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This document summarizes the current concepts regarding functional appliances and their ability to stimulate mandibular growth. It discusses that:
1) Many previous studies on functional appliances have been criticized for poor methodology and retrospective observations rather than prospective randomized clinical trials, which are considered the best standard of evidence.
2) While some studies have reported favorable growth changes following functional appliance therapy, the effects are generally small and long-term stability appears poor.
3) On the basis of available evidence, it cannot be conclusively determined that functional appliances are effective in significantly stimulating and increasing mandibular growth in the long run.
Originalbeschreibung:
Current Concepts on Functional Appliances for orthodonctis
This document summarizes the current concepts regarding functional appliances and their ability to stimulate mandibular growth. It discusses that:
1) Many previous studies on functional appliances have been criticized for poor methodology and retrospective observations rather than prospective randomized clinical trials, which are considered the best standard of evidence.
2) While some studies have reported favorable growth changes following functional appliance therapy, the effects are generally small and long-term stability appears poor.
3) On the basis of available evidence, it cannot be conclusively determined that functional appliances are effective in significantly stimulating and increasing mandibular growth in the long run.
This document summarizes the current concepts regarding functional appliances and their ability to stimulate mandibular growth. It discusses that:
1) Many previous studies on functional appliances have been criticized for poor methodology and retrospective observations rather than prospective randomized clinical trials, which are considered the best standard of evidence.
2) While some studies have reported favorable growth changes following functional appliance therapy, the effects are generally small and long-term stability appears poor.
3) On the basis of available evidence, it cannot be conclusively determined that functional appliances are effective in significantly stimulating and increasing mandibular growth in the long run.
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 Johnston5 who wrote: No biological and increasing mandibular growth in the long term. basis? No evidence? No 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. epidemiologist 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, homeopathy, and orthomolecular therapy and on a par with Introduction scientology . . .. More recently, in 1995, Sackett7 Functional appliances have become 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. The ability of orthodontics. Although Sackett6,7 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. The 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 However, there is overall agreement the randomized change in the skeletal pattern. The mandibular trial is the best method for minimizing biases and growth aspect is of particular interest as most skeletal detecting differences between treatments. Class II patterns have as their main component mandibular retrognathia.1 Cephalometric landmarks Previous 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 Much of the earlier literature relating to functional supporting functional appliance stimulated 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 The 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. many, with inconsistent findings. Functional Australian Dental Journal 2000;45:3. 173 Fig. 2. Modified Bionator type appliance. Headgear tubes allow application of extra-oral traction.
Fig. 3. Teuscher appliance. Note the characteristic anterior
torquing springs which are adjusted to minimize upper incisor Fig. 1. Cephalometric landmarks used for mandibular growth proclination. analysis. Ar-articulare; Co-condylion; Gn-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. Claims 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 number of consecutively treated Fig. 4. Frankel FR-2 appliance. patients. It is attractive to believe in functional appliance stimulated growth for, as Johnston14 poor methodology (Table 2), or are simply anecdotal noted, it is a very good idea and also has the case reports.2 The 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 Class II cases can be rectify the situation. When assessing the effects of treated the same way. appliances, the hierarchy of evidence shown in Table Many of the reports concerning growth effects of 3 should be borne in mind. Case reports, although at functional appliances have been characterized by the lower end of the hierarchy, do serve a useful purpose. Case 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 Harvold Activator Conclusions from isolated cases Herbst appliance Lack of suitable controls Herren Activator Compliance measurement Modified Bionator Inadequate sampling Orthopaedic corrector (1 and 2) Retrospective observations Stockli Type Activator Data measurement and evaluation Robin Monobloc Detecting 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 Case report mandibular length,2,20-29 other studies have concluded Opinion of expert that functional appliances do not affect mandibular growth.30-36 The studies reporting a positive effect on mandibular growth still leave this question reports provokes further investigation. Numerous 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 randomized 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 The clinical significance of a measured increase in treatment.15-19 Clinicians do not generally persist mandibular length needs to be considered in terms with treatment that is not producing the desired of forward chin positioning. The 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 McNamara 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.This table is Herbst appliance did demonstrate this effect.24
Erverdi and Ozkan, 1995 20 Elastic bite-blocks, retention with Bionator Fidler et al., 1995 16 Retrospective; successful cases studied Ghafari et al., 1998 21 Prospective randomized clinical trial; no control group Gianelly et al., 1984 54 Retrospective; compliant cases Illing et al., 1998 46 Clinical 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 McNamara, 1998 38 Retrospective; Herbst 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 Mamandras and Allen, 1990 19 Retrospective; successful cases, Bionator McNamara, 1985 11 FR-2, cooperative patients McNamara et al., 1985 22 Retrospective; FR-2 McNamara et al., 1990 23 Retrospective radiographic study; FR-2 , Herbst McNamara et al., 1996 24 Retrospective study; FR-2 Mills and McCulloch, 1998 44 Prospective radiographic study; Twin Blocks Nelson et al., 1993 33 Prospective, randomized; FR, Harvold and control groups Pancherz et al., 1979, 1990, 1991, 1997 37, 39-42 Herbst 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 Class I Robertson, 1983 34 Prospective; FR-2, emphasized need for RCT Rudzki-Janson and Noachtar, 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. The UNC 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. This finding agrees with previous studies that also failed to demonstrate any benefits in terms of skeletal change with early phase 1 therapy.53-56 Johnston5 reduced this debate to the simple statement: 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 The study of Keeling et al.48 concurred with that of evaluated carefully. Johnston5,14 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. The change in mandibular length two. In addition, analyses that rely on the measure- was greater in the functional group than the control ment articulare15,18 are unable to discriminate 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-time functional appliance wear (and post-phase 2) data have yet to be collected. Does the lack of appreciable growth in some The clinical trial of Illing et al.46 also lacks long- studies relate to a lack of full-time use? One variant term data. The trial examined the responses to of the functional appliance that is worn for 24 hours treatment with Bass, Bionator and Twin Block is the Herbst appliance. Many of the reports relating appliances. The treatment and control groups effects of the Herbst appliance have been authored consisted of patients with mandibular retrusion and by Pancherz. Pancherz37 initially claimed the an ANB 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 SNB angle was noted. increase in mandibular length (or mandibular Unfortunately, the long-term results were not so displacement), as measured from articulare to encouraging.38-43 Subsequently, Pancherz concluded gnathion, compared with the control. However, 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. None of studies are inconclusive. While short-term data44 the appliances were successful in increasing either have suggested increased chin projection with the the SNB 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 treatment Mandibular growth and results of prospective In cases where functional appliances are utilized, randomized clinical trials the patient usually requires further detailing with Illing et al.,46 Keeling et al.47,48 and the University of fixed appliances.57 Although early functional North Carolina (UNC)49-52 have recently undertaken appliance therapy has been reported to decrease the prospective randomized clinical trials of Class 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 Ghafari 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 Jakobsson30 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 UNC 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. Thus, 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 maxilla could not be appliances do not provide an option to surgery in demonstrated. A similar negative outcome was severe Class II cases. Evidence suggests the modest observed in a follow-up of patients treated with the skeletal changes revert with time. In assessing Herbst appliance.41 In the study of Livieratos and functional appliances, results from prospective Johnston,56 headgear treated patients were found to randomized clinical trials should be given have undergone more maxillary change, while those prominence. treated with a Bionator demonstrated more mandibular change (growth or displacement) after References phase 1 therapy. However, these changes were no 1. Ngan PW, Byczek E, Scheick J. Longitudinal evaluation of longer evident at the completion of phase 2 fixed growth changes in Class II division 1 subjects. Semin Orthod 1997;3:222-231. appliance therapy. As Johnston5 noted, regardless of 2. Tulloch JF, Medland W, Tuncay OC. Methods used to evaluate the appliance a common outcome is likely, implying growth modification in Class II malocclusion. Am J Orthod a common mechanism. The prime candidate is Dentofacial Orthop 1990;98:340-347. normal facial growth. 3. Nies AS, Spielberg SP. Principles of therapeutics. In: Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, Gilman AG, eds. Goodman and Gilmans the pharmacological basis of Clinical applications therapeutics. 9th edn. New York: McGraw-Hill, 1996:43-62. In terms of practical clinical applications, a lack of 4. Sackett DL. On identifying the best therapy. In: Trotman C-A, McNamara JA Jr, eds. Orthodontic treatment: Outcome and significant skeletal change with functional appliances effectiveness. Volume 30: Craniofacial growth series. Ann Arbor: does not diminish their use in correcting overjets. The University of Michigan, 1995:7-19. The appliance is still a useful orthodontic tool for 5. Johnston LE Jr. Growing jaws for fun and profit: A modest correcting Class II malocclusions, although not proposal. In: McNamara JA Jr, ed. Growth modification: What works, what doesnt, and why. Volume 25: Craniofacial growth unique in this regard. Of relevance are the series. Ann Arbor: The University of Michigan, 1999:63-86. concluding remarks of Livieratos and Johnston,56 6. Sackett DL. The 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. Monograph 19: Craniofacial growth series. Ann Arbor: The University of Michigan, 1986:237-251. management problem . . . Recent findings underpin 7. Sackett DL. Nine years later: A commentary on revisiting the the importance of correct diagnosis and being able Moyers symposium. In: Trotman C-A, McNamara 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 Craniofacial growth series. Ann Arbor: The University of Michigan, 1995:1-5. has a severe retrognathic profile with a deficient chin 8. Johnston LE Jr. Clinical studies in orthodontics: Taking the low where surgery may be required, the use of a road to Scotland. In: Trotman C-A, McNamara JA Jr, eds. functional appliance is unlikely to change the long- Orthodontic treatment: Outcome and effectiveness. Volume 30: Craniofacial growth series. Ann Arbor: The University of term surgical needs. However, in many cases Michigan, 1995:21-41. favourable profile changes can occur. The overall 9. Vig WL, Bennett ME, 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, McNamara JA Jr, eds. Orthodontic treatment: Outcome and effectiveness. Volume 30: Craniofacial may result in an improved profile due to more growth series. Ann Arbor: The University of Michigan, favourable soft tissue drape. For example, consider 1995:227-254. the patient with a Class II division 1 pattern with a 10. McNamara JA Jr. Neuromuscular and skeletal adaptations to large overjet and lower lip habit (the lower lip at rest altered function in the orofacial region. Am J Orthod 1973;64:578-606. being positioned behind the upper labial segment). 11. McNamara JA Jr. The role of functional appliances in Reduction of the overjet can result in a substantial contemporary orthodontics. In: Johnston LE Jr, ed. New vistas improvement in facial aesthetics, without altering in orthodontics. Philadelphia: Lea & Febiger, 1985:38-75. the skeletal base relationship. After reduction of the 12. 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