Informed consent is an important aspect of research, medicine, and dentistry, as well as the patient’s right to autonomy. While a patient’s right to autonomy can become blurred in the face of certain ethical decisions, it should never be ignored outright.
Medicine and medical research have a past that haunts me since early research rarely, if ever, considered patients’ autonomy. Additionally, certain members of society were blatantly abused in the name of medical advancements and research. As health care providers, we are ethically bound to ensure this never happens again.
Informed consent is required for multiple aspects of health care, including, but not limited to, treatment, dissemination of patient information, HIPAA, surgery, blood transfusions, and anesthesia. Other common procedures do not require informed consent, such as taking vital signs, including blood pressure.1
Acquiring adequate informed consent is an important aspect of treating patients that will protect the practitioner as well as the patient. The three acceptable legal approaches to informed consent are 1) subjective standard, 2) reasonable patient standard, and 3) reasonable physician/dentist standard.1
The subjective standard is best described as what the patient needs to know and understand to make an informed decision. The reasonable patient standard focuses on patient knowledge and begs the question, “What would the average patient need to know to be an informed participant in the decision?” This allows for fewer technical terms and more patient-friendly explanations.
However, it is still important that the patient understand the proposed treatment. The reasonable physician (dentist) standard focuses on what the typical physician/dentist says about the procedure being proposed.1
Most states allow the reasonable patient standard as an acceptable measure for informed consent. However, always refer to your state dental practice act to ensure there isn’t a specific standard they require. The requirements for informed consent vary by state; this article will cover the basics of what is needed for legal informed consent. Nevertheless, I cannot stress enough how important it is to check your state dental practice act to ensure you are following all the requirements for your state.2
Components of Informed Consent
When proposing treatment for patients, basic elements of informed consent should be included to assist the patient in making an informed decision. The following should be explained in language the patient clearly understands:3
- The patient’s diagnosis
- The nature and purpose of the proposed treatment/procedure
- The advantages and risks of treatment
- The alternative treatments available to the patient regardless of their cost and whether they will be covered by the patient’s insurance plan (if applicable)
- Potential outcomes of treatment
- What might occur, both benefits and risks, if treatment is refused
It is also important to understand patients are not free of some level of responsibility. For dental professionals to provide information clearly for the patient to understand the risks and benefits, expected outcomes, and alternative treatment options, the patient is required to own some responsibility in their care. Patient responsibilities include the following:3
- Provide accurate and complete information; this includes full medical history disclosure
- Follow the treatment plan as recommended
- Report any unexpected changes in their condition as soon as possible
- Inform the dentists or dental staff if they have questions they need answering
- Inform the dentist or dental staff if they are experiencing pain
By not adhering to these responsibilities, it is difficult for dental professionals to provide information that could alter treatment options as well as risks and benefits. For instance, a patient with uncontrolled diabetes may not yield the same results from nonsurgical periodontal therapy as a patient with controlled diabetes. If the patient does not disclose this information, true risks and benefits and expected outcomes cannot be articulated.
This component of informed consent can change at any time. One of the most common changes that occurred when I was working clinically was a patient who was scheduled for a prophy, but after assessment, they actually required scaling in the presence of gingival inflammation. For instance, after completing a periodontal evaluation, I would quickly realize the patent had raging gingivitis. In this case, more therapeutic treatment was required (i.e., scaling in the presence of gingival inflammation) rather than a preventative procedure (i.e., prophy), which is the treatment the patient understood they would be receiving that day.
It is imperative that you inform the patient of their diagnosis and the change in treatment before proceeding. You should also acquire informed consent for scaling in the presence of gingival inflammation. Otherwise, you have created a liability if the patient decides to seek legal recourse.
Why would a patient seek legal recourse in a situation like this? Because the patient did not understand their diagnosis, the need or risks versus benefits of the procedure, and/or they owe a fee they don’t feel is fair because they were under the assumption they would be getting their “free cleaning.” If you work clinically, you know this is a very plausible situation. This leads right into the next component of informed consent, the nature and purpose of the proposed treatment.
Nature and Purpose of the Proposed Treatment
I’m going to stick with the same scenario because I feel like this is a scenario many dental hygienists struggle to explain and manage, leaving the patient unaware of the actual diagnosis and treatment they received. Many hygienists will simply default to billing out a prophy, even though their patient clearly has gingivitis.
Advising the patient that they are in a diseased state with generalized gingivitis, yet no bone loss or clinical attachment loss, is all that is necessary to describe the diagnosis. Always allow the patient to ask questions. I find it best to ask the patient, “Do you have any questions about your diagnosis?”
Then explain the difference between a prophy and scaling in the presence of gingivitis. I’m certain some of you are asking, “What is the difference exactly, and how can I explain that to the patient?” The difference is that the patient is in a diseased state, with supra bony pocketing requiring more intense debridement.
Scaling in the presence of gingival inflammation may also require a topical anesthetic to complete treatment effectively, and I like to implement chlorhexidine-thymol varnish as part of the procedure as well. Of course, using any adjunctive needs to be discussed with the dentist. However, studies indicate CHX-thymol varnish is very effective in the management of gingival inflammation.4 Simply applying the varnish and explaining the purpose changes the procedure in the patient’s mind because, ultimately, the patient’s perception is very important in their understanding of their diseased state.
Advantages and Risks of Treatment
Risks associated with scaling in the presence of gingival inflammation are self-limiting. They include soreness and discomfort that can usually be managed by over-the-counter pain medication when necessary. This is assuming the patient has given you all the correct information regarding their medical history. For example, the patient shared a comprehensive list of their medications, which doesn’t include medications or supplements that could cause prolonged bleeding. If patients take medications or supplements that cause prolonged bleeding, that information must be disclosed as a risk.
Additionally, there is a very small risk of bacteremia, and though it is a very low risk, it is still a risk and should be disclosed.5 All risks, no matter how rare, if there is knowledge of the risk, should be disclosed when acquiring informed consent.
Benefits, as we know, are many, with the biggest being the halt of the progression of the disease. Reduced risk of developing systemic diseases and/or progression of already existing systemic diseases. Managing gingivitis is less invasive and less expensive when compared to treatments needed for periodontitis. Gingivitis is also reversible, which is the goal of providing therapeutic treatment.
This is a difficult aspect to cover from a dental hygiene perspective because there are very few alternatives. If a patient has gingivitis, we have one option ‒ scaling in the presence of gingival inflammation. If they have localized or generalized mild to moderate periodontitis, we start with nonsurgical periodontal therapy, with the only other option being for the patient to see a periodontist.
However, when it comes to certain preventive and restorative options, we can offer alternatives. Silver diamine fluoride instead of a restoration for deciduous teeth is a great example, or sealants for non-cavitated carious lesions instead of a preventive restoration requiring tooth structure removal. Minimally invasive dentistry should be an option for patients. However, I often see dental hygienists and dentists staunchly opposed to sealants because they believe they are ineffective or conducive to developing decay. However, studies indicate otherwise.6
Unfortunately, it isn’t the dental hygienist or dentist’s choice to make. It is their duty to present all options for the patient to make an informed decision. This is an essential part of informed consent.
Potential Outcome of Treatments
You must give the patient the good, the bad, and the ugly for them to make an informed decision and for your informed consent agreement to be legal. We all want to sugarcoat the bad and ugly, but a better choice is to be straight with the patient. Ensure they understand there is a possibility the treatment could fail and what will happen if it does.
If a patient does not respond well to nonsurgical periodontal therapy, they may need periodontal surgery with a periodontist. They may end up losing teeth over time. This is not the ideal outcome, but it is a possibility and should be disclosed when reviewing the patient’s treatment plan for the patient to decide whether they want to move forward with treatment or not.
Risks and Benefits if Treatment is Refused
When it comes to treatment for periodontal disease, the refusal does not provide many benefits beyond financial benefits. The loss of teeth down the road could be an expense that needs to be considered as well. Nonetheless, this “benefit” should be discussed as the risks of worsening or onset of systemic diseases and tooth loss. This is where patients’ questions may provide more insight into their goals for oral health and what they see as a benefit, which you do not see quite as clearly.
Allow them to ask questions, determine their idea of a benefit for refusal, and lay out your counterargument for the possible risks. That is all you are required to do to provide this element of informed consent. You do not have to like or even support the patient’s decision; you only have to honor it.
This in no way allows you to provide an alternative treatment that does not fit the patient’s needs, such as providing a prophy instead of nonsurgical periodontal therapy. The patient has a right to refuse treatment, but they do not have the right to consent to substandard care. It is your responsibility to make sure they understand this.
If they refuse a treatment that does not have an alternative, they will not be treated at all. This doesn’t mean you dismiss the patient. They may come in for an exam, radiographs, a review of their disease progression, and oral hygiene instructions. They can choose to get a second opinion and/or see a specialist, but they cannot consent to substandard care.
Providing the right components for informed consent may seem like a mental exercise, but honestly, it is easy to condense in a very brief conversation. One of the most important aspects is to make sure the patient’s questions are answered if they have any.
Most dental software has informed consent forms that can be printed for the patient to sign. Make sure the proper treatment is listed on the forms, and keep a copy for your records. Remember that, ideally, informed consent should be signed prior to treatment. Therefore, if the diagnosis or treatment plan changes during treatment, the patient should sign a new informed consent form.
Patients’ decisions about their treatment may not always meet our expectations, but it is our duty to honor them and provide them with all the information they need to make these decisions. If you are withholding any information regarding any component of informed consent, you are doing your patient an injustice. I encourage you to be transparent and honest regarding treatment options, risks versus benefits, potential outcomes, and risks and benefits of treatment refusal.
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- Shah, P., Thornton, I., Turrin, D., et al. Informed Consent. [Updated 2022 Jun 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. https://www.ncbi.nlm.nih.gov/books/NBK430827/
- Types of Consent: Guidelines for Practice Success/Managing Professional Risk/The Consent Process. (n.d.). American Dental Association. https://www.ada.org/resources/practice/practice-management/types-of-consent
- Fremgen, B. F. (2020).Medical Law and Ethics(6th ed.). Pearson.
- Yucel-Lindberg, T., Twetman, S., Sköld-Larsson, K., Modéer, T. Effect of an Antibacterial Dental Varnish on the Levels of Prostanoids, Leukotriene B4, and Interleukin-1 Beta in Gingival Crevicular Fluid.Acta Odontologica Scandinavica. 1999;57(1): 23-27. https://doi.org/10.1080/000163599429066
- Maharaj, B., Coovadia, Y., Vayej, A.C. An Investigation of the Frequency of Bacteraemia following Dental Extraction, Tooth Brushing and Chewing.Cardiovascular Journal of Africa. 2012;23(6): 340-344. https://doi.org/10.5830/CVJA-2012-016
- Frencken, J.E., Peters, M.C., Manton, D.J., et al. Minimal Intervention Dentistry for Managing Dental Caries – A Review: Report of a FDI Task Group.International Dental Journal. 2012;62(5): 223-243. https://doi.org/10.1111/idj.12007