Research Paper Imaging
Nasolabial shape and
aesthetics in unilateral cleft lip and palate: an analysis of
nasolabial shape using a mean 3D facial template
M.A.R.Kuijpers,T.J.J.Maal,J.W.Meulstee,C.E.L.Carels,E.M.Bronkhorst,S.J.
Berge´,P.S.Fudalej:Nasolabialshapeandaestheticsinunilateralcleftlipand palate:ananalysisofnasolabialshapeusingamean3Dfacialtemplate. Int.J.Oral Maxillofac.Surg.2019;xxx:xxx–xxx. ã2020TheAuthor(s).PublishedbyElsevier LtdonbehalfofInternationalAssociationofOralandMaxillofacialSurgeons.Thisis anopenaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/
licenses/by-nc-nd/4.0/).
M.A.R.Kuijpers1,2,T.J.J.Maal3,4, J.W.Meulstee3,4,C.E.L.Carels5, E.M.Bronkhorst1,6,S.J.Berge´4, P.S.Fudalej7,8,9
1DepartmentofDentistry,Sectionof OrthodonticsandCraniofacialBiology, RadboudInstituteforHealthSciences, RadboudUniversityMedicalCenter, Nijmegen,TheNetherlands;2CleftPalate CraniofacialUnit,RadboudUniversityMedical Center,Nijmegen,TheNetherlands;
3Radboudumc3DLab,RadboudUniversity MedicalCenter,Nijmegen,TheNetherlands;
4DepartmentofOralandMaxillofacial Surgery,RadboudUniversityMedicalCenter, Nijmegen,TheNetherlands;5Departmentof OralHealthSciences,KULeuvenand UniversityHospitalsKULeuven,Leuven, Belgium;6DepartmentofDentistry,Sectionof CariologyandEndodontology,Radboud UniversityMedicalCenter,Nijmegen,The Netherlands;7DepartmentofOrthodontics andDentofacialOrthopaedics,Universityof Bern,Bern,Switzerland;8Departmentof Orthodontics,Palacky´ University,Olomouc, CzechRepublic;9Departmentof
Orthodontics,InstituteofDentistry, JagiellonianUniversity,Krakow,Poland
Abstract. Theaimofthisstudywastodeterminetheamountofdeviationinnasolabial shapeinpatientswithacleftcomparedwithanaveragenon-cleftface,andtoassess whetherthisdifferenceisrelatedtonasolabialaesthetics.Three-dimensional stereophotogrammetricimagesof60patientswithaunilateralcleftwereused.To quantify shapedifferences,fouraveragenon-cleftfaceswereconstructedfrom stereophotogrammetricimagesof141girlsand60boys.Three-dimensionalshape differenceswerecalculatedbetweensuperimposedcleftfacesandtheaveragenon- cleftfaceforthesamesexandagegroup.Nasolabialaestheticswereratedwiththe modifiedAsher-McDadeAestheticIndexusingavisualanaloguescale(VAS).
MeanVASscoresrangedfrom51.44to60.21forclefts,withloweraestheticratings associated withincreasingcleftseverity.Shapedifferenceswerefoundbetween cleftfacesandtheaveragenon-cleftface.NorelationshipwasfoundfortheVAS, age,andsex,exceptthatalowerVASwasrelatedtoahighernoseandlipdistance betweenthesuperimposedcleftandaveragenon-cleftfacesfornasalprofile(P= 0.02),buttheexplainedvariancewaslow(R2=0.066).Inconclusion,exceptfor nasalprofile,nasolabialaestheticswerenotinfluencedbytheextentofshape differencesfromtheaveragenon-cleftface.
Key words:cleft lip; cleft palate; aesthetics;
face; three-dimensional imaging; photogram- metry.
Acceptedforpublication4June2020 https://doi.org/10.1016/j.ijom.2020.06.003,availableonlineathttps://www.sciencedirect.com
0901-5027/000001+06 ã2020TheAuthor(s).PublishedbyElsevierLtdonbehalfofInternationalAssociationofOralandMaxillofacialSurgeons.Thisisan openaccessarticleundertheCCBY-NC-NDlicense(http://creativecommons.org/licenses/by-nc-nd/4.0/).
Thetreatmentofpatientswithcleftlipand palate (CLP) involves several surgeries aimedatanatomical,functional,andaesthet- iccorrectionofthecongenitalmalformation.
The ultimate treatment goal for these patients,however,mustbetocreateahappy healthyindividualwhosedeformityisnotan issueintheirpersonallife.Deviationfrom theaveragemayaffectthepatient’swellbe- ing;therefore,clinicianstrytoimprovethe patient’sappearancewithoutcleftstigmata.
Facialappearanceplaysaroleinthesocial interactionsbetweenindividualsandinflu- encesaperson’sperceptionofothers1,2.It mayalsoinfluencethequalityoflife(QoL) oftheaffectedperson2–4.
Deviationfromtheaverageisdifficultto measure.Two-dimensionalanalysisofthe face,asperformedinthepast,isoflimited value.Incontrast,three-dimensional(3D) imaging techniques are more adequate.
Studiesoffacialasymmetryinpatientswith CLP using 3Dimaging have shownthat asymmetryismostapparentinthecentre partoftheface,includingthenose,lips,and partlythemidface5–7.Inastudyusing3D analysisandstereophotogrammetry,itwas shownthatpreadolescentchildrenwithdif- ferent types ofunilateral cleft had more facialasymmetryinthemidface,whereas controls showed more asymmetry in the chinarea.Whentheunilateralcleftdefect alsoinvolvedbonystructures,asymmetry inthemidfacewasmoreprominent7.
Patientswithoutacleftalsoshowawide rangeofasymmetry,yetnospecificarea seemstoinfluencetheaestheticratingof facialappearance8,9.Incontrast,asymme- tryinthenasolabialareainpatientswitha cleft has been associated with a lower aesthetic ratings5,9. However, it is not clear how the aesthetics are related to deviationsfromanon-cleftreferenceface.
Awaytostudyshapedifferencesbetween the faces of patients with and without clefts is to construct a mean face of non-cleft individuals and then compare itwithfacesofpatientswithclefts.Using thismethod, theshapedifferencesinthe midfacecanbequantified.Thiscouldbe very usefulwhen attempting toimprove theappearance ofpatients withorofacial cleftsandavoidcleftstigmata.Thisstudy wasperformedtoinvestigatethenullhy- pothesis that a larger deviation in nasal and labial shape is related to a worse aestheticnasolabialscoreinCLPpatients.
Subjectsandmethods Patients
This study was conducted at the Cleft Palate Craniofacial Unit of Radboud
University Medical Center, Nijmegen, The Netherlands. The study was per- formedinaccordancewiththeDeclaration of Helsinki with regard to research in human subjects. The use of anonymous datagatheredduringroutinepatientcareis inaccordancewithDutchlawsonmedical research. A written statement was obtained from the institutional review boardstatingthatthisstudydoesnotfall withintheremitoftheMedicalResearch InvolvingHumanSubjectsAct(WMO).
Atotalof60patientswithaunilateral orofacial cleft, born between 1998 and 2004, were included in the study. The inclusion criteria were: (1) Caucasian, (2) non-syndromic complete unilateral cleft lip (UCL, n=10), unilateral com- plete cleft lip and alveolus (UCLA, n
=23), or unilateral complete cleft lip, alveolus, and palate (UCLAP n=27);
(3)presenceof3Dstereophotogrammetric imagesofthefaceat9–11yearsofage;
and(4)alltreatmentsreceivedatthesame cleft centre, according to the treatment protocol used until 200810. Lip closure (Millardtechnique)andprimarynosecor- rection(McCombtechnique)weredoneat the age of 6–8 months, and soft palate closure(accordingtoamodifiedvonLan- genbeck procedure) at the age of12–14 months.Theseprocedureswereperformed bytwosurgeonswithmorethan10years ofexperienceincleftsurgery.Hardpalate closurewasdoneatthesametimeasthe bonegraftingprocedureforclosureofthe alveolar cleft, if present. The timing of bonegraftingwasbasedoneruptionofthe canine; this is usually doneat age 9–11 years ofage.All stereophotogrammetric images were obtained prior to the bone grafting procedure and hardpalate pala- toplasty.
Thepatientsamplewasdividedintotwo groups: 10.5years old(range8.6–10.5 years) and>10.5 yearsold(range 10.6–
12.3years).Theyoungergroupconsisted of23boysand18girls(8UCL,15UCLA, and 18 UCLAP). The older group con- sistedof14 boysand 5girls(2UCL, 8 UCLA,and9UCLAP).Forcomparison,a compoundfacewascreatedfromthecon- trol children (see below). For the com- poundfaces,patients(141girls,62boys) wereselectedfromthefilesoftheDepart- mentofOrthodontics,RadboudUniversi- ty Medical Center, Nijmegen, The NetherlandsandtheDepartmentofOrtho- dontics, UniversityofBern,Switzerland.
Inclusioncriteriaforthecontrolswere(1) Caucasianand(2)amaximumoverjetof 6mm.Exclusioncriteriawere(1)congen- ital malformation, (2) forced bite with lateraldisplacement ofthemandible, (3)
juvenileidiopathicarthritis,(4)impacted canines,and(5)anegativeoverjet.
3Dimageacquisitionandprocessing Three-dimensional facial images of patients and controls were taken witha 2-podcameraset-upforstereophotogram- metric imaging (3dMDface System;
3dMD LLC, Atlanta, GA, USA) with spatial resolution of0.2mmunder stan- dardizedconditions.Imagesweretakenin natural head position, and the patients wereasked tokeep their eyesopen and to relax their facial musculature. All imageswereobtainedbythesameopera- tor who has taken more than five such images a week for more than 5 years.
All right-sided clefts were mirrored to ensurethat,forcalculations,allcleftswere onthesame side,i.e.theleftsideofthe face.Confoundingregions(neck,ears,and hair) inthe images were removed using 3dMDpatientv3.1.0.3software(3dMDpa- tientSoftwarePlatform;3dMDLLC).The adjusted3Dphotographwasimportedinto Maxilimsoftware(MedicimNV,Meche- len,Belgium).
Fortheolderagegroup(>10.5years), themeanof97facesofgirlsand41faces ofboyswereusedforthecompoundfaces ofgirlsandboys,respectively(agerange 10.6–12.10 years). For the younger age group(10.5years),thecompoundfaces forgirlsandboyswerecreatedusingthe meanof44girlfacesand21boyfaces(age range 8.10–10.5 years). The compound face was created asfollows: theimages were pre-aligned using five landmarks (left and right endocanthion and exo- canthionandsubnasale);ifnecessary,ad- ditional manual positioning was performed. The polygon meshes of the 3Dstereophotogrammetric imagesof all controlsof the same sex and age group weresuperimposedtocreatethefourcom- poundfacesusinganiterativeclosestpoint (ICP)-basedalgorithm11,12.
For measuring shape differences be- tween the compound face and the cleft faces, the faces in the 3D images were separatedintothenoseandlipareasusing themethoddescribedbyKuijpersetal.7. The chin and forehead were used by a surface registration algorithm (ICP)12. Theareasofsuperimpositionweredefined usingagrid(Fig.1).Adistancemapwas createdbetween the compound face and thecleftface.Foreachpatient,themean andstandarddeviation(SD)forthatdis- tance map were used as the outcome.
The measurements from the distance mapsofthenoseandlipswereimported into MATLAB software version 7.4.0
(R2007a)(MathWorksInc.,Natick, MA, USA)tocalculatetheabsolutemeandis- tancesandthe95thpercentilesoftheshape differencesinthenasolabialarea.
VASscores
Nasolabialaestheticscoresforthepatients withacleftwereassessedbyeightortho- donticresidents(fourmenandfourwom- en in their second year of training; age range25–31years)whohadnoexperience with CLP treatment. The raters were instructed onhow tomanipulate the 3D image inall directionsonthe computer.
Theyratedthenasolabialaestheticsofthe 3D images (Fig. 2) using the modified Asher-McDadeAestheticIndex13.Thein- dexmeasuresfournasolabialcomponents:
nasal form (NF), nasal deviation (ND), vermillion border (VB), and nasolabial profile(NP).SincetheVBoftheAsher- McDade Indexcannot be validated asa distance,wedidnotusethiscomponentin the comparison. In addition, a 100-mm visual analogue scale (VAS) (score 0–
100, from ‘not aesthetically pleasing’ to
‘aesthetically pleasing’) wasused forall components9,insteadoftheoriginalfive- pointscale.Themean VASscore ofthe threenasolabialcomponents(NF,ND,and NP) was used as the overall aesthetic score.Intra-raterandinter-raterreliability wereassessedasdescribedpreviously9.
Statisticalanalysis
Absolute distance values between the superimposed surfaces of the cleft and compound faces were calculated for the nose, lips, and nose and lips combined.
Descriptivestatisticswereusedtodefine differences between the cleft and com- pound faces regarding the lip and nose on the cleft and non-cleft sides. Scatter plotsweredrawnfortheVASscoresand absolutedistancesperclefttypetoassess if the relationship between the two was dependentontheclefttypeandifallcleft typescouldbecombinedintheregression analysis. A regression analysis was per- formed for the mean VAS for NF and absolute distance of the complete nose, themean VASforNDandabsolute dis- tanceofthecompletenose,themeanVAS forNPandabsolutedistanceofthecom- plete nose,andmean VASscore forthe NF–ND–NPandabsolutedistanceofthe completenoseandlip.Thedistanceswere thedependentvariableinallfouranalyses andtheVAS scorewasusedasaninde- pendentvariable. Asageandsex canbe potentialconfounders,theywerecorrected
forbyaddingthemtothemodelasinde- pendentvariables.
Allstatisticalanalyseswereperformed withIBMSPSSStatisticsversion22(IBM Corp., Armonk,NY, USA) bythe same
statistician (EB). The significance level was 0.05. For all models, the residuals weretestedusingtheKolmogorov–Smir- novtest.Inallcases,alackofnormality wasnotfound.
Fig.1. Areasforsuperimposingeachcleftfaceonthecompoundface.Yellowareasusedfor basicsuperimposition.
Fig.2. Nasolabial3Dstereophotogrammetricimageusedforaestheticrating.Thisimagecould bemanipulatedinalldirections.
Results
The mean aestheticscores for the three nasolabial components separately (NF, ND, and NP) and the overall aesthetic scores (NF–ND–NP) in subjects with UCL, UCLA,andUCLAParepresented intheSupplementaryMaterial(TableS1).
Themeanoverallaestheticscores(mean VAS forNF–ND–NP) forthethreecleft groups ranged from 51.44 (SD 8.79) to 60.21 (SD 8.41), with a lower aesthetic ratingcorrespondingwithincreasingcleft severity. Thesamepatternwas observed forthethreeaestheticcomponentsofthe noseseparately.
Themean distances between the cleft andcompoundnon-cleftfacesforthethree different clefttypes and twoage groups arepresentedintheSupplementaryMate- rial(TableS2).Thelargestshapediffer- ences, which were mostly >4.0mm in bothagegroups,werefoundforthecom- bined nasolabial area. The mean of the standarddeviationswas high(age10.5 years: range 3.06–3.44mm; age >10.5 years:range2.53to3.60mm).
Scatter plots were used to analyse whethertherelationship between the3D score (theabsolute distance between the cleft and compound face) and the VAS
scoredependedontheclefttype(Supple- mentary Material, Fig. S1). The scatter plotsshowedthattherelationshipbetween the twowas not influenced by the cleft type; hence,theresultsofallclefttypes weregroupedtogetherforfurtheranalysis.
Theresultsoftheregressionanalysisare shown in Table 1. Theoverall aesthetic score,sex,andagehadnoinfluenceonthe absolutedistanceofthedeviationsofthe noseandupperlip,andtheVASscoresfor NFandNDwerenotrelatedtotheabso- lutedistanceofthedeviationsofthenose.
Theonlysignificantrelationship was for theVASforNP:alowerVASscoreforNP was associated with a higher absolute distance for the deviation of the nose andlips;howevertheexplainedvariance was verylow(R2=0.066).
Discussion
The goal ofCLP treatmentis torestore theanatomyandfunctionoftheoralfacial regionandcreateafacialappearancethatis asnormalaspossible,withtheleastcleft stigmata.Todeterminethedeviationfrom the average, cleft faces were compared with3Dcompoundfacesofnon-cleftindi- vidualsforboysandgirlsintwoagegroups.
Multiplecompound faceswereused,be- causepotentialdifferencesinfacialmor- phologybetweensexesandageshasbeen demonstrated14,15andfacialgrowthdefor- mitiesinthecleftgroupmayexpressdiffer- entlyovertime.Therationaletodividethe sampleinto ‘younger’and‘older’ groups wasthatdifferencesinfacialmorphology beforepubertal growthfor boysand girls are minimal,but mayoccur intheolder age groups.Therefore, a cut-off age of 10.5 yearswaschosen.
Themethodusedinthisstudytocreate thecompoundfaces,basedon3Dstereo- photogrammetric images, was described byKau et al.14,15 and has been used in several studies16–18. However, most of these studies were performed on adult patients.A systematicreviewcomparing different3Dimaging techniquesdemon- stratedthat3D stereophotogrammetry in youngerchildrenisareliableandaccurate methodtoquantifysofttissue-basedfacial dimensions19. However, non-cleft com- pound faces still have to be developed forawide rangeofdifferent agegroups andethnicities in order to assess, at the individualpatientlevel,howthefaceofa patientwith a cleftdiffers from a mean non-cleftface.
Table1. ResultsofregressionanalysesusingthemeanVASfordifferentcomponentsofthenasolabialregion,sex,andageasindependent variables,andtheabsolutedistancebetweenthecompoundfaceofnon-cleftindividualsandthesuperimposedcleftfaceasthedependentvariable.
Estimateofeffects
Dependentvariable Independentvariable Effect 95%CI P-value AdjustedR2
Absolutedistancenoseandlip Constant 5.648 3.833to7.463 <0.001
MeanVASNP,NF,ND 0.018 0.049to0.013 0.250
Sex 0.401 1.103to0.300 0.257
Age 0.154 0.580to0.887 0.677
0.005
Absolutedistancenoseandlip Constant 6.289 4.809to7.770 <0.001
MeanVASNP 0.031 0.057to 0.005 0.020
Sex 0.374 1.051to0.303 0.273
Age 0.174 0.533to0.881 0.624
0.066
Absolutedistancenose Constant 2.300 1.537to3.064 <0.001
VASNF 0.001 0.014to0.012 0.893
Sex 0.293 0.667to0.052 0.093
Age 0.086 0.290to0.046 0.650
0.000
Absolutedistancenose Constant 2.553 1.606to3.500 <0.001
VASND 0.005 0.021to0.010 0.507
Sex 0.315 0.674to0.044 0.084
Age 0.080 0.294to0.455 0.669
0.007
Absolutedistancenose Constant 2.414 1.536to3.292 <0.001
MeanVASNFandND 0.003 0.017to0.012 0.698
Sex 0.309 0.669to0.050 0.090
Age 0.083 0.293to0.459 0.659
0.002 VAS,visualanaloguescalescore;CI,confidenceinterval;NP,nasolabialprofile;NF,nasalform;ND,nasaldeviation.
Thecompound faceswereused toad- dress theresearch questionofwhethera largerdeviationinnasalandlabialshapeis associatedwithaworseaestheticscorefor thenasolabialregioninpatientswithCLP.
A previousstudy showed anincrease in VAS scores, meaning better aesthetics, whenthesymmetryofthenasolabialarea increased9. However, in that study, a quantitativeassessmentoftheasymmetry inthe nasolabialarea wasonlydonefor cleftfacesandnotfornon-cleftfaces.Ina follow-up study using 3D stereophoto- grammetry, we found that preadolescent childrenwithunilateralcleftsshowedsig- nificantly more facial asymmetry than children without clefts, especiallyinthe nasolabial area. The nose was the most asymmetricregioninUCLAandUCLAP patients7.Inthepresentstudy, theshape differences of the nasolabial area were quantified bycomparing cleftfaces with ameancompoundfaceofboysandgirlsof twoagegroupstoinvestigatewhetherthe shape difference would affect aesthetic ratings.Superimposingthecleftfaces on thecompoundfaceswasdonebysurface registration. As most differences were expectedinthenasolabialarea,superim- positionwasdoneonregionsoutsidethis area. Surface registration is facilitated whenusingcurvaturesinafaceasfaras possible from each other; therefore, the eyebrowregionwasusedtogetherwiththe chin.
Shapedifferencesinthenoseandlips compared with non-cleft controls were found. These differences, however, did notaffecttheVASaestheticrating,except for the nasal profile. In this study, the vermilionborderscoringusedintheAsh- er-McDade Aesthetic index was not in- cluded, because the vermilion border cannotbemeasuredasashapedifference.
This may have changed the mean VAS slightly. However, nasal shapeseems to have the greatest impact on satisfaction withtheresult5,20,21;therefore,excluding the vermillion border may be of minor importance.TheAsher-McDadeAesthetic Indexwas used becauseit isconsidered superior toother systemsinnon-syndro- micCLP22.Insteadofthefive-pointscale used intheoriginalAsher-McDadeAes- theticIndex,itwasdecidedtouseaVAS, asitwas feltthatthiswas more reliable andsensitivethanacategoricalscale23,24. Ratingsweredonebypostgraduateswho hadjuststartedtheirtraininginorthodon- tics. Even though they had notbeen in- volved in cleft palate treatment, their dentalbackgroundmayhavehadaninflu- enceontheVAS.However,arecentsys-
tematicreviewconcludedthatitremains unclearwhetherprofessionalsandlayper- sonsratethefacialappearanceofpatients withcleftsdifferently.Somestudieshave shown thatprofessionals are more criti- cal25,whereasothershaveshowntheop- posite26. Thus, the background of our layperson group probably did not affect theVASresults.
Nocorrelationwas foundbetweenthe aestheticratingandthemagnitudeofthe shape difference between patients with clefts and controls. In 2016, Kaipainen etal.8assessedtheamountoffacialasym- metryinnon-cleftindividualsandtriedto clarifytherelationshipwithfacialattrac- tiveness. They found comparableresults tothoseofthepresentstudy,i.e.theywere notabletoshowaneffectofasymmetryon facial appearance. Thisis in contrast to Meyer-Marcottyetal.27,whofoundlower aesthetic scores when asymmetry was presentinthemidfacialarea,whileasym- metryintheouterregionsofthefacehad less influence on aesthetic scores. This mayhavebeeninfluencedbythescoring method. InthestudyofMeyer-Marcotty etal.27,thewholefacewasvisible,where- as inthe presentstudy, aesthetic ratings were performed on the nasolabial area without showingtherestoftheface.As our focus was on nasolabial aesthetics, otherfacialfeatureswereeliminatedfrom the3Dstereophotogrammetricimages.In all previously mentioned studies, aes- thetics weremeasured on static records.
However,facialaestheticscanbedifferent at restand duringfunction. Four-dimen- sional stereophotogrammetry could pro- vide further insights, because functional facial differences between patients with cleftsandcontrolsmaybecomeapparent withthis method28. Furtherstudies must be performedtounderstandthecomplex relationship between facial morphology andaesthetics.
Therearesomelimitationstothisstudy.
The number of patients with a cleft lip onlywas smalland differencesfromthe average face should be interpreted with caution.Boththepatientsandtheratersin this studywereCaucasian. We werenot abletocreateacompound non-cleftface for other ethnic groupsdue toa lack of data.It was decidedtoexclude allother ethnicitiesfromthepatientgroup,asstud- ies using 3D soft tissue imaging have shown differences in facial morphology between ethnicgroups29. Thecompound faces were created using the ICP algo- rithm30. This was to minimize outlying points12. It was decided to divide the control group into two different age
groups because we expected differences infacialmorphologybetweenages.This resultedinasmallersampleperagefrom whichtheaveragefaces weredeveloped, which mayhaveinfluencedthe rangeof shapedifferences.Ourfocuswasonnaso- labial aesthetics; therefore other facial featureswereexcludedfromthescoring, but this may have influencedthe raters’
perceptions23. Furthermore, this was a scoringofaestheticsonstatic3Dimages.
Aestheticsmaybeperceiveddifferentlyin fourdimensions,forexampleduringsmil- ingandspeaking28.
Inconclusion, undertheconditionsof thisstudy,itisconcludedthatthepercep- tionofnasolabial aesthetics isnot influ- enced bytheextentofshapedifferences fromtheaveragenon-cleftface,exceptfor nasal profile. Thus, factors other than nasolabial deviation may influence the rating ofnasolabialaesthetics.Futurere- search should focuson identifyingthese potentialfactorsastheymaycontributeto higher treatment satisfaction for our patients.
Competinginterests None.
Funding
Nofundingwasreceived.
Ethicalapproval
The study was performedin accordance withtheDeclarationofHelsinkiwithre- gard toresearch inhumansubjects. The use of anonymous data gathered during routinepatientcareisinaccordancewith Dutchlawsonmedicalresearch.Awritten statement was obtainedfrom theinstitu- tionalreviewboardstatingthatthisstudy doesnotfallwithintheremitoftheMedi- cal Research Involving Human Subjects Act(WMO).
Patientconsent
Forthistypeofstudy,formalconsentwas notrequired.
Statementtoconfirm
This is to confirm that all authors have viewedandagreedtothesubmission.
AppendixA. Supplementarydata
Supplementarymaterialrelatedtothis articlecanbefound,intheonlineversion, atdoi:https://doi.org/10.1016/j.ijom.2020.
06.003.
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Address:
PiotrS.Fudalej
DepartmentofOrthodontics InstituteofDentistry JagiellonianUniversity ul.Montelupich4 31-155Krakow Poland
Tel.:+48124245402.
Fax:+48124245494 E-mail:piotr.fudalej@uj.edu.pl
