Wherever you may practice implant dentistry, there will be laws and regulations that govern dental practice. Each jurisdiction will have its own specific regulations, but the common aims will be to protect the safety of patients and to set standards of care to ensure high-quality outcomes. Communities will also have expectations about how professionals like dentists should practice. These expectations are often embodied in ethical codes developed by professional groups. The codes detail the attitudes and responsibilities that dental practitioners owe to their profession, to their colleagues, and to the community at large. This module will provide an overview of the likely legal and ethical considerations you should be aware of and familiar with in the environment in which you practice. It is a general legal principle that ignorance of the law is not a defense.

After completing this ITI Academy Module, you should be able to: recognize the legal environment in which you practice; describe the key factors in obtaining informed patient consent; complete necessary medicolegal documentation; and explain the concepts of "duty of care" and "ethical obligations".

The specific legal environment for practicing dentistry will depend on where you practice. Many levels of government may make laws that impact on your practice of dentistry. Such regulations may be enacted by national governments, regional or state governments, or by local authorities. Even international treaties and agreements have the potential to affect the way you practice. Groups of nations, for example, the European Union, may collectively agree on legislation or treaties that may impact dental practice.

Legislation or statutes that have an impact on the practice of dentistry can generally be divided into four areas: First, who can practice. Registration or licensing of dentists and dental specialists may require a specific level of training, competency in various treatment modalities, continuity of practice, that is, actively practicing dentistry, continuing education, and peer review. Second, legislation regarding the physical facilities where services are provided. These regulations are aimed at ensuring that dental practices meet standards relating to governance, that is, how a practice may be run, infection control and workplace health and safety, quality assurance, and patient safety.

Third, which materials may be used for treatment. Government organizations like the United States Food and Drug Administration have the power to control the approval of medical devices and materials. These organizations also develop the standards and procedures for the approval of such devices and materials. Fourth, many jurisdictions also have laws aimed at protecting consumers from substandard or faulty goods and services. In some places, these laws are also applicable to treatment provided by dentists.

In addition to statutes, common law or case law decisions may set standards that must be met in dental care. Precedents set in lawsuits pertaining to medical or dental treatment cases may define standards of care, such as dictating what constitutes adequate warning of potential complications, and whether signed consent forms have any value in the informed consent process. Research into the circumstances of your particular legal environment is a wise precaution to ensure that you are compliant. The advice of an attorney or your professional association may be necessary.

So, within the legal framework that exists where you practice, how can you be sure that you are practicing within the law? The answer is relatively straightforward. First, you need to know what laws and regulations apply to you, and comply with these to the best of your ability. You need to follow the consent process to ensure that your patient understands the risks and benefits of their proposed treatment and has realistic expectations regarding outcomes. You must then carry out any treatments to the best of your ability, only providing treatments in which you are adequately trained and experienced and are competent to perform. Finally, you should record in detail all aspects of the care you provide, from assessment through to completion of treatment, in the patient's dental record.

Your Legal Environment, Key Learning Points: The legal environment will depend on where you practice. All levels of government can enact legislation regulating dental practice. Generally, legislation addresses by whom, where, and how can dentistry be practiced. In addition to statutes, common law decisions may also impact your practice. To ensure compliance, you must be aware of the laws that apply to your practice. It may be wise to seek the assistance of your professional association or the advice of an attorney.

Informed patient consent can be defined as "The voluntary and continuing permission of the patient to receive a particular treatment. It must be based on adequate knowledge of the purpose, nature and likely effects and risks of that treatment, including likelihood of its success and any alternative to it".

Informed consent is based on a number of key factors and requires an ongoing process of communication between clinician and patient. The patient should continually be a party to progress of the treatment, and informed consent is therefore not a one-time action of signing a consent form. Informed consent must also be based on fair and objective representation of any and all appropriate treatment options, and the patient should be made aware of any treatment-modifying factors that may apply. The patient must be informed about treatment difficulty and any risks involved and, finally, the consent process should include establishing realistic patient expectations of the end result.

In obtaining informed patient consent to implant therapy, it is important to remember that it is an elective treatment modality with the purpose of facilitating prosthodontic rehabilitation. By its nature, implant placement is also an invasive treatment. Options for treatment cover the full range of rehabilitation from a single-tooth space up to a fully edentulous arch. Whilst clinical and technological advances have led to an expansion of indications, and implant therapy is now considered routine, it is clear that implant therapy also presents with differing levels of difficulty and differing degrees of risk for esthetic, prosthodontic, and surgical complications. In most cases implant therapy is not the only possible treatment option, and it is therefore important to ensure that detailed documentation of all the treatment alternatives discussed is included in the patient's dental records. This will serve as an important point of reference for the premises of the agreed treatment at subsequent stages of progress.

As a general rule, the patient must be offered the full range of appropriate treatment options for dental rehabilitation. In the clinical situation illustrated here, a mandibular right second premolar and first molar are missing. Depending on variations in the clinical situation, the options for replacement could include traditional conventional prosthodontics via a conventional fixed dental prosthesis or a conventional removable dental prosthesis, as well as use of implant therapy. Space closure might also be an option, and, in some cases where the occlusion is stable and there is no risk of unwanted tooth movement, it may not be esthetically or functionally necessary to do any treatment at all. In order to advise the patient fully, fairly, and objectively, the clinician must therefore have insight into all treatment options. This must also include insight into possible combinations of treatment options.

An important aspect of informed patient consent is to ensure that the patient is made aware of any treatment modifying factors that may apply. As part of assessing possible risks, effects, and likelihood of success, a number of general and local modifying patient factors should be considered, and, if applicable, discussed with the patient. The general factors include medical status, skills, age, preferences, and economics. The local factors include general status of the dentition and reasons for tooth loss. They also include any specific prosthodontic and surgical conditions of the treatment site and region as well as evidence of parafunction. These modifying factors will influence and guide the selection of the most appropriate treatment. The aim must be to solve the patient's problem as effectively as possible with minimal intervention and risk.

The ITI SAC Classification is a valuable risk management tool for dental practitioners to assess level of treatment difficulty and degree of risk. The SAC Assessment Tool has been developed for systematic assessment to identify and document modifying factors and risks, thereby allowing contingency planning to be undertaken to minimize risks and undesirable outcomes. The SAC tool is available as a free service on the ITI Academy for assessment of both restorative and surgical aspects of implant therapy. More information about the SAC Classification can be found in the Academy Learning Module "The SAC Classification".

As an elective therapy, implant treatment requires comprehensive documentation of the informed consent in the patient's dental records. It is important to demonstrate that the informed consent is specific to the patient and their particular circumstances and that the consent is a continuing process throughout the patient's treatment. The wording of the consent form should therefore also be specific to the individual patient. The consent form should include all relevant information, conveyed in clear and neutral language, to ensure patient comprehension. The continuing informed consent process should be demonstrated in the patient's dental records by recording the details of ongoing communication between clinician and patient.

Informed Patient Consent, Key Learning Points: Informed consent requires the patient's voluntary and continuing permission to undergo a particular treatment. It should be based upon the patient's adequate knowledge of the purpose, nature, and likely effects and risks of that treatment, including likelihood of its success. All applicable treatment options should be presented and discussed objectively. Patients should be aware of any treatment-modifying factors that may apply. The ITI SAC Assessment Tool is useful to determine treatment complexity and risks. Documentation of informed patient consent should demonstrate that all relevant information has been conveyed and that the consent process is continual throughout the treatment. A consent form should be specific to the individual patient.

The patient's dental record is a legal document that registers all aspects of the relationship between the dental practitioner and the patient. As a legal document, it must be complete, accurate, and legible. It must also be easily understood by others. It is important that dental records be contemporaneous, that is, made at, or very near, the time of the treatment encounter. Abbreviations or shorthand may be used if they are in common usage, but as a general rule they should be kept to a minimum.

Your dental records are your means of accurately recording what happened in a treatment encounter that may be contested in the future. They are your best and, realistically, only defense if your patient decides to complain to statutory bodies such as dental registration boards about treatment that you have provided, or if they elect to take legal action against you. The quality of these records - the detail in the information recorded in them and how this information is recorded - will determine the level of defense that you might rely on. This translates into a legal mantra: Good records will mean that you have the best possible defense. Poor records will lead to a poor defense, and no records will leave you with no defense at all.

The patient's dental record must contain all of the information held by the dentist about that patient. Thus, the dental record should contain all patient information and history forms, correspondence regarding the patient and their treatment, including emailed correspondence, and the dentist's clinical notes regarding their findings and discussions, diagnoses, and provided treatments. Non-text information such as images and radiographs are also part of the dental record and must be included. Finally, laboratory prescriptions, patient study casts, working models, and diagnostic wax-ups are considered part of the patient's dental record.

All stages of the treatment process should be recorded. Documentation begins at the patient's first presentation and the information-gathering phases of anamnesis and assessment, including the development of diagnoses. The recording process continues during discussions of treatment options, risks, and costs - all aspects must be recorded in detail as proof of the continuing consent process. Further, when treatment is provided, detailed notes of the treatment process - both surgical and prosthodontic - and its outcomes must also be made. Finally, continuing care, with the results of visits for monitoring and maintenance and other treatment encounters, should also be recorded in similar detail. Documentation for each of the four categories listed here will be discussed in more detail in the following slides.

In the first phase, anamnesis, records for a specific treatment plan should start with the patient's reason for seeking care. This is also termed "chief complaint", and it forms the basis for all further considerations. We should also assess all other aspects of their condition and lifestyle that may impact on our providing implant treatment, or that might have an effect on the long-term outcome of care. Thus, their medical and dental treatment history, as well as their family and social circumstances, should be assessed and the relevant information recorded. Our examination of the patient should progress from the general to the specific. A clinical assessment of their general health and extraoral condition can then be followed by an intraoral examination and a specific assessment of the site where teeth are missing and some form of prosthesis is desired. Again, information relevant to our possible treatment of this patient must be recorded in their dental record. Treatment planning should include risk assessment as a routine part of the process. In assessing patients for implant treatments, two tools developed by the ITI can be especially useful. The Esthetic Risk Assessment and the SAC Classification system can be used to highlight areas of risk that need to be considered in our discussions with the patient, as well as in our final treatment plan. The online SAC Assessment Tool, which can be found in the ITI Academy, can be used to assess these issues for your patient cases. The results of these assessments can then be included in the documentation of your cases.

When we proceed with the surgical phase of treatment, a basic set of information, common to dental surgical procedures, should be recorded. All surgical procedures will likely involve medications for pain and anxiety control and the prevention of infection. The types of medication administered or prescribed must be recorded, as well as details of dose and routes of administration. The type of surgical access and flap design should be described along with any non-implant-related site preparation. The method of final wound closure should be detailed. Finally, any postoperative instructions and care regimes must be recorded. Information specific to implant treatments must also be recorded. Details of the implant components used, especially any items that are intentionally left in the patient's body, must be recorded. This information should include part and lot numbers for the implant components. Similar details must also be documented regarding any grafting materials or membranes used in guided bone regeneration procedures. Finally, many operators will record the primary stability of implants placed by listing the insertion torque or ISQ values recorded at the time of surgery.

During the prosthodontic phase of treatment, similarly detailed records should be kept. Information routinely recorded during impression-taking procedures for fixed prostheses includes the following: The clinician must record the use of any medications administered as part of treatment. These might include anesthetics, anti-anxiety medications, and antibiotics. The drugs, doses, and routes of administration must be recorded. The impression technique and materials used are recorded as well. The clinician must document the occlusal registration (or bite registration) step, as well as shade selection and other pertinent information related to the patient's esthetic needs and desires. Finally, a copy of the written prescription sent to the dental technician who will manufacture the provisional and/or final prosthesis also becomes part of the treatment record. Implant treatments require additional information. The details of implant impression components should be recorded. Additionally, many clinicians will test implant integration at this stage to ensure that the implant has achieved the necessary level of stability to proceed with loading the implant with a prosthesis. Again, all of this information should be recorded as part of your clinical notes.

When a prosthesis is delivered, a routine set of information is recorded. This relates to any medications used, as well as an assessment of the prosthesis for fit, contact points, occlusion, and esthetics. Implant treatment notes also need to include the details of implant components, abutment screw torque values, and the specifics of the prosthesis retention: either the cement used to retain the prosthesis or, if applicable, the retention screw torque. For screw-retained prostheses, the materials used to close the screw access channels in the prosthesis are recorded.

When the treatment is finished and the prosthesis has been delivered, you should record the following baseline data: Radiographs, to document the initial bone level; Photographs, to record the intraoral clinical appearance; Peri-implant probing depths at four surfaces (mesial, distal, buccal, and lingual); Hygiene instructions, including technique and utensils to be used; and a plan for continuing care and recall intervals.

Implant treatments all require regular maintenance to optimize their potential for survival and success. The recall interval for implant patients should be based on their individual risk of complications with their prosthesis. Recall assessment appointments should be recorded with a diligence similar to treatment appointments. A basic level of documentation should include information about: the integrity and stability of the prosthesis (noting any areas of damage and any signs of screw loosening); any changes in the occlusion or signs of damage from bruxism; the assessment of peri-implant mucosal health, including probing depths and signs of bleeding on probing; and the findings of any radiographic assessment, if indicated.

"How long must patient records be retained?" is a difficult question to answer definitively. Most jurisdictions have a legislated limit on the time a litigant can wait before bringing an action to court. This "statute of limitations" is usually less than 10 years for medicolegal matters but varies between jurisdictions. Unfortunately, the limitation period does not begin until the patient becomes aware of the problem - the so-called "date of discovery," which may be many years after the treatment has been completed. Matters are more complicated in the case of children, where this time period cannot begin until they become legally competent adults. As a general rule, because there is no certainty of protection with the passage of time, you should retain your patient dental records for as long as possible, even after you retire from practice. Your professional association can probably give you specific advice for the jurisdiction in which you practice.

Medicolegal Documentation, Key Learning Points: The dental record is a legal document that registers all aspects of the dentist-patient relationship. The information contained in the patient dental record must be complete, accurate, and recorded in a timely manner. Good patient records are your best defense against patient complaints or legal actions and provide proof of continuing consent. All stages of the patient's implant treatment should be recorded in detail, from initial patient presentation to treatment planning, delivery of treatment, and continuing care. Patient dental records should be retained for as long as possible.

Patients, colleagues, and the community at large have expectations with respect to your professional behavior. "Duty of care" and "ethical obligations" are two important aspects of the profession of dentistry. Duty of care can be defined as your responsibility to the patient to exercise appropriate knowledge, skill, and care during treatment. This responsibility is part of an implicit, although legally binding, agreement between you and your patient. Ethics encompasses a set of rules that defines membership of a profession. As a dentist, you have an ethical obligation to adhere to the rules or standards for the right conduct or practice of your chosen profession.

Duty of care is subject to local regulations and precedents and is likely to include, although not restricted to, the following: Making an accurate diagnosis; Giving unbiased, evidence-based advice to the patient regarding treatment options, risks, benefits, and costs; Providing appropriate warnings; and providing treatment to an acceptable standard. Failing to adequately discharge these duties may leave you liable to regulatory action or to lawsuits brought by your patient.

In dentistry, ethical obligations are covered by codes of ethics issued by most national and international professional associations. These professional ethical obligations are usually owed to patients, colleagues, and the community in general. The codes define, in most circumstances, a series of obligations that members of the profession agree to meet. Examples of obligations to patients include the duty of care covered in the previous slides, together with providing evidence-based treatment, keeping up-to-date, and practicing within your limits. Examples of ethical obligations to colleagues include advising referring practitioners of your findings and details of any treatment you provide. It also extends to confining comments on treatment carried out by others to matters of fact, and therefore limiting expressions of opinion. For the community at large, ethical obligations include striving to meet expectations and preserving the reputation of the profession. A topical example is truthful and appropriate advertising. Your national professional association can provide you with information regarding their code of ethical practice.

Duty of Care and Ethical Obligations, Key Learning Points: Duty of care is your responsibility to your patients to exercise appropriate knowledge, skill, and care when treating them. This responsibility is part of an implicit, although legally binding, agreement between the clinician and patient. Ethics encompasses a set of rules that defines membership of a profession. These translate into certain obligations owed to patients, colleagues, and the community. Failure to meet the standards of care, or your responsibility to the patient, can lead to liability or allegations of negligence.

Legal and Ethical Considerations in Implant Practice, Module Summary: All levels of government can enact legislation regulating dental practice; common law decisions may also impact the practice of dentistry. To ensure compliance, you must be aware of the laws that apply to your practice. Informed consent is the patient's voluntary and continuing permission to undergo a particular treatment. The basis of informed consent is the patient's adequate knowledge of the purpose, nature, and likely effects and risks of the treatment, including likelihood of its success. All applicable treatment options should be presented to the patient and discussed objectively.

The dental record is a legal document that registers all aspects of the dentist-patient relationship, from initial patient presentation to treatment planning, delivery of treatment, and continuing care. Good patient records are your best defense against patient complaints or legal actions and provide proof of continuing consent. Patient dental records should be retained for as long as possible. Failure to meet the standards of care or your ethical responsibility to your patient can lead to liability or allegations of negligence.