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The use of biopsy in dental practice: The position of Contact
the American Academy of Oral and Maxillofacial Send to a
By Raymond J. Melrose, DDS Send to
Janice P. Handlers, DDS Printer
Stanley Kerpel, DDS Close
Don-John Summerlin, DMD Window
Charles J. Tomich, DDS
Featured in General Dentistry, September/October 2007
Posted on Wednesday, August 22, 2007
Biopsy is the gold standard of diagnostic procedures. The American Academy of Oral and Maxillofacial
Pathology has stated its position concerning biopsy use in dental practice, believing that using the
procedure more frequently will enhance diagnosis and contribute substantially to the quest for more
evidence-based practice. Biopsy is a technique within the scope of practice of general dentists. It is
vital to understand that biopsy is a tool for the diagnosis of myriad benign and malignant oral
conditions. More frequent use of biopsy in dental practice will likely reduce the number of successful
lawsuits brought for delay or failure to diagnose. This article offers 10 guidelines to dentists to help
assure the success of the procedure.
Received: December 15, 2006
Accepted: February 20, 2007
The American Academy of Oral and Maxillofacial Pathology (AAOMP) recommends that any abnormal
oral tissue removed from a patient be submitted promptly for microscopic evaluation and diagnosis,
preferably by an oral and maxillofacial pathologist.1 Exceptions to this recommendation may include
tori, exostoses, and alveolar bone removed for prosthetic reasons; carious or periodontally involved
teeth without attached soft tissue; radiographically normal impacted teeth with no soft tissue attached;
and clinically normal appearing tissues removed for crown lengthening, periodontal pocket depth
reduction, or functional or cosmetic purposes. Nonsubmission of abnormal tissue may result in patient
care that is only partially evidence-based.1
Biopsy is defined as the removal for diagnostic study of a piece of tissue from a living body.2
Biopsy has been used for more than 150 years to establish the diagnosis of an unknown medical
condition. It can be stated with certainty that biopsy also is the oldest and most reliable method
currently available that can establish the definitive diagnosis of a clinical abnormality in dentistry.
Although specialized techniques such as immunofluorescence, immunohistochemistry, and electron
microscopy have deepened and extended the diagnostic reach that a biopsy can provide, none can
be implemented without a piece of tissue.
The practice of modern dentistry and medicine increasingly demands evidence-based treatment
decisions and therapeutic outcomes. Nothing is more basic to initial treatment decisions and
subsequent follow-up care than determining an accurate diagnosis. In 2001, the American Association
of Oral and Maxillofacial Surgeons (AAOMS) stated that “[e]vidence-based medicine demonstrates that
treatment decisions and their outcomes should be based on a definitive pathologic diagnosis obtained
either by preoperative biopsy or post-treatment submission of surgical specimens.”3 Three years later,
the American Association of Endodontists (AAE) announced:
“A biopsy is appropriate if any of the following conditions exist: A) When an adequate amount of tissue
or foreign material can be removed from the surgical site for histopathologic examination. B) Persistent
pathosis or pathosis inconsistent with endodontic disease is noted on clinical or radiographic
examination. C) Medical history indicates the merits of biopsy.”4
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These statements from two respected dental specialty organizations strongly support the position
of the AAOMP. What these dental specialty organizations recommend to their members is equally
applicable for general dentists or for other specialists who may remove abnormal tissue in the course of
Performing a biopsy procedure is well within the scope of training and ability for a general dentist.
However, individuals who elect to perform biopsies in clinical practice must determine their comfort level
with the various types of biopsy and develop criteria to refer patients to those with more biopsy
The most important issue, however, is not who should perform the procedure but when it should be
recommended to patients. In this regard, several myths surrounding biopsy may discourage dentists
from recommending the procedure in some cases and may reduce the likelihood of patient
First and foremost among these myths is the notion that a biopsy is used only to test for cancer.
Patients fear that biopsy will disclose cancer, while dentists labor under the mistaken notion that the
only reason to biopsy is to “rule out” cancer. It is correct that a cancer diagnosis typically is based on a
biopsy but the real purpose of a biopsy is to determine a definitive diagnosis, which often cannot be
established from clinical findings alone. Cancer is merely one of hundreds of diagnoses that can be
made from biopsy examinations. The authors surveyed the records of several large oral and
maxillofacial pathology laboratory practices and discovered that cancer represented less than 1.0% of
all diagnoses made. However, too many oral cancer cases continue to be diagnosed at an advanced
stage because biopsy was not recommended or performed when the first signs of disease were
A second myth is that the diagnosis of common conditions does not require biopsy verification
because the judgment and experience of the clinician are sufficient. This approach raises concerns of
clinical bias, which says that if a lesion looks like “Disease X” it most likely is “Disease X” and treatment
is based on that diagnosis. However, the treatment is based on a premise that is not substantiated
and cannot be proved except empirically (that is, by treatment that yields a satisfactory result). This
approach has a long history in the management of conditions like dental caries and periodontal
disease but it does not satisfy the need for better evidence-based decisions regarding other diseases.
In addition, it may lead the dentist to place undue reliance on a single working diagnosis without
considering plausible alternatives. Errors in judgment are more likely to occur if dentists do not consider
alternative diagnoses. Conversely, performing a biopsy to establish a definitive diagnosis does not
relieve the clinician of the need to consider a differential. Biopsy is not intended to be a substitute for
thoughtful evaluation of the patient’s condition.
Tissue submitted for microscopic examination should be accompanied by a clinical diagnosis. This
is valuable for the pathologist because it gives him or her an idea of what the dentist is seeing and
thinking. In the great majority of cases, the diagnosis returned by a pathologist should be completely
consistent with that clinical diagnosis; if it is not, the dentist should contact the pathologist to ensure
that a laboratory error has not occurred.
This study surveyed the records of three large oral and maxillofacial pathology laboratory practices,
evaluating 1,500 consecutive cases (500 cases per laboratory) by looking at the rate of concordance
between clinical and histopathologic diagnoses. For purposes of this article, concordance was defined
as essential agreement; that is, the pathologic diagnosis rendered for the biopsy material did not
require substantially different treatment or prognosis when compared to the clinical diagnosis. The
concordance rate was 90.7%.
There was remarkable similarity among the three laboratories’ findings. The variance of nearly 10%
between clinical and histopathologic diagnoses is significant; however, it should be noted that the
clinicians who performed the biopsies promptly learned of the correct diagnoses. The principal
diagnoses that were not suspected clinically included squamous cell carcinoma, epithelial
dysplasias/carcinoma in situ, odontogenic keratocyst, ameloblastoma, salivary gland tumors, and
lichenoid mucositis. The latter often was commonly misinterpreted clinically as lichen planus or
leukoplakia. Figures 1–4 offer examples of cases for which there was not essential agreement
between clinical and histopathologic diagnoses. By contrast, some cases that were thought to be
serious diseases (such as carcinoma) actually represented ulcers or inflammatory processes.
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The results from this laboratory survey are similar to those reported by Czerninski et al, who studied
136 cases of mucosal diseases and found a 78% overall rate of agreement between clinical and
histopathologic diagnoses.6 The highest rate of agreement in their report was found in
vesiculo-erosive diseases, while the lowest rate was observed in cases described as nonspecific
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Benefits that result when the submitted clinical diagnosis and the pathologic diagnosis correlate
include increased confidence on the part of the clinician in his or her diagnostic skill, increased patient
respect, and satisfaction that the treatment performed was appropriate. In addition, the written
diagnosis usually brings closure to the clinical situation. Although it may be disconcerting when an
unsuspected and/or serious diagnosis is rendered, both patient and doctor can readily appreciate the
benefits of a timely, correct diagnosis.
Failure to diagnose oral disease is a leading cause of legal action against dentists.7 A 2006 study
regarding medical malpractice claims noted that missed or delayed diagnoses represented the grounds
for lawsuits in 30% of 1,452 settled malpractice claims.7 Only claims that related to surgical
misadventures represented a larger proportion (31%) of cases.8 By instituting practice guidelines that
are in consonance with the AAOMP position on routine submission of tissues, clinicians can
substantially protect themselves from the risk of a successful lawsuit based on failure to diagnose.
From a practical standpoint, the two most commonly used types of biopsy are excisional and
incisional. Fine needle aspiration biopsy, the cytobrush technique, and exfoliative cytology (PAP
smear) are adjunctive techniques and will not be discussed in this article because they do not produce
a definitive diagnosis.
An excisional biopsy is a surgical procedure that removes the entire clinical abnormality for
microscopic examination. An incisional biopsy is a surgical procedure that removes only a
representative portion of the abnormality. The principal purpose of both types of biopsy is the
establishment of a definitive diagnosis.
An excisional biopsy may be employed to remove an undiagnosed abnormality. In this clinical
setting, it is considered to be the correct treatment for the presumptive clinical diagnosis. An excisional
biopsy also may be used to ensure that a previously diagnosed lesion has been removed completely
and thus represents definitive treatment for that condition.
The clinical decision to perform one type of biopsy over the other is based partly on the diagnosis
that is considered to be most likely, partly on anatomic considerations, and partly on the doctor’s
experience and comfort level. The decision to perform a biopsy or to refer the patient to a specialist for
the procedure is based on similar considerations. It is completely acceptable for clinicians to decide
that they do not wish to perform biopsies in their practices, provided the necessity of biopsy is not
Oral and maxillofacial pathologists rely on their dental and medical contributors for several important
factors: that the tissues they examine and diagnose are representative of the patient’s disease; that
tissues are provided in sufficient quantity to ensure that the diagnosis is likely to represent what
actually is occurring; and that the artifacts routinely induced during surgical tissue removal are
minimized. Suggestions that will improve the result of the procedure are listed below.
Methods for optimum results
Biopsy site selection
Site selection typically is not a concern for an excisional biopsy procedure. Incisional biopsies should
try to include as much as possible of what appears to be the disease process. For large lesions or
those with variable features, it may be wise to select several sites to biopsy to provide sufficient
sampling. Including a border of clinically normal tissue at the expense of sufficient abnormal tissue may
produce a less conclusive result. Because the purpose of an incisional biopsy is to establish a
definitive diagnosis, providing sufficient abnormal tissue should be the chief focus.
Ulcers often are found as a component of mucosal problems. When an ulcer is present, including
adjacent, non-ulcerated tissue in the specimen is more likely to improve the diagnostic yield. When
tissue sloughing is part of the problem, dentists should select an atraumatic, thin suture and pass the
suture first through the sloughing surface tissue into the submucosa and out through a non-sloughing
tissue surface. Use the suture to handle the tissue during the surgical procedure, remove the needle,
and place the specimen (including the suture) in the container. It is not necessary to knot the suture.
The suture prevents loss of sloughing tissue, both intraoperatively and during specimen transport.
Remove sufficient tissue
It is a good rule to excise small lesions rather than subject them to incisional biopsy. For incisional
biopsies, it is best to provide the pathologist with as large a sample as is consistent with care for the
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patient’s postoperative comfort. Tiny samples may inhibit the histology technician from producing a
quality slide and also may impair the pathologist’s ability to provide an unequivocal diagnosis. When it
is important for the pathologist to examine and comment on the lesion’s margins of excision, the
margins must be identified clearly. Using one or more sutures often is the simplest method. Incisional
biopsy of swellings should take into account that a deep biopsy usually is more representative than a
shallow one. A biopsy of solid bony lesions may be a challenge, although a trephine instrument can
be helpful. Instruments now available for coring out bone for implant placement are excellent tools for
many bone biopsies.
Handle the specimen gently
Do not grasp a soft tissue mass with a clamp, as this will crush the specimen. For a difficult site, such
as the soft palate or pharynx, a suture should be used to handle or control a specimen. It usually is
preferable to use a sharp cutting instrument (rather than one that induces heat) to remove a
specimen. The heat produced by laser or cautery instruments induces artifact on the surface (and
sometimes into the depth of the specimen) that may interfere with evaluation.
Avoid the use of solutions that stain the surface
Using colored antiseptics or similar materials to clean the surface or outline the incision on an oral
mucosal site is not recommended. Conversely, substances like toluidine blue (tolonium blue) do not
interfere with staining.
Immediately place the specimen in the fixative provided
Most oral pathology laboratories will provide bottles containing formalin for the fixation of tissue.
Formalin is considered the standard fixative. Fixation is mandatory to inhibit autolysis of tissues once
they are removed from the patient. Neither water nor saline solution will preserve tissue. Do not
change or dilute the fixative unless instructions are given.
Specimens that are to be submitted for immunofluorescence testing should not be placed in formalin;
in such situations, the solution provided by the laboratory should be used. Diluting alcohol with water
to 40–50% is less satisfactory because it dehydrates the tissues substantially. Formalin is a dilute
solution of formaldehyde buffered to neutral pH. Formaldehyde is considered a toxic substance and a
carcinogen when used inappropriately but it is not a significant risk in the very small quantities found in
biopsy containers. However, bottles should remain tightly closed until use and should be resealed
tightly before they are shipped to the laboratory. Follow the laboratory shipping directions that meet
U.S. Postal Service or commercial shipper requirements.
Clearly identify specimens from separate oral sites or place them in separate containers
When more than one specimen is taken for examination, it may not be possible to identify the separate
sites unless the specimens are identified, such as with a suture or by placing each one in a separate
specimen container. If the sites cannot be identified precisely, it may not be possible to correlate the
diagnoses with the specific sites.
Submit a brief, thorough history and radiographs as appropriate
Oral and maxillofacial pathologists are dentists with specialty training in pathology. Examining a piece
of tissue under the microscope is not a task performed in isolation. To diagnose a specimen properly,
the oral pathologist may need to review the clinical history and the setting in which the patient’s
condition manifested. The evaluation of pertinent radiographic images often is invaluable for proper
disease classification and diagnosis. These factors are among the reasons why the knowledge of an
oral and maxillofacial pathologist often is beyond that of an otherwise completely competent medical
pathologist. Oral pathologists understand dentistry and they converse easily in dental terminology.
They are going to use diagnostic terminology familiar and useful to dentists.
Submit legible and complete paperwork
Legibility requires no explanation. Complete paperwork means that the doctor or a designated staff
person familiar with the forms used by the laboratory takes responsibility for completing the entire form.
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The information requested is not superfluous. The federal and state regulations that apply to
pathology laboratories demand that patients be uniquely identifiable to the greatest possible degree,
consistent with HIPAA requirements. This is not intrusion on privacy; rather, it is for patient protection.
The information provided as history is treated with similar discretion.
Forward the specimen to the laboratory promptly
The laboratory usually will provide a method for returning the specimen. Do not delay in sending it, as
this will only delay the receipt of the result. Tissues placed in formalin for prolonged periods remain in
diagnostic condition but it serves no useful purpose to hold them.
Always correlate the diagnosis received with the clinical impression
This is one of the most important caveats of biopsy. If a dentist receives a diagnosis that does not
correlate substantially with the clinical situation, it is the doctor’s responsibility to investigate. The
easiest way to do this is to telephone the laboratory and talk directly with the oral pathologist. He or
she will investigate and determine if a laboratory error has occurred or if the diagnosis is correct but
unsuspected. Oral and maxillofacial pathology laboratories can be found in most portions of the United
States. The laboratories can receive specimens from anywhere in the country that is served by the
U.S. Postal Service. A list of the names, addresses, and directors of all oral and maxillofacial pathology
laboratories in the U.S. and Canada can be found at the AAOMP Web site.9
The routine submission of abnormal tissue to an oral and maxillofacial pathologist for diagnosis is a vital
link in the development of truly evidence-based clinical practice. Biopsy is a simple, reliable, and
indispensable tool in the practice of dentistry and medicine. Biopsy is not a panacea for protection
against claims of malpractice but the timely and routine use of biopsy in the dental setting likely will
substantially reduce the success rate of claims. It is eminently more satisfying for a doctor to know that
he or she has a correct diagnosis upon which to base treatment than to plan treatment predicated on
the assumption that a clinical diagnosis is accurate.
Dr. Melrose is a Fellow and Past President, American Academy of Oral and Maxillofacial Pathology and
co-owner of Oral Pathology Associates, Inc. in Los Angeles, California. Dr. Handlers is co-owner of
Oral Pathology Associates. Dr. Kerpel is Associate Director of Oral Pathology Laboratory, Inc. in
Queens, New York, and Associate Director, Section of Oral Pathology residency training program, New
York Hospital Queens. Dr. Summerlin is a professor, Department of Oral and Maxillofacial Pathology,
Indiana University in Indianapolis. Dr. Tomich is a Past President, American Academy of Oral and
Maxillofacial Pathology, currently in private practice for oral pathology in Indianapolis.
1. Tissue submission policy. Available at: http://www.aaomp.org/general/tissue.htm. Accessed May
2. Webster’s Universal College Dictionary. New York: Random House, Inc.;1997:78.
3. American Association of Oral and Maxillofacial Surgeons. Parameters and pathways: Clinical
practice guidelines for oral and maxillofacial surgery; diagnosis and management of pathologic
4. American Association of Endodontists. Guide to clinical endodontics. Chicago;2004.
5. Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ. Cancer statistics, 2006. CA
Cancer J Clin 2006;56:106-130.
6. Czerninski T, Nadler C, Kaplan I, Regev E, Maly A. Comparison of clinical and histologic diagnosis
in lesions of oral mucosa. Essay presented at: Annual Meeting of the American Academy of Oral
and Maxillofacial Pathology;April 24,2006; San Antonio, TX.
7. Rapp C. Oral cancer malpractice claims increasing. Today’s FDA 2005;17:37-38.
8. Studdert DM, Mello MM, Gawande AA, Gandhi TK, Kachalia A, Yoon C, Puopolo AL, Brennan TA.
Claims, errors, and compensation payments in medical malpractice litigation. N Engl J Med
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9. Biopsy services. Available at: http://aaomp.org/general/lab_main.html. Accessed May 2007.
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