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Human dermis graft versus autogenous connective tissue grafts for thickening soft

tissue and covering multiple gingival recessions: 6-month results from a prefer
ence clinical trial
Key words :
aesthetic, connective tissue graft, gingival recession, preference controlled cl
inical trial,
soft tissue augmentation
Purpose:Toevaluatewhetherahumandermisgraft(HDG)couldbeusedinsteadofanautogenous
aft(ACT)toincreasegingivalthicknessandtocovermultiplegingivalrecessions.
Materials and methods: Forty-two consecutive patients with multiple gingival recessions
were offeredtheoptiontohavetheirrecessionscoveredeitherwithACTsharvestedfromthei
utcomemeasureswerecomplications, gingivalrecessionchanges(REC),gingivalbiotypechanges
,probingattachmentlevelchanges(PAL),probingpocketdepthchanges(PPD) andkeratinisedm
hanges(KER)evaluatedbyanindependentandmaskedassessorafter6 months.
Results:Twenty-onepatientswith110recessionsoptedforACTsand21patientswith160reces
.Nopatientsdroppedout.Onlyoneminor complicationoccurredatone HDG-treatedsite.Rece
antlydecreasedinbothgroups(2.7mmforACTand2.0mm
forHDG),however,ACTsresultedinastatisticallysignificantlyimprovedroot coverageand
las18%morerootcoveragethanHDGs.
Conclusions:HDGscanbeaneffectivealternativetoACTsforcoveringexposedrootsandincre
hickness,especiallywhenmanyrecessionshavetobetreatedinthesamemouth,though theym
ssrootcoveragethanACTs.
Introduction
Exposed root surfaces can be unaesthetic, more pronetohypersensitivityandrootcarie
ficulttobemaintainedcleanofdentalplaque.Gumrecessionscanbecausedbyhighpressure
diatrogenicdentaltreatmentssuch asorthodontictoothmovement.Athingingivalbiotypeand
onofthetootharethemost relevantfactorsassociatedwithincreasedgingival recessions,t
ckgingivaislesspronetorecession.Variousproceduresareusedfor root coveragetothicke
vaandimprove aesthetics.Thesetechniquesincludevariouslateral orcoronalslidingflaps1
sueregeneration2,3,andimplantationofgrafts3,4.Asubepithelialconnectivetissuegraft(A
tedfromthepalatehasbeenintroducedtoincreaserootcoverage andgumthickness2,5.TheA
h asplit-thicknessflapwhichcanbecoronally,laterallyornotmobilised,thustheACTis
edbytheflap.Becauseofthegoodclinicalsuccessandcolourmatch,ACTshavebeenregarded
.However,bleedingofthedonorsite, hyposensitivityofthepalate,andpostoperativepain
noccur.Forpatientswithmultiple recessionsitmaybedifficulttoharvestenoughconnecti
ateandmultiplesurgeriesmaybenecessary.Therefore,itmightbeadvantageoustoreplaceau
lternativegraft.Differenttypesofhumanacellularfreezedried humandermisarecurrent ly
guetransplantstoavoidasecondsitesurgery6-8.
Theaimofthispreferencecontrolledclinicaltrialwastoevaluatewhetherasolventdehydra
ndermisgraft(HDG)couldbeusedinsteadofanACTtoincreasegingivalthicknessandtocov
sions.
Materials and methods
Anypatient,18yearsoldorolder,requestinggingivalcoverageatmorethanonetoothaffect
cessions(novisiblelossofinterdentalpapillaanddistancebetweencemento enamel junctio
est2.5mmmeasured onperiapicalradiographs,though,whenpresent, MillerclassIIIand
eated andconsideredintheanalyses)9,andabletosignan
informedconsentform,waseligibleforinclusioninthistrial.Patientswerenot admittedto
efollowingexclusioncriteriawerepresent:
anypathologicsystemiccondition
smokers(ex-smokerscouldbeincludedifnotsmokingforatleast6months)
affectedbyperiodontitis
poororalhygieneandmotivation(plaqueandbleedingsscores<15%before surger
pregnant
participantinotherclinicalstudieswithinthelast6monthsbeforesurgery.
Patientswererecruitedandtreatedinoneprivatepracticebythesameoperator(MS),
cedures.ThestudywasapprovedbytheEthicsCommissionInternationalFreiburg,Germany(stud
2006-01;feciCode:010/1462).Theprinciples outlined in the Declaration of Helsinki o
earchinvolvinghumansubjectswere adheredto.Patientswereinformedthattheycouldchoose
renttreatmentoptions.Anypotentialadvantagesand disadvantageswitheachtechniquewereex
heoperator,andthepatientswerelefttochoosewhattheypreferred.Allpatientssignedan
iortobeingenrolledinthetrial.Followinginitialexamination,patientswere instructedin
ndaprofessionaltoothcleaningwasdeliveredasrequired.

Surgical procedure
Besidescompleterootcoverage,theaimofthesurgerywastoincreasethethicknessofthegi
rieswereperformedbythe sameoperator(MS).Noantibioticswereprovided.Afterlocalanae
edrootswerescaledandplanedtothebottomofthepocketwithrotatingburs,ultrasonicins
s.Deeperinstrumentationwasavoidedtopreventdamagetotheperiodontal ligament.Inadditi
ntrootswereflattened.Nochemicalroot conditioningwasperformed.Aftersulcularincision
isplacedsplit-thicknessflapwasperformedwithoutreleasingincisionaccordingtotheincisi
escribedby Zucchelli10,thoughacompletesplit-thicknessflapwaselevated.Theflapwascon
bilisedenoughwhenitstayedpassivelyatalevelslightlycoronaltotheCEJ.Accordingtop
epithelialconnectivetissuegrafts(Fig1)wereharvestedfromoneortwopalatalsides,depen
oftissueneeded,orhumandermisacellularallografts(Fig2)wereused.
Tutoplast Dermis Allograft Tissue Matrix TutogenMedical,NeunkirchenamBrand,G
[nowavailableasPurosDermis,ZimmerDental,Carlsbad,CA,USA])wasusedasahumandermis
ainsthenaturalcollagenmatrixandmechanicalpropertiesofnativedermis11.Thetissueproce
nactivatesbacterial,viraland prioncontaminationandeliminatesantigenicity.The
solvent-driedmaterialispackagedwiththeabsenceofresidualantibioticsandterminallyste
- dosegammairradiation.Thegraftwasrehydrated
for30minutesinsterilesaline,adaptedinsize,placed underneaththeflapandfixedaroun
thslingsutures(Prolene,6-0,Braun,Melsungen,Germany).Themostcoronalpositionwas abo
heflapwascoronally advancedtocompletelycoverthegraftandwasalso fixedwithslingsu
eciseadaptationaroundteeth.Sutureknotswereplacedonthe lingualaspecttodecreasepati
uringremoval.
Whensubepithelialconnectivetissuegraftswereused,asingleincisionparalleltoth
argin usingascalpelwitha15cbladewasmadeinthepalate12.Aftertheseparationofthe
talandtwoverticalincisions,theconnective tissuewasremoved,leavingtheperiosteumatt
.Thedonorregionwassuturedandepitheliumwascarefullyremovedfromthegraft.TheACTs
esamemannerastheHDGs.
Fig 1 Clinicalpicturesofonepatientincludedinthecon-
nectivetissuegraftgroup:a)preoperativesituation,b)just
aftersuturing,c)after6months.
Fig 2 Clinicalpicturesofonepatientincludedinthe
humandermisgroup:a)preoperativesituation,b)after
positioningofthehumandermisgraft,c)after6months.
Patientswereinstructedtoavoidanymechanical traumatothewoundandtorinsewit
mouthwash(0.12%)twiceadayfor1minute,for4 weeks.Ibuprofen(400mg)wasprescribedas
lammatorymedication.Sutureswere removedafter2weeksandpatientswererecalled1,2and6
yforprofessionalsupragingivaltoothcleaningandreinforcementofmotivation for good or
Patients were alsoinstructedtouseagentlerolltechniquewithsoftbrushesforbrushing
ntstudytestedthenullhypothesisthattherewerenodifferencesbetweenthetwoprocedures
ivehypothesisofadifference.Outcomemeasureswere:
Complication:anycomplicationthatoccurred duringorafterthegraftingprocedure
upperiod.
Gingivalrecessionchanges(REC):measuredfromtheCEJtothemostapical positi
calaspectoftheroot.Itwasexpressed in percentagesaccordingtothefollowingformula
months]/ RECbaseline).Whennotvisible,theCEJposition wasestimatedbythe outcom
Gingival biotype changes (BIO): gingiva was consideredtobethickwhenthe probe
ethroughthetissue;ifvisible,itwasclassifiedasthin biotype.
Probingpocketdepthchanges(PPD):measured fromthemostapicalpositionofthe
laspectoftheroottothebottomofthegingivalsulcus.
Probingattachmentlevelchanges(PAL):calculatedbyfollowingtheformula:
D.
Keratinisedmucosawidthchanges(KER):measuredfromthegingivalmarginto themu
).
Allclinicalperiodontalmeasurementsweremadeprior tosurgery(baseline)and6mont
hapressuresensitiveperiodontalprobe(PCP-UNC15probe,Hu-Friedy,USA)usingacalibrated
earest0.5mmbyone independent,experienced andblindeddentalhygienist(TatjanaHuck).No
calculation was performed. Abiostatisticianwithexpertiseindentistryanalysedthedata,
wingthegroupcodes.Thepatient wasthestatisticalunitoftheanalyses.Differencesin t
ntswithcomplicationswerecomparedbetweenthegroupsusingtheFisherexact probabilitytes
esofmeansatpatientlevel forcontinuousoutcomesbetweengroupswerecomparedbyttests.
nthebaseline measurements and 6 months after augmentation
weremadebypairedttests.Allstatisticalcomparisonswereconductedatthe0.05levelofs
Results
Forty-twopatientswhowereinterestedinhavingtheirrecessiontreatedforaesthetic
e consideredeligibleandwereconsecutivelyenrolledinthetrial.Twenty-onepatientsopted
eirowntissuesand21preferredtobetreatedwithahumandermis.Allpatientsweretreated
rence.PatientsweretreatedbetweenSeptember2005andJanuary2010.Nopatientdroppedout.
tswereincludedinthestatisticalanalysesandnodeviation
fromthestudyprotocoloccurred.
ThemainbaselinepatientcharacteristicsarepresentedinTable1.Therewerenoappa
nt baselineimbalancesbetweenthetwogroupswiththe
exceptionofmorerecessionsperpatientinthegrouptreatedwithhumandermis(7.6versus5.
Themainresults6monthsaftertheaugmentationprocedurearesummarisedinTable2.
toperativecomplicationwasobservedduringtheentirefollow-upperiod:atsutureremoval, 7
fting,aHDGwasexposed.Thisthinbiotypesitewithnokeratinisedgingivashoweddermisexp
sionofthecoronallyrepositionedflap.TheexposedHDGresorbedovertime
andtherecessionimprovedfrom4to2.5mm.After6 months,thesitewasstillcharacterised
t1mmofkeratinisedgingivawaspresent.
Six months after grafting, recessions in both groups were statistically signi
ntlyreduced2.7mmforACTsand2.0mmforHDGs;Table3).On average, there was 0.5mm l
tedsites,andthiswasstatisticallysignificant(Table2).Morespecifically,ACTsdetermine
ootcoveragethanHDGs,whichwasstatisticallysignificant(Table2)
Bothproceduresthickenedbiotypeinthesameway(Tables13)withno differencesbet
dures(Table2).
Bothprocedureswereabletoincreasetheheight ofkeratinisedmucosa(onaverage1.7
d0.95mmforHDGs;Table3),thedifferencebetweengroupsbeingnotstatisticallysignifican
bingattachment levels significantly improved for both groups (on average 2.75mmfor
orHDGs;Table3),though ACTsprovided,onaverage,anadditionalsignificant
improvementof0.52mm(Table2).
Therewerenosignificantchangesforprobingpocket depths over time (Table 3)
ups(Table2).

Discussion
ThispatientpreferencetrialwasdesignedtoassesswhetherHDGscould replaceautoge
r treating multiple root recessions. Both procedures wereeffectiveincoveringtheexpos
ndinincreasingsofttissuethickness,thoughslightlybetterclinicalresultswereobtained
ttemptingtocomparethepresentresultswiththoseofsimilartrials,thepresentauthorscou
fourrandomisedcontrolledtrials(RCTs)13-16comparingACTswithanotheracellulardermalmat
lloderm,LifeCellCorporation,TheWoodlands,TX,USA),whichwereevaluatedinasystematic
Themeta-analysesofthesefourtrials(60patients pergroup)forrootcoverageandK
ystatisticallysignificantdifferences6monthsaftergraftingbetweenthetwodifferentproc
comparingdirectlythesameHDGsusedinthepresent investigation(TutoplastDermis)withth
mentionedacellulardermalmatrixgraft(Alloderm)inonesplit-mouthRCTincluding14patien
recessions8,nostatisticallysignificantdifferencecould beobservedafter6monthsforroot
ER, PALandPPD.
Themainlimitationsofthepresentstudyarethe lackofrandomisation,thestrictin
ia,the lackofassessmentofpostoperativepain,thelackof
colourmatchevaluationofthegraftedareas,andthe smallsamplesize.Theclinicalinvestig
letpatientschoosetheinterventiontheypreferred becausethiswasconsideredtobethesimp
strialinaprivatepracticesetting. However,patientscanbeinfluencedbytheclinician
allocationisatahighriskofbias. Curiously,thepatientchoicegeneratedtwogroups with
ents.Thoughgroupallocationwasnotperformedat random,allassessmentswereperformedbya
sessor.
Theresultsofthisstudymaynotbegeneralisedwithconfidencetootherpopulations
clusioncriteriaandlackofrandomisation.Itisnotpossibletodefinitivelyrecommendany o
duressincepersonalvaluesareinvolved.Patientsshouldbecorrectlyinformedthat therecou
perativepain/discomfort andaslightlybetter(18%moregingivalcoverage) aestheticoutcome
gtheirowntissues,and shoulddecidebythemselveswhattheyprefer.

Conclusions
Humandermisgraftscouldbeanalternativetreatmentoptiontoautogenousconnectivetissueg
ringexposedrootsandincreasingsofttissue thickness.WhileHDGsprovidedslightlyinferio
age,theymaycauselesspostoperativepain/discomfort.

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