Three-Dimensional Imaging for Orthodontics and Maxillofacial Surgery

Chung H. Kau, Stephen Richmond, Chung H. Kau, Stephen Richmond

• Publisher: Wiley-Blackwell
• Year: 2011
• ISBN:
  9781444347647
• Edition: 1
• Topic: Medicine
• Subtopic: Dentistry

Three Dimensional Imaging for Orthodontics and Maxillofacial Surgery is a major new specialist resource that identifies and applies the principles of three dimensional imaging to orthodontic practice. Readers are introduced to three-dimensional imaging, comparing it with the traditional two-dimensional assessments and exploring the benefits and drawbacks of these imaging modalities.

Three Dimensional Imaging for Orthodontics and Maxillofacial Surgery centers on the appropriate application of three-dimensional imaging in the various practices related to orthodontic delivery and craniofacial surgery. The book guides the reader through detailed and illustrated examples of three-dimensional patient management in the context of daily practice. Both three-dimensional static and motion analyses are explored. The book also addresses growth, orthodontic treatment and surgical prediction, both static and dynamic and explores the use of morphing and finite element analyses with particular focus on surgical intervention.

A key resource for specialist working in the fields of orthodontics and cranio-maxillofacial surgery.

KEY FEATURES

· Applies principles of 3D imaging to orthodontic practice

· Surveys and analyzes current technologies and modalities, relating them to clinical usage

· Companion website with motion images ( www.wiley.com/go/kau )

· Richly illustrated in full color throughout

· Brings together expert contributors for an international perspective

Part 1

Imaging, Diagnostic, and Assessment Methods

1

The Legalities of Cone Beam Imaging

Kenneth Abramovitch, Christos Angelopoulos, and Randall O. Sorrels

INTRODUCTION

When a patient requires an imaging procedure, there are several underlying scenarios that are part of the process. These events have a complicity of legal implications. The legal implications may vary from one jurisdiction to another, regardless of whether one is referring to national, state/provincial, county/ parish, city, or municipality. The intent here is to describe legal processes that can establish guidelines consistent with good quality healthcare delivery.

Imaging procedures are required to evaluate the presence or absence of a disease state or to perform the craniofacial morphometric analyses necessary to develop dentoalveolar and craniofacial treatment plans. The latter are frequently indicated to evaluate craniofacial esthetic and functional relationships.

The indications for a cone beam computed tomography (CBCT) scan are usually associated with some degree of morbidity, hence there is an element of risk associated with either performing or abstaining from the procedure. These associated risks may be from either the physical harm from the procedure, the potential morbidity of a misdiagnosis, or the potential morbidity from a failure to diagnose. Physical harm from imaging procedures is related to the harmful biologic effects of ionizing radiations. These risks are very low and are discussed in another chapter. Legal issues associated with misdiagnosis and a failure to diagnose, as well as disclosure and informed consent and adequate documentation, are discussed here.

EDUCATION AND TRAINING

The utilization of any diagnostic procedure, including cone beam imaging, should be ordered and performed based on a sound knowledge of the potential diagnostic yield of the procedure. Due to the increased popularity of and excitement generated by this imaging modality, cone beam imaging is often thought of as the “gold standard” for craniofacial imaging. It is expected by novices to provide a solution to every diagnostic need. As with every diagnostic procedure that may be potentially harmful, cone beam scans should be ordered and performed when there is justification that the benefits of the examination outweigh the possible risks (European Academy of Dento- Maxillofacial Radiology). It is the duty of the oral health professional to be educated as to the diagnostic potential and to the possible benefits as well as risks of this technology.^1,2

The auxiliary personnel involved in all the stages of image acquisition (patient referrals, patient history, patient preparation, image acquisition, and data- handling) must have received the appropriate education and training for proper technique and for radiation safety and protection measures for the patient as well as for the operators. Similarly, training is imperative for the dental professionals who will utilize the acquired data. Proper image selection for the diagnostic task at hand and proper reconstructions in order to yield the required information is frequently the result of training and experience together. CBCT is becoming part of the routine curriculum in most accredited graduate dental programs. Accredited continuing education courses are also available to practicing clinicians. These courses are readily found through routine Internet- based search engines. An example of one resource is listed in the reference section.³

DISCLOSURE AND INFORMED CONSENT

When an imaging procedure is requested for a patient, the patient must be given specific information about the procedure. The legal process of informing a patient about the medical procedure is referred to as disclosure. The patient is informed of the imaging procedure indicated and then the need and benefits associated with the procedure. The patient must also be informed of any harm or side effects from the procedure (biologic harm), as well as the risks associated if a disease is not diagnosed because the procedure is not performed or the patient refuses the procedure. The patient must also be informed of other possible diagnostic tests or alternate diagnostic procedures that may be available instead of the imaging procedure, for example ultrasound, standard computed tomography, serum analysis, etc. Patients must also be permitted to ask additional questions to clarify their understanding of the information that has been presented.

If this degree of disclosure has been performed, the patient has been presented with adequate information to be better informed to make a decision on whether or not to give his or her consent for the imaging procedure. The process of informing the patient with this degree of information is the knowledge base necessary for a patient to give informed consent. The components of informed consent are summarized in Box 1.1.

Box 1.1 Summary of inclusions necessary for the process of informed consent

a. the imaging procedure and the purpose of the procedure

b. potential benefits of the procedure

c. risks to the patient’ s health if the procedure is performed

d. risks to the patient’ s health if the procedure is not performed

e. opportunity for the patient, legal guardian or trustee to ask for additional information or for clarifications

From Iannucci and Howerton.¹⁹

Box 1.2 Factors that contribute to negligence with informed consent

a. lack of patient (legal guardian or trustee) consent

b. consent from a minor

c. consent from an inappropriate (illegal) guardian

d. consent from an individual under emotional duress or under the influence of drugs or alcohol

e. consent based on fraudulent or incorrect statements

f. d isclosure from unqualified (non-licensed) personnel

From Iannucci and Howerton.¹⁹

The basic tenet of informed consent is that the clinician supplies adequate medical and dental knowledge necessary for the patient to make an intelligent decision on whether or not to undergo the recommended imaging procedure. Since the written documentation of this process should be in the patient’ s record, this is best achieved with a written consent form. The informed consent (if given) is confirmed with the patient’ s signature and is often also signed by at least one witness. This consent often serves as a legal document if it contains disclosure and is obtained freely.

After an appropriate disclosure, a patient may decide to decline the procedure. In such instances, the clinician’ s ability to treat the patient may be compromised. If the dentist’ s treatment will be compromised by the lack of essential diagnostic data, the patient should be so informed. In these situations where the “untrained” patient dictates the course of the diagnostic workup and treatment and this limits the diagnostic ability of the clinician, it is often best to terminate further professional interaction.

NEGLIGENCE AND MALPRACTICE

Procedures performed on a patient without their consent is not considered good practice, that is, is negligent behavior, and is susceptible to a legal claim of malpractice. Negligence in most jurisdictions means the failure of a healthcare provider to act as an ordinary reasonable healthcare provider would act in the same or similar circumstances. This means that the act or action taken would not be performed by a reasonable clinician. In litigation scenarios, negligence may also mean failing to do something that a reasonable clinician would not do in a similar situation.

Although it may be subject to legal and professional opinion, there are several situations in which negligence can be legally determined. These situations are outlined in Box 1.2. Each situation is subject to legal and professional opinion before the decision of negligence is made.

WRITTEN DOCUMENTATION FOR AN IMAGING SCAN

“Do it right - write it down” and “If it’ s not in the record - it did not occur” are popular axioms that serve as guiding principles for dentists and other healthcare professionals to minimize professional risks. In keeping with the rationale and need for a patient record, the written record preserves the memory of the patient - clinician interactions (treatments or discussions) that have occurred. This written record can be used to share protected health information. These records are also permissible for legal proceedings in the event that there is litigation. But proper documentation protects the treating clinician. It is recommended that a standard entry in a patient record for an imaging procedure should include the patient’ s informed consent and the specific imaging strategies and reconstructions utilized to investigate the diagnostic task. The imaging procedure should have some documentation of the exposure settings, that is, kilovolt and milliamp è re values, and seconds of exposure or scan sequence. In many instances, a review of the scan sequence will disclose these aforementioned technical parameters. The size of the area exposed, that is, the field of view, should also be included. This exposure information is required in the record in the event that effective dose or dose equivalence needs to be calculated for a specific procedure.

The types of image reconstruction and the software utilized for the reconstructions should be included to demonstrate the steps followed and the views evaluated in arriving at professional decisions and diagnoses. In the event that one had to replicate these reconstruction data to see how diagnoses or decisions on treatment planning were made, the sequence steps would be available in the record. This information is also helpful in the event that the imaging strategy does not provide the diagnostic information necessary. With this imaging history, the treating or consulting clinician can develop other imaging strategies (software reconstructions, software programs, or different imaging acquisitions) to address the diagnostic task at hand.

DOCUMENTATION OF DIAGNOSTIC FINDINGS

Most regulatory agencies stipulate that there must be an entry in the record reporting the diagnostic information obtained from the imaging procedure. This entry is usually complementary to the clinical indication for the procedures in the informed consent, for example reporting morphometric data for an edentulous ridge site prior to dental implant surgery.

If a patient is referred for an implant evaluation, it is understood that the focused area of the implant receptor sites and possibly bone graft donor sites will be evaluated. Hence if an area of edentulous ridge will be used as a receptor site for an implant placement, the selection site should be identified, along with the reasons why. However, it is not acceptable to merely report these findings and not document other significant information, that is, disease that may affect the patient’ s long-tem prognosis.

In another instance, a CBCT scan may be requested to evaluate pathology around an impacted mandibular third molar, but there may be other disease processes in the jaws that are within the field of view imaged. This latter would include a number of possible entities involving the orbits, paranasal sinuses, and scanned cranial and cervical areas. Multiple reportable findings are noted on CBCT scans.^4,5 Hence, it is not acceptable to avoid the rest of the dataset. There is probable liability for failing to diagnose conditions in the entire dataset of the CBCT scan. If a significant finding is missed, and this causes harm to the patient, the referring clinician and even the imaging facility (if it is not the patient’ s treating clinician) may be liable for being negligent.

The entire dataset in all planes of view needs to be viewed, and any abnormalities must be reported. In cases with positive findings, appropriate referrals may be further indicated. If the imaging facility or the referring clinicians are not able to review the data, there are dental and or medical radiology reporting services that can perform these services. This process can minimize liability from failing to report pathology and referring it in a timely manner.⁶

WAIVERS FOR IMAGING LIABILITY

It is fairly standard in dental education that dentists receive training in reading two- dimensional images of the dentoalveolar structures and adjacent anatomy in the head and neck region on bitewing, periapical, panoramic, and skull cephalograms (lateral and posteroanterior). However, most dentists are not trained to interpret the multiangle and three- dimensional (3D) projections obtained from cone beam scanners and the related software imaging. It has been suggested that patients can sign waivers of liability for disease that may be present in the scan data. The reasoning for the liability waiver is because it is not a disease that the clinician is specifically investigating or is not within a dental clinician’ s training or expertise.⁷

However, liability cannot be signed off by a patient. Statutes, legal opinions, and malpractice insurance companies have stepped forward to negate the legitimacy of this waiver of liability. Both the referring/ treating clinician and the imaging facility have a legal obligation to assure that the entire dataset is reviewed and that potential conditions not in the areas specifically reviewed by a referring doctor are reported.⁸

A patient is not as knowledgeable to assess the risk - benefit analysis for the necessity to have a scan read. Dental clinicians are more knowledgeable than patients concerning the incidence, pathophysiology, and recognition of diseases in the jaws. Hence the patient is not as knowledgeable to assess the same risks and make a reasoned opinion on whether or not to overlook interpreting the data. In the event that an occult lesion is noticed at a later date but was found to be present in the data of a cone beam scan ordered for dental treatment, there is a strong likelihood that the dentist will be liable for failure to diagnose. The dentist has more expertise than the patient to recognize the disease process, and hence should not have left the decision to interpret all the data with the patient. The doctor is liable in the event that a disease process is detected.^8,9

Because of the potential harm to patients from failing to report on all the data in a CBCT scan, professional organizations have prepared recommendations and guidelines that pertain to the need for formal written interpretation reports in the patient’ s record based on a review of the entire CBCT dataset.^1,2,10,11 The treating or consulting clinician must review the entire dataset and interpret the significance of the findings. Since interpreting advanced images is not a standard curricular subject in accredited teaching institutions, most dentists do not have this training. If a dentist without advanced training assumes the responsibility of reading the data, he is accepting a greater duty to the patient than he or she may be prepared for. If an occult disease is missed, the clinicians have breached this greater duty that they assumed, and this may be considered to be an act of professional negligence.

The data must be read by a trained clinician. Oral and maxillofacial radiologists have acquired this knowledge in advanced training programs. Although the data do no...

Table of contents

• Cover
• Title page
• Copyright
• Contributors
• Preface
• Part 1: Imaging, Diagnostic, and Assessment Methods
• Part 2: Applications, Physiological Development, and Surgical Procedures
• Part 3: Movement and Facial Dynamics
• Index