Effectiveness of two integrated systems for the treatment of maxillary central incisors with periapical lesion: an 18-month randomized clinical trial

ORIGINAL

ARTICLE/ARTICOLO

ORIGINALE

CONGRESSO

INTERNAZIONALE

ROMA

2016

—

VINCITORE

PREMIO

RICCARDO

GARBEROGLIO

Effectiveness

of

two

integrated

systems

for

the

treatment

of

maxillary

central

incisors

with

periapical

lesion:

an

18-month

randomized

clinical

trial

§

Efficacia

di

due

sistemi

integrati

per

il

trattamento

di

incisivi

centrali

mascellari

con

lesione

periapicale:

Trial

clinico

randomizzato

a

18

mesi

Daniele

Angerame

*

,

Matteo

De

Biasi

,

Vittorio

Franco

,

Lorenzo

Bevilacqua

,

Attilio

Castaldo

a

DentalClinic,UniversityClinicalDepartmentofMedical,SurgicalandHealthSciences,UniversityofTrieste, Trieste,Italy

b

PrivatePractice,Rome,Italy

Received12January2017;accepted20January2017 Availableonline16February2017

GiornaleItalianodiEndodonzia(2017)31,44—47

KEYWORDS

Periapicallesion; Integratedendodontic techniques;

Carrierbasedsystems; Healing.

Abstract

Aim: Toassessthe18-monthsuccessrateofrootcanaltreatmentwithtwointegratedshaping andfillingsystemsonuppercentralincisorswithchronicperiapicalpathosis.

Methodology: Sixty patients with an upper central incisorswith a chronic periapical lesion smallerthan5mmindiameterwererandomlyallocatedtotwotreatmentgroups,whichonly differedintermsofcanalshapingandfillingprotocol:G1(n=30),Revo-S/OneStepObturator; G2(n=30)GTX/GTXObturator.Thepatientsunderwentclinicalassessmentatbaselineandafter 6,12and18months.Radiographichealingwasscoredaccordingtoapreviouslydescribedscale by twoindependentexaminers, whoanalysedtheperiapicalradiographstakenattherecall

§_{CongressoInternazionaleRoma2016VincitorePremioRiccardoGarberoglio.}

PeerreviewunderresponsibilityofSocieta` ItalianadiEndodonzia.

* Correspondingauthorat:UniversityClinicalDepartmentofMedical,SurgicalandHealthSciences,PiazzaOspedale1,I-34125Trieste,Italy. Fax:+390403992665.

E-mail:d.angerame@fmc.units.it(D.Angerame).

Availableonlineatwww.sciencedirect.com

ScienceDirect

jo ur na l h o m ep a ge : w w w.e ls e v i er.c o m / lo c at e /gi e

http://dx.doi.org/10.1016/j.gien.2017.01.002

Introduction

A trend of simplification of root canal shaping and filling techniqueshasariseninthefieldofEndodontics.1Therotary file sequences of modern Ni-Ti systems are composed of fewerinstrumentsincomparisontothepast.1Similarly,canal fillingcanbesimplifiedandperformedinasinglestepusingof carrier-based systems, which might introduce less filling defectscomparedtomulti-steptechniques,especiallywhen usedbynovices.2Evenifthereisnodoubtthatawidearrayof technologicaladvanceshasimprovedthetreatmentdelivery inthefieldofEndodontics,thescientificcommunityisstill questioning whether using modern techniques and instru-mentsimpliesalsobettersuccessrates,evenmoreincase of periapical pathosis.3 This work presents the updated findingsofapreviouslypublishedtrial,inwhichtwo simpli-fiedtechniqueswereclinicallytested.1Thesetechniquesare found on similar principles but are proposed by different manufacturers.Theyconsistinashapingprotocolwithrotary filescomposedofastandardsequenceoffewinstruments, namelytheRevo-S(Micro-Mega,Besanc¸on,France)andGTX (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) files

systems.Bothshapingprotocolsare followedbyrootcanal fillingbymeansofcarrier-baseddedicatedsystems,the One-StepObturator(CMSDentalApS,Copenhagen,Denmark)and GTXObturator (DentsplyTulsaDental Specialties), respec-tively.

Theaimofthepresentstudywastoassessthe18-month successrateofrootcanaltreatmentwiththetwo aforemen-tionedintegratedshapingandfillingsystemsofuppercentral incisorswithchronicperiapicalpathosis.

Materials

and

methodology

Thepresent randomized controlled trialwas conducted in accordancewith the principles expressed in theCONSORT statement4_{andthelastupdateoftheHelsinkiDeclaration.}

Theprimaryoutcomemeasuresweretheradiographic heal-ingandthesensitivitytotoothpercussionandpalpationof thebuccalsulcus.The trialrecruited patientsaffectedby chronicorasymptomaticapicalperiodontitis, accordingto thedefinitiongivenbyGutmannetal.5_{Sixtyadultpatients}

needing a primary endodontic treatment on a maxillary

PAROLECHIAVE Lesioneperiapicale; Tecnicheendodontiche integrate; Sistemicarrier-based; Guarigione.

visits.Intra-andinter-observerreliabilitywastestedwithKappastatistics.Thesignificanceof thedifferences betweenthe twogroups and amongtimepoints withregard toclinical and radiographicdatawasevaluatedwithnon-parametrictests(p<0.05).

Results: Allenrolledpatientswereavailableforre-evaluation.Atthefinalrecall,thecaseswere scoredastotalhealing,partialhealingandfailurewiththefollowingfrequencies:93.3%,3.3% and3.3%ofcasesinG1andin93.3%,0%and6.7%ofcasesinG2.Radiographichealingscoreswere similar in the two groups irrespective of the experimental time point. The prevalence of symptomswasscarce(0—10%),stableovertimeandsimilarinthetwogroups.

Conclusions: Theclinicalperformanceoftwoconsideredintegratedsystemsfortheendodontic treatmentofuppercentralincisorswithperiapicallesionwascomparableandallowedforhigh successratesafter18months.

ß2017Societa` ItalianadiEndodonzia.ProductionandhostingbyElsevierB.V.Thisisanopen accessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/ 4.0/).

Riassunto

Obiettivi: Valutareilsuccessoa18mesideltrattamentoendodonticodiincisivicentralisuperiori affettidapatologiaperiapicalecronicacontecnicheintegratedistrumentazioneeotturazione. Materialie metodi: Sessantapazienti conunincisivo centraleaffettodalesione periapicale cronicadidiametroinferiorea5mmsonostatiassegnaticasualmenteaduegruppiditrattamento, diversitralorosoloperprotocollodisagomaturaeotturazionecanalare:G1(n=30),Revo-S/One StepObturator;G2(n=30)GTX/GTXObturator.Ipazientisonostatisottopostiaesameclinico inizialeedopo6,12e18mesi.Allaguarigioneradiograficae` statoassegnatounpunteggiosulla base di una scala descritta in precedenza analizzandole radiografie periapicali acquisite ai richiami.Ilgrado diaccordointra-einterosservatoree` statotestatoconKappadiCohen.La significativita` delledifferenzetraiduegruppietraitempiinrelazioneaidaticlinicieradiografici e

` statavalutatacontestnonparametrici(p<0,05).

Risultati: E` statopossibilerivalutaretuttiipazientiarruolati.Alrichiamofinalelelesionisono stateclassificatecomeguarita,guaritaparzialmenteenonguaritaconleseguentifrequenze: 93,3%,3,3%e3,3%dei casiin G1e93,3%, 0%e6,7%deicasi inG2.Ipunteggi diguarigione radiograficasonorisultatisimilineiduegruppiindipendentementedaltemposperimentale.La prevalenzadeisintomie` statascarsa(0-10%),stabileneltempoesimileneiduegruppi. Conclusioni: Laperformanceclinicadeiduesistemiintegraticonsideratineltrattamento endo-donticodiincisicentralisuperioriconlesioneperiapicalee` risultatacomparabileehapermesso tassidisuccessoelevatidopo18mesi.

ß2017Societa` Italiana diEndodonzia.ProductionandhostingbyElsevier B.V.Cetarticleest publie´ enOpenAccesssouslicenceCCBY-NC-ND( http://creativecommons.org/licenses/by-nc-nd/4.0/)

centralincisorwithachronicperiapicallesionsmallerthan 5mmindiameterwereenrolledinthetrialandreceiveda single-sessionrootcanaltreatmentbyanexperienced opera-tor.Theywererandomlyallocatedtotwogroups,whichonly differedintermsofcanalshapingandfillingprotocol:group1 (G1, n=30), Revo-S/One Step Obturator; group 2 (G2, n=30),GTX/GTXObturator.Randomization,sequence gen-erationandallocationtogroupswereconductedinadvance bysubjects notdirectlyinvolvedintheexperimentalpart. Restrictedrandomisationwas carriedoutassumingablock sizethatwasamultipleofthenumberoftreatments.

Beforerootcanaltreatment,allteethwereisolatedwith rubberdam.Ifneeded,theteeth tobetreatedreceiveda compositeresinbuild-up.Afterstandardaccesscavity pre-paration,thecanalwasscoutedwithasize10Kfile(Dentsply Maillefer,Ballaigues,Switzerland)andtheelectroniclength determined electronically (Root ZX, Morita Co., Tokyo, Japan).The irrigation protocol was standardised and con-sistedofrinseswith2.5ml5.25%sodiumhypochlorite(Niclor 5,Ogna,Muggio`,Italy)aftereachinstrument.InG1,canals wereshapedwithSC1(25/.06),SC2(25/.04)andSU(25/ .06)Revo-Sfiles(Micro-Mega)andthenfilledwithOne-Step Obturators(CMSDentalApS).Similarly,20/.04,20/.06,30/ .04and30/.06GTXrotaryfiles(DentsplyTulsaDental Spe-cialties) were used in combination with GTX Obturators (DentsplyTulsaDentalSpecialties)toperformcanalshaping andfillinginG2.Priortorootcanalfilling,inbothgroupsthe apexwasmanuallygauged(MityTurbo,JSDental,Ridgefield, CT, USA) and then enlarged with the rotary finishing files belongingtotherespectivefilesystem.

Sensitivity to percussion of the designated tooth and palpationofthebuccalsulcuswastestedbeforethe treat-ment,after6,12and18monthsbyasingleoperatorwearing 4magnifyingloupes,whowasunawareoftheallocationto groups.

To ensurereliabilityandrepeatabilityoffilmpositioning duringtheradiographicanalysis,RinnXCPdevices(RinnCorp., Elgin,IL,USA)werecustomizedwithasiliconregistrationand usedwithaparallelingtechnique.Theimageplatesofadigital X-raysystem(VistascanDentalPerio,Du¨rrDentalAG, Bietigh-eim,Germany)wereexposedtoanX-raysource(2200Intraoral XRaySystem,KodakDentalSystems,Rochester,NY,USA)setat 70kVp,10mA,and0.20sexposuretime.Alltheimageswere registeredin‘‘Endo’’modetoenhancereadability.6

Theradiographichealingwasscoredbytwoblind exam-inersontheperiapicalradiographstakenattherecallvisits accordingtothescalebyKatebzadehetal.7_,which

contem-platesthefollowingfourscores:

1.healing:normaltrabecularboneandphysiological period-ontalligamentwidth;

2.improvement:decreaseofthelesionsize;

3.failure:increaseoflesionsizeorabsenceofchangesfrom theinitialstatus;

4.unreadableradiograph.

Intra- and inter-observer reliability was assessed by weightedCohen’sKappa.Theabsenceofdifferencesinterms ofbaselineclinicalparametersbetweenthetwogroups(age, apicalgauging,tendernesstopercussionandpalpation)was verified by means of non-parametric statistics. A Mann— WhitneyandaFriedmantestservedtocomparethe radio-graphic healing scores between groups and time points, respectively.Theclinicaldataregisteredinthetwogroups at therecallswerecompared witha chi-squaredtest; the comparison between time points was carried out with a Cochranetest(p<0.05).

Results

No drop-outs or withdrawals occurred.The baseline para-meters were comparable in the two groups. Radiographic healingwasprogressiveduringtheobservationperiod.After oneyearandahalf,thecaseswerescoredastotalhealing, partialhealingandfailurein93.3%,3.3%and3.3%ofcasesin G1andin93.3%,0%and6.7%ofcasesinG2(Table1).There wasnodifferenceinradiographichealingbetweenthegroups atanyoftheassessmenttimepoints.Duringthefollow-up period,thepatientswereinfrequentlyreporting symptoms (0—10%ofcases);theprevalenceofsymptomsdidnotvary overtimeandwassimilarinthetwogroups(Table2).

Table1 Frequencyoftheradiographichealingscoresatthe differentobservationtimepoints.

Radiographicscore Months

6 12 18 G1 Totalhealing 43.3% 80.0% 93.3% n=30 Partialhealing 53.3% 16.7% 3.3% Failure 3.3% 3.3% 3.3% G2 Totalhealing 43.3% 73.3% 93.3% n=30 Partialhealing 50.0% 20.0% 0% Failure 6.7% 6.7% 6.7% Diff. NS NS NS

Table2 Comparisonoftheclinicaldataregisteredinthetwogroups. Age(y) Apical

gauging (10 2_mm)

Baseline 6months 12months 18months

Discussion

Primary and secondary research studies have taken into account the success rate of the endodontic treatment, reportingits remarkablevariability.8—10_{Withregardto the}

six-monthresultsonpersistenttoothsymptomsafter endo-dontictreatment,ourdataareinaccordancewiththetooth painprevalencereportedinliterature,11equalto5.3%after 6months.To thebestofourknowledge,no systematically gatheredinformationconcerningtendernesstopalpationor percussionisavailableforlongerperiodsofobservation.

Irrespective of the integrated system being used, the present studyon uppercentralincisorsdemonstrated that even simplified techniques can lead to treatment success almostin all cases. The finalsuccessrate obtainedin the presentstudyissuperiortothatobtainablewithteethwith necroticpulpandperiapicallesionaccordingtothe systema-ticreviewbyNgetal.10Anexplanationtothisfindingmaybe that,inabsenceofparticularobstaclesoranatomic aberra-tions,maxillarycentralincisorsrarelypresentpeculiar hin-drancestoastandardizedrootcanaltreatmentsothatthey canhaveabetterprognosisthanothertoothtypes.

Thepresenttrialalsoatteststhatsomelesionsundergoa progressivehealingthatmayrequiremorethanoneyear.An extended follow-upperiod is advisablefor these patients. When planning the radiographic monitoring of periapical lesions,anopenquestioniswhetherextendingthe follow-upoflesionsthathavecompletelydisappearedafteroneyear is appropriateor not,because it isknown that late endo-dontic failure is rare. However, cases presenting partial healingmaycometoacompleteresolutionevenafterway longer periodsand should be followed-up further, as sug-gested by review papers and endodontic scientific socie-ties.9,12 Furthermore, it is interestingthat almost all the lesions scored as partially healed reached the status of complete radiographic healing. Nevertheless, since it has notbeendemonstratedyetwhetheralesionthatstartsto diminish in sizewill always result in complete resolution, furtherstudiesareneededtoaddressthisissue.

The cases consistently scored as radiographic failures after18monthswerenotsubjectedtoretreatment,because thepatientswerenotwillingtoundergosuchtherapygiven the absence of major complications. Indeed, the authors agreewiththeconceptsalreadyexpressedbyother research-ers13,14 that state that from the patient’s perspective a functionaltoothmaybeacceptableevenwithanimperfect periapicalstatus.Furthermore,thehurrytoproceedwitha surgical or non-surgical retreatment may leadto an over-treatment.

Conclusions

The presenttrial registeredhigh18-monthsuccess rateof endodontictreatmentsperformedwiththetwoconsidered

integratedsystemsoncentralincisorswithperiapical patho-sis. The clinical performance of the two techniques was similar.

Conflict

of

interest

Theauthorshavenoconflictsofinteresttodeclare.

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