SPECIAL ARTICLE

Understanding science and evidence-based

decision making in orthodontics
Donald J. Rinchuse,a Emily M. Sweitzer,b Daniel J. Rinchuse,a and Dara L. Rinchusec
Pittsburgh, Pa

T
he early part of the 1990s ushered in evidence- science. In the present age of EBD, orthodontists need
based decision making for health care.1 Pres- to understand the basic tenets of science and research.
ently, there is a resurgence in evidence-based The purpose of this article is to highlight and demon-
decision making with evidence-based dentistry (EBD) strate the importance of understanding the principles of
the buzzword in dental periodicals.2-4 The call for scientific inquiry so that the orthodontist has a greater
dentists to understand science and research is not new. appreciation for well-conceived clinical orthodontic
The Geis Report5 of the early 1920s petitioned medical research and evidence-based care.
and dental schools to become more scientific in their
teaching and practice. William Geis’s cry for dentists to THE FAULTY ARGUMENT AGAINST EVIDENCE-
be educated and practice in a climate of science was BASED DECISION MAKING
evident in the last part of the 20th century. In orthodon-
Tragically, some in and outside the health profes-
tics, several icons in the profession have stressed the
sions deny the validity and usefulness of science and
importance of science in clinical practice. William
the evidence-based paradigm. Instead of carefully con-
Proffit6 wrote, “The orthodontic practitioner is akin to the
sidering defensible arguments fostered by science, they
scientist who must continually evaluate new research
credulously swallow dogmatic assertions based on
findings.” Furthermore, Peter Vig7 stated, “orthodontists
emotionalism. The print, air, TV, and cyber media are
have lain greater emphasis on mastering their art than
replete with views that discredit the evidence-based
mastering their science. . . . There are many orthodontic
approach. One argument is that the powerful drug
controversies, past and present, that center on whose art
companies fund most evidence-based pharmacologic
is superior.” Lysle Johnston8 claimed, “Those who
research, and, therefore, the findings are biased. This
advocate new therapies seem disinclined to provide
conspiracy theory is perhaps evident in orthodontics;
evidence of efficacy (it may be bad for business); the
some argue that the refereed orthodontic journals are
profession as a whole, perhaps being convinced in
biased against experience-based clinical views. They
dental school of the irrelevance of ‘science,’ seems
complain that much of the clinical research is per-
equally disinclined to demand it.” And it is conceivable
formed by academics with little or no clinical experi-
that the apparent disregard for the principles of scien-
ence.10
tific inquiry prompted Alton Moore9 to write, “Clearly,
the promulgation of simple rules and pat formulas and Another argument advanced against scientific in-
the immediate and uncritical adoption of them prior to quiry, often by new-age believers and alternative health
testing . . . have inhibited true progress.” advocates, is the “Galileo ploy.”11 That is, the ideas of
our most prominent historic and scientific figures were
It seems, however, that dentistry and orthodontics
criticized in their day. They claim that people mocked
have lagged behind medicine in the quest to incorporate
and laughed at Columbus, Galileo, and Copernicus. But
science into clinical practice. Perhaps the art in the
they also laugh at clowns in a circus!
practice of dentistry has overshadowed the need for
Ismail and Bader2 argued against making clinical
a
Clinical professor, Department of Orthodontics and Dentofacial Orthopedics, decisions based exclusively on empiricism. They pro-
University of Pittsburgh School of Dental Medicine.
b
Assistant professor, School of Psychology, California University of vided the following argument against clinical expert
Pennsylvania. testimony: “its [empiricism] minimal scrutiny of the
c
First-year dental student, University of Pittsburgh School of Dental Medicine. basis of the master clinician or educator, and the
Reprint requests to: Dr Donald J. Rinchuse, 510 Pellis Rd, Greensburg, PA
15601; e-mail, bracebrothers@aol.com. absence of formal and independent mechanisms for
Submitted, August 2004; revised and accepted, September 2004. considering clinical observations that do not agree with
Am J Orthod Dentofacial Orthop 2005;127:618-24 the master educator’s opinion (parentheses added by
0889-5406/$30.00
Copyright © 2005 by the American Association of Orthodontists. the authors of the present article).”2 Although empiri-
doi:10.1016/j.ajodo.2004.09.016 cism (knowledge acquired through personal experience
618
American Journal of Orthodontics and Dentofacial Orthopedics
Volume 127, Number 5
or perception) is a valid element in science, its use (in
science) is limited to the collection of data with the
scientific method, not the personal experience of an
event.12 When people rely totally on their senses to
observe, evaluate, and make judgments about nature
and the universe, they often find that their perceptions
are misleading and wrong. For example, our human
perceptions tell us that we stand on a stationary and flat
planet; the reality is that we are constantly moving as
our spherical earth spins, rotates, and orbits. The
problem with relying totally on empiricism is that
human perception can be affected by such factors as
past experience, belief in and expectation for success,
predetermined bias, motivation, distortion of memory,
the possibility for spontaneous remissions and cures,
the cyclic nature of certain disorders (such as temporo-
mandibular disorders [TMD]), and others).13-15
WHY SCIENCE?
EBD is the conscientious, explicit, and judicious
use of current best evidence in making decisions about
the care of each patient.1-4 Turpin16 stated, “The pur-
pose of using the evidence-based approach is to close
the gap between what is known and what is practiced,
and to improve patient care based upon informed
decision making.” Not all evidence is given the same
weight. The double blind, placebo control experimental
design (incorporating randomized clinical trials
[RCTs]) is regarded as the top of the hierarchy of
research.2,3
The foundational tenet of EBD is science. Science
is a logical search for knowledge about the universe
obtained by the examination of the best available
evidence, and it is always subject to correction and
improvement upon discovery of better evidence. Sci-
ence is considered the superior approach for acquiring
knowledge because it is devoid of personal beliefs,
values, attitudes, and emotions. The scientific method
also has the means for controlling confounding factors.
Objectivity is emphasized in science because the data,
the testing procedures, and the investigations’ conclu-
sions are open to public and scientific scrutiny.12
Furthermore, experiments can be replicated by other
researchers. Without science, the health professions
would be back to the days of snake-oil salesmen.
Most discussions about science, research, and ex-
perimental design assume a true experiment. The hier-
archy of human research surely culminates with the
“true experiment”—ie, double blind, placebo control,
prospective, longitudinal, experimental design with
RCTs. However, in many instances, it is impossible to
conduct experimental research. For instance, it would
be unethical in a civilized, moral society to assign
Rinchuse et al 619
certain people to a disease group and then create a
disease or disorder merely for research purposes.17 The
cost and the time needed to complete prospective,
longitudinal studies that incorporate RCTs make them
quite prohibitive, but popular, for testing new drug
therapies. For these reasons, many medical and health
care studies are observational (retrospective) rather
than experimental.1-3 In observational, retrospective
research, the researcher obtains a group of subjects who
already have (or had) the disease (treatment) and
compares them with a group of subjects who do not
have the disease (treatment).
Lower-level research encompasses such designs as
quasi-experimental, retrospective/observational, asso-
ciational/correlational, descriptive/epidemiologic, and
case series studies. In addition, some studies are di-
rected at identifying cause and effect, whereas others
are aimed at demonstrating an association between
certain variables. The reliance on anecdotal reports
such as testimony and a clinician’s own experiences are
antithetical to science.
The experimental design of a study is the structure
of an experiment. It includes the experimental proce-
dures, the selection of subjects, and the allocation of
subjects to different experimental procedures. Poor
experimental designs create problems that cannot be
rectified by sophisticated statistical procedures. As
Dingle17 stated, “No intelligent person would underes-
timate the importance of mathematics in science or
question the necessity of its correctness, but it cannot
bring truth out of error. If it is applied to truth, it will
produce truth, and if it is applied to error, it will almost
certainly produce error.”
UNTESTED HYPOTHESES AND THEORIES VS
SCIENCE AND EVIDENCE-BASED CARE
Some clinicians deride academics and EBD. These
clinicians’ views are often couched in rhetoric and
hype. S. Jay Bowman18 said, “‘Wet-fingered’ ortho-
dontists” question “the competency of academic pencil-
pushers . . . bent on demanding proof.” These so-called
clinicians “invoke their ’20 years of experience and
successful results’ and argue that these should outweigh
any findings published on three or four pages of slick
paper.” We are therefore encouraged to follow them on
“blind faith.”
Arguing for science and evidence-based decision
making, Sheldon Peck19 stated, “Today scientists, not
philosophers, contribute to our understanding of myriad
aspects of our life and universe. . . . We have an
obligation to be clinical scientists providing the best
evidence-based service.”
Many past and present notions and ideas in den-
620 Rinchuse et al
tistry and orthodontics have been and are promoted as
“facts” when they are merely untested hypotheses and
theories. Although these notions appear rational, many
have been proven fallacious by scientific inquiry. There
are numerous examples of seemingly logical notions
that have been disproved by valid research. In 1985,
Proffit6 cited several examples: myofunctional therapy,
functional appliances for adults, and corticotomy to
speed tooth alignment. Furthermore, a persuasive no-
tion in orthodontics for decades professed that an
anterior component of eruptive force from impacted
mandibular third molars caused postorthodontic man-
dibular incisor crowding once retainers are abandoned.
Although this notion is intuitively appealing, recent
evidence refutes this long-held orthodontic tenet.20
CONFOUNDING EFFECTS
A goal of sound experimental research and design is
the control (elimination or neutralization) of confound-
ing factors. When confounding factors are not con-
trolled, the effects of treatment are clouded with the
outside influences of extrinsic factors, and the treatment
effects cannot be isolated and analyzed. And, if the
findings of confounded studies are accepted, there is the
strong possibility that this will negatively impact pa-
tient care; ie, beneficial treatments will be ignored and
useless treatments adopted.
The use of human subjects (rather than experimen-
tal animals, cells, or tissues) in research complicates the
control of confounding variables. Human cognition and
psyche can impact the results of a study, and their
influences must be accounted for. Furthermore, sound
research attempts to control for the effects of such
confounding variables as subject characteristics, sam-
pling errors, data collector characteristics, Hawthorne
effects (explained later), weak experimental designs,
and sample sizes. Although these confounding vari-
ables are only a few of the potential threats to a study’s
internal and external validity, they represent some of
the most critical experimental elements that a reader
must consider when evaluating research findings. As
these threats are controlled, or at least accounted for,
the extent to which the research can be generalized to a
larger population is greatly enhanced, as is the extent to
which the research can be considered reliable and valid.
CONTROL GROUP
Some research (eg, descriptive and case studies)
does not lend itself to the use of a control. Nonetheless,
when controls are required and used, the reliability and
validity of a study are improved. With observational
research vis-á-vis experimental research, the group not
having treatment (disease) is often called the compari-
American Journal of Orthodontics and Dentofacial Orthopedics
May 2005
son or matched group rather than the control group.
Through the use of a control group in experimentally
designed studies, a researcher can assert with confi-
dence that the treatment or condition introduced is
directly responsible for the findings obtained, instead of
due to chance or some other extraneous variable.
Typically, a researcher will introduce a treatment con-
dition to an experimental group, whereas the control
group does not receive treatment or is treated with
standard methods.
Application 1
In the 1950s through the 1970s, the notion was
promulgated that occlusal disharmonies, particularly
centric slides, caused TMD.21 However, these studies
lacked control or comparison groups. Later studies
incorporating control or comparison groups found that
asymptomatic subjects (those without TMD) also had
equivalent slides (diagnostic sensitivity, but not diag-
nostic specificity).21 Likewise, several orthodontic
studies in the 1960s and 1970s reported that postortho-
dontically treated subjects had centric slides and bal-
ancing contacts.22,23 These studies also lacked control
or comparison groups, and later studies found no
difference in the functional occlusion characteristics of
orthodontically treated versus untreated subjects.
Diagnostic sensitivity is the ability of a test to
identify a disease when it is actually present. Poor
diagnostic sensitivity can result in a false negative
diagnosis. That is, a person is not diagnosed with a
disease that he or she actually has. Diagnostic specific-
ity is the ability of a test to detect the absence of disease
when the person does not have it. Poor diagnostic
specificity can result in a false positive test; ie, a tested
subject is diagnosed with a disease he or she does not
have. The negative consequences of false tests are
unnecessary treatments for patients without disease,
and, conversely, undiagnosed diseases are left un-
treated.
Application 2
Many descriptive and epidemiological studies vis-
á-vis experimental research in the healing arts have
provided much useful information that has had a
positive impact on patient diagnoses and treatments.
This type of research does not require control or
comparison groups mainly because it does not intend to
test cause and effect. The purpose is merely to report
the incidence, prevalence, or level of a disease or
disorder. For example, Angle reported the incidence or
prevalence of his various malocclusion classes in his
1899 study, finding that the Class I malocclusion type
was the most common.24 Because Angle’s study was
American Journal of Orthodontics and Dentofacial Orthopedics
Volume 127, Number 5
descriptive and epidemiologic and not experimental, no
control or comparison group was necessary.
Furthermore, several of the authors of this article
have been involved in descriptive studies not requiring
control or comparison groups. One study compared
Angle’s static occlusion types (Classes I, II, III) with
the functional occlusion types (canine rise, group func-
tional occlusion, balanced occlusion) of a dental school
population.25 Another study compared the reliability of
several occlusal classification systems such as those of
Angle and Katz and the British system.26
There are also so-called “crossover studies” in
which subjects (or possibly half of the dental arch) are
given treatment, and later the same subjects are given
the placebo and vice versa. Even though it does not
seem that there is a control group, the subjects serve as
their own controls in the crossover design.
HAWTHORNE EFFECT
Despite the effectiveness of experiment design,
potential threats can directly impact validity. Foremost,
the researcher must consider the influence of the
subjects’ attitudes. For instance, a time-management
study in 1930 at Western Electric’s Chicago-based
Hawthorne Plant desired to improve employee morale
and particularly productivity. Several independent vari-
ables were tested, including lighting, room temperature,
and length and scheduling of rest periods. The opinions
and preferences of the employees were solicited. In
response to each intervention, employee morale and
productivity temporarily improved. It was concluded
from the results of this study that the experiment itself
(ie, interest in it and involvement of the employees)
induced positive attitudinal and behavioral responses.
The outcome of the study became known as the
Hawthorne effect—temporary, measurable changes in
attitude or behavior of experimental subjects because of
changes in the physical environment or social interac-
tion that includes input by the target audience.27
The Hawthorne effect typically manifests when
subjects in the experimental group display favorable
results to a treatment simply because of the increased
attention they receive or as a reaction to the novelty of
the treatment introduced. A reverse Hawthorne effect
can also arise in the control group. That is, if a control
group does not receive a treatment condition, resent-
ment or apathy might develop. These psychological
variables can then manifest in poor behavior or im-
provement in the control group; this might inaccurately
produce a perception that the treatment is responsible
for either favorable or unfavorable results in the exper-
imental group.
Rinchuse et al 621
PLACEBOS AND SHAMS
Research subjects’ beliefs, hopes, and suggestibility
might have a significant confounding effect on a study.
“Placebo” is a Latin word that means, “I shall please.”
The placebo effect is the measurable, observable, or felt
improvement in health not attributable to treatment. To
combat the effects of the Hawthorne and reverse
Hawthorne effects, many researchers use a placebo
with the control group. When research involves a
placebo, both the experimental and the control groups
receive a treatment, but 1 treatment is fake. Thus, the
placebo allows for the exercise and display of psycho-
logical variables in the control group without compro-
mising the validity of the treatment in the experimental
group. Considered with placebo procedures are “sham
procedures,” which closely resemble treatment proce-
dures but are not intended to provide effective treat-
ment. Results from research studies that do not use
placebo or sham procedures might be questionable and
due instead to common psychological variables rather
than the introduction of specific treatments.16
Application 3
Occlusion and TMD studies have demonstrated
placebo effects from mock equilibration, nonoccluding
splints, and placebo medicinals.13-15,28 Therefore, just
because practitioners adjust TMD patients’ occlusions,
or place occlusal splints and the symptoms subside,
does not necessarily mean that the cause has been
identified and the occlusion is the proven etiologic
agent. Cognitive nonspecific factors that center on the
placebo effect(s) must be evaluated, as well as the
cyclic nature of TMD.14
BLINDING
In addition to their influence in control and exper-
imental groups, psychological variables can also affect
the experimenter’s judgment. Experimenter bias un-
folds as the experimenter or data collector uncon-
sciously influences or manipulates subject responses or
inaccurately reports or classifies data obtained from the
research participants. Robert Rosenthal29 described this
effect as a transfer of experimenter anticipations and
expectations in regard to the outcomes of a study. This
effect can be likened to the popular quote from the
movie Field of Dreams, “If you build it, they will
come.” The only difference is that, instead of building,
all the researcher has to do is to think or expect, and his
feelings, emotions, and expectations will often affect
the behaviors of the study’s subjects. Although this
may seem like magic, it is not. The researcher simply
behaves in a manner that directly influences subject
622 Rinchuse et al
behavior, or the researcher interprets data in a biased
manner.
Research studies can, however, use preventive mea-
sures to reduce the effects of the experimenter bias
threat. Foremost, the experimenter should use trained
data collectors who are blind to the study’s purposes.
Second, consideration should be given to the use of
trained, but blind raters, if the research requires that
measurements be scored. These efforts will assist in the
control of the psychological variables that sometimes
distort the experimenter’s perceptions and uncon-
sciously produce expected behaviors in their partici-
pants. A study is single blind if the researcher (or
person collecting the data) alone knows which groups
the subjects are in (experimental vs control); the sub-
jects do not. A study is double blind if neither the
researcher nor the subjects know whether the subjects
are assigned to the control or the treatment group. The
obvious purpose of blinding is to reduce bias.
Application 4
In the early 1980s, Gelb propagated the idea that
eccentricity of the condyles in the glenoid fossae, rather
than occlusion, caused TMD.13,14 Dentists were ortho-
pedists of the stomatognathic system. The operative
word for TMD occlusal splints was “oral orthotics.” In
keeping with this thinking, dentists could not only treat
TMD with oral splint orthotics, but also increase
anaerobic and aerobic endurance.30-32 After engaging
Philadelphia Eagles football players with occlusal wax
wafers, deltoid strength tests increased in 17 of 22
players.33 No control or comparison group was used,
and later studies with controls did not find a treatment
or appliance effect.34-36 Not only does this reinforce the
need for control groups but perhaps also illustrates the
possible influence of the beliefs, biases, or opinions of
the researcher impacting the subjects’ psyches, empha-
sizing the need for blinding on the part of the re-
searcher. Furthermore, subjects having prior knowl-
edge of the expected outcome of the therapy could also
influence the results; thus, the subjects should be blind.
RANDOM ASSIGNMENT
Research conducted with human subjects has the
potential for many confounding variables that can
directly threaten the study’s replication and accuracy.
One of the most critical factors for a reader to consider
is the use of random sampling. Randomization, or
random assignment, is the assignment of subjects to
either the treatment or the control group based on some
chance-governed mechanism, such as a coin toss or a
table of random numbers. Random sampling ensures
that each member of the population of interest has an
American Journal of Orthodontics and Dentofacial Orthopedics
May 2005
equal chance for selection and participation. Random-
ization directly enhances the potential for a study’s
results to be generalized to a larger population.
Because of such feasibility issues as time, money,
and accessibility, most studies rely on purposive sam-
ples. Purposive sampling allows the researcher to use
his or her judgment, based on the characteristics of
interest, to select a sample and matched group for
comparison. When purposive sampling is used, a de-
tailed description of the subjects should be provided.
Through the detailed description of such characteristics
as sex, age, ethnicity, education, and socioeconomic
status, the reader can critically examine the study’s
implications and application value. In experimental
studies, the researcher assigns subjects to the groups
studied, using randomization or some other method. In
an observational study, the researcher cannot assign
subjects to the groups studied, and, therefore, random-
ization is not requisite.
Application 5
Random assignment is only possible for “true”
experiments (prospective, longitudinal, incorporating
RCT). In this respect, there must be an equal likelihood
that subjects will be assigned to the experimental versus
the control groups. There are few experimental studies
in orthodontics, and, therefore, the issue of randomiza-
tion would not typically apply. At times, the word
“randomization” is used in nonexperimental research
and, in these instances, does not refer to an experimen-
tal design protocol but, rather, the “random” acquisition
of a proportion of data from “stored” records.
SAMPLE SIZE AND POWER
Directly related to randomization is sample size. In
general, as the size of the sample increases, the likeli-
hood that it represents the characteristics in the general
population is increased. A general rule for adequate
sample size is that the number of subjects in the
treatment and control groups should at least be larger
than the number of variables being tested. The better a
study is controlled, with confounding factors elimi-
nated or neutralized, the smaller the sample size and
vice versa. Sample size directly impacts the type of
statistical analysis used; it also directly affects the
generalization of a study.37
The notion of “power” is often considered with
sample size. Power deals with the probability of avoid-
ing a type II error by accepting the null hypothesis
when it should be rejected, most likely because of a
small sample.38 When studies lack power, there is an
increased chance of committing a type II error. How-
ever, power depends not only on sample size but also
American Journal of Orthodontics and Dentofacial Orthopedics
Volume 127, Number 5
on the discrepancy between the hypothesized popula-
tion parameter and the actual population parameter.
Because the probability of type II error decreases as the
sample size increases, it might seem that the best
strategy is to obtain the largest possible sample. But
increasing sample size is time consuming and expen-
sive. Ideally, the appropriate sample size should not be
larger than the minimum necessary for a small proba-
bility of a type II error. Some studies erroneously
reported what is termed “negative results” (no treat-
ment effect; acceptance of null hypothesis) due possi-
bly to small sample sizes (type II error). More studies
need to incorporate “power analyses” a priori to avoid
type II errors.
Application 6
A study published in the 1970s39 used 9 subjects
with 7 in the diseased group (TMD) and 2 in the
nondiseased group (TMD free). There was an obvious
bias in the selection of the 9 subjects. The author,
although noting that the article was a preliminary study,
stated that, with articulator mountings and occlusal
adjustments, he could confirm that occlusal interfer-
ences, particularly balancing contacts, caused TMD.
Because of the very small sample size and how the
subjects were selected, this study was totally meaning-
less. Nonetheless, this article was the impetus for the
peremptory orthodontic gnathology movement that pe-
titioned orthodontists to incorporate the principles of
gnathology and the use of articulators into their diag-
noses and treatments. (This article is still on the ABO
reading list for prospective candidates.)
MISCELLANEOUS NONSPECIFIC EFFECTS
Certain nonspecific effects can influence the inter-
pretation of observations or data or treatments that
reinforce the need for controls, placebos, and adequate
sample sizes. First, some diseased subjects exceed
mortality or morbidity predictions and spontaneously
remiss or cure, sometimes irrespective of therapy.
Without appropriate controls, a researcher or practitio-
ner might erroneously conclude that the treatment was
responsible for the cure rather than nature or the divine.
Next, certain diseases or disorders such as TMD are
cyclic, and, irrespective of treatment, the signs or
symptoms will remiss at the down side of the cycle.14
Confusion occurs when the treatment is rendered dur-
ing this time period. A researcher or practitioner can
never be certain that the therapy had caused the
improved medical condition. He or she might errone-
ously believe that the treatment provided the important
ingredient for the success when it had little or nothing
to do with it. For example, a patient enters the physi-
Rinchuse et al 623
cian’s office for treatment of a common cold at day 7
and was given a remedy with a positive result. Was it
the treatment or the timing and the cyclic natural
regression of the disease that caused the cold to
disappear?
CONCLUSIONS
Human subjects bring many characteristics and
experiences to a research study. The complexities of the
human psyche (vis-á-vis experimental animals or cells)
can influence and impact research findings making the
controlling of experiments challenging. By understand-
ing sound experiment design strategies and principles
and issues related to specific patient characteristics,
orthodontists will be better able to critically evaluate
the periodic literature. Marc Ackerman4 has stated,
“The challenge facing orthodontists in the 21st century
is the need to integrate the accrued scientific evidence
into clinical orthodontic practice.”
Evidenced-based data is the most trusted informa-
tion for making decisions relative to patient diagnosis
and treatment. However, one must be cautious in using
and interpreting this data; it is merely a tool. The
practitioner must familiarize himself or herself with the
use of this tool. He or she must examine the threats that
encompass research and strive to account for them by
developing a critical understanding of experimental
design and research. If orthodontists desire to be part of
the learned professions, the science part of orthodontics
must not be ignored in favor of the art. Orthodontic
patients deserve the highest level of care that is possible
only through the judicious use of the best available
current information.
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