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

Clinical Evaluation of Laser Microtexturing百好瑞激光蚀刻技术的临床评估

IMPLANTDENTISTRY/VOLUME18,NUMBER1200957

ClinicalEvaluationofLaserMicrotexturingforSoftTissueandBoneAttachmentto

DentalImplants

GabrieleE.Pecora,DDS,MD,*RolandoCeccarelli,DDS,?MarcoBonelli,DDS,?HaroldAlexander,PhD,§

andJohnL.Ricci,PhD?

itaniumalloydentalimplantshavebeendesigned,fabricated,andtestedwithmicrogeometries(surfacecharacteristicsinthemicronrange)tocontrolboneandsoft-tissueintegration.Thesesurfaceshavehighlyoriented,consistentmicrostructuresthatareappliedusingcomputer-controlledlaserablationtechniquesusingapulsed,computer-controlledExcimerlasersys-temandlarge-areamasking.Animalex-periments1indicatethatthistechnologyenhancesboneandsoft-tissueintegra-tionandcontrolsthelocalmicrostruc-turalgeometryofattachedbone.

Coloniesofcellsgrownonthelasermachinedsurfacesshowpreferentialcolonizationparalleltothegrooves.Themicrogroovedsurfacescauseelongatedcolonygrowth,whichisacceleratedinthexdirection(paralleltothesurfacemicrogeometry)andinhibitedintheydirection(perpendiculartothesurfacemicrogeometry).Onanindividualcelllevel,thecellsareobservedtoattachandorientalongthesurfacegrooves.Thiscausesthecellstobe“channeled”inthexdirection,ascomparedwithcon-trolcultures,wheretheoutgrowingcellsmoverandomlyonflatsurfaces.Cellsareobservedtoattachandorientwithinthegroovesandonflattopsofthe

T

Introduction:Atapereddentalimplant(Laser-Lok[LL]surfacetreatment)witha2mmwidecollar,thathasbeenlasermicromachinedinthelower1.5mmtopreferentiallyaccomplishboneandconnectivetis-sueattachmentwhileinhibitingepi-thelialdowngrowth,wasevaluatedinaprospective,controlled,multi-centerclinicaltrial.

Materials:Dataarereportedatmeasurementperiodsfrom1to37monthspostoperativefor20pairsofim-plantsin15patients.Theimplantsareplacedadjacenttomachinedcollarcontrolimplantsofthesamede-sign.Measurementvaluesarereportedforbleedingindex,plaqueindex,prob-ingdepth,andcrestalboneloss.

Results:Nostatisticaldifferencesaremeasuredforeitherbleedingorplaqueindex.Atallmeasurementpe-riodstherearesignificantdifferencesintheprobingdepthsandthecrestalbonelossdifferencesaresignificantafter7months(P?0.001).At37monthsthemeanprobingdepthis2.30mmandthemeancrestalbone

grooves.Thisresultsinenhancedxaxisgrowthandalmostnoyaxisgrowthbycellsonthesesurfaces;thecellsarespindleshapedandwelloriented.

Implantchambermodelstudies2showthatcaninebonegrowsintochannelslinedwiththelasermicroma-chinedsurfacesfasterandmoreexten-sivelythaninchannelslinedwithblasttexturedsurfaces.Newboneisob-

lossis0.59mmforLLversus3.60and1.94mm,respectively,forcontrolim-plant.Also,comparingresultsinthemandibleversusthoseinthemaxillademonstratesabiggerdifference(controlimplant?LL)inthemeanincrestalbonelossandprobingdepthinthemaxilla.However,thisresultwasnotstatisticallysignificant.

Discussion:Theconsistentdiffer-enceinprobingdepthbetweenLLandcontrolimplantdemonstratesthefor-mationofastablesoft-tissuesealabovethecrestalbone.LLlimitedthecrestalbonelosstothe0.59mmrangeasopposedtothe1.94mmcrestalbonelossreportedforcontrolimplant.TheLLimplantwasfoundtobecomparablewiththecontrolimplantinsafetyend-pointsplaqueindexandsulcularbleed-ingindex.Thereisanonstatisticallysig-nificantsuggestionthattheLLcrestalboneretentionsuperiorityisgreaterinthemaxillathanthemandible.(ImplantDent2009;18:57–66)

KeyWords:alveolarboneloss/etiology,dentalprosthesisdesign,crestalbone,implant

surface

servedtoattachdirectlytothelasermicromachinedsurfacesandthetra-becularboneadjacenttothesesurfacesisstronglyorientedparalleltothemi-crogrooves.Thisorientationaleffectofthelasermicromachinedsurfacesonattachedboneisconfirmedinanintramedullaryrodsamplewhereori-entationofattachedbonetrabeculaefollowsmicrogrooveorientation

*PrivatePractice,Rome,Italy.?PrivatePractice,Lucca,Italy?PrivatePractice,Imperia,Italy.

§President,Orthogen,LLC,Springfield,NJ.

?AssociateProfessor,DepartmentofBiomaterialsand

Biomimetics,NewYorkUniversityCollegeofDentistry,NewYork,NY.

ISSN1056-6163/09/01801-057ImplantDentistry

Volume18?Number1

Copyright?2009byLippincottWilliams&WilkinsDOI:10.1097/ID.0b013e31818c5a6d

58CLINICALEVALUATION

OF

LASERMICROTEXTURING?PECORA

ET

AL

whetheritiscircumferentialorlongi-tudinal.Boneattachmenttothelasermicromachinedsurfacesisstrongenoughtomeasureintensionandtensile-testedspecimensoftenshowboneleftbe-hindinthemicrogrooves.Bonesurfacesexposedafterimplantremovalalwaysshowextensiveboneattachmentandgrowthintothemicrogrooves,withtra-becularattachmentsspreadingparalleltothemicrogroovesandblendingtogethertoformcontinuousbands.

Electronmicroscopicresults1,2sug-gestthatthesesurfacescauseorientationofattachedcells,whichproducesori-entedextracellularmatrixandorientedbonemicrostructure.Thisisnotob-servedontexturedorpolishedsurfaces.Texturedsurfacesshowmoderatedirectboneattachment,whichisnotdirec-tional,andpolishedsurfacesshowlittledirectboneattachmentandmostlyfi-brousencapsulation.

Crestalbonelossaroundendostealimplantsisacommonphenomenon.Riccietal3reported2.17?1.6mmofcrestalbonelossat5yearspostoperativeandZechneretal4reported2.4?0.23mmoflossat3to7years.Evenasearlyas1yearpostoperative,Abboudetal5reportedupto1.21mmofcrestalbonelossandBryantandZarb6reported1.4mmloss.Tayloretal7andDeLeonardisetal,8usinganimplantwithasimilarscrewthreadandscrewsurfaceastheimplantusedinthisexperimentalstudyfound1.23mmand?1mmofboneloss,respectively.

Theclinicalquestionaddressedbythestudydescribedhereisasfollows:Willthelasermicrotexturingsurfacetreatmentoftheimplantcollarreducecrestalbonelossandestablishastablesoft-tissuesealwithnoincreaseinin-flammationmeasuressuchasbleedingandplaqueindex?

2mmwidecollar.Thebodyoftheimplanthasbeenroughenedbyblast-ingwitharesorbableblastmedia.TheSilhouettewithlasermicrotexturingsurfacetreatmenthasthesamebodydesignandscrewareasurfacetreat-mentasthecontrol,buthasalasermicromachinedcollar.Thisimplant,showninFigure1,hasa2mmwidecollarthathasbeenlasermicromach-inedinthelower1.5mm.Thelower,0.8mm(bonecontacting)region,hasbeenlasergroovedwith12?mwideby10?mdeepgroovesthathavebeenpreviouslyshowninpreclinicalstud-iestooptimizethesurfaceforboneattachment.1,2Thenext0.7mmofthecollarhasbeenlasergroovedwith8?mwideby5?mdeepgroovesthathavebeenpreviouslyshowntoopti-mizethesurfaceforconnectivetissueattachment.Theupper0.5mmofthe

collar,asmachined,encouragesepi-thelialtissuecolonization.

BaselineDemographicData

ClinicaltestinghasbeenperformedbythegroupforimplantresearchinItaly.The2implantsarecomparedagainsteachotherandwithhistoricalcontrolsprevi-ouslypublishedontheBio-LokMicro-Lokimplantsystem.8,9Eachpatientreceived2singletoothimplants,withandwithoutlasersurfacetreatment(LLvscontrolimplant).Allimplantswerere-storedat4monthspostoperative.Thestudywasperformedwith5investigatorsandatotalof15patientswhoreceived20setsofimplants.Thepatientsin-cluded6menand9womenranginginagefrom42to69yearsoldwithameanageof55.8years.Amongthe20implantpairs,8wereintheman-dibleand12wereinthe

maxilla.

Fig.1.Positioningofthelasermicrotexuredcollarin

bone.

MATERIALS

AND

METHODS

ThisstudyevaluatestheSilhou-etteDentalImplant(Laser-Lok(LL),Bio-LokInternational,DeerfieldBeach,FL)withlasermicrotexturingsurfacetreatmentoftheimplantcollar(LL)versusacontroltaperedimplantwithastandardmachinedcollar(con-trolimplant).Thecontrolimplantusedinthisstudyisataperedimplantwithareversebuttressthreaddesignanda

Fig.2.Atimplantplacementand25monthspostoperative,44year,male.ControlandSilhouettewithLaser-Loksurfacetreatment(LL).

IMPLANTDENTISTRY/VOLUME18,NUMBER12009

Eachpatientsignedaconsentformindicatingtheexperimentalnatureofthedevices,thepurposeofthestudy,theirrights,andtheirobligations.

Endpoints

59

AcomparisonbetweenmeanswasdoneusingttestsforallmeasurementsandtheresultingPvalueswererecorded.

Effectivenessendpoints.Thepri-maryeffectivenessendpointsareprobingdepth(theaverageof4measurementstakenatthemesial,buccal,distal,andlin-gualsurfacesoftheimplant)andcrestalboneloss(averageofthe2radiographicmeasurementstakenatthemesialanddis-tallocationsoftheimplant).

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