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www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

Rapid

maxillary

expansion

in

mouth

breathers:

a

short-term

skeletal

and

soft-tissue

effect

on

the

nose

Fauze

Ramez

Badreddine

,

Reginaldo

R.

Fujita,

Fabio

Eduardo

Maiello

Monteiro

Alves,

Mario

Cappellette

Jr.

UniversidadeFederaldeSãoPaulo(UNIFESP),SãoPaulo,SP,Brazil Received24August2016;accepted30January2017

Availableonline24February2017

KEYWORDS Maxillaryexpansion; Palatalexpansion technique; Nasalcavity; Nose Abstract

Introduction:Rapidmaxillaryexpansion canchangetheformandfunctionofthenose. The skeletalandsofttissue changescan influence theestheticsand thestability oftheresults obtainedbytheprocedure.

Objective:Theaimofthisretrospectivestudywastoevaluatetheshort-termeffectsofrapid maxillaryexpansionontheskeletalandsofttissuestructuresofthenose,inmouth-breathing patients,usingareliableandreproducible,butsimplemethodology,withtheaidofcomputed tomography.

Methods:Atotalof55mouth-breathingpatientswithmaxillaryhypoplasiawereassessedand weredividedintoanexperimentalgrouptreatedwithrapidmaxillaryexpansion(39patients, 23ofwhichweremaleand16female,withanaverageageof9.7yearsandastandarddeviation of2.28,rangingfrom6.5to14.7years)andacontrolgroup(16patients,9ofwhichweremale and7female,withanaverageageof8.8years,standarddeviationof2.17,rangingfrom5.11 to13.7years).Thepatientsoftheexperimentalgroupweresubmittedtomultislicecomputed tomographyexaminationsattwodifferentpointsintime:(T1)pre-rapidmaxillaryexpansion and(T2)threemonthsaftertheprocedure.Thecontrolgroupunderwenttothesameexams atthesameintervalsoftime.Fourskeletalandsofttissuevariableswereassessed,comparing theresultsofT1andT2.

Results:Therewasintheexperimentalgroupasignificantincreasesinalltheskeletalandsoft tissuevariables(p<0.05)butnosignificantalterationwasfoundinthecontrolgroup.When comparingtheexperimentalgroupandthecontrolgroup,themostimportantchangeoccurred inthewidthofthepyriformaperture(p<0.001).

Pleasecitethisarticleas:BadreddineFR,FujitaRR,AlvesFE,CappelletteJr.M.Rapidmaxillaryexpansion inmouthbreathers:a short-termskeletalandsoft-tissueeffectonthenose.BrazJOtorhinolaryngol.2018;84:196---205.

Correspondingauthor.

E-mails:[email protected],[email protected](F.R.Badreddine).

PeerReviewundertheresponsibilityofAssociac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial. https://doi.org/10.1016/j.bjorl.2017.01.009

1808-8694/©2017Associac¸˜aoBrasileiradeOtorrinolaringologiaeCirurgiaC´ervico-Facial.PublishedbyElsevierEditoraLtda.Thisisanopen accessarticleundertheCCBYlicense(http://creativecommons.org/licenses/by/4.0/).

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Conclusion: Rapidmaxillaryexpansion is capable ofalteringthe shapeand functionofthe nose,promotingalterationsinskeletalandsofttissuestructures.Thiskindofstudymay,inthe future,permittheproperplanningofestheticproceduresatthetipandbaseofthenoseand alsotheperformanceofobjectivemeasurementsinearlyorlatesurgicaloutcomes.

© 2017 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Published by Elsevier Editora Ltda. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/). PALAVRAS-CHAVE Expansãodamaxila; Técnicadeexpansão palatal; Cavidadenasal; Nariz

Expansãorápidadamaxilaemrespiradoresorais:efeitosesqueléticos etegumentaresdonarizemcurtoprazo

Resumo

Introduc¸ão: Aexpansãorápidadamaxilapodealteraraformaeafunc¸ãodonariz.Asalterac¸ões doesqueletoedostecidosmolespodeminfluenciaraestéticaeaestabilidadedosresultados obtidosatravésdesteprocedimento.

Objetivo: Avaliar,em curtoprazo, os efeitosda expansãorápidada maxilasobreas estru-turasesqueléticasetegumentaresdonarizempacientesrespiradoresoraispormeiodeuma metodologia confiável ereprodutível, porémsimples, comaajudada tomografia computa-dorizada.

Método: Foramavaliados55 pacientesrespiradoresorais comhipoplasiamaxilarque foram divididosemgrupoexperimentaltratadocomexpansãorápidadamaxila(39,23dosexo mas-culino e16dofeminino,commédiade9,7anosedesviopadrãode2,28,variac¸ãode6,5a 14,7anos)eumgrupocontrole(16pacientes,novedosexomasculinoesetedofeminino,com médiade8,8anos,desviopadrãode2,17,variac¸ãode5,11-13,7anos).Ospacientesdogrupo experimentalforamsubmetidosaexamesdetomografiacomputadorizadamultisliceemdois temposdistintos:(T1)pré-expansãorápidadamaxilae(T2)trêsmesesapósoprocedimento. Ogrupocontrolefoisubmetidoaosmesmosexamesnosmesmosintervalosdetempo.Foram avaliadasquatrovariáveisesqueléticasequatrotegumentarescomparando-seosresultadosde T1eT2.

Resultados: Ogrupoexperimental apresentouaumentos significativosem todasasvariáveis esqueléticasedetecidosmoles(p<0,05),masnãohouvealterac¸õessignificativasnogrupo con-trole.Aocomparar-seogrupoexperimentaleogrupocontrole,foiobservadoqueaalterac¸ão maisimportanteocorreunalarguradaaberturapiriforme(p<0,001).

Conclusão:Aexpansãorápidadamaxilaécapazdealteraraformaeafunc¸ãodonariz, pro-movendoalterac¸õesnasestruturasesqueléticasedostecidosmoles.Essetipodeestudopode, nofuturo,permitiroplanejamentoadequadodeprocedimentosestéticosnapontaebasedo narizetambémarealizac¸ãodemedidasobjetivasemresultadoscirúrgicosiniciaisoutardios. © 2017 Associac¸˜ao Brasileira de Otorrinolaringologia e Cirurgia C´ervico-Facial. Publicado por Elsevier Editora Ltda. Este ´e um artigo Open Access sob uma licenc¸a CC BY (http:// creativecommons.org/licenses/by/4.0/).

Introduction

Itiswellknownthatthenasalcavityplaysanimportantrole in respiratory physiology,1,2 exerting a fundamental

influ-ence on facialgrowth and developmentand occlusion.3,4

Inviewof thestrong relationshipthat existsbetween the nasal cavity and the maxilla, and as the maxillary bone forms around 50% of the anatomic structure of the nasal cavity,5,6 changes to the maxilla could also be the cause

of nasal obstructions, the transverse deficiencies, which include maxillary hypoplasia, being the most frequently observed.2,7

Therefore, the occurrence of maxillary hypoplasia togetherwithrespiratory problems, mainly nasal obstruc-tion,hasattractedtheattentionof variousresearchersto thepossibilityoftheseeventsharboringanintimate,mutual

relationship.8---10 RME, in addition to rectifying occlusion,

mayhave an influence on respiratory nasal activity,1,2,7,11

aswell as promotingpositive changes in cervical posture andpositionofthehead asa resultof thesmallerairway resistance.12,13

FromtheearliestevidenceoftheeffectsofRMEonthe nasalcavity8,9variousstudieshavebeenundertaken

focus-ingonskeletal changes5,7,11,14---32 thefirstspecificstudy on

therepercussionofRMEonthesofttissueofthenasal cav-itywasonlyconductedasrecentlyas1999.33Sincethistime,

fewstudieshaveassessedthemodificationstothefacialsoft tissuethathave atendency tostretch,accompanyingthe changesinthe hardtissuedue tobone expansion.9,23,33---35

The softtissue,in additionto theestheticimpact itmay haveontheface,36mayalsohaveaprimaryroleinthe

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aftertheRME.Thishappensbecause,after3---4monthswith aretainer,therecouldstillbealackofadaptationofthesoft tissue,includingthatofthecheeks,whichcouldbecomea recurrencefactor.9,23,33Moreover,therecouldalsobelosses

inocclusalstabilityandrespiratoryefficiencydueto resis-tanceof the soft tissueand maxillarysutures aroundthe nose.Soitisessentialthattheprofessionalshouldconsider thepossibleconsequencesforthesofttissueasaresultof thistreatment.9,23,36

Thevastmajorityofstudiesexistingintheliteraturehave approached skeletal and soft tissue alterations by means oftwo-dimensionalexaminations5,6,11,14---18,20,21,29,30,32,33

how-ever technologicaladvancesin digital imaginghave made itpossible to performthese evaluationsin 3D. Computed tomographyisareliablemethodforrepresentingand mea-suring the thickness of facial soft and skeletal tissue37,38

providinghighlypreciseandaccuratedata,producing full-sizeanatomicalimages(1:1).Themajority ofstudiesthat use three-dimensional examinations,7,19,22---28,30,31,35,36,39,40

however,have notexplored the study of thenasal cavity in three dimensions, instead placing greater emphasis on alterationsinwidth.19---26,28,30,39

Due tothe conflictingliterature and the lack of infor-mation about three-dimensional skeletal alterations, and mainlythroughtheabsenceofamorecomprehensive liter-atureintermsofsofttissuenasalalterations,theobjective ofthepresentstudyistoevaluate,usingasimplebut reli-ableandreproduciblemethodologythe effectsof RMEon theskeletalandsofttissuestructuresofthenose,inthree dimensions, in mouth-breathing patients, with the assis-tanceofcomputedtomography.

Methods

The sample comprised55mouth-breathing individuals suf-fering from maxillary constriction, referred for RME treatment.Thepatientsweredividedintothe experimen-talgroup(EG)(39patients---23maleand16femalewithan averageageof9.7years,standarddeviationof2.28,ranging from6.5to14.7years)andaControlGroup(CG)(16patients ---9maleand7femalewithanaverageageof8.8years, stan-dard deviation of 2.17, ranging from 5 to 13.7years).All patientswereevaluatedbyamulti-disciplinaryteamandthe diagnosesweremadethroughastandardizedquestionnaire, andENTandorthodonticevaluation.Syndromicpatientsor patientswithcraniofacialabnormalitiessuchasPierreRobin andTreacherCollins,amongothers,andpatientswith den-talor periodontalchanges wereexcluded fromthe study. This study was approved by the Committee for Ethics in InstitutionalResearch.

ThepatientsoftheEGweretreatedbyusingtheHyrax maxillaryexpanderwithsix-quarterinitialactivationsand two-quarterdaily activationsuntil the necessary quantity ofexpansionwasobtainedforeachpatient,inotherwords, untilthesuperiorbuccalbonebeseemcompatiblewiththe inferiorWALA edge.Once the activationswere complete, theapplianceswerekeptinplaceforaperiodof3months, asaretainer,toenablenewbonetoformingtheregionof themid-palatalsuture.CTexaminationswereconductedat twodifferentpointsintime:(T1)pre-RMEand (T2)three monthsaftertheretainerisfitted.ThepatientsintheCG

Table1 Pointslocatedintheskeletaltissue.

Nasion(N) Intersectionofthefrontal boneandtwonasalbones. AnteriorNasalSpine(ANS) Mostanteriorpointofthe

maxilla’snasalspine. PosteriorNasalSpine(PNS) Mostposteriorpointofthe

maxilla’snasalspine.

weresubjectedtothesameCTexaminations(T1andT2)on similarperiodstothosein theEG (threemonths between them).All thepatientsin theCG wereduly treatedusing thesamestandardprocedureemployedintheEG,oncethe studywasover.AlltheCTscanswereperformedinthesame locationandwiththesameequipment,namely: Multislice (PhilipsBrillianceCT64channelscanner).Forthese exami-nations,aFOVof20cmandVoxelof0.25mmwereused.All patientswereundermedicaltreatment,allTCscanswere partof thediagnosisprocessand bymedicalprescription, respectingtheALARAprincipleaccordingtotheskullsizeof eachpatient.

Theskeletalandsofttissuestructuresofthenosewere dulymanipulatedandmeasuredinthreedimensionsbased onanatomicalpointsdefinedinthegloballiterature36,40---42

(Tables 1and 2),withthe aidof OsiriXMD software(FDA approved, version 1.4.2; Pixmeo, Geneva, Switzerland), which, by means of specific tools, permittedthe acquisi-tionofmultiplanarslices(sagittal,axialandcoronal)ofCT images,throughwhichthedatawerecollected.Inorderto assurethecorrectlocalizationoftheanatomicalpoints,41,42

good reproducibility and reliable measurements, prior to measuring, therepositioning of the head wascarried out foralltheCTmages,followingthemethodologyadvocated byCevidanesetal.43(Fig.1A---C).

The skeletal structures were measured in the sagittal andcoronalimagesofthemultiplanarslices.Inthesagittal image(Fig.2A),thenasalheightismeasuredviathe mea-surementoflineardistance(mm)betweenpointsNandANS andthetotallengthofthenoseviathedistance,in millime-ters, betweenthe pointsANSandPNS. As for thecoronal image, the height of the pyriform aperture is measured, obtained via thelineardistance (mm) betweenthe upper andlowertangentsofthisstructureabovethemidsagittal

Table2 Pointslocatedinthesofttissue.

Nasion(N) Pointofthemidlineofthesoft tissuethatliesdirectlyover thehardtissue,inthedirection oftheskeletalNasion(N). Pronasal(Prn) Mostprominentpointofthe

noselocatedonthemedian. Alar(Al) Themostlateralpointofthe

contourofeachnostril. AlarCurvature(Ac) Pointlocatedatthesofttissue

insertionofeachalarbase. Subnasal(Sn) Mid-pointbetweenthemeeting

oftheloweredgeofthenasal septumandupperlip,located onthemedian.

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Figure1 Finalrepositioningoftheheadwiththesagittal(A), axial(B)andcoronal(C)slicesdulyorientedinrelationtothe Frankfurtplaneandthemidsagittalplane.

A

N

ANS

PNS Length: 2.1

B

C

Figure2 (A)Measurementofthenasalheight(N-ANS)andtotallength(ANS-PNS)inthesagittalslice.(B)Measurementofthe heightofthepyriformapertureinthecoronalslice.(C)Measurementofthewidthofthepyriformapertureinthecoronalslice.

plane (Fig. 2B)and the nasal width through the distance (mm)betweentheoutermostpointsofthelateralwallsof thelowerthirdofthepyriformaperture(Fig.2C).

The soft tissue measurements were measured in the sagittal and axial images of the multiplanar slices. The heightwasobtainedinthesagittalimageviathelinear dis-tance(mm)betweenthepointsNandSn(Fig.3A)andthe length, alsoin the sagittal image,via the lineardistance (mm) betweenthepointsPrn andSn (Fig.3A).The width ofthenasalsofttissuewasobtainedfromtheaxialimage viathelineardistance(mm)betweenthepointsAlr andAlL (alarwidth)andbetweenthepointsAcr andAcL (widthof thesofttissueinsertion)(Fig.3BandC).Fig.4shows the samepointsreferredto3Dreconstruction.

Statisticalanalysis

Thestatisticalanalysisanddatatreatmentwasperformed using the program Statistical Package for the Social Sci-ences (SPSS),version 22 for Windows. The measurements

areshowninmillimeters(mm)anddescribedviathemean (M)andstandarddeviation(SD),theresultsbeingdisplayed intheformatM±DP.

In order toverify the adequacy of the sample for the study, Student’s t-tests were performed for paired sam-ples.The calculationswerecarriedoutusingtheprogram G*Powerandshowedasample(n=55)withpowerof80%at a5%levelofsignificance,demonstratingthatthesampleis sufficienttoassurethecredibilityoftheresultsobtained.

Thesignificance values(p)oftheShapiro---Wilktest for the analysis of normality of data were greater than or equal to 0.05 for all variables. These results with a 5% level of significance permit us to assume that the data haveanormaldistribution,guaranteeingtheprerequisites for the performance of parametric tests for the statisti-calanalysis andtreatment of theresults obtained in this study.

Inordertocheckforthepossibilityofpotential interfer-encefromgender andage,intheresultsofthestudy,the Fisher’sexacttestwasusedforthegendervariable(58.2% male and 41.8% female) and the independent Student’s

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A

N′ Alr AlL Acr AcL Prn Sn

B

C

Figure3 (A)Measurementoftheheightofthenasalsofttissue(N---Sn)andlengthofthenasalsofttissue(Prn---Sn)inthesagittal slice.(B)Measurement ofthe alarwidth (Alr---All)intheaxial slice.(C) Measurementofthewidth ofthe softtissueinsertion

(Acr---Acl)intheaxialslice.

AIr Acr AIr AII AII AcI Ac I Sn Prn Acr Prn N′

Figure4 Pointsin3Dsofttissuereconstruction.

t-testfor the age variable(inthe global sample the ages

rangefrom5.92to14.17years,withM=9.45andSD=2.26). The test results demonstrate there were no significant differences either in terms of gender (p=1.000) or age (p=0.191).Basedontheseresults,it maybestatedthat, despitetherebeing moremales thanfemales anda large agevariationbetweenthesample elements,therewasno interferencefromeitherofthesetwofactorsintheoutcome ofthestudy.

Inordertoanalyzemethoderror,intra-examiner reliabil-itywasassessedusingtheStudent’st-testforpairedsamples andtheIntraclassCorrelationCoefficient(ICC).Allthe pre-andpost-RMECTexaminationsweremeasuredagain30days aftertheinitialmeasurements,assuming alevelof signifi-cance of 5% for the decision with regard tothe outcome ofthe statisticaltests. Theresults showedthat thereare nosignificant differences(p>0.05) betweenthemeans of thefirstandsecondmeasurementsinanyofthesofttissue orskeletalvariables,norinthepre-andpost-RME tomog-raphy. The ICC values were above 0.05 for all variables, indicatingan excellentconsistencybetweentheresultsof thefirstandsecondmeasurements,assuringexcellent intra-examinerreliability.

For the analysisof the inter-examiner method error a totalof 27patients were selectedat random(totalof 54 CTs) out of the 39 patients in the EG sample who were measured by a second examiner. The Student’s t-test for paired samplesdetected nostatistically significant differ-ences (p>0.05)between the means of the firstexaminer andthemeansofthesecondexaminerforanyofthe varia-bles nor in the pre- and post-RME tomography. The ICC valueswere in excessof 0.95 for all variables, indicating

excellent consistencybetween theresults ofthe firstand second measurements, assuring excellent inter-examiner reliability.

FortheanalysisofthecomparisonbetweenT1andT2 val-uesinbothgroups,fortheskeletalandsofttissuevariables, andforthecomparisonbetweenthegroups,theStudent’s

t-testforpairedsampleswasused.

Results

AlltheCTimagesweremeasuredtwicebythesame exam-ineratan intervalof 30days.TheCT’swerenumberedso that the examiner would not know if he was measuring imagesfromthepre-orpost-RMEimages.AftertheCT mea-surement, theCT’s werearrangedinto(T1)pre- and(T2) post-RME.ThesameprocedurewasusedfortheCTscansof theCG.

The evaluation of the results on the skeletal and soft tissue structures in both groups was conducted using the valuesoftheT1andT2measurementsandtheresultsforthe skeletalalterationsaredisplayedinTable3andtheresults forthesofttissuevariablesareshowninTable4.

Fortheskeletalvariables,intheEG,asignificantincrease (p<0.05) was observed in all the structures. The largest increasewasfoundwiththewidthofthepyriformaperture (+9.15%),followed bythe heightofthepyriformaperture (+4.00%),nasalheight(+3.37%)andthetotallengthofthe nose(+1.12%).AmongthepatientsoftheCG,nosignificant changeswere observed.When comparingtheEG withthe CG,themostsignificantdifferencewasfoundinthewidthof thepyriformaperture,post-RME(p=0.001).Changesintotal

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Table3 Comparisonbetweenpre-RMEandpost-RMEvalues,andbetween theExperimentalGroup (EG)andControlGroup (CG),oftheskeletalvariables(valuesdisplayedinmm).

Variable Group Pre-RME

M±DP (Min---Max) Post-RME M±DP (Min---Max) Pre-RMEpost-RME alteration(average) pa (pre-RME---post-RME) mm % Nasalheight EG 44.81±4.01 (38.37---57.34) 46.32±3.94 (40.23---57.14) +1.51 +3.37% <0.001 CG 44.93±4.35 (38.01---52.13) 45.05±4.21 (38.41---52.91) +0.12 +0.27% 0.537 pb(betweengroups) 0.920 0.003 Heightof pyriform aperture EG 31.52±3.42 (22.66---37.15) 32.78±3.40 (24.72---39.33) +1.26 +4.00% <0.001 CG 31.24±3.51 (25.05---37.26) 31.14±3.24 (25.40---37.98) −0.10 −0.32% 0.776 pb(betweengroups) 0.790 0.003 Widthof pyriform aperture EG 21.64±1.73 (17.83---25.34) 23.62±2.45 (18.19---31.39) +1.98 +9.15% <0.001 CG 21.28±1.98 (17.52---24.55) 21.28±1.88 (17.83---24.41) 0.00 0.00% 0.985 pb(betweengroups) 0.503 0.001 Totallengthof thenose EG 47.25±3.35 (37.76---54.61) 47.78±3.53 (37.18---54.87) +0.53 +1.12% 0.002 CG 47.50±3.09 (41.22---53.16) 47.71±2.83 (42.08---52.75) +0.21 +0.44% 0.444 pb(betweengroups) 0.796 0.938

a p,significancevalueofStudent’st-testforpairedsamples(differencebetweenpreandpost).

b p,significancevalueofStudent’st-testforindependentsamples(differencebetweentheEGandtheCG).

noselengthwerenotsignificantinthecomparisonbetween groups.

With regard to the soft tissue variables, it was also found,intheEG,asignificantincrease(p<0.05)inallthe analyzedstructuresbetweenthepointsintimeT1andT2. Inpercentageterms,theincreasewas+4.39%inthewidth ofthesofttissueinsertion,+3.46%inthealarwidth,+3.73% intheheightofthenasalsofttissueand+4.28%inthelength ofthenasalsofttissue.Among thepatientsoftheCG,no significantchangeswereobserved.WhencomparingtheEG withtheCG,thegreatestdifferencewasfoundinthewidth ofthesofttissueinsertion(p=0.002)andthelengthofthe nasalsofttissuedidnotshowsignificantchanges.

Theanalysisoftheratiosbetweentheskeletalandsoft tissuemeasurements,intheEG,showedthatthealterations occurinaproportioncloseto1:1.The meanofthe alter-ationsofthe4softtissuevariableswasdividedbythemean ofthealterationsinthe4skeletalmeasurements.The out-comeallowsustostatethat,foreachmillimeterincrease intheskeletalvariables,thesofttissuevariablesincrease 0.95mm. In percentage terms, for each percentage unit increaseintheskeletalmeasurement,thesofttissue mea-surementsincrease0.9%.

Discussion

SinceRMEwasintroducedin1860,becomingestablishedin the period between the end of the 1860s8 and beginning

ofthe1870s,9orthodontistshaveextensivelyevaluatedthis

procedurewithregardtodentoskeletalalterationsandthe repercussions for the nasal cavity. The close relationship between themaxilla and the nasalcavity5,6 may have an

influence on the physiology1,2 and format of the nose,10

increasingthechancesofindividualswithmaxillary hypopla-siaacquiring aclinical mouth-breathing condition10 which

mayhaveseriousconsequencesforthegrowthand develop-mentofthefaceandocclusion,2---4,7besides problemsofa

medicalnature,andonthedevelopmentofthebody.3,12,13

Accordingly,variousresearchershave sought toshedlight onthepossiblebenefitsofRMEforthenasalcavityandon theincreaseinnasalbreathingcapacity.1,2,7,11

In recent years, the soft tissue of the nose has been citedbysomeresearchersasbeingastructureofextreme importance for maintaining the stability of the results obtainedwithRME,23,33 inadditiontothe estheticimpact

thatmayensueaftertheprocedure.36Evenso,studies

deal-ingwiththesestructuresarescarce,andthemainfocusof almostall the works citedin the literature is onskeletal alteration.

Theproposalinourstudywas,usingCT,toevaluatethe repercussionsofRMEontheskeletalandsofttissue struc-turesofthenoseinmouth-breathingpatientswithmaxillary hypoplasia. CT has been shown to be an excellent diag-nosticresourceprovidingconditionsfor locating anatomic pointswithahigh degree ofreliability, aswellas provid-ingmeasurementsofsoftandskeletaltissuewithextreme precision.38

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Table4 Comparisonbetweenpre-RMEandpost-RMEvaluesandbetweentheExperimentalGroup(EG)andControlGroup(CG), ofthesofttissuevariables(valuesdisplayedinmm).

Variable Group Pre-RME

M±DP (Min---Max) Post-RME M±DP (Min---Max) Pre-RMEPost-RME alteration(average) pa (pre-RME---post-RME) mm % Widthofthe softtissue insertion EG 32.59±2.84 (28.73---39.95) 34.02±2.85 (29.58---41.99) +1.43 +4.39% <0.001 CG 32.71±1.72 (30.09---35.44) 32.78±1.89 (29.88---36.19) +0.07 +0.21% 0.758 pb(betweengroups) 0.876 0.002 Alarwidth EG 32.68±3.27 (27.13---40.59) 33.81±3.32 (27.43---42.75) +1.13 +3.46% <0.001 CG 32.69±1.74 (30.16---35.81) 32.29±2.08 (29.13---36.31) −0.40 −1.22% 0.085 pb(betweengroups) 0.990 0.003 Heightofthe nasalsoft tissue EG 47.95±4.07 (41.27---58.77) 49.74±4.39 (41.70---59.14) +1.79 +3.73% <0.001 CG 47.49±4.69 (40.16---55.89) 47.69±4.67 (40.41---55.86) +0.20 +0.42% 0.101 pb(betweengroups) 0.714 0.003 Lengthofthe nasalsoft tissue EG 15.89±1.62 (12.17---18.84) 16.57±1.67 (12.38---20.68) +0.68 +4.28% <0.001 CG 15.41±1.38 (13.30---17.74) 15.66±1.57 (12.05---18.29) +0.25 +1.62% 0.161 pb(betweengroups) 0.301 0.068

ap,significancevalueofStudent’st-testforpairedsamples(differencebetweenpreandpost).

b p,significancevalueofStudent’st-testforindependentsamples(differencebetweentheEGandtheCG).

PatientstreatedwithRMEpresentwithtransverse defi-cienciesofthemaxillaand,therefore,additionaltransverse alterationscanbeexpected.Theresultsshowed,however, thatafterRME,changesoccurredinthe3dimensionsofthe noseandnotjustthewidth,whichhasbeenthemainfocus ofthemajorityofthestudiesreviewed.

With regard to skeletal alterations, our studies found larger alterations in the width of the pyriform aper-ture with a significant average increase (p<0.001) of 1.98mm (+9.15%). Similar results were obtained by Her-shey et al. (+2.12mm),15 Sila Filho et al. (+2.07mm),16

Chung and Font (+1.75mm),5 Garret et al. (+1.89mm),18

Iwasakietal.(+2.09mm),25Bargazanietal.(1.4---2.7mm),27

Hakan and Palomo (+1.5mm),30 and Leri and Basciftci

(+1.97mm).32 Larger increases innasal width, also

signif-icant, were observed by Wertz (+4mm),14 Basciftci and

Karaman(+3.47mm),18Christieetal.(+2.73mm),21Görgülü

etal.(+5.28mm),22Smithetal.(+3.15mm)23andTokuetal.

(+2.54mm).31 Thestudies conductedbyCross and

McDon-ald(+1.06mm),17Ballantietal.(+1.22mm),20Ribeiroetal.

(+1.28mm),26 Kanomi etal.(+1.36mm)28 andC¸örekc¸iand

Göyenc¸(+0.81mm)29 alsoshowedincreasesinnasalwidth,

howeveronlythestudybyCrossandMcDonald17 exhibited

any statistical significance. The largest differences noted occurredinstudiesthatadoptedmethodologieswhichused two-dimensional diagnosis.14,29 Of the three-dimensional

methodologiesemployed,onlythestudybyGörgülüetal.22

found larger deviations than the means of the other studies.

Theanalysisofpossiblealterationsintheheightofthe nasalcavity,showedthatinsagittalform(multiplanar sagit-talimage)nasalheightincreasedsignificantly(p<0.001)by 1.51mm (+3.37%)andinfrontalform(multiplanarcoronal image)theheightofthepyriformapertureshowed signifi-cantaverageincreases(p<0.001)of1.26mm(4%).Theonly works thatevaluated skeletalalterations in the height of thenasalcavity,post-RME,werethoseofCrossand McDon-ald(+1.26mm)17andC¸örekc¸iandGöyenc¸(+1.35mm).29Both

usedtwo-dimensionalmethodologiesinfrontalform. Wealsoevaluatedthetotallengthofthenasalskeleton, notingasignificantincrease(p<0.002)of0.53mm(+1.12%). None of the evaluated works researched potential alter-ationsintheskeletallengthofthenasalcavity.

All the studies surveyed in the literature performed short-termevaluations(between3 and6 monthson aver-age) and,aswiththeresultsof ourstudy,alarge part of them found thereto benoinfluence on growthby virtue of the short space of time between pre- and post-RME evaluations,7,10,11,14,20,30,32contradictingthefindingsofSilva

Filho et al.,16 Cross andMcDonald,17 Kanomi etal.28 who

determinedthat,evenintheshortterm,thegrowthfactor couldaffectthestructuresbeingmeasured.

Inmakingashort-termstudy,thegoalwastoanalyzethe realnasalalterationsfromspecificallytheactionsoftheREM attheevaluatedstructures,avoidingthatthegrowthfactor wouldinterfereintheresultsifevaluatedinlongterm.

Some authors checked for skeletal modifications by means of ENT examinations,1,2,7,11 with the aim of

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evaluatingtherealbenefitsofRMEonthenasalphysiology and found that,in the main, thealterations in the width ofthenasalcavitycontributesignificantlytoincreasedflow andnasalairwayvolumeinpatientswithmaxillary hypopla-siawhohadbeensubjectedtoRMEtreatment.

Intheevaluationofthesofttissuestructuresofthenose, intheEG,thelargestincreasesfoundinourstudyoccurred inthewidthofthesofttissueinsertionwithanaverageof +1.43mm(+4.39%)(p<0.001).Thealarwidthincreasedon aslightlylowerscaleat1.13mm(+3.46%),thoughwiththe samestatisticalsignificance(p<0.001).Severalofthealbeit few studies found in the literature that deal with alter-ationsinthewidthofthesofttissueofthenose,post-RME, havefoundvaluessimilartothoseinthepresentstudy,for exampleBergeretal.(+2mm),33Johnsonetal.(+1.5mm)37

andYlmazetal.(+1.19mm),40andothersexhibitedhigher

valueslike the studies of Kulbersh et al.(+3.2mm)39 and

Magnusson etal.(+2.88mm)36 or muchlowervalues,asis

the case withKim etal.(+0.96mm),35 though all

demon-stratedstatisticallysignificance.

By evaluating the length of the nasal soft tissue, we foundasignificantaverageincrease(p<0.001)of0.68mm (+4.28%) in the EG, post-RME. The studies by Karaman etal.(+2.53mm)34andMagnussonetal.(+3.09mm)36

exhib-ited greater increaseswhile Ylmaz et al. detected lower increases(+0.31mm),40 howeverall weresignificant,

con-tradicting the results of Kilic¸ et al.6 whose increase of

0.23mminthesofttissuelengthwasdeemedinsignificant (p>0.05).

In a study ofthe potential alterationsin the heightof thenasalsofttissue,post-RME,wefoundintheEGa signif-icantaverageincrease(p<0.001)of1.79mm(+3.73%).The onlystudythatdealtwiththeheightofthenasalsofttissue wasthatofMagnussonetal.36withaninsignificantaverage

(p>0.05)of+0.18mm,buttheseauthorsanalyzedthe alter-ationsoccurredaftersurgerydisjunctionandnotaRMEas inourstudy.

Theonlystudyonsofttissuealterationswhich,likethe present study,studied modifications to the nose in three dimensions, was that of Magnussen et al.36 as previously

dimensioned, a work based on surgical expansion which makesourstudythefirsttotakethisapproachwithpatients whohavebeenexclusivelytreatedwithorthopedicRME.

Aswiththosestudiesthatevaluatedskeletalalterations, all the workson soft tissue wereperformed over a short period of time,6,33,37,40 showing all alterations occurred

exclusivelybytheeffectoftheRMEwithouttheinfluence ofthegrowthfactorduetotheshortintervalbetweenT1 andT2.

According to Berger et al.33 and Kulbersh et al.,39 the

softtissuetendstoaccompanyRMEskeletalalterationsin a1:1proportion(100%).Thesevaluesclosely approximate theresults ofourstudy whichfound that,for every1mm ofskeletalincrease,0.5mm ofsofttissuealterationtakes place(0.90%),contradictingthestudiesofKaramanetal.,34

whichstatethatthereisonly18%ofsofttissuealteration duringskeletalmodifications.

An essential factor in performing a correct analysis is the reliability of the measurements, i.e., the preci-sion of the selected points41---43 and the analysis of the

method error in the measurements. Our study demon-stratedahighreliabilitywithICCvaluesinexcessof0.95,

both for the intra-examiner and the inter-examiner eval-uations. For the most part, the studies quoted in the literature did not display method error and several did not present a sampling calculation, to validate the size ofthe sample, which may lead tobias in theresults and interpretation.

TheresultsobtainedintheEG madeitclearthat post-RME nasal changes occur in the three dimensions, both in soft tissues and in skeletal tissues, but the compari-sonbetweentheEGwiththeCGshowedthatthechanges in length are those that have the less significant impact amongthe evaluatedstructures. In addition, the statisti-calresultsobtainedintheCG,whencomparingT1andT2 times,showedthattherewasnointerferenceofthegrowth factorbetweentheevaluationperiods.

We should remember again that all patients that took partofthisresearchwereundermedicaltreatmentin hos-pitallevelandallCTexams,antheintervalsbetweenthem wereundertakenbyexclusivemedicalneeds,respectingthe ALARAprincipletoeachpatient.Furthermore,itisalso nec-essary to clarify that no medical conduct was performed priortoRME,i.e.,themedicalconductsweredetermined onlyafterRME,therefore,noneofthesepatientsinthe sam-plewereunderwenttoanymedical/surgicalprocedurethat couldchange the characteristics of the nasal soft tissues withinthistimeinterval.

Itisalsoimportanttoclarifythat,aftertheendofthe study,thepatientsintheCGwereproperlytreatedwiththe sameproceduresoftheEG,withoutanyprejudicetothem, duetothesmalltimeofthreemonthsbetweenT1andT2 times.

Ourstudyutilizedanalreadyexistingdatabasewiththe pertinentauthorizationsandsoughttofollowallthesteps requiredtoguaranteemaximumcredibilitywiththeresults obtained, ranging from the use of a simple methodology thatisreliableandeasilyreproducibletotheperformance ofallthenecessary statistical studiestodiminish therisk ofbias,therebyincreasingthereliabilityofthestudy,duly approvedbytheresearchethicscommitteeandbythe Clini-calTrials(ID:CRB-ORTO-3).Thiskindofstudymaypermitin thefuture,throughtheevaluationofsofttissue,adequate planningofestheticproceduresatthetipandbaseofthe noseandalsotheperformanceofobjectivemeasurements inearlyorlatesurgicalresults.

Conclusion

1. In the shortterm, RME caused significant skeletal and softtissuealterationsinallthevariablesstudiedwhen analyzingpre-andpost-RMEmeasurements.

2. The soft tissues of the nose accompany the skeletal alterationsinaproportioncloseto1:1,andforevery mil-limeterofskeletalincreasethereisasofttissueincrease of0.95mm(0.90%).

3. Thiskindofstudymaypermitinthefuture,throughthe evaluationofsofttissue,adequateplanningofesthetic proceduresatthetipandbaseofthenoseandalsothe performanceofobjectivemeasurementsinearlyorlate surgicalresults.

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Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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