Abstract responsible for suggesting spurious associations and
The mode of action of functional appliances, promoting useless treatments. It should be borne in particularly in relation to stimulating mandibular mind that the path to introducing a new drug into growth, is a controversial subject. Many of the the market place involves a prospective randomized reports concerning growth effects of functional appliances have been characterized by poor clinical trial. 3,4 Yet, for many years, the orthodontic methodology. In assessing functional appliances, profession has accepted certain claims regarding the results from prospective randomized clinical trials clinical efficacy of appliances, in the absence of any should be given prominence. On the basis of scientific evidence. A very unflattering observation available evidence, it cannot be concluded that functional appliances are effective in stimulating was made by Johnston 5 who wrote: N o biological and increasing mandibular growth in the long term. basis? N o evidence? N o matter. Facial growth, surely Although favourable growth changes have been one of the most complex of all biological processes, reported following phase 1 therapy, they are is now thought to have yielded without a struggle generally not substantial and long term stability appears to be poor. and in some unknown way to the ministrations of small, eponymous pieces of plastic. Sackett, 6 an Key words: Class II treatment, dentofacial orthopaedics, functional appliance, mandibular growth. epidem iologist who assessed the orthodontic literature for scientific validity, wrote in 1986 . . . in (Received for publication August 1999. Revised March terms of the number of published randomized trials, 2000. Accepted March 2000.) orthodontics was behind such treatment modalities as acupuncture, hypnosis, hom eopathy, and orthomolecular therapy and on a par with Introduction scientology . . .. M ore recently, in 1995, Sackett 7 F unctional appliances have becom e part of noted the increase in randomized trials in orthodontics contemporary orthodontic practice, however, their and applauded the move to evidence-based mode of action is still controversial. T he ability of orthodontics. Although Sackett 6,7 has argued for functional appliances to reduce overjets by means of acceptance of the randomized clinical trial, others modifying dental relationships (incisor angulation have proposed alternative approaches to research, and position) is not in dispute. T he controversy largely due to the cost of randomized trials as well as surrounds the ability of the appliances to increase their labour intensive and time consuming nature. 8,9 mandibular growth, and thus result in a long-term H owever, there is overall agreement the randomized change in the skeletal pattern. T he mandibular trial is the best method for minimizing biases and growth aspect is of particular interest as most skeletal detecting differences between treatments. C lass II patterns have as their main component mandibular retrognathia. 1 C ephalometric landmarks P revious studies used in mandibular growth analysis are shown in Fig. 1. In the 1970s and 80s there was an increase in the numbers of papers published in refereed journals M uch of the earlier literature relating to functional supporting functional appliance stim ulated appliances has been criticized on the basis of mandibular growth. scientific methodology. 2 Tulloch et al. 2 stated there are many examples in the health sciences where T he question of whether the effect of mandibular opinions based on the observation of a few patients forward positioning appliances in increasing or studies that used relatively weak design have been mandibular growth in animal studies10-13 can be reproduced in humans has been widely addressed by *Orthodontist. m any, with inconsistent findings. F unctional Australian Dental Journal 2000;45:3. 173 Fig. 2. M odified Bionator type appliance. H eadgear tubes allow application of extra-oral traction.
Fig. 3. Teuscher appliance. N ote the characteristic anterior
torquing springs which are adjusted to minimize upper incisor Fig. 1. C ephalometric landmarks used for mandibular growth proclination. analysis. Ar-articulare; C o-condylion; G n-gnathion; N -nasion; Po pogonion; S-sella.
appliances are varied and diverse in design (Table 1,
Fig. 2-5) with their proponents often having a proprietary interest in the appliance. C laims as to the efficacy of the appliances by clinicians with a financial interest should be treated with caution. Presentations which consist of carefully chosen cases may not necessarily reflect the actual results seen over a large num ber of consecutively treated Fig. 4. Frankel FR-2 appliance. patients. It is attractive to believe in functional appliance stim ulated growth for, as Johnston 14 poor methodology (Table 2), or are simply anecdotal noted, it is a very good idea and also has the case reports. 2 T he problem has been recognized and advantage of removing some of the decision making acknowledged by the profession, with steps taken to in treatment planning if all C lass II cases can be rectify the situation. When assessing the effects of treated the same way. appliances, the hierarchy of evidence shown in Table M any of the reports concerning growth effects of 3 should be borne in mind. C ase reports, although at functional appliances have been characterized by the lower end of the hierarchy, do serve a useful purpose. C ase reports may identify a possible effect Table 1. Examples of various functional (or adverse effect) of a therapy, and a body of such appliances Andresen Activator Bass appliance Table 2. Common problems with clinical Bionator (and variants) Elastic Bite-block research studies concerning growth effects Elastic Open Activator of functional appliances Frankel FR-2 Functional Regulator H arvold Activator C onclusions from isolated cases H erbst appliance Lack of suitable controls H erren Activator C ompliance measurement M odified Bionator Inadequate sampling Orthopaedic corrector (1 and 2) Retrospective observations Stockli Type Activator D ata measurement and evaluation Robin M onobloc D etecting minimal changes Teuscher appliance Biological variation Twin Block Experimental versus clinical significance Woodside Type Activator Lack of long-term studies
174 Australian Dental Journal 2000;45:3.
Table 3. Hierarchy of clinical evidence for not intended to be all-inclusive, but rather an example assessment of the effects of functional of what has been published over the last 30 years. appliances Prospective randomized clinical trial Mandibular growth Prospective study non-random Retrospective study pretreatment selection criteria While some reports in the literature conclude that Retrospective study post-treatment selection criteria functional appliances are effective in increasing C ase report mandibular length, 2,20-29 other studies have concluded Opinion of expert that functional appliances do not affect mandibular growth. 30-36 T he studies reporting a positive effect on m andibular growth still leave this question reports provokes further investigation. N umerous unanswered due to characteristics such as lack of a case reports do not constitute definitive evidence control group, 21,27 clinically minimal effects20 and and a well conducted prospective random ized clinical trial(s) must be given a higher ranking. A patients being retained with a mandibular positioning notable shortcoming of clinical retrospective studies appliance. 20,25 is the selection of only those patients who completed T he clinical significance of a measured increase in treatment. 15-19 C linicians do not generally persist mandibular length needs to be considered in terms with treatment that is not producing the desired of forward chin positioning. T he increase in length response. It is easy to assume a lack of cooperation, may be negated by clockwise mandibular rotation. however, it is also possible the appliance had no For example, in the studies of M cN amara et al., 22-24 significant therapeutic effect and the study simply despite giving an increase in mandibular length, the selected patients experiencing favourable growth. Frankel appliance did not increase anterior chin Table 4 lists papers which are representative of projection compared with the control, although the studies concerning functional appliances. T his table is H erbst appliance did demonstrate this effect. 24
Adenwalla and Kronman, 1985 53 Retrospective; FR versus edgewise
Bishara and Ziaja, 1989 28 Review C reekmore and Radney, 1983 32 Retrospective; successfully treated malocclusions D erringer, 1990 15 Retrospective; Andresen, successful cases studied D eVincenzo, 1991 18 Retrospective; successful cases studied D rage and H unt, 1990 31 Retrospective; successful cases, relapse studied Erverdi and Ozkan, 1995 20 Elastic bite-blocks, retention with Bionator Fidler et al., 1995 16 Retrospective; successful cases studied G hafari et al., 1998 21 Prospective randomized clinical trial; no control group G ianelly et al., 1984 54 Retrospective; compliant cases Illing et al., 1998 46 C linical trial; Bass, Bionator, Twin Block Jakobsson, 1967 30 Prospective randomized study; Activator Johnston, 1999 5 Review Johnston, 1996 14 Review Johnston, 1986 55 Retrospective; Bionator, Activator, Sagittal appliance Keeling et al., 1995, 1998 47, 48 Prospective clinical trial Lai and M cN amara, 1998 38 Retrospective; H erbst appliance Lange et al., 1995 17 Retrospective; successfully treated cases, Bionator Livieratos and Johnston, 19?? 56 Two phase therapy versus phase 1 therapy Lund and Sandler, 1998 45 Prospective studies, not randomized; Twin Blocks M amandras and Allen, 1990 19 Retrospective; successful cases, Bionator M cN amara, 1985 11 FR-2, cooperative patients M cN amara et al., 1985 22 Retrospective; FR-2 M cN amara et al., 1990 23 Retrospective radiographic study; FR-2 , H erbst M cN amara et al., 1996 24 Retrospective study; FR-2 M ills and M cC ulloch, 1998 44 Prospective radiographic study; Twin Blocks N elson et al., 1993 33 Prospective, randomized; FR, H arvold and control groups Pancherz et al., 1979, 1990, 1991, 1997 37, 39-42 H erbst appliance effects and long-term follow-up Perillo et al., 1996 25 Retrospective; some cases retained with Activator Righellis, 1983 26 Retrospective; successfully treated to molar C lass I Robertson, 1983 34 Prospective; FR-2, emphasized need for RC T Rudzki-Janson and N oachtar, 1998 35 Initial prospective study with post-retention follow-up Tulloch et al., 1990 2 Review Tulloch et al., 1995, 1997, 1998 49-52 Prospective randomized clinical trial Tuncay and Tulloch, 1992 29 Review Weiland et al., 1997 27 Retrospective; radiographic study Wieslander, 1993 43 Retrospective; available post-retention records analysed Wieslander and Largerstrom, 1979 36 Patient sample compared with retrospective control group
Increased weighting should be given to prospective randomized clinical trials.
Australian Dental Journal 2000;45:3. 175 differences in the jaw relationship or dental occlusion, compared with later one-stage treatment. T he U N C group also attempted to objectively measure compliance by incorporating timing devices into some of the appliances. Although favourable skeletal changes were noted in the functional appliance group following phase 1 therapy, the changes were not maintained. T his finding agrees with previous studies that also failed to demonstrate any benefits in terms of skeletal change with early phase 1 therapy. 53-56 Johnston 5 reduced this debate to the sim ple statem ent: Absent a ponderable difference in outcome, the inescapable fact that a Fig. 5. Twin Block appliance. two year treatment is three years faster than a five year treatment may speak for itself. Also, initial mandibular changes need to be T he study of Keeling et al. 48 concurred with that of evaluated carefully. Johnston 5,14 has suggested that Tulloch et al. 50 in that functional appliances brought what may be interpreted as growth in fact amounts about some favourable skeletal change following to mandibular displacement or a combination of the phase 1 treatment. T he change in mandibular length two. In addition, analyses that rely on the measure- was greater in the functional group than the control m ent articulare 15,18 are unable to discrim inate and amounted to a little less than 1 mm per year. In between growth and displacement. Keelings study the changes appeared to be stable 12 months after therapy, although further long-term Full- tim e functional appliance wear (and post-phase 2) data have yet to be collected. D oes the lack of appreciable growth in some T he clinical trial of Illing et al. 46 also lacks long- studies relate to a lack of full-time use? One variant term data. T he trial examined the responses to of the functional appliance that is worn for 24 hours treatment with Bass, Bionator and Twin Block is the H erbst appliance. M any of the reports relating appliances. T he treatm ent and control groups effects of the H erbst appliance have been authored consisted of patients with mandibular retrusion and by Pancherz. Pancherz37 initially claim ed the an AN B angle of greater than 6. Of the three appliance increased mandibular growth and an appliances, the Bionator and Twin Block gave an associated increase in the SN B angle was noted. increase in m andibular length (or m andibular U nfortunately, the long-term results were not so displacem ent), as m easured from articulare to encouraging. 38-43 Subsequently, Pancherz concluded gnathion, compared with the control. H owever, the that the inherent morphogenetic pattern dominates effect on the profile seemed to be negated by an over the treatment procedure. 41 increase in facial height. Also, only the Bionator Twin Blocks are also promoted as virtually full- recorded a significant increase in mandibular length time wear appliances. Results from Twin Block as measured from condylion to gnathion. N one of studies are inconclusive. While short-term data 44 the appliances were successful in increasing either have suggested increased chin projection with the the SN B angle or the forward projection of pogonion, appliance, other studies have been unable to compared with the control group. demonstrate this effect. 45,46 Length of treatm ent Mandibular growth and results of prospective In cases where functional appliances are utilized, random ized clinical trials the patient usually requires further detailing with Illing et al., 46 Keeling et al. 47,48 and the U niversity of fixed appliances. 57 Although early functional N orth C arolina (U N C ) 49-52 have recently undertaken appliance therapy has been reported to decrease the prospective randomized clinical trials of C lass II time in fixed appliances (phase 2), the total treat- appliances. A randomized clinical trial has also been ment time is generally increased over that for fixed conducted by G hafari et al., 21 however, their lack of appliances only. 50,56,58 a control group is a drawback. An earlier prospective study was conducted by Jakobsson 30 and, as Maxillary restraint mentioned above, the conclusion was that activators A restraining effect on the maxilla has also been do not bring about an increase in mandibular growth. reported with use of functional appliances. 30,38,44 Of Tulloch et al. 50 concluded on the basis of the U N C course, maxillary change is generally measured to A two-phase randomized trial that early treatment point, which is a dento-alveolar landmark rather (phase 1) followed by later comprehensive treatment than true skeletal point. T hus, observed maxillary (phase 2), on average, does not produce major restraint does not necessarily reflect skeletal 176 Australian Dental Journal 2000;45:3. modification. In various prospective studies45,46,48,50 in anterior chin positioning, indicating that these such an effect on the m axilla could not be appliances do not provide an option to surgery in demonstrated. A similar negative outcome was severe C lass II cases. Evidence suggests the modest observed in a follow-up of patients treated with the skeletal changes revert with time. In assessing H erbst appliance. 41 In the study of Livieratos and functional appliances, results from prospective Johnston, 56 headgear treated patients were found to random ized clinical trials should be given have undergone more maxillary change, while those prominence. treated with a Bionator dem onstrated m ore mandibular change (growth or displacement) after References phase 1 therapy. H owever, these changes were no 1. N gan PW, Byczek E, Scheick J. Longitudinal evaluation of longer evident at the completion of phase 2 fixed growth changes in C lass II division 1 subjects. Semin Orthod 1997;3:222-231. appliance therapy. As Johnston 5 noted, regardless of 2. Tulloch JF, M edland W, Tuncay OC . M ethods used to evaluate the appliance a common outcome is likely, implying growth modification in C lass II malocclusion. Am J Orthod a common mechanism. T he prime candidate is D entofacial Orthop 1990;98:340-347. normal facial growth. 3. N ies AS, Spielberg SP. Principles of therapeutics. In: H ardman JG , Limbird LE, M olinoff PB, Ruddon RW, G ilman AG , eds. G oodm an and G ilm ans the pharm acological basis of Clinical applications therapeutics. 9th edn. N ew York: M cG raw-H ill, 1996:43-62. In terms of practical clinical applications, a lack of 4. Sackett D L. On identifying the best therapy. In: Trotman C -A, M cN amara JA Jr, eds. Orthodontic treatment: Outcome and significant skeletal change with functional appliances effectiveness. Volume 30: C raniofacial growth series. Ann Arbor: does not diminish their use in correcting overjets. T he U niversity of M ichigan, 1995:7-19. T he appliance is still a useful orthodontic tool for 5. Johnston LE Jr. G rowing jaws for fun and profit: A modest correcting C lass II malocclusions, although not proposal. In: M cN amara JA Jr, ed. G rowth modification: What works, what doesnt, and why. Volume 25: C raniofacial growth unique in this regard. O f relevance are the series. Ann Arbor: T he U niversity of M ichigan, 1999:63-86. concluding remarks of Livieratos and Johnston, 56 6. Sackett D L. T he science of the art of clinical management. In: who wrote: We suspect that the decision to use Vig PS, Ribbens KA, eds. Science and clinical judgement in functional appliances is fundamentally a practice- orthodontics. M onograph 19: C raniofacial growth series. Ann Arbor: T he U niversity of M ichigan, 1986:237-251. management problem . . . Recent findings underpin 7. Sackett D L. N ine years later: A commentary on revisiting the the importance of correct diagnosis and being able M oyers symposium. In: Trotman C -A, M cN amara JA Jr, eds. to differentiate between the skeletal and dental Orthodontic treatment: Outcome and effectiveness. Volume 30: components of a malocclusion. For a patient who C raniofacial growth series. Ann Arbor: T he U niversity of M ichigan, 1995:1-5. has a severe retrognathic profile with a deficient chin 8. Johnston LE Jr. C linical studies in orthodontics: Taking the low where surgery may be required, the use of a road to Scotland. In: Trotman C -A, M cN amara JA Jr, eds. functional appliance is unlikely to change the long- Orthodontic treatment: Outcome and effectiveness. Volume 30: C raniofacial growth series. Ann Arbor: T he U niversity of term surgical needs. H owever, in m any cases M ichigan, 1995:21-41. favourable profile changes can occur. T he overall 9. Vig WL, Bennett M E, OBrien K, Vayda D, Vig PS, Weyant RJ. facial profile is the result of skeletal, dental and soft Orthodontic process and outcome: Efficacy and effectiveness tissue contributions. Improving dental relationships studies. In: Trotman C -A, M cN amara JA Jr, eds. Orthodontic treatment: Outcome and effectiveness. Volume 30: C raniofacial may result in an improved profile due to more growth series. Ann Arbor: T he U niversity of M ichigan, favourable soft tissue drape. For example, consider 1995:227-254. the patient with a C lass II division 1 pattern with a 10. M cN amara JA Jr. N euromuscular and skeletal adaptations to large overjet and lower lip habit (the lower lip at rest altered function in the orofacial region. Am J O rthod 1973;64:578-606. being positioned behind the upper labial segment). 11. M cN am ara JA Jr. T he role of functional appliances in Reduction of the overjet can result in a substantial contemporary orthodontics. In: Johnston LE Jr, ed. N ew vistas improvement in facial aesthetics, without altering in orthodontics. Philadelphia: Lea & Febiger, 1985:38-75. the skeletal base relationship. After reduction of the 12. M cN amara JA Jr. On the possibilities of stimulating mandibular overjet, the lower lip can rest and function in front of growth. In: G raber LW, ed. Orthodontics: State of the art, essence of the science. St Louis: M osby, 1986. the upper teeth. 13. Petrovic AG , Stutzmann JJ, Lavergne JM . M echanisms of craniofacial growth and modus operandi of functional appliances: Conclusion A cell-level and cybernetic approach to orthodontic decision making. In: C arlson D S, ed. C raniofacial growth theory and On the basis of available evidence, it cannot be orthodontic treatment. M onograph 23: C raniofacial growth concluded that functional appliances are effective in series. Ann Arbor: T he U niversity of M ichigan, 1990:13-74. stim ulating and increasing m andibular growth. 14. Johnston LE Jr. F unctional appliances: A m ortgage on mandibular position. Aust Orthod J 1996;14:154-157. D espite claim s to the contrar y, the superior 15. D erringer K. A cephalometric study to compare the effects of functional appliance has yet to be demonstrated. cervical traction and Andresen therapy in the treatment of C lass Although favourable growth changes have been II division 1 malocclusion. Part 1 Skeletal changes. Br J Orthod reported following phase 1 therapy, they are generally 1990;17:33-46. not substantial and long-term stability appears to be 16. Fidler BC , Artun J, Joondeph D R, Little RM . Long-term stability of Angle C lass II, division 1 malocclusions with success- poor. T he positive reports as to functional appliance ful occlusal results at end of active treatment. Am J Orthod stimulated growth show only minor improvements D entofacial Orthop 1995;107:276-285. Australian Dental Journal 2000;45:3. 177 17. 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Stability or Orthop 1990;97:113-120. relapse? Am J Orthod D entofacial Orthop 1993;104:319-329. 20. Erverdi N , Ozkan G. A cephalometric investigation of effects of 44. M ills C M , M cC ulloch KJ. Treatment effects of the twin block the Elastic Bite-Block in the treatment of C lass II division 1 appliance: A cephalometric study. Am J Orthod D entofacial malocclusions. Eur J Orthod 1995;17:375-384. Orthop 1998;114:15-24. 21. G hafari J, Shofer FS, Jacobsson-H unt U, M arkowitz D L, Laster 45. Lund D L, Sandler PJ. T he effects of twin blocks: A prospective LL. H eadgear versus function regulator in the early treatment of controlled study. Am J O rthod D entofacial O rthop C lass II, division 1 malocclusion: A randomized clinical trial. Am 1998;113:104-110. J Orthod D entofacial Orthop 1998;113:51-61. 46. Illing H M , M orris D O, Lee RT. A prospective evaluation of Bass, 22. M cN amara JA, Bookstein FL, Shaughnessy T G. Skeletal and Bionator and Twin Block appliances. 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