JOralMaxillofacSurg67:1947-1960,2009Pivotal,Randomized,ParallelEvaluationofRecombinantHumanBoneMorphogeneticProtein-2/AbsorbableCollagenSpongeandAutogenousBoneGraftforMaxillarySinusFloorAugmentationR.GilbertTriplett,DDS,PhD,*MyronNevins,DDS,†RobertE.Marx,DDS,‡DanielB.Spagnoli,PhD,DDS,§ThomasW.Oates,DMD,PhD,�PeterK.Moy,DMD,¶andPhilipJ.Boyne,DMD,MS,DSc#Purpose:Thepurposeofthisprospectivestudywastoevaluatethesafetyandeffectivenessofrecombinanthumanmorphogeneticprotein-2(rhBMP-2)onanabsorbablecollagensponge(ACS)comparedwithanautogenousbonegraftwhenusedfor2-stagemaxillarysinusflooraugmentation.Thestudyassessednewboneformation,placementintegration,andfunctionalloadingafter6monthsandlongtermfor2years.MaterialsandMethods:Atotalof160subjectswererandomized,enrolled,andfollowedfromJanuary1999toFebruary2004at21centersintheUnitedStates.Thesubjectswithlessthan6mmofnativeboneheightweretreatedwith1.50mg/mLrhBMP-2/ACSorwithanautograft.Theheightanddensitymeasurementswerequantifiedbycomputedtomographyscans.Corebiopsieswereobtainedatdentalimplantplacementandusedforhistologicalanalysis.Safetywasevaluatedbyoralexaminations,radiographs,serumchemistries,andhematology.Results:Asignificantamountofnewbonewasformedby6monthspostoperativelyineachgroup.ThemeanchangeinboneheightintherhBMP-2/ACSsubjectswas7.83�3.52mmversus9.46�4.11mmforthebonegraftsubjects.At6monthsafterdentalrestoration,theinducedboneintherhBMP-2/ACSgroupwassignificantlydenserthanthatinthebonegraftgroup.Nomarkeddifferenceswerefoundinthehistologicparametersevaluatedbetweenthe2groups.Thenewbonewascomparabletothenativeboneindensityandstructureinbothgroups.ThesuccessratefortherhBMP-2/ACSgroupwas79%(64of81subjects),and201of251implantsplacedinthebonegraftgroupand199of241implantsplacedintherhBMP-2/ACSgroupwereintegrated,retained,andfunctionalat6monthsafterloading.Noadverse*RegentsProfessor,DepartmentofOralandMaxillofacialSur-gery,TexasA&MHealthScienceCenter,BaylorCollegeofDen-tistry,Dallas,TX.†ClinicalAssociateProfessor,Harvar...
