLLimplantinpatient1failedat7monthsandtheimplantwasremoved.Toconductanintenttotreatanalysis,whichusesallimplants,adifferencebetweentreatmentsofzero(consistentwiththenullhypothesisofnoeffectduetotheLLsurfacetreatment)wasimputedforallmissingdataforPatient1forbothprob-ingdepthandcrestalboneloss,andtheaforementionedanalyseswererepeated.Theresultingdifferencesateachofthevisitsinwhichavaluewasimputed(months9–37)remainedsignificant(P?0.001).

Asubgroupanalysiswasperformedonthe20pairsofimplantstocompareimplantsinthemandiblewiththoseinthemaxilla.Meandifferencesbetweentreatmentswerecomputedforprobingdepthandcrestalboneloss.LLwasnumericallysuperiortothecontrolim-plantateachmonthforimplantsinthemandibleandimplantsinthemaxilla,forbothprobingdepthandcrestalboneloss.However,thereisnostatisticalsig-nificancetothesedata.Therefore,thedataonlysuggestapossiblegreateref-fectofLLsurfacetreatmentonimplantsinthemaxillathaninthe

mandible.

Fig.3.Probingdepth,LLversuscontrolfor37-monthfollow-up.Errorbars?standarderror:P?0.005foralltime

periods.

RESULTS

PatientAccountability

Nopatientwaslosttofollow-up.Inonepatient(patient1)thesiteim-plantedwiththeLLimplantfailedtoosseointegrateandtheimplantwasre-moved.Allotherimplants,LLandcontrolimplant,havebeenfollowedforthefull37months.

EffectivenessResults

X-raysforatypicalcasepostop-erativelyandat25monthsareshown

Fig.4.Crestalboneloss,LLversuscontrolfor37-monthfollow-up.Errorbars?standarderror:P?0.005aftermonth5.

60CLINICALEVALUATION

OF

LASERMICROTEXTURING?PECORA

ET

AL

Fig.5.Plaqueindex,LLversuscontrolfollowedfor37months.Errorbars?standarderror:notsignificantlydifferentforalltimeperiods.

Fig.6.Sulcularbleedingindex,LLversuscontrolfollowedfor37months.Errorbars?standarderror:notsignificantlydifferentforalltimeperiodsexceptmonths21and37whereLLis

superior.

JustificationforPoolingInvestigators

Fivesurgeonsimplantedbetween2and7pairsofimplantseach.Toassessthepoolabilityofthedatafromthese5surgeons,themonth37dataforeachoftheeffectivenessendpointswasanalyzedbysurgeon.Themeansforeachsurgeonandtreatmentwerecomputed,alongwiththedifferencesbetweentreatments.TheLLtreatmentwasconsistentlysuperiortotheSil-houetteforeachendpointandsurgeon.Thisconsistencyoftreatmenteffectamongthe5surgeonsindicatesthatthedataarepoolable.

SafetyResults

significantdifferencesinthe2datasetswerefoundexceptforsulcularbleedingat21and37monthswhereLLwassuperior.Generally,however,thereseemstobenoclinicallysignif-icantsafetyendpointdifferencesbe-tweenLLandcontrolimplant.

DISCUSSION

TheSilhouettedesignimplantcom-binesprovendesignconcepts7,9(reversebuttressthreadandhighsurfaceareamicrotextures)withanoveltaperedde-sign.10TheSilhouetteimplantwithLLsurfacetreatmentcombinestheseSil-houettefeatureswithorganizedmicro-texturesincriticalareas.TheOsseo-Lokhighsurfaceareamicrotextureonthethreadedportionoftheimplanthasbeenshowninpreclinicalanimaltestingtoenhanceboneappositiontotheim-plant.11TheLLsurfaceshavebeenshowntoinhibitfibrousencapsulation,enhancingbonyattachmentinbonyareas,enhancetheformationofasoft-tissuesealinsoft-tissueareasandcontrollocaltissuemicroarchitecture.11Thiscom-binationoforganizedcellsandorganized

Thesafetyendpointswereplaqueindexandsulcularbleedingindex.Allindividualvaluesforeachofthesein-diceswereeithera0ora1,hence,theresultingaveragesofthemesialanddistaldeterminationswereeithera0,0.5(onevaluewas0andtheotherwas1),or1.TheresultingdataateachvisitareshowninFigures5and6,respec-tively.Aone-sided95%upperconfi-denceboundonthedifferencesinthemeanswascomputed.Nostatistically

extracellularmatrixresultsinuniquetissueformationattheinterfaceresultingintrue“endosseousincorporation.”1,2

Thebleedingindexforbothim-plantsaftertheinitialhealingperiodrangesfrom0.45to0.03withnostatis-ticaldifferencebetweenpairsexceptat2timepointswhereLLissuperior.ThehistoricaldatafromanearlierstudyofBio-Lokimplantspresentsarangefrom0.00to0.50withameanof0.25.8,9Theplaqueindexgoesashighas0.27forthecontrolimplantsand0.25fortheLLimplantswithnostatisticaldifferencebetweenpairs.Thehistoricaldatahadameanplaqueindexof0.27,closetothehighestmeanatanytimeperiodforei-thertheLLorthecontrolimplants.Thesedataindicatethatthereisnoin-creaseintheseinflammationmeasures(bleedingandplaqueindices)ascom-paredwitheitherprospectivecontrolsorhistoricaldata.

Theconsistentdifferenceinprob-ingdepthbetweentheimplantpairswithandwithouttheLasermicrotex-turesurfacetreatmentimpliesthatasoft-tissuesealabovethebonehasbeenestablishedintheLLimplantedsites.Thiswasdemonstratedhistolog-icallyinapreviouscanineimplantstudy.11Accountingforthecrestalbonelosswithbothimplants,an?1.0to0.7mmprobingdifferenceismain-tainedthroughoutthestudy.Thisisapproximatelytheheightofthe8?mtexturing(0.7mm)ontheLLimplant.

Thecrestalbonelossdataarethemostdramaticresultofthisstudy.TheLLbonelossislimitedto0.59mmwhereasthecontroldatademonstratesupto1.94mmofboneloss.Thedatareportedforotherimplantsystemsisintherangefrom1.0to2.5mm.3,6,12TheLLsurfacedimplantissuperiorinthisimportantmeasuretoconsecutivecontrolsandliteraturereportsonotherimplantsystems.

CONCLUSIONS

Thecombinedresultsofthisstudywithpreclinicalanimalstudies1,2,11andanalyses13havedemonstratedthatitisnotnecessarytoacceptupto2.5mmofcrestalbonelossarounddental

implants

IMPLANTDENTISTRY/VOLUME18,NUMBER12009

ashasbeenproposedinthelitera-ture.3,6,12At3yearspostoperativetheSilhouetteimplantwithLLsurfacetreatmentenablesthereductionofcr-estalbonelossto0.59mm.Itishypoth-esizedthatthishasbeenaccomplishedbyreducingthestressinthecrestalbonethroughacombinationofimplantde-signandsurfacemodification13andef-fectingsoft-tissueattachmentabovethebone.11Thesebenefits,accomplishingtrue“endosseousincorporation,”weredemonstratedwithoutanydegradationinplaqueindexandsulcularbleedingindexascomparedwithcontrols.

Disclosure

61

JohnL.RicciandHaroldAlexanderwereconsultantstoBioLokinthedevel-opmentoftheimplantstudied.GabrieleE.Pecora,RolandoCeccarelli,andMarcoBonelliclaimtohavenofinancialinterestinanyentitythatiscommerciallyrelatedtotheproductsmentionedinthisarticle.

REFERENCES

1.RicciJL,CharvetJ,FrenkelSR,etal.Boneresponsetolasermicrotexturedsur-faces.In:DaviesJE,ed.BoneEngineering.Toronto,ON:EM2Inc;2000.Chapter25.2.FrenkelSR,SimonJ,AlexanderH,

etal.Osseointegrationonmetallicimplantsurfaces:Effectsofmicrogeometryandgrowthfactortreatment.JBiomedMaterRes.2002;63:706-713.

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