Soft Tissue Changes with Fixed Functional Appliances in Class II division 1

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Review Article Soft Tissue Chnges with Fixed Functionl Applinces in Clss II division 1 A Systemtic Review Crlos Flores-Mir ; Michel P. Mjor b ; Pul W. Mjor c ABSTRACT Objective: To evlute fcil soft tissue chnges fter the use of fixed functionl pplinces in Clss II division 1 mlocclusion cses using systemtic review of the literture. Mterils nd Methods: Severl electronic dtbses (PubMed, Medline, Medline In-Process & Other Non-Indexed Cittions, Cochrne Dtbse, Embse, Web of Sciences, nd Lilcs) were serched with the help of senior Helth Sciences librrin. Abstrcts tht ppered to fulfill the initil selection criteri were selected by consensus. The originl rticles were then retrieved. Their references were lso hnd-serched for possible missing rticles. Clinicl trils ssessing fcil soft tissue chnges with the use of fixed functionl pplinces without ny surgicl intervention or syndromic chrcteristics were considered. A comprble untreted control group ws required to fctor out norml growth chnges. Four rticles using Herbst nd one using Jsper Jumper fulfilled the selection criteri. An individul nlysis of these rticles ws mde nd some methodologicl flws were identified. Results: Although fixed functionl pplinces produce some significnt sttisticl chnges in the soft tissue profile, the mgnitude of the chnges my not be perceived s cliniclly significnt. Conclusions: The conclusions from this systemtic review should be considered with cution becuse only secondry level of evidence ws found. Long-term double-blinded prospective rndomized clinicl trils re needed. Three-dimensionl quntifiction of the soft tissue chnges is required to overcome current limittions in our understnding of the soft tissue chnges obtined with the use of fixed functionl pplinces. (Angle Orthod 2006;76:712 720.) KEY WORDS: Functionl pplinces; Soft tissue; Profile; Fcil chnges INTRODUCTION Clss II division 1 mlocclusions with mndibulr deficiency hve been treted for more thn century Clinicl Associte Professor, Orthodontic Grdute Progrm, Fculty of Medicine nd Dentistry, University of Albert, Edmonton, Albert, Cnd nd Director, Crniofcil nd Orl Helth Evidence-bsed Prctice Group. b DMD Student, Goldmn School of Dentl Medicine, Boston University, Boston nd Member of the Crniofcil nd Orl Helth Evidence-bsed Prctice Group. c Professor, Director, Orthodontic Grdute Progrm, Fculty of Medicine nd Dentistry, University of Albert, Edmonton, Albert, Cnd nd Member, Crniofcil nd Orl Helth Evidence-bsed Prctice Group. Corresponding uthor: Dr. Crlos Flores-Mir, Orthodontic Grdute Progrm, Fculty of Medicine nd Dentistry, Room 4051A, Dentistry/Phrmcy Centre, University of Albert, Edmonton, Albert, Cnd T6G 2N8 (e-mil: crlosflores@ulbert.c) Accepted: August 2005. Submitted: June 2005. 2006 by The EH Angle Eduction nd Reserch Foundtion, Inc. with different types of functionl pplinces. Esthetics is one of the min resons for seeking orthodontic tretment. 1 It hs been suggested tht mxillry, mndibulr, nd dentl morphologies hve n indirect effect on the perception of fcil beuty. 2 It seems cler tht t lest Cucsins prefer stright profile. 3 Therefore, one of the gols of functionl tretment is to ttin strighter profile from strting retrognthic profile, chrcteristic of Clss II division 1 ptients. 4 From the hundreds of reports emphsizing chnges produced by functionl pplince use, only reltively smll proportion reported soft tissue chnges. For Clss II corrections, severl removble functionl pplinces re vilble, but only few fixed functionl pplinces exist (ie, Crossbow, Forsus, Herbst, Jsper Jumper, MARA). Fixed functionl pplinces hve the dvntge of not requiring ptient complince. They cn lso be used concurrently with brckets. Their disdvntges re tht they re prone to brekge nd difficult to clen or remove. 5 712

SOFT TISSUE CHANGE WITH FIXED FUNCTIONAL APPLIANCE Although literture reviews bout skeletl nd dentl chnges with the use of fixed functionl pplinces hve been mde, no such review hs been mde for the soft tissue chnges. It hs been shown tht fixed functionl pplinces enhnce mndibulr growth nd tht they tend to produce more horizontl condylr growth compred with removble functionl pplinces. 6 A comprison of dentolveolr nd skeletl effects between Herbst nd Twin Block 7 showed tht most of the chnges were dentl in nture, with proclintion of mndibulr incisors nd retroclintion of mxillry incisors, which cn potentilly lter the lipprofile reltionship. Becuse of the volume of new publictions produced every yer, the development of systemtic pproch to serch, identify, nd summrize vilble evidence hs become incresingly necessry. In the pst, conventionl literture reviews were written by people deemed experts on prticulr topic. However, such reviews were bsed on the uthority of the most populr lecturers nd reserchers rther thn relying on the best vilble evidence nd, therefore, prone to bis. Conversely, systemtic review cn be defined s review tht hs been prepred using systemtic pproch to minimize bises nd rndom errors which is documented in mterils nd methods section. 8 The distinct dvntge of the systemtic review compred with the conventionl literture review is the trnsprency nd reproducibility of its literture serch. 9 In this mnner, systemtic reviews cn both deduce consensus mong previous reserch with minimized bis nd identify topics requiring further reserch. Although significnt improvement of the fcil profile fter fixed functionl pplince use hs been reported previously, no study hs yet systemticlly reviewed these clims. The objective of this systemtic review is to evlute fcil soft tissue chnges fter the use of fixed functionl pplinces in Clss II division 1 mlocclusion cses using lterl cephlogrms. This will permit distinctive differentition between the chnges reported on the bsis of sound methodologicl study designs nd the necdotl reported informtion. MATERIALS AND METHODS A computerized serch ws conducted using Medline (from 1966 to week 1 of August 2005), Medline In-Process & Other Non-Indexed Cittions (up to August 12, 2005), Lilcs (from 1982 to July 2005), Pubmed (1966 to week 1 of August 2005), Embse (from 1988 to week 32 of 2005), Web of Science (1945 to week 32 of 2005), nd ll EBM reviews (Cochrne Dtbse of Systemtic Reviews [CCTR], ASP Journl 713 Club, Dtbse of Abstrcts of Reviews of Effects, nd CCTR) (to the second qurter of 2005) dtbses. Terms used in this literture serch were functionl pplinces, soft tissue, profile or fcil chnges, nd humn studies. The selection nd specific use of ech term inside every dtbse serch were mde with the help of senior librrin who specilized in Helth Sciences dtbse serches (Tble 1). The following inclusion criteri were chosen to initilly select potentil rticles from the published bstrct results: humn clinicl trils; fcil soft tissue chnges; fixed functionl pplinces to correct Clss II division 1 mlocclusions; nonsyndromic or mediclly compromised ptients; no individul cse reports or series of cses; nd no surgicl intervention. No ttempts were mde t this stge to identify which studies did not use dequte control groups to fctor out growth chnges. It ws considered improbble tht the bstrcts would report enough informtion regrding control groups. This would potentilly exclude some rticles. All the rticle bstrcts tht ppered to meet the initil inclusion criteri were selected, nd the ctul rticles were collected irrespective of the lnguge in which they were published. The selection process ws independently conducted by two reserchers, their results compred nd ny discrepncies settled through discussion. The Lilcs dtbse rticles were evluted only by one of the reserchers becuse of lnguge limittions. If n rticle bstrct did not provide enough informtion to mke decision, the ctul rticle ws obtined. The rticles ultimtely selected were chosen with the following dditionl inclusion criteri: evlution of soft tissue chnges through lterl cephlogrms; comprble control group to fctor growth chnges if required; nd only fixed functionl pplinces used. The ctul rticles from the selected rticle bstrcts were independently evluted by two reserchers. A consensus ws reched regrding which rticles fulfilled the finl selection criteri nd were to be included in the systemtic review. Articles tht did not fctor out growth when required (growing smples) were rejected t this stge. Fctoring out crniofcil growth in the nlysis ws considered importnt to mke n ccurte ssessment of the mount of tretment produced soft tissue chnge. Filure to consider crniofcil growth chnges would result in potentil overestimtion of the mount of chnge produced by the tretment. Simultneous use of fixed bnded pplinces ws considered confounder nd reson for exclusion. Although mesurement error is needed for correct interprettion of the clinicl significnce of the findings, it ws not considered reson to reject

714 FLORES-MIR, M.P. MAJOR, P.W. MAJOR TABLE 1. Abstrct Serch Results from Different Electronic Dtbses,b Dtbse Key Words Results Selected PubMed (1) functionl pplince*; (2) orthodontic pplinces, functionl; (3) Crossbow or Forsus or Jsper Jumper or Herbst or MARA; (4) #1 or #2 or #3; (5) soft tissue*; (6) fcil chnge*; (7) profile chnge*; (8) #5 or #6 or #7; (9) #4 nd #8; (10) limit #9 to humns Medline (1) functionl pplince$.mp; (2) EXP orthodontic pplinces, functionl/; (3) (Crossbow or Forsus or Jsper Jumper or Herbst or MARA).mp; (4) #1 or #2 or #3; (5) soft tissue$.mp; (6) fcil chnge$.mp; (7) profile chnge$.mp; (8) #5 or #6 or #7; (9) #4 nd #8; (10) limit #9 to humns Medline In-Process & Other Non-Indexed Cittions (1) functionl pplince$.mp; (2) EXP orthodontic pplinces, functionl/; (3) (Crossbow or Forsus or Jsper Jumper or Herbst or MARA).mp; (4) #1 or #2 or #3; (5) soft tissue$.mp; (6) fcil chnge$.mp; (7) profile chnge$.mp; (8) #5 or #6 or #7; (9) #4 nd #8 Embse (1) functionl pplince$.mp; (2) EXP orthodontic pplinces, functionl; (3) (Crossbow or Forsus or Jsper Jumper or Herbst or MARA).mp; (4) #1 or #2 or #3; (5) soft tissue$.mp; (6) fcil chnge$.mp; (7) profile chnge$.mp; (8) #5 or #6 or #7; (9) #4 nd #8; (10) limit #9 to humns All EBM reviews (Cochrne Dtbse of Systemtic Reviews, ACP Journl Club, DARE nd CCTR) Web of Science (1) functionl pplince$.mp; (2) EXP orthodontic pplinces, functionl/; (3) (Crossbow or Forsus or Jsper Jumper or Herbst or MARA).mp; (4) #1 or #2 or #3; (5) soft tissue$.mp; (6) fcil chnge$.mp; (7) profile chnge$.mp; (8) #5 or #6 or #7; (9) #4 nd #8 TS (functionl pplince* or Crossbow or Forsus or Jsper Jumper or Herbst or MARA) nd (soft tissue* or fcil chnge* or profile chnge*) DocType Article; Lnguge All lnguges; Dtbse(s) SCI-EXPANDED % of Totl Selected Abstrcts (9)* 97 5 55.6 87 5 55.6 1 0 0 13 0 0 10 1 11.1 28 5 55.6 Lilcs [(Crossbow or Forsus or Jsper Jumper or Herbst or MARA) nd fcil] 8 3 33.3 Hnd-serch Reference list from selected rticles 0 0 EBM indictes evidence-bsed medicine; ACP, Americn College of Physicins; DARE, Dtbse of Abstrcts of Reviews of Effects; nd CCTR, Cochrne Dtbse of Tril Registrtion. b Asterisk indictes tht percentges do not dd up to 100% becuse the sme reference could be found in severl dtbses. TABLE 2. Studies tht Fulfilled Initil Selection Criteri But Were Lter Rejected Authors Eicke nd Wieslnder 20 Schutz et l 17 Schutz et l 18 Soytrhn nd Isiksl 19 Reson(s) for Rejection Only photos used No control group No control group No control group n rticle but ws considered in the interprettion of the dt. Knowing tht more methodologiclly sound studies my provide more relible conclusions, methodologicl scoring process ws developed to identify which selected studies would be most vluble (Tble 2). No ttempt ws mde to imply tht this evlution tool hs been properly vlidted. Previous reports 10 12 hve shown tht there is no sound evidence bout the vlidity of the use of qulity ssessments of clinicl trils, nd they recommend reserchers exmine individully the influence of key components of methodologicl qulity. The reference lists of the retrieved rticles were lso hnd-serched for dditionl relevnt publictions tht my hve been missed in the dtbse serches. In cses where extr informtion ws required for discussion or sttisticl nlysis, nd ws not specificlly stted in the rticle, contct with the uthors ws sought to obtin the required informtion. RESULTS The serch results nd the finl number of bstrcts selected ccording to the initil selection criteri from the vrious dtbses re provided in Tble 1. From the nine studies which bsed on the bstrcts seemed to be potentilly useful, only five 4,13 16 (56%) ctully fulfilled the finl selection criteri fter reding the complete rticle. Of these five studies, three 4,15,16 were done with dolescents nd two 13,14 with dults. From the remining four rticles, three 17 19 were rejected becuse of the lck of n dequte control group to fctor out expected norml growth chnges nd one 20 becuse it only used lterl extrorl photos

SOFT TISSUE CHANGE WITH FIXED FUNCTIONAL APPLIANCE 715 TABLE 3. Flow Digrm of the Literture Serch TABLE 4. Methodologicl Score for the Clinicl Trils I. Study Design (11 ) A. Objective objective clerly formulted ( ) B. Popultion described ( ) C. Selection criteri clerly described ( ); dequte ( ) D. Smple Size considered dequte ( ); estimted before collection of dt ( ) E. Bseline chrcteristics bseline chrcteristics ( ); similr between groups ( ) F. Timing prospective ( ); long-term follow-up ( ) G. Rndomiztion stted ( ) II. Study Mesurements (4 ) H. Mesurement method pproprite to the objective ( ) I. Blind mesurement blinding (exminer, sttisticin ) J. Relibility described ( ) III. Sttisticl Anlysis (5 ) K. Dropouts included in dt nlysis ( ) L. Sttisticl nlysis pproprite for dt ( ) M. Confounders included in nlysis ( ) N. Sttisticl significnce level P vlue stted ( ); confidence intervls ( ) Mximum number of s 20 (Tble 2). A flow digrm of the literture serch is shown in Tble 3. A methodologicl qulity checklist (Tble 4) ws developed to evlute the methodologicl soundness of the selected rticles nd the ppliction of the sme is provided in Tble 5. Further detils bout the methodology of the selected studies cn be found in Tble 6. The following dt represent summry of the soft tissue chnges stted in ech individul study. Plese refer to Tble 7 for specific informtion bout the mesurements used nd the mgnitude of the chnges. Jsper Jumper An increse in the nsiolbil ngle, more retruded position of Lbrle Superious reltive to the verticl reference plne, nd protrusion of Lbrle Inferious reltive to Esthetic Plne (E-plne) were found. No chnges were found in the H-ngle, upper lip reltive to the E-plne, nd lower lip reltive to the verticl reference plne. 16 Herbst All studies 4,13 15 reported significnt chnges in the fcil ngles relted to soft tissue menton protrusion. Regrding the nose-bse ngultion, no significnt chnges were found. 15 Subnsle, but not the nose tip, ws more retrusive fter tretment. 15 Contrdictory results hve been reported regrding the nteroposition of the upper lip. Wheres one study 4 reported retrusion, nother 14 reported protrusion. Studies 4,14,15 consistently reported no chnge to the lower lip nd the soft tissue menton. DISCUSSION The present systemtic review ws performed to systemticlly nlyze the soft tissue chnges tht were produced by fixed functionl pplinces in Clss II division 1 mlocclusions. Despite the extensive mount of published studies regrding therpeutic effects produced by fixed functionl pplinces, lmost exclusively with the use of the Herbst pplince, only few clinicl trils fulfilled the selection criteri. Furthermore, the level of evidence found in them ws low. The use of properly designed clinicl trils with n d-

716 FLORES-MIR, M.P. MAJOR, P.W. MAJOR TABLE 5. Methodologicl Score of Selected Articles Articles A B C D E F G H I J K L M N Totl Number of Checks Pncherz nd Anehus- Pncherz 4 11 60 Nlbntgil et l 16 9.5 45 Ruf nd Pncherz 13 11 60 Ruf nd Pncherz 14 10 50 Ursi et l 15 11 60 A to N indictes methodologicl criteri in Tble 4;, fulfilled stisfctorily the methodologicl criteri (1 check point);, fulfilled prtilly the methodologicl criteri (0.5 check point);, did not fulfill the methodologicl criteri (0 check point). %of the Totl TABLE 6. Key Detils About the Selected Articles Study Yer Smple Size Nlbntgil et l 16 2005 15 (7M/8F; 15 y 2 mo SD 9 mo) Pncherz nd Anehus- Pncherz 4 1994 69 (49M/ 20F; 12 y 6moSD 1y2mo) Ruf nd Pncherz 13 1999 18 (4M/10F; 18 y 5 mo SD ) Ruf nd Pncherz 14 2004 23 (4M/19F; 26 y SD ) Ursi et l 15 2000 35 (14M/ 21F; 9 y 10 mo SD ) Nontreted Smple Selection Error Applince Tx Length 15 (6M/9F; 15 y 1 mo SD1y) 24 (M/ F; ge 11 y 4 mo SD 9 mo) NA NA 29 (19M/ 10F; 10 y 9moSD ) Retrospective, bsed on vilble records Retrospective, bsed on vilble records Prospective, consecutive Retrospective, bsed on vilble records Retrospective, bsed on vilble records M indictes mle; F, femle;, not stted; NA, not pplicble. y yers; mo months Mesurements Yes Jsper Jumper Ceph Yes Herbst Seven mo SD 1 mo Long-term 5 10 y in 44 subjects Ceph Yes Herbst 8.5 mo SD Ceph Yes Herbst One y 9 mo SD Yes Herbst One y 9 mo SD Ceph Ceph equte nontreted control group, if growth is expected, is the only scientific pproch to quntify chnges produced by therpeutic pplinces. Considertion of retrospective clinicl trils, series of cses, or cse reports is prone to bis nd exggertion of chnges ttined. 9 This hs been shown in rndomized clinicl tril bout the Herbst compred with retrospective studies. 7 Jsper Jumper The Jsper Jumper is reltively new fixed functionl pplince, 21 nd therefore the number of published clinicl trils 16,22 25 is smll. Only one 16 of these studies fulfilled the selection criteri. Contrdictory results were found becuse the significnce of chnges in the lip positions depended on the reference plne used. The chnge of the upper lip ws ssocited with n increse in the nsolbil ngle. These results re consistent with the results from the selected Herbst studies. No direct comprison with other Jsper Jumper studies ws fesible. Herbst Much hs been written bout the skeletl nd dentl effects produced by the use of the Herbst pplince s shown by few literture reviews. 26 30 However, very few studies hve delt with immedite soft tissue chnges 4,13 15,17 20 nd even fewer with long-term chnges. 4 Soft tissue chnges in growing subjects A significnt improvement of the fcil profile fter Herbst pplince use hs been reported previous-

SOFT TISSUE CHANGE WITH FIXED FUNCTIONAL APPLIANCE 717 TABLE 7. Reported Soft Tissue Mesurements from the Finlly Selected Studies,b Pncherzstble group 4 Pncherzrelpse group 4 Ruf nd Pncherz 13 Ruf nd Pncherz 14 Ursi et l 15 Nlbntgil et l 16 Fce Pronsle N Prn^PrnPg 1.6 0.9 1 TrOrpN^PrnPg c Subnsle SnPg ^SnNBt SnLs^SnNBt 3.5 N Sn^SnPg 3.4 3.3 2.8 d 3.1 Sulcus Superious N Ss^SsPg 3.5 Nose Pronsle horizontl Prn-TrOrpN Subnsle horizontl Sn-TrOrpN 1.5 Upper lip Lbrle Superious horizontl Ls-PrnPg 1.5 2 1.1 Ls^TrOrpN Ls-TrOrpN 2 Ls-TrOrpS 3.1 Lower lip Lbrle Inferious horizontl Li-PrnPg 1.2 Li-TrOrpN Ls-TrOrpS Menton ST Pogonion horizontl Pg -TrOrpN In the third column the bbrevitions re s follows: -indictes liner mesurement (in mm); ^, ngle; nd p, perpendiculr to. b See Figure 1 for definition of cephlometric points. c indictes not significnt. d No sttisticl comprison. ly. 20,31 34 The selected rticles 15,35 consistently report n increse in different fcil ngles, which is correlted to n improvement in the fcil profile. This improvement is not the product of more forwrd position of the lower lip but more likely retrusion of the upper lip. A possible explntion my be the restriction of the mxillry growth tht ppers to hppen with the use of the Herbst, 32,34,36 lthough the mgnitude does not seem to be lrge. It should be noted, however, tht one study 37 did not report ny significnt chnge in mxillry position. A more detiled nlysis using mesurements with reference structures not so prone to growth or tretment chnges (N perpendiculr to Frnkfort) showed tht the nteroposterior position of the upper lip gets less prominent but the inclintion of the lip per se does not chnge, 15 which is explined by similr posterior reposition of both Subnsle nd Lbrle Superious. Most likely, combintion of skeletl nd dentl chnges produced these chnges. 26 30 No significnt chnges were reported for the lower lip nd the soft tissue Pogonion in ny of the two selected studies, 15,35 regrdless of the mesurements used. These results re contrdictory to the numerous studies 31,34,36 38 tht hve reported n increse in mndible growth (either by increse of condylr growth or by chnges in the gonil ngle) with the use of the Herbst pplince. Chnges like those should hve displced the Pogonion forwrd with the consequent forwrd movement of the soft tissue Pogonion. The reported 26 30 lower incisor protrusion produced by the Herbst tretment did not pper to be ssocited with the protrusion of Lbrle Inferious in these studies. The soft tissue dptbility to hrd tissue chnges hs been shown to be complex, not liner ssocition. 39 Only one long-term study (more thn 1 yer fter ctive use of Herbst) bout the soft tissue chnges produced by Herbst pplince ws found. Five to 10 yers fter the completion of the ctive phse of tretment, n increse of the fcil convexity ws reported if the nose ws included. 4 If the nose ws not included, the fcil convexity ws reduced in stble group nd remined unchnged in relpse group. 4 Also, retrusion of both lips ws observed. 4 Soft tissue chnges in nongrowing subjects Two 13,14 of the selected studies evluted chnges in young dults. The observed chnges in the soft tissues were similr in nture nd direction compred with the chnges in growing individuls. An improvement in the fcil profile ws ssocited with retrusion of the upper lip but not forwrd position of the lower lip. A possible explntion is significnt dentl retrusion of the upper incisors combined with protrusion of the lower incisors similrly to the ones reported 7 recently in rndomized clinicl tril. Becuse both lips re supported more significntly by the upper incisors, chnges in the nteroposterior position of the upper incisors more significntly ffects the lip position thn do chnges in the lower incisors. No long-term studies bout the effects of Herbst tretment in young dults hve been found.

718 FLORES-MIR, M.P. MAJOR, P.W. MAJOR FIGURE 1. Cephlometric points. S, Sell; N, Nsion; N, Soft tissue Nsion; Tr, Trgus; Or, Orbitle; Prn, Pronsle; Sn, Subnsle; Ss, Stomion Superious; Ls, Lbrle Superious; Li, Lbrle Inferious; Si, Stomion Inferious; Pg Soft tissue Pogonion. Generl considertions bout the reported results A previous study 40 showed tht rt students, dentl students, nd prents of orthodontic ptients did not perceive ny significnt chnges in subjects treted with the two types of removble functionl pplinces. No similr evlution ws found for fixed functionl pplinces; therefore, lthough some sttisticlly significnt soft tissue chnges were found fter the use of Herbst pplinces, the clinicl significnce is still questionble. A detiled esthetic judgment of the fce should be crried out using the ptient s frontl fce view during converstion, with their fcil expressions nd smiling. 41 Conventionl orthodontic lterl cephlometric nlysis is not cpble of this kind of evlution. A frontl cephlometric nlysis is lso not useful becuse of the lck of soft tissue structures to do the superimposition with hrd tissue structures. Use of stereophotogrmmetry or lser surfce scnner my likely overcome these limittions. A very limited number of studies evluting threedimensionl soft tissue chnges fter functionl tretment hve lredy been published. 42 44 Their min limittions re filure to use norml nontreted control group nd presenting the results s visul chnges rther thn ctul volumetric chnges. Although n increse of the lower third of the fce is ssocited with functionl pplince tretment, none of the selected studies reported ny soft tissue verticl mesurements. Verticl chnges re n importnt component of functionl pplinces s shown for some removble functionl pplinces in studies fctoring out growth. 43,45,46 Severl different mesurements hve been used to evlute the soft tissue chnges fter fixed functionl tretment. Some of these hve to be considered crefully becuse reference structures were used tht could potentilly chnge the end result of the tretment. For exmple, the esthetic plne (E plne) is not good reference plne to quntify chnges in the lips becuse simultneous chnges in the soft tissue Pogonion or Pronsle could crete the impression of lip chnges tht re relly nonexistent. As lredy discussed, in one study, 16 if the E plne ws not used, then significnt retropositioning of the upper lip ws found nd no chnge ws found for the lower lip. If the E plne ws used s reference, then no significnt nteroposterior chnge of the upper lip, but significnt protrusion of the lower lip, ws found. Future studies in this re should consider threedimensionl comprison of the soft tissue chnges produced from the Herbst pplince ginst nontreted control group. A double-blinded rndomized clinicl tril should be the formt of choice becuse it will give the best possible scientific evidence. This is obviously lso the cse for the other fixed functionl pplinces (Crossbow, Forsus, Jsper Jumper, nd MARA) reported in the literture. CONCLUSIO The following systemtic review conclusions should be considered with cution becuse only secondry level of evidence ws found. Long-term prospective double-blinded rndomized clinicl trils re needed to support these conclusions. An improvement of the fcil convexity ws found. Chnges produced by fixed functionl pplinces seem to restrict the forwrd movement of the upper lip. No chnge in the nteroposterior position of the lower lip nd soft tissue menton ws found. Soft tissue chnges re similr between nongrowing young dult nd growing dolescent smples. ACKNOWLEDGMENT Specil thnks to Lind Sele for her professionl ssistnce in the dtbse serch. REFERENCES 1. Vig KW, Weynt R, O Brien K, Bennett E. Developing outcome mesures in orthodontics tht reflect ptient nd provider vlues. Semin Orthod. 1999;5:85 95. 2. Kerns LL, Silveir AM, Kerns DG, Regennitter FJ. Esthetic

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720 FLORES-MIR, M.P. MAJOR, P.W. MAJOR 42. Illing HM, Morris DO, Lee RT. A prospective evlution of Bss, Biontor nd Twin Block pplinces. Prt I the hrd tissues. Eur J Orthod. 1998;20:501 516. 43. Morris DO, Illing HM, Lee RT. A prospective evlution of Bss, Biontor nd Twin Block pplinces. Prt II the soft tissues. Eur J Orthod. 1998;20:663 684. 44. McDongh S, Moss JP, Goodwin P, Lee RT. A prospective opticl surfce scnning nd cephlometric ssessment of the effect of functionl pplinces on the soft tissues. Eur J Orthod. 2001;23:115 126. 45. Lnge DW, Klr V, Brodbent BH Jr, Powers M, Nelson S. Chnges in soft tissue profile following tretment with the biontor. Angle Orthod. 1995;65:423 430. 46. Flck F, Kobel EM. Chnges in the soft tissue profile in tretment with function regultors. Fortsch Kieferorthop. 1985;46:407 415.