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En la Tierra de la No-Evidencia, el Vendedor es el Rey?

Kevin OBrien and Jonathan Sandler. Manchester and Chesterfield, United Kingdom
Am J Orthod Dentofacial Orthop 2010;138:247-9 0889-5406/$36.00 Copyright _ 2010 by the American Association of
Orthodontists. doi:10.1016/j.ajodo.2010.06.010

Hace algunos aos, durante la presentacin de los resultados de una investigacin


clnica sobre el tratamiento temprano de la Clase II, en una conferencia nacional, se
argumentaba que los efectos reportados del aparato funcional en la relacin esqueltica,
durante el tratamiento temprano, eran insuficientes. Uno de los expositores manifest
que en nuestro estudio no se haban conseguido los cambios esquelticos con el Twinblock porque ''habamos sujetado los primeros molares inferiores, reduciendo con esto el
efecto ortopdico del aparato sobre el crecimiento de la mandbula''. Nuestra respuesta
fue que, nos pareca difcil de creer que un tramo de alambre pudiera cambiar el patrn
de control gentico del crecimiento en los nios del estudio.
Debemos confesar que entonces nos sentimos decepcionados cuando esta
explicacin pareci demeritar el enfoque de nuestro argumento. Este incidente nos llev a
la conclusin de que, lamentablemente se carece de una comprensin e interpretacin
correctas en la investigacin ortodncica contempornea, y que como especialidad, en
realidad la Ortodoncia no se fundamenta en una clnica basada en evidencia. Como
resultado decidimos escribir a esta editorial considerando que representa el estado del
avance actual de esta especialidad. En el presente documento tratamos de adoptar el
enfoque de alguien que participa en la transicin de una especialidad con baja en
evidencia a una que, esperamos, viene mejorando gradualmente.
Considerando los cambios en la investigacin ortodncica durante los ltimos 20
aos, dos precedentes notables sugieren que no todo ha estado bien. El caso ms
conocido es el de David Sackett, investigador mdico fundador del movimiento ''Atencin
Basada en la Evidencia''; cuando se le pidi valorar la calidad de la investigacin
ortodncica en el Simposio Moyers de 1986, coment que ''el fundamento de la prctica
ortodncica con base en evidencia se encuentra al nivel de la podologa, la quiroprctica y
la aromaterapia''. Esta observacin pronto fue seguida por las conclusiones de Tulloch y
colaboradores en una revisin de la literatura sobre aparatos funcionales publicada en
1990, donde llegaron a la conclusin de que los resultados eran tan dbiles, en trminos
de confiabilidad en investigaciones retrospectivas mal controladas, clculos basados en
muestras deficientes y un uso inadecuado de los anlisis estadsticos, que no era
argumentable apoyar ni rechazar el efecto de los aparatos funcionales sobre el
crecimiento.

Esto obliga a preguntarse: hemos avanzado desde entonces? Muchos opinaran


como aceptable que la mayora de los tratamientos ortodncicos debieran apoyarse en
resultados de estudios cientficos controlados, pero siempre y cuando estn disponibles.
Se han publicado estudios importantes sobre una gran variedad de protocolos incluyendo,
el tratamiento temprano de la Clase II, tipos de brackets, regmenes de retencin, manejo
de caninos ectpicos y fuerza extraoral. Estos reportes no slo han cambiado la prctica
de los clnicos experimentados, sino que tambin la de todos. Aunque la ventaja de los
estudios cientficos es innegable, los resultados de las investigaciones en ortodoncia no
siempre son aceptados, ya que tienden a desafiar las creencias a menudo arraigadas en
nuestros enfoques teraputicos.
Esta renuencia a cambiar convicciones no es inesperada, aunque manifiesta un
conocimiento pobre del recurso cientfico. Meikle lo resume de manera concisa,
sealando que el enfoque clnico se encuentra aun fuertemente influenciado por la
evidencia anecdtica as como por la formacin y experiencia personal del mdico, y no
precisamente por el recurso estadstico basado en normas. En otras palabras, nos
basamos en nuestros casos buenos que en realidad se encuentran varias desviaciones
estndar fuera de la norma; estos son los casos que mostramos en los congresos y donde
tratamos de fundamentar nuestro entrenamiento. Sin embargo nos olvidamos de que un
anlisis cientfico de los resultados no se basa en una coleccin de oropeles, sino en el
efecto del tratamiento promedio en el paciente promedio. Es verdad que este concepto
no es tan espectacular como la presentacin de un caso impresionante, sin embargo
constituye una base ms racional, pragmtica y vlida en la toma de decisiones
teraputicas. Cabe agregar que todos comenzamos un tratamiento con el objetivo de
lograr una respuesta fantstica y un resultado excelente, sin embargo, la verdad es que el
tratamiento ortodncico produce una respuesta altamente variable donde debemos
reconocer que el tratamiento perfecto o milagroso, a pesar de nuestras mejores
intenciones, lamentablemente no ocurre en todos nuestros pacientes.
Un tema comn de crtica es que los resultados con base en investigacin cientfica
no son aplicables en los pacientes de la prctica privada, ya que los investigadores se
ajustan a protocolos clnicos tan minuciosos que no tienen parecido con el mundo real.
Una vez ms, mientras que esto parece ser una crtica razonable, ha sido refutada en
cierto modo por numerosas investigaciones que han vinculado las escuelas dentales con el
entorno existente. Nuestra especialidad es a menudo renuente a aceptar resultados de
estudios de peso y cientficamente vlidos, realizados mediante procesos sencillos de
tratamiento. Sin embargo admite con entusiasmo mtodos que no han sido clnicamente
probados para un nivel de evidencia capaz de soportar el escrutinio cientfico pero estn
maravillosamente ilustrados y descritos en los folletos de mercadotecnia. Ejemplos de
esto, incluyen la promocin y la adopcin generalizada de correctores de Clase II para
pacientes no cooperadores, dispositivos de anclaje temporal (DAT o micro-tornillos) y
brackets de auto-ligado. Como especialistas buscamos brindar tratamientos ms rpidos,
fciles y cmodos para nuestros pacientes; ello implica no slo la bsqueda de mtodos
eficaces de tratamiento como alternativa al aparato extra-oral, sino tambin brackets con

menor friccin y tal vez hasta el desarrollo de nuevas filosofas invulnerables a la crtica
cientfica.
Si vemos el micro-tornillo como una alternativa de soporte, es sabido que a pesar
de su gran potencial an no est demostrada su eficacia como refuerzo de anclaje. No
obstante la informacin publicitaria sugiere que estos adminculos no slo son una
alternativa segura y eficaz al recurso extraoral, sino adems cmodo, que reducen la
necesidad de extracciones, aceleran el tratamiento y conducen a una menor necesidad de
ciruga ortogntica. Con todo, no deben confundirse los hechos crudos y realistas de la
ciencia pura con los sueos y aspiraciones de los pioneros que desarrollan las nuevas
tcnicas, particularmente cuando su objetividad se antoja algo turbia. Cuando se revisa de
modo crtico la literatura sobre estos dispositivos, lamentablemente parece ser que pese a
haber ms de 3500 artculos reportados sobre micro-tornillos, no existen estudios
aleatorios que corroboren cientficamente los argumentos. El conocimiento actual reporta
que, se sabe que un micro-tornillo se puede colocar fcil y relativamente sin dolor y que
tiene aproximadamente un 80% de posibilidades de permanecer donde sea colocado,
incluso despus de aplicar fuerzas para mover los dientes. Fuera de esto, no sabe mucho
acerca de su efectividad en comparacin con otras formas de anclaje.
Ahora que el uso de los micro-implantes se viene generalizando, sin embargo se ha
visto ensombrecido por una mayor aceptacin de los brackets de auto-ligado,
acompaados a menudo por nuevas filosofas de tratamiento. Cul es la evidencia de
este cambio de direccin en la efectividad teraputica? Una fuente directa de informacin
es la publicidad disponible difundida por los fabricantes, e indirectamente aquella que
involucra la propaganda proveniente de las redes promocionales de los propios
ortodoncistas. Curiosamente toda esta mercadotecnia est dirigida no slo a la profesin,
sino ms a menudo a nuestros pacientes y sus padres; sta es una tendencia preocupante.
Dnde est la evidencia detrs de estos testimonios? los anuncios con frecuencia se
basan en estudios de bajo nivel divulgados en publicaciones no cientficas; de hecho,
algunos de los reportes estn producidos por los fabricantes. Paradjicamente, diversos
estudios cientficos basados en revisiones sistemticas han demostrado que los brackets
de auto-ligado no confieren ninguna de las supuestas ventajas sobre los aparatos
convencionales, con respecto a la rapidez en la alineacin inicial o un mayor confort. Lo
que es ms importante, ningn estudio de calidad ha concluido el seguimiento de un
grupo de pacientes hasta la terminacin del tratamiento, con brackets convencionales y
de auto-ligado. Esta vendr a ser la prueba definitiva de las propiedades de los brackets de
auto-ligado; esperamos los resultados de estos estudios con gran inters. Es posible que
aquellos ortodoncistas que se involucraron con estos brackets y filosofas nuevas, con
base en la promesa de reducir el tiempo de tratamiento y las molestias, as como una
menor necesidad de extracciones, lleguen a creer que han padecido un caso evidente de
fraude. En perspectiva, de algn modo es obvio que los fabricantes pueden publicar
afirmaciones sin control sobre la validez o veracidad de sus declaraciones, mientras que al
mismo tiempo luchamos en apoyo de la investigacin cientfica.

En resumen, es claro que en los ltimos 20 aos la ortodoncia ha comenzado a


desarrollar una base cientfica slida con el objeto de apoyar algunas modalidades
teraputicas. Este fundamento en evidencias es probable que se haya originado como
consecuencia de la introduccin de los mtodos adecuados de investigacin clnica y en
los programas de estudio de odontologa. Desafortunadamente, existe una tendencia en
nuestra especialidad a olvidar los fundamentos cientficos una vez que se desarrollan
nuevos y mejores tratamientos.
Creemos que estamos ignorando las bases cientficas ante la creciente presin en
la bsqueda del tratamiento rpido, mejor y ms cmodo. Si queremos ganar el respeto
de nuestros colegas y pacientes, debemos considerar con cuidado los argumentos de los
proveedores e interpretarlos con fundamentos cientficos. Si no hacemos esto cada vez
que un producto nuevo sacude el mercado, estamos en grave peligro de decepcionar no
slo al pblico en general, sino hasta la profesin.
Nos gustara agradecer a Steve Chadwick, Ortodoncista Consultor, por sus valiosas
reflexiones en este documento.

GUEST EDITORIAL

In the land of no evidence, is the salesman king?


Kevin OBriena and Jonathan Sandlerb
Manchester and Chesterfield, United Kingdom

everal years ago, while presenting the results of


a randomized clinical trial about early Class II
treatment at a national conference, we reported
that that there was a limited effect of early functional
appliance treatment on the skeletal relationship. When
it came to question time, a delegate explained that we
did not get skeletal changes in our Twin-block group
because we had clasped the lower first molars which
reduced the orthopedic effect of the appliance on
mandibular growth. Our reply was that we found it
hard to believe that a little piece of wire would
change the genetically controlled growth pattern for
the children in the study. We must confess to feeling a little disappointed that the question seemed to have missed
the point of our presentation. This led us to the conclusion that a thorough understanding of contemporary
orthodontic research and its interpretation was sadly
lacking and that, as a specialty, we are not really adopting evidence-based orthodontic care. As a result, we
wrote this editorial, which we hope is an account of
where we are now. We have tried to adopt the viewpoint of people who have been involved in the transition
from a specialty with a low evidence base to one that, we
hope, is slowly improving.
When we consider the changes in orthodontic
research over the past 20 years, 2 notable milestones
coincide with an acknowledgment that all was not
well. The most well-known quote is that of David
Sackett,1 an American-based medical researcher and
a doyen of the evidence-based care movement.
When asked to review the quality of orthodontic research at the Moyers Symposium of 1986, he stated
that orthodontics is reliant on an evidence base that is
on a par with podiatry, chiropractitionary and aromatherapy. This was soon followed by the conclusions of a review into the functional appliance literature by
Tulloch et al,2 published in 1990. They concluded that
the literature was so weak, in terms of reliance on
poorly controlled, restrospective studies, poor sample
a

Professor of Orthodontics, University of Manchester, Manchester, United


Kingdom.
b
Consultant orthodontist, Royal Hospital, Chesterfield, Derbyshire, United
Kingdom.
Am J Orthod Dentofacial Orthop 2010;138:247-9
0889-5406/$36.00
Copyright 2010 by the American Association of Orthodontists.
doi:10.1016/j.ajodo.2010.06.010

size calculations and inappropriate use of statistical tests,


that it was not possible at that time to support or dismiss
the growth modifying effects of functional appliances.
This then begs the question, have we moved
forward since then? Many people would say that we
have, since there has been general acceptance that
most orthodontic interventions should be supported by
the results of randomized controlled trials, when and
if they are available. Many important studies have
been published about a variety of treatments including
early Class II treatment, bracket types, retainer regimens, management of displaced canines, and extraoral
headgear.3-8 These articles should not only have
changed the orthodontic practice of more enlightened
clinicians but should change the practice of everyone.
Although the advantages of randomized controlled
trials are undeniable, the findings of orthodontic trials
are not always universally accepted, because they tend
to challenge long-held beliefs that are often ingrained
into our treatment approaches. This reluctance to
change beliefs is not unexpected, but it demonstrates
a poor understanding of statistics. This was concisely
summarized by Meikle,9 who pointed out that clinical
opinion is still strongly influenced by anecdotal evidence and the training and experience of the clinician,
not always by the statistical artifact reported by the
mean. In other words, we remember our good cases,
which are often several standard deviations from the
mean. These are the cases we show at meetings and
on which we try to base our training. We forget, however, that a scientific analysis of outcomes is not based
on our collection of precious things but on the mean
effect of treatment for the average child. Such a concept
is admittedly not as attractive as an impressive case report but is a more rational, pragmatic, and valid basis on
which to make treatment decisions. It can be argued that
we all start a patients treatment with the aim of achieving a fantastic response and an excellent outcome. The
unfortunate truth, however, is that orthodontic therapy
has a variable response, and we should acknowledge
that the miracle or perfect treatment, despite our
best intentions, sadly does not occur for all our patients.
A common criticism is that the findings of clinical trials are not relevant to patients in private practice, because
the operators in trials are working to such tight protocols
that their treatment bears no resemblance to the real
247

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Guest editorial

world.10 Again, whereas on the surface this seems to be


a reasoned criticism, it has been answered to a certain extent by multi-center trials that have bridged the gap between dental schools and more real-world settings.6
Our specialty is often unwilling to accept the results
of well-conducted, scientifically valid trials of common
treatment methods but enthusiastically embraces treatment methods that have not been clinically tested to
a level of evidence that withstands scientific scrutiny
but are perhaps beautifully described and illustrated in
marketing brochures.
Current examples of this include the promotion and
widespread adoption of noncompliance Class II correctors, temporary anchorage devices (TADs), and selfligating brackets. As clinicians, we constantly aim to
provide treatments that are quicker, easier, and more
comfortable for our patients. This involves not only
the search for effective methods of treatment as alternatives to headgear, but also appliances offering less
friction in the bracket systems, and perhaps even the
development of totally new philosophies, which do
not necessarily stand up to scientific critique.11
If we look at the use of TADs as an alternative to
other forms of anchorage supplementation, it is clear
that, despite their great potential, they are as yet unproven with respect to their effectiveness in anchorage
reinforcement. Nevertheless, the advertising material
suggests that TADs are not only a safe and effective alternative to headgear, but also comfortable; they reduce
the need for extractions, speed up treatment, and lead to
less orthognathic surgery. However, we must not confuse the cold, hard facts of science with the dreams
and aspirations of the pioneers who are developing
the latest techniques, particularly when their objectivity
is somewhat opaque.
When we critically review the literature on these devices, it unfortunately appears that, despite 3500 articles
reporting on TADs, there are no randomized trials that
scientifically evaluate these claims. The current state
of knowledge is that we know that a microscrew can
be placed easily and relatively painlessly and has approximately an 80% chance of staying where we place
it, even after forces are applied to move nearby teeth.
We know nothing about their effectiveness compared
with other forms of anchorage. The use of TADs is
now widespread but has been overshadowed by the
wholesale acceptance of self-ligating brackets, often
accompanied by a new treatment philosophy. What is
the evidence for this clear change in treatment delivery?
One source of information is the marketing literature
available both directly from the manufacturing
companies and indirectly from orthodontists websites.
Interestingly, this advertising is directed not only to the

American Journal of Orthodontics and Dentofacial Orthopedics


September 2010

profession but also often to our patients and their


parents. This is a worrisome trend.
Where is the evidence behind these claims? The
advertising material often quotes research that is at
a low scientific level and published in journals that are
not refereed; some of these are actually produced by
the manufacturers. Paradoxically, several randomized
clinical trials and a systematic review have shown that
self-ligating brackets confer none of the claimed advantages over conventional brackets with regard to the
speed of initial alignment or increased comfort for the
patient.12-18 More importantly, no high-quality studies
have followed a group of patients to the completion of
treatment with self-ligating vs conventional brackets.
This will be the ultimate test of the claims concerning
self-ligating brackets, and we await the results of these
studies with great interest.
It may be that orthodontists who bought the new
brackets and philosophy based on the promise that
they reduce treatment time and discomfort with less
need for extractions will come to believe that a compelling case of misselling has taken place. In retrospect, it
is somewhat remarkable that manufacturers can make
claims with no apparent checks on the validity or
veracity of their statements, while at the same time we
struggle for support for scientific research.
In summary, it is clear that, over the last 20 years,
orthodontics has begun to develop a strong scientific
basis to support some of our treatment modalities.
This evidence base is likely to have had its origins after
the introduction of proper research methodology into
our dental schools and curricula. Unfortunately, there
is a tendency for our specialty to forget its research
base when new and better treatments are developed.
We fear that we are currently ignoring our scientific
knowledge with the increasing pressure to provide treatment that is faster, better, and more comfortable.
If we are to have the respect of our colleagues and
our patients, we must very carefully consider the claims
of sales representatives and interpret them with due consideration of our scientific knowledge. If we do not do
this every time a new product hits the marketplace, we
are in serious danger of letting down not only the
general public but ultimately the entire profession.
We would like to thank Steve Chadwick, Consultant
Orthodontist, for his thoughtful comments on this paper.
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