dentalsebao

RESEARCHARTICLEOpenAccessEvaluationofthelevelsofpainanddiscomfortofpiezocision-assistedflaplesscorticotomywhentreatingseverelycrowdedloweranteriorteeth:asingle-center,randomizedcontrolledclinicaltrialOmarGibreal1,MohammadY.
Hajeer2*andBasselBrad3AbstractBackground:Norandomizedcontrolledtrial(RCT)hascomparedflaplesspiezocision-assistedcorticotomyintheextraction-basedorthodonticdecrowdingofloweranteriorteethwiththeconventionaltreatmentintermsofpain,discomfortandacceptability.
Therefore,theaimofthistrialwastocomparepiezocision-basedorthodonticdecrowdingofloweranteriorteethfollowingpremolar-extractionwiththeconventionalorthodontictreatmentregardinglevelsofpain,discomfort,andpatients'satisfaction.
Methods:Aparallel-groupRCTwasconductedon34patientswithseverelycrowdedloweranteriorteeth.
Subjectswererandomlyallocatedtoeithertheexperimental(ExpG)orthecontrolgroup.
PiezoelectriccorticotomieswereperformedonthelabialsurfacesofthealveolarboneintheanteriorregionintheExpG.
Levelsofpain,discomfort,swelling,difficultiesofmastication,swallowingandjawsmovementlimitationwererecordedonaVisualAnalogScale(VAS)at1,7,14and28days.
IntheExpG,patientswerealsoaskedtoratetheirlevelofsatisfactionfollowingacceleration.
Two-samplettestswereemployedtodetectsignificantdifferences.
Results:Nostatisticallysignificantdifferenceswerefoundbetweenthetwogroupsatonedayfollowingtreatmentcommencementregardingpain,discomfort,difficultiesofmastication,swallowingandlimitationinjawsmovement(P=0.
082,0.
367,0.
062,0.
446,0.
359;respectively).
However,astatisticallysignificantdifferencewasfoundbetweenthetwogroupsregardingtheperceptionofswellingatthefirst-dayassessment(P=0.
011).
Nostatisticallysignificantdifferencesweredetectedbetweenthetwogroupsat7daysregardingthefivepreviouslymentionedvariables.
Therewasadropdowntozerolevelattwoweeksandfourweeksfollowingtreatmentonsetforallvariables.
ThelevelofsatisfactionintheExpGhadameanvalueof86.
47(±22.
47)andallpatientswerepositivetowardsrecommendingthesurgicalinterventiontoafriend.
Conclusions:NosignificantdifferencesinthelevelsofpainanddiscomfortwerefoundbetweentheExpGandthecontrolgroupforallvariablesexceptfortheperceptionofswellingatonedayfollowingintervention.
Patient-centeredoutcomesrevealedahighlevelofacceptanceandsatisfactionwiththistechnique.
Trialregistration:ThistrialwasregisteredatClinicalTrials.
gov(IdentifierNCT02975765).
Keywords:Piezoelectric,Visualanalogscale,Flaplesspiezocision,Patient-centeredoutcomes,SeverecrowdingalignmentTheAuthor(s).
2019OpenAccessThisarticleisdistributedunderthetermsoftheCreativeCommonsAttribution4.
0InternationalLicense(http://creativecommons.
org/licenses/by/4.
0/),whichpermitsunrestricteduse,distribution,andreproductioninanymedium,providedyougiveappropriatecredittotheoriginalauthor(s)andthesource,providealinktotheCreativeCommonslicense,andindicateifchangesweremade.
TheCreativeCommonsPublicDomainDedicationwaiver(http://creativecommons.
org/publicdomain/zero/1.
0/)appliestothedatamadeavailableinthisarticle,unlessotherwisestated.
*Correspondence:myhajeer@gmail.
com2DepartmentofOrthodontics,UniversityofDamascusDentalSchool,Damascus,SyriaFulllistofauthorinformationisavailableattheendofthearticleGibrealetal.
BMCOralHealth(2019)19:57https://doi.
org/10.
1186/s12903-019-0758-9BackgroundManysurveyshavedeclaredthat70–95%ofpatientscomplainfrompaincausedbyorthodonticappliances[1].
Orthodonticpainhasbeendescribedasamainreasonforpatients'withdrawalandcessationoftreat-ment[2–4].
Furthermore,someauthorshavereportedthatpainanddiscomforthavebeenmoreintenseinadultsandcouldbeoneofthemainreasonsbeyonddiscouragingthemfromundergoingorthodontictreat-ment[5–7].
Dentalcrowdingisconsideredoneofthemostcom-montypesofmalocclusion[8].
Methodsofconventionaltreatmentsvarybetweenextractionandnon-extractionapproaches[9].
Non-extractiontherapyisusuallyusedtoresolvemildtomoderateconditions,whileextractionmethodisusuallyusedtoaidinthecorrectionofmod-eratetoseverecases.
Extraction-basedtreatmentcouldlastforalongperiodoftimeandhasitbeendocu-mentedthatitwouldtakeupto35months[10].
Reducingorthodontictreatmenttimeisoneofthemaingoalsfororthodontistsandpatientsespeciallyadults[11].
Prolongedorthodontictreatmenttimeshavepossiblecomplicationssuchasrootresorption,peri-odontaldisease,cariesinadditiontotheundesirablepainaccompanyingthetreatmentproceduresatdifferentstages[12].
Onesurveydescribedpainasthegreatestdislikeduringtreatmentandfourthamongmajorpre-treatmentfearsandconcerns[13].
Severaltechniqueshavebeenproposedtoaccelerateorthodontictreatmentandthemostcommonapproacheswerethesurgicalones[14]suchas:interseptalalveolarsurgery[15],osteotomy[16],corticotomy[17,18],den-toalveolardistraction[19,20],periodontaldistraction[21],corticision[22,23]andPiezocisiontechnique[24–26].
Theacceptanceoftraditionalcorticotomy-assistedortho-donticsamongpatientswasgenerallylow,mainlybecauseoftheinvasiveproceduresandpostoperativediscomfortandcomplications[27].
Flaplesspiezocision-assistedcorti-cotomyhasbeenfoundtohavevariousadvantagesoverthetraditionalmethodsofcorticotomyandisconsideredapromisingminimallyinvasivetoothaccelerationtech-nique[28].
Althoughvarioustechniquesofpiezocisionflaplesscorticotomyhavebeenreportedtobesuccessfulinprac-tice[25,29],scientificevidenceontheiraccompanyingpain,discomfort,acceptanceandqualityoflifeislittleintheliteratureandmorehigh-qualityRCTsinvestigatingthoseaspectsarerequired[28,30].
Threetrialsevalu-atedthelevelsofpainassociatedwithminimallyinvasivesurgicalprocedures[29,31,32].
Alikhanietal.
assessedpainanddiscomfortlevelsduringcanineretractionafterapplyingmicro-osteoperforations,whileMehrandCharavetstudiedpainlevelsduringtheaccelerationofpiezocision-assistednon-extractiontoothdecrowdingcases.
Therefore,itseemstobethatdecrowdingstrategiesbasedonextrac-tionplansaccompaniedwithaccelerationmodalitieshavenotbeenevaluatedyetintermsofpain,discomfortandacceptability.
Thepresentrandomizedcontrolledclinicaltrialaimedtocomparepiezocision-assistedorthodonticdecrowdingofloweranteriorteethfollowingpremolar-extractionwiththeconventionalorthodontictreatmentregardinglevelsofpainanddiscomfortaswellaspatients'post-treatmentsatisfaction.
MethodsStudydesignThisstudywasatwo-arm,parallelgrouprandomizedcontrolledtrialcomparingthelevelsofpainanddiscom-fortbetweenpiezocision-assistedorthodontictreatmentandthetraditionalmethodofaligningcrowdedloweranteriorteeth.
ParticipantswererecruitedfromtheDepartmentsofOrthodonticsatDamascusUniversityDentalSchoolbetweenMarch2016andFebruary2017.
TheLocalResearchEthicsCommitteeApprovalwasobtained(UDDS-2455-15,032,015/SRC-4991).
ThistrialwasregisteredatClinicalTrials.
gov(IdentifierNCT02975765)andwasfundedbytheUniversityofDamascusDentalSchoolPostgraduateResearchBudget(Refno:83054206785DEN).
SamplesizeestimationSamplesizewascalculatedusingtheG*power3.
1.
7soft-warewithanalphalevelof0.
05,apowerof80%.
Thesmallestdifferencerequiringdetectioninpainlevelwasassumedtobe25mmonavisualanalogscale(VAS)withastandarddeviationof23.
75mm(fromapreviousstudy[31]);therefore,asamplesizeof32patientswasrequiredforbothgroups(i.
e.
,n=16foreachgroup).
Patientselection,recruitment,andfollow-upPatientswereselectedfromtheDepartmentofOrtho-donticsatUniversityofDamascusDentalSchool.
Thetreatmentplanof98severedentalcrowdingpatientswasreviewed,butthenumberofpatientswhomettheinclusioncriteriaandagreedtoparticipateinthisstudyaftertheacquaintancewiththeinformationsheetwas40.
Accordingtoapriorisamplesizecalculationwhichindicatedtheneedfor32patients.
Thirty-foursubjectswereequallyandrandomlyassignedtothetwogroups;thisnumberwaschosenforanypotentialdrop-outafterthecommencementofthetrial.
Patients'selectionandfollow-upisshowninFig.
1.
Informationsheetsweredistributedtoallpatientsandinformedconsentswereobtained.
Theinclusioncriteriawere:(1)Adulthealthypatientsfrombothsexeswithinanagerange17–24years;(2)absenceofpreviousorthodontictreatment;(3)ClassIIdivisionIpatientsrequiringfirstupperpremolarsextraction;(4)completionpermanentGibrealetal.
BMCOralHealth(2019)19:57Page2of9dentition(exceptofthirdmolars);(5)absenceofmedica-tionsintakethatinterferewithpainperceptionforatleastoneweekbeforethebeginningofthetreatment;(6)goodoralhygieneandhealthyperiodontiumwhichwasevalu-atedclinically(probingdepth≤3mm,noradiographevi-denceofboneloss,plaqueandgingivalindex≤1accordingtoSilnessandLoe[33]).
Exclusioncriteriawere:(1)Medicalconditionsthataffecttoothmovement(Corticosteroid,NSAIDs,Bisphosphonates,Hyperparathyroidism,OsteoporosisandUncontrolleddia-betes);(2)medical,socialandpsychocontraindicationstooralsurgery;(3)presenceofprimaryteethinthemandibulararch;(4)missingpermanentmandibularteeth(exceptthirdmolars);(5)patientshadpreviousorthodontictreatments;Fig.
1CONSROT2010flowdiagramofpatients'recruitmentandfollow-upGibrealetal.
BMCOralHealth(2019)19:57Page3of9(6)poororalhygieneorconcurrentperiodontaldisease:probingdepth≥4mm,radiographicevidenceofboneloss,gingivalindex>1,plaqueindex>1[33].
RandomizationandallocationconcealmentPatientswereassignedtotheexperimentalgrouporthecontrolgroupwithanallocationratioof1:1usingasoftware-generatedlistofrandomnumbers.
Alloca-tionsequencewasconcealedusingsequentiallynum-bered,opaque,sealedenvelopeswhichwereopenedonlyafterthecompletionofpremolarsextraction.
Firstgroupreceivedpiezocision-assistedorthodontictreatment,whereasthesecondgroupreceivedcon-ventionalorthodontictreatment(Fig.
1).
Thegener-ationofrandomallocationsequence,participants'enrollmentandassignmenttothetwogroupswereperformedbyoneoftheacademicstaffnotinvolvedinthisresearch.
OrthodonticproceduresAllsubjectsunderwentconventionalorthodontictreatmentwithfixedappliances.
Oneweekfollowingfirst-premolarextraction,fixedorthodonticapplianceswithanMBTprescriptionand0.
022-in.
slotheight(MasterSeries,AmericanOrthodontics,Sheboygan,WIUSA)werebonded.
Forbothgroups,thearchwiresequenceusedwas0.
014-in.
NiTifollowedby0.
016-in.
,0.
016X0.
022-in.
and0.
017X0.
025-in.
NiTi,andfinally0.
019X0.
025-in.
stainlesssteel[25].
Changeinarchwireswasperformedwhenitwasfeltthatanimprovementhadoccurredinteethpositionsandtherewasapossibilityofinsertingthenextarch-wirewithoutexertingexcessiveforceontheengagedteeth.
TreatmentwasconsideredfinishedwhenLIIwaslessthan1mm,indicatingcompletealignmentoftheteethandthefeasibilityofinsertingthefinalarchwirepassivelyintoallbrackets[34].
PiezocisionsurgicalprocedureRadiographicmetalguideswereplacedonthearchwirefortheexperimentalgroupsubjectsasaguidetomakeprecisemucoperiostealincisionsavoidingperiodontalligamentsandteethroots.
PatientswereaskedtorinsewithChlorhexidineGluconate0.
12%for1minimmedi-atelybeforethesurgicalintervention,thenlocalInfiltra-tionwasinjected(lidocainehydrochloride2%withepinephrine1:80,000).
Thesurgicalprotocolwasper-formedasdescribedbyDibart[35].
Theincisionsbegan4mmbelowthepapillatopreventanyfurthergingivalrecessions,thenaPT1periotome(Hu-FriedayMfg.
Co.
,Chicago,USA)wasusedtoconfirmtheincisionslineswithoutelevatingtheperiosteumandraisinganyflaps.
Vertical5to8-mm-longand3-mm-deepcorticotomieswereperformedutilizingaPiezosurgicalMicrosaw(ImplantCenter2,Satelec,France)withaBS1cuttingtipandirrigationsolutionpump80ml/m(Fig.
2).
NosubsequentsutureswereperformedandthesurgicalsidewascoveredbyapieceofIodoformgauze.
Afterthesurgicalprocedure,patientswereprescribed:asoftdietfor3daysafterthesurgery,rinseswithChlor-hexidineGluconate0.
12%twiceadayfor1week,icepacksforthefirst12hfollowingsurgery;andwereinstructedtotakeoneortwotablesofPanadol(acet-aminophen;500mg)whentheysufferfrommoderate/se-verepainprovidedthatquestionnairesarecompletedfirst.
Noanti-inflammatorydrugswereprescribed.
Experimentalpatientscheck-upswerescheduledadayaftertheprocedureensuringabsenceofpostoperativecomplications,andwerefollowedupeverytwoweeksfororthodontictreatmentsequence.
OutcomemeasuresTheoutcomemeasuresforbothgroupsincludedlevelsofpain,discomfort,andswelling,difficultiesofmastication,swallowingandjawsmovementlimita-tion.
Thequestionnairewasgiventopatientsatoneday,7days,14days,28daysfollowingtheonsetoftreatment(Additionalfile1).
AllpatientswereinstructedtoratetheirlevelsonaVisualAnalogScale(VAS)questionnaire.
Alineof100-mmlengthwasusedwiththeleftsiderepresentingnopain,dis-comfort,swelling,difficultiesofmastication,swallow-ingorjawsmovementlimitation(i.
e.
,score=0)andtherightsiderepresentingtheworstpain,highestlevelsofpain,discomfort,swelling,difficultiesofmas-tication,swallowingandjawsmovementlimitation(i.
e.
,score=100).
Eachpatientwasaskedtoputaverticalmarkonthelineatapointwhichbestrepre-sentedtheperceivedlevelsoftheaforementionedvar-iables.
Patientswereinstructednottotakeanyanalgesicduringpainassessmentperiod.
Inaddition,experimentalpatients'acceptanceofthereceivedintervention,thetreatmentduration,andwhethertheywouldrecommendtheproceduretofriendswereassessedaftertreatmentcompletion.
Patientswerealsoaskedtorecordanyconsumptionofanalgesicsandnumberoftablesused(Additionalfile2).
StatisticalanalysisParametrictestswereusedsinceAnderson-DarlingNormalitytestsshowednormaldistributionsofthecol-lecteddata.
Two-samplet-testswereusedtodetectsignifi-cantdifferencesbetweenthetwogroupsateachassessmenttime.
Singleblindingwasemployedinthistrialregardingoutcomemeasureassessmentanddataanalysis.
Allstatisticalanalyseswereperformedbyoneofthecoauthors(MYH)usingMinitabVersion17(MinitabInc.
,Pennsylvania,USA).
Gibrealetal.
BMCOralHealth(2019)19:57Page4of9ResultsInitially,34patientswereenrolledinthisstudy.
Unfortu-nately,onepatientineachgroupdroppedoutbeforetheendofthetrialduetopersonalreasons(i.
e.
movingtoanothercity),leaving16patientsineachgroupforthedataanalysisstage.
BasicsamplecharacteristicsaregiveninTable1,whiledescriptivestatisticsofthesampleregardingtheevalu-atedvariablesatoneday,7daysaregiveninTables2and3,respectively.
Nodescriptivestatistsaregivenre-gardingthevariablesassessedat14daysand28dayssinceallobtainedvaluesdroppeddowntozero.
There-sultsofsignificancetestsregardingpain,discomfort,andswelling,difficultiesofmastication,swallowingandjawsmovementlimitationaccordingtoassessedtimepointsaregiveninTable4.
Nostatisticallysignificantdifferencesbetweenthetwogroupswerefoundatonedayfollowingtreatmentcom-mencementregardingpain,discomfort,difficultiesofmastication,swallowingandlimitationinjawsmove-ment(P=0.
082,0.
367,0.
062,0.
446,0.
359,respectively).
However,astatisticallysignificantdifferencewasfoundbetweenthetwogroupsregardingtheperceptionofswelling(P=0.
011).
Theexperimentalsubjectsdevel-opedahigherfeelingofswellingwithameanof26.
18(±3.
02)comparedtothecontrolgroup(x=13.
82±3.
44).
Moreover,nostatisticallysignificantdifferencesbetweenthetwogroupsweredetectedat7daysregardingpain,discomfort,swelling,difficultiesofmasticationandjawsmovementlimitation(P=0.
093,0.
068,0.
372,0.
117,0.
215,respectively).
Difficultiesofswallowinglevelsreachedzeroinbothgroupsat7daysaftertreatmentonset.
Experimentalsubjects'acceptancemeanvaluewas86.
47(±22.
47)aftertreatmentcompletion,andallofthemansweredthattheywouldrecommendthisacceler-ationproceduretoafriend.
Surprisingly,noneofthepa-tientsineithergrouptookpainkillersduringthelevelingandalignmentstage.
DiscussionThisisthefirstRCThavingtheobjectiveofevaluatingthelevelsofpainanddiscomfortbetweenflaplesspiezo-cisiontechniqueandthetraditionalmethodinthealign-mentofseverelycrowdedloweranteriorteethinextractioncases.
TheVASwasusedasatooltomeasurepainpercep-tionbecauseofitssuperiorityonotherscalesandhasbeenusedinpreviousstudies[29,36,37].
Patient-centeredoutcomeswerefirstmeasuredat24hfollowingtreatmentcommencementinordertoavoidtheanalgesiceffectofthelocalanesthesiaintheexperi-mentalgroup.
Hence,ourresultsshowedthattherewereFig.
2Theminimallyinvasivepiezocisionintervention.
a:Theinstrumentusedforperformingthecorticalcuts.
b:FiveverticalcorticotomieswereperformedintheloweranteriorsegmentTable1BasicsamplecharacteristicsGroupGendern(%)P-valueaMeanAge(SD)Min.
AgeMax.
AgeP-valuebControlMale7(43.
75%)0.
53121.
27(1.
87)18240.
092Female9(56.
25%)ExperimentalMale6(37.
5%)20.
86(1.
98)1723Female10(62.
5%)Allsample32(100%)21.
03(1.
96)1724Minminimum,Maxmaximumaemployingchi-squaretestbemployingtwo-samplettestGibrealetal.
BMCOralHealth(2019)19:57Page5of9nosignificantdifferencesinpainanddiscomfortlevelsbetweenthetwogroupsatonedayaftertreatmentcom-mencement(P=0.
082;P=0.
367;respectively),norat7days(P=0.
093,P=0.
068;respectively).
Thentheyreachedzerovalueafter14and28days.
Thiscouldbeexplainedbytheprecisionofthepiezosurgerymicro-sawthatpermittedasafecuttingmodewithmax-imumcontrolandthepossibilityofconductingselectivecuttingdesignspreservingrootintegrityandreducingpost-surgicalpainthatiswellknownwithconventionalcuttingtools(i.
e.
surgicalburs)[38–40].
Similarly,twoprevioustrialsreportednosignificantdifferencesinpainanddiscomfortlevelsafterapplyingpiezocisionflaplesscorticotomiesintermsoforthodonticdecrowdingaccel-erationcomparedtoconventionalorthodontictreat-ments[29,31].
Bothaforementionedtrialsadoptedvisualanalogscalestoevaluatepatient-centeredout-comes.
However,bothstudiesincludednon-extractioncasescomparedtoextractioncasesinthecurrenttrial.
Whenevaluatingpost-interventionpainatthesameas-sessmenttimeamongthecurrenttrialandtheafore-mentionedstudies(i.
e.
at7dayspostoperatively),theexperimentalsubjects'levelsofpainwasgreaterintheCharavet'sandMehr'sRCTsthanthoseofthecurrenttrial(i.
e.
,meanvalues:60mm,30.
28mm,and6.
47mmrespectively).
Inthisstudy,meanpainlevelsintheexperimentalgroupwas32.
06mmatonedayfollowingsurgeryanditdecreasedsignificantlyafteroneweektobecome6.
47mm,thenitreachedthezerolevelat14daysand28days.
Thiscouldbeexplainedthatinoursurgicalproto-col,aperiotomewasfirstutilizedtoconfirmtheincisionTable2Descriptivestatisticsofpatients-centeredvariablesatonedayafterfirstorthodonticarchwireinsertioninthetwogroupsusingvisualanalogscales(n=16foreachgroup)VariableGroupMeanSDSEMMinQ1MedianQ3MaxPainExp.
32.
0615.
923.
8610.
0020.
0030.
0040.
0070.
00Control21.
7612.
623.
065.
0010.
0020.
0030.
0050.
00DiscomfortExp.
28.
8218.
674.
5310.
0010.
0020.
0040.
0070.
00Control23.
5314.
873.
615.
0010.
0020.
0035.
0050.
00SwellingExp.
26.
1812.
443.
0210.
0015.
0030.
0037.
5050.
00Control13.
8212.
203.
440.
002.
5010.
0020.
0040.
00MasticationExp.
33.
8222.
475.
455.
0020.
0030.
0045.
0070.
00Control20.
5913.
793.
350.
0010.
0020.
0030.
0050.
00SwallowingExp.
4.
713.
102.
420.
000.
000.
0020.
0020.
00Control4.
111.
720.
710.
000.
000.
0010.
0010.
00LimitationExp.
22.
0612.
883.
125.
0010.
0020.
0035.
0040.
00Control17.
067.
211.
950.
000.
000.
0015.
0060.
00Exp.
experimentalgroup,SDStandardDeviation,SEMStandardErrorofthemean,Minminimum,Q1firstquartile,Q3thirdquartile,MaxmaximumTable3Descriptivestatisticsofpatients-centeredvariablesat7daysafterfirstorthodonticarchwireinsertioninthetwogroupsusingvisualanalogscales(n=16foreachgroup)VariableGroupMeanSDSEMinQ1MedianQ3MaxPainExp.
6.
477.
451.
810.
000.
005.
0010.
0030.
00Control1.
1762.
8110.
6820.
000.
000.
000.
0010.
00DiscomfortExp.
6.
037.
801.
020.
000.
005.
0010.
0020.
00Control2.
355.
041.
220.
000.
000.
005.
0020.
00SwellingExp.
1.
7653.
5090.
8510.
000.
000.
002.
5010.
00Control0.
8821.
9650.
4770.
000.
000.
000.
005.
00MasticationExp.
2.
941.
870.
480.
000.
000.
0010.
0030.
00Control1.
181.
170.
700.
000.
000.
0020.
0020.
00SwallowingExp.
0.
000.
000.
000.
000.
000.
000.
000.
00Control0.
000.
000.
000.
000.
000.
000.
000.
00LimitationExp.
2.
3533.
9990.
9700.
000.
000.
005.
0010.
00Control0.
8822.
6430.
6410.
000.
000.
000.
0010.
00Exp.
experimentalgroup,SDStandardDeviation,SEMStandardErrorofthemean,Minminimum,Q1firstquartile,Q3thirdquartile,MaxmaximumGibrealetal.
BMCOralHealth(2019)19:57Page6of9linesinanintentiontoavoidperiosteumshreddingthatwouldresultfromusingonlytheBS1piezoelectrictipsincethistipcutsonlyhardtissues.
Ignoringthispar-ticularstepbeforeconductingthepiezoelectriccutswouldbeareasonbeyondtheincreasedpainlevelsfol-lowingsurgeryfoundintheprevioustrials.
OurprotocolofpainassessmentpointswasidenticaltothethatofAlikhanietal.
whoemployedanumericratingscaleduringpiezocision-assistedcanineretraction[32].
Althoughnosignificantdifferenceswereobservedbetweenthecontrolgroup(i.
e.
,noacceleration)andtheexperimentalgroupintheirstudy,thedirectcomparisonwiththecurrentresultsisnotstraightforward.
Thisisbecauseofthedifferencesexistingintheorthodontictoothmovementstrategy,biomechanicsandlevelofforceemployed;i.
e.
,bilateralcanineretractionversusdecrowdingmovementsforthesixanteriorteeth,bodilymovementforonetoothinonedirectionversusthree-dimensionalmultiplederotations,distaltipping,oruprightingforseveralteeth,and150–175gemittedfromaNiTicoilspringoneachsideversusdifferentamountsofforceemittedbythealigningNiTiarchwiresanddis-tributedamongsixteeth.
Asignificantdifferenceatonedayintheperceptionofswelling(12.
36;P=0.
011)wasfoundbetweentheex-perimentalandthecontrolsubjectsbutitdecreasedsig-nificantlyafter7days(P=0.
372)reachingthezerolevelafter14and28days.
Thiscouldbeexplainedbypiezo-electricblade'sprecisionthatpermittedfasthealingandfinecuttingswithminimalmorbidity[39].
Eventhoughthedifferencebetweenthetwogroupswasstatisticallysignificantatdayone,itcannotbeconsideredclinicallyimportantsinceitdidnotexceedtheassumedthresholdof25-mmdifferenceontheVASscale.
Tothebestofourknowledge,noprevioustrialshaveevaluatedswellingperceptionfollowingflaplesscorticot-omy.
Neverthelessinconventionalcorticotomy,twoprevi-oustrialsquantifiedtheperceptionofswelling[18,27]andrevealedhigherandlongerlastinglevelsofswellingpercep-tion.
Al-Naoumetal.
mentionedthattheproportionofpatientswhoreportedmediumorsevereswellingonedayfollowingthecorticotomywas80%,whereas70%ofthepa-tientsreportedafeelingofmildtomoderateswellingaftersevendaysoftheoperation[18].
Again,thedramaticlesspercentageofpatientssufferingfromuntowardeffectscanbeexplainedbytheminimallyinvasivenatureofflaplesspiezocisionconductedinthecurrentstudycomparedtothetraditionaltechnique.
Furthermore,nosignificantdifferenceswerefoundatonedayorat7daysregardingdifficultiesofmastication,swallowingorjawsmovementlimitation.
Thesethreepossiblepost-corticotomyfunctionalimpairmentshavenotbeenyetevaluatedintheliteratureemployingRCTdesigns.
However,apreviousnon-controlledcohortprospectivestudyevaluatedtheoralhealth-relatedqualityoflifeusingtheshort-formOralHealthImpactProfile(OHIP-14)-whichcontainedaspecificdomainfocusingonfunctionalimpairment[41].
InthisstudypiezoelectricsurgerytechniquesdidnotsignificantlymodifytheOHIP-14scoresatthe3-day(P=0.
20)or7-day(P=0.
89)follow-up.
Theinterventionintheexperimentalgroupshowedahighlevelofpatients'acceptance(x=86.
47±22.
47).
Thiscouldbeexplainedbyabsenceofneedforflapsandsuturesbesidesofthelesspainfulandtraumaticinci-sionscomparedtotheconventionalmethods.
Thisagreeswiththeresultsoftwoprevioustrialsthatre-portedhighpatients'acceptabilitytothepiezocisionintervention[29,31].
Recommendationofthisproceduretofriendswasthelastquestiongiventothepatientsintheexperimentalgroup.
Surprisingly,theanswerwaspositivefromallpa-tients.
Inthesamecontext,thesurgicalinterventioninMehr'sstudydidnothaveanynegativeeffectonpa-tients'willingtoadvicefriendstoundergoasimilarpro-cedure[31].
Furthermore,Charavetetal.
mentionedthatintheirexperimentalgroup,significantlygreaternum-bersofpatientsreportedthattheywouldundergothetreatmentagainandthattheywouldrecommendittoafriendincomparisonwiththecontrolgroup[29].
Table4Theresultsofsignificancetestsoftheobservedpatients-centeredvariablesonvisualanalogscalesat1and7daysfollowingtheonsetoftreatment(n=16ineachgroup)aVariableOnedayOneweekMeandifferenceSD95%CIfordifferenceP-valueSignificanceMeandifferenceSD95%CIfordifferenceP-valueSignificanceMinMaxMinMaxPain10.
2914.
30.
2620.
330.
082NS5.
295.
631.
369.
230.
093NSDiscomfort5.
2916.
86.
5017.
090.
367NS4.
126.
350.
338.
560.
068NSSwelling12.
3513.
43.
0321.
680.
011*0.
8822.
841.
102.
8690.
372NSMastication13.
2418.
60.
2126.
260.
062NS4.
718.
521.
2510.
660.
117NSSwallowing7.
066.
32.
6511.
470.
446NSLimitation10.
5910.
73.
0818.
090.
359NS1.
473.
380.
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