Defining Evidence-Based Orthodontics by Dr. Michael K. DeLuke

   

A closer look at how research, clinical judgment, and patient values intersect

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by Dr. Michael K. DeLuke

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Introduction
The term evidence-based orthodontics (EBO) has seemingly become a badge of professional credibility and shorthand for scientific rigor and modern, enlightened care. Yet, beneath this thinly veiled confidence lies a troubling reality. While many clinicians champion evidence-based principles, few can articulate what those principles actually require, and many refuse to acknowledge the inconsistency with which they are applied.

In contemporary orthodontics, “evidence-based” is often invoked as a rhetorical weapon rather than a philosophical framework. It is used selectively to defend one’s preferred techniques while dismissing those of others, rather than as a neutral guide to better decision-making in patient care. Critics demand randomized controlled trials (RCTs) and systematic reviews for new or unfamiliar approaches, while continuing to perform long-accepted procedures with little or no RCT support. The hypocrisy is difficult to ignore.

This misunderstanding is not merely semantic. It shapes how we judge colleagues, how we justify our own treatment choices, and ultimately, how we care for patients. To confront this issue honestly and with integrity, we must examine what evidence-based medicine (EBM) was intended to be, what it has become, and what it means for our specialty both today and in the future.


The birth of evidence-based medicine:A counter-cultural movement
Although the roots of EBM stretch back centuries to the Paris clinical school,¹ its modern incarnation began in the 1960s, when scholars recognized a troubling gap between emerging biomedical knowledge and everyday clinical decision-making. Robert and Suzanne Fletcher, among others, concluded that although science was advancing rapidly, its discoveries were not reliably influencing medical practice.²

The transformation accelerated in the 1970s with Archie Cochrane, a Scottish physician and epidemiologist whose wartime experiences reinforced the dangers of untested medical assumptions. While imprisoned during World War II, Cochrane performed a rudimentary comparative trial on fellow prisoners of war to assess the effect of yeast extract on nutritional deficiencies. Crude as it was, the experiment ignited his lifelong belief that medical claims should be supported by controlled evaluation rather than tradition or authority.³

Cochrane argued that RCTs should serve as the gold standard for assessing treatment efficacy. His vision reverberated through the medical community, eventually inspiring the founding of the Cochrane Collaboration, one of the world’s foremost organizations dedicated to synthesizing clinical evidence. Yet the story of EBM would not be complete without David Sackett.


Sackett’s contribution: Evidence as a three-part synthesis
David Sackett, often described as the “father of EBM,” advanced the movement from an abstract ideal to a disciplined clinical methodology. In the 1970s and 1980s, he and his colleagues at McMaster University introduced the concept of “critical appraisal,” teaching clinicians not merely to read research, but to evaluate its relevance, strengths, and limitations.

By 1991, Sackett’s student Gordon Guyatt had formalized the term evidence-based medicine, and Sackett later clarified its meaning in a landmark 1996 British Medical Journal article.¹ There, he defined EBM as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients.” Crucially, Sackett insisted that EBM was not synonymous with RCT worship. Nor was it a rejection of clinical wisdom.

To better explain this philosophy, he developed a triangular epistemology (Fig. 1) comprising clinical judgment and expertise, the best available external evidence, and patient values and preferences. The balanced integration of these three elements constitutes the foundation of EBM and requires that no single element predominate. To that point, Sackett warned that without clinical judgment, practitioners risk becoming “tyrannized by evidence,” since even the strongest trials may be inapplicable to a unique patient. Conversely, without external evidence, practice risks devolving into anecdote and habit. Therefore, the essence of EBM lies in synthesis rather than hierarchy.



When evidence becomes a weapon instead of a guide
Despite Sackett’s clarity, many in health care now misconstrue EBM as an unwavering demand for RCT-level evidence for every intervention. This drift is not accidental. As medicine has commercialized over recent decades, the concept of evidence has been co-opted for power struggles, reimbursement decisions, and professional self-protection.

Alvan Feinstein, a mathematician- turned-physician who helped establish clinical epidemiology, identified this trend as early as 1997, warning that EBM had become disproportionately reliant on RCTs and vulnerable to misuse.⁴ Feinstein argued that while RCTs compare treatments, they are not inherently superior forms of truth and fail to account for variables central to clinical practice, including illness trajectory, symptom severity, and patient individuality.

More recently, John Ioannidis sharpened this critique, lamenting that EBM had been “hijacked.” In a 2016 article, he noted that guidelines and meta-analyses often reflect financial or academic interests, and that RCTs are increasingly designed to serve industry rather than patients.⁵ Still, Ioannidis concluded that what EBM was meant to be remains “an unmet goal, worthy to be attained,” emphasizing that evidence, while certainly not irrelevant, must be interpreted and critically evaluated, not idolized.


Orthodontics and the evidence paradox
Orthodontics is a procedural specialty in which many outcomes are mechanical, technique-dependent, and grounded in well-understood biological principles. As such, much of what orthodontists do daily is not supported by high-quality RCTs or meta-analyses, yet these treatments are widely accepted and rarely questioned. This acceptance persists until a new or unfamiliar idea challenges tradition. Only then do accusations of “pseudo-science” surface, even when the critics’ own practices lack robust evidence.

In fact, orthodontists frequently criticize colleagues for employing techniques “not supported by the evidence,” even as they themselves perform interventions without high-level evidence. Consider the following commonly accepted practices:

• Establishing Class I occlusion
• Waiting until age seven for initial evaluation
• Selecting wire sequences or bracket prescriptions
• Treating according to cephalometric norms
• Performing interproximal reduction
• Using self-ligating brackets
• Providing permanent retention

Despite their ubiquity, none of these practices is supported by robust RCTs.

Additionally, the lack of high-level evidence in orthodontics has been repeatedly addressed in the literature. A 2010 Cochrane review of systematic analyses in orthodontics found that none provided clear proof in support of any single treatment modality.⁶ Papadopoulos echoed these conclusions, identifying persistent methodological weaknesses and excessive heterogeneity in orthodontic systematic reviews.⁷ A 2014 study evaluating leading orthodontic journals (American Journal of Orthodontics and Dentofacial Orthopedics, Angle Orthodontist, European Journal of Orthodontics, and Journal of Clinical Orthodontics) concluded that the reporting quality of RCTs was suboptimal.⁸ More recently, Alharbi and colleagues reported that only 9% of articles appearing in the same four journals between 2018 and 2022 were RCTs, highlighting how small a fraction of the orthodontic literature is trial-based.⁹

Mulimani noted that orthodontics often operates in domains where complete answers are unavailable, and treatment uncertainties are part of everyday clinical reality. As a result, he argued that EBO requires clinicians to develop the ability to practice effectively despite limited evidence, and, at times, in its absence.¹⁰ He emphasized that the goal is not to wait for perfect data, but to apply evidence “where it exists and where it does not exist, using clinical expertise to select the best option, and explain the same to the patient.”

In summary, if we applied the same evidentiary threshold to our own daily practices that we demand from alternative philosophies, large swaths of orthodontics would be rendered non-evidence-based overnight. This is not an argument against evidence. Rather, it is an argument for consistency.


Why RCTs are not the only valid formof evidence in orthodontics
The core misunderstanding fueling this hypocrisy is the belief that EBM requires an RCT before a treatment is justified. Sackett explicitly rejected this notion. RCTs hold a privileged place because they control for bias, but they are not always feasible, ethical, or necessary. Orthodontics often deals with predictable mechanical systems, directly observable outcomes, and low-risk, reversible interventions. Unlike pharmaceuticals, which can produce systemic, unpredictable effects, orthodontic forces act locally, in biologically constrained ways. When mechanism, outcome, and risk are clear, the evidentiary burden shifts. In such contexts, insisting on RCTs is obstructive, not scientific.

The gold standard of pediatric ethics reinforces this point. RCTs in children present unique challenges, including the assignment of a minor to a no-treatment control group when a clinician believes treatment may be beneficial. Ethical review boards often reject such studies on the premise that equipoise does not truly exist, as delaying treatment may compromise facial growth, airway development, or occlusal stability, and the developmental process is time-sensitive and irreversible. Institutional review boards must weigh risk and anticipated benefit, and children’s vulnerability necessitates a lower threshold for acceptable risk.¹¹ As a result, the absence of pediatric RCTs often reflects ethical responsibility rather than scientific deficiency.¹² Thus, demanding RCTs for early intervention or airway-oriented pediatric treatment is not evidence-based; it is evidence-misunderstood. Further, it demonstrates a clear lack of epistemic humility.


Early treatment as preventive care
Preventive medicine rarely rests on RCTs. We do not require randomized trials to justify helmets for children, parachutes to skydive, seat belts in cars, or caries prevention. We act because the mechanism is clear and inaction courts harm. The same logic applies to interceptive orthodontics. Malocclusion, especially when caused by improper breathing, rarely, if ever, completely self-corrects. Instead, it worsens with time, negatively impacting a patient’s neurocognitive, behavioral, and craniofacial growth and development.^13–28 This can heighten the complexity of future treatment and even reduce treatment options. Therefore, “watchful waiting” to address certain orthodontic problems is not neutral; it is a decision with consequences.

One of the most important and all-too-often-forgotten insights Sackett offered is that not acting is itself a clinical decision, and it too requires justification. If delaying treatment predictably worsens prognosis, failing to intervene is not the cautious approach; it is the irresponsible one. By contrast, early treatment, when based on biological plausibility, clinical observation, and patient-specific context, is evidence-based in Sackett’s framework. It does not contradict EBM; it exemplifies it.

The absence of an RCT does not negate clinical reasoning when the mechanism is sound, the outcome is observable, the risk is low, and the patient’s needs are clear. Therefore, EBO demands thoughtful action, not paralysis.


Conclusion
Orthodontists must decide whether EBO is a standard to be applied universally or a badge to be displayed selectively. Additionally, we must stop wielding “evidence-based” as a weapon and start applying it proportionally, transparently, and consistently, as Sackett intended. We should continue to pursue high-quality research whenever and wherever possible, as RCTs and meta-analyses remain indispensable tools. But tools are not idols. When we insist that every intervention demands an RCT, we indict our own daily practices. If we treat RCTs as the only legitimate source of truth, we demonstrate a fundamental misunderstanding of the premise of EBM, and betray the very patients we claim to serve.

EBO is not the absence of uncertainty. Rather, it is the ethical management of it, attainable only when the best available evidence is integrated with clinical expertise and the values and preferences of the patient. When this epistemological balance is maintained, EBO functions not as a rigid mandate, but as the principled framework for thoughtful, individualized clinical decision-making—decision-making that can elevate both patient care and the profession of orthodontics as a whole. 

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