Materiality and materials

A group of readers posted the following comments and questions:

As clinicians, we have always been aware of the cytotoxic potential of the intraoral appliances that we place during treatment. With improving technology, there is an increasing body of data that is suggestive of the possible mutagenic nature and carcinogenic potential of the materials we use clinically, and these facts raise several serious outstanding legal issues. . . . [I]n the light of present knowledge, there is no evidence that short-term use of fixed appliances for orthodontic treatment [has] an impact on the systemic and general well-being of the patient. In this litigious day and age, would we be held liable for failing to inform the prospective patient regarding the “material safety facts”? How well informed is the average practitioner on the “safety aspects” of the materials we use? Do we even bother to refer to the “material safety data sheet” provided by manufacturers? . . . [C]ould it be possible that in the future we may have to leave the ultimate choice of “material of braces” to our patients? With a broader array of materials . . . the clinician often [has a] choice between titanium, low-nickel stainless steel, ceramic brackets or [aligners]. Would we be ethically wrong by deciding or helping to decide “what may be best suited for a patient”? Should it be “economics” that dictates the “choice of material” for our patient? We all insist on recording a clear medical history, but what sort of patients are at greater risk from the metallic ions leached out from appliances? I do not have clear-cut answers to these questions. But . . . [i]t would be good to [have some] legal views on this matter in a forthcoming issue. In the meantime, we can be optimistic and hope that tomorrow’s technology will either vindicate the clinical use of present-day materials or come up with better clinical alternatives . . . to better serve the “interests of the patient.”

The first question asks about our legal duty to inform the patient regarding the material used in fabricating our hardware. It is a fair enough concern and question. The answer depends on which state you practice in, and the states are split almost equally. Standards of care concerning informed consent fall into 2 general categories. In states that use the professional standard, one must inform the patient of the information that a reasonable practitioner would divulge under the same or similar circumstances. In the other states, one needs to inform the patient of all material information that a reasonable patient would need to know to accept or reject treatment. Obviously, the higher standard is the one based on a patient’s need to know. You can never go wrong using it, because it will always transmit the same if not more information than if you used the professional standard.

The question then becomes “would a reasonable patient need to know that our appliances decrease cellular viability, induce DNA damage, and increase the nickel and chromium content of the buccal mucosa cells”? (Hafez HS, Selim EMN, Eid FHK, Tawfik WA, Al-Ashkar EA, Mostafa YA. Cytotoxicity, genotoxicity, and metal release in patients with fixed orthodontic appliances: a longitudinal in-vivo study. Am J Orthod Dentofacial Orthop 2011;140:298-308). When stated that way, of course they would. But how about if you added the following facts? After 6 months, the levels of these 2 metals are not significantly different from the pretreatment levels. In addition, although increased levels of the metals are also found in the saliva, at the end of a month, they are “well below the normal dietary levels” (Sahoo N, Kailasam V, Padmanabhan S, Chitharanjan AB. In-vivo evaluation of salivary nickel and chromium levels in conventional and self-ligating brackets. Am J Orthod Dentofacial Orthop 2011;140:340-5). What you need to do at this very instant is to take off your orthodontist’s hat and put on the one worn by the patient. If you can divorce yourself and truly become a mere reasonable patient, would this information be important to you in deciding to accept or reject orthodontic therapy with a particular set of appliances? Your answer is the answer to our reader’s question.

The next 2 questions ask how well informed the average practitioner is regarding the “safety aspect” of the materials we use, and do practitioners even bother to look at the material safety data sheets associated with these materials? Although it is impossible to know the answer, it is critical, from a legal perspective, that we are required to know everything about the materials we use at the level that would be known by the average practitioner of good standing in our community. We don’t have to know more, but we can’t know less. Once again, ask yourself a simple question. Of all the orthodontists I know, how much knowledge does the average doctor possess regarding the leaching out and the effects of any number of potentially toxic materials that make up the appliances we use? Regardless of your answer, it is clear that maybe this is a topic that should be addressed by some of our gurus on the orthodontic lecture circuit and repeated at local, regional, and national meetings around the country.

The next 3 questions are all related. First, should we leave the choice of materials to our patients? Second, since we have a choice among stainless steel, titanium, ceramic, and plastic brackets, as well as clear aligners, are we ethically wrong by deciding or helping the patient to decide which material should be used? Finally, should economics dictate the choice of material? Get your skis on, because you are about to embark on a voyage down a slippery slope. Let’s answer the second question first.

After a diagnosis is made, whether or not a problem list is developed, a treatment plan is devised. The clinician then must decide on the appropriate mechanotherapy to effectuate the goals of treatment. That in and of itself might, depending on the patient, rule out aligners and acrylic removable appliances, leaving metal and composite as the materials to choose from. At this point, if the patient has said that esthetic concerns are a nonissue, it might be possible to reduce the choice further; this would leave metal hardware to choose from. Which metal could depend on certain clinical parameters such as the availability of a particular bracket prescription in a particular metal, the preference regarding the bracket’s system of ligation, the clinician’s experience with a specific bracket, and so on. This then is coupled with the patient’s medical history vis-a-vis any known allergies. The point is that this is usually a clinical decision to be made by the clinician.

On the other hand, if the practitioner believes that there is no fundamental difference between 1 bracket and another, laying them all out for inspection like different cuts of meat and allowing the patient to choose, based on factors such as esthetics alone, shininess of the metal, size of the bracket, cost of each system, and so on, does not appear to be either illegal or unethical, although I can’t help but think that on some level and in some manner it denigrates our specialty. Imagine my interventional cardiologist showing me several types of stents, giving me a rough overview of the pluses and minuses of each, the cost for each, and telling me to pick the one I want to have placed in one of my coronary arteries. You think it’s not the same thing, but some would say that it’s pretty close. This of course brings us full circle back to the first question that dealt with allowing a patient to choose the bracket to be used.

As to the third question, unfortunately, in today’s hardware supply marketplace, cost can be a factor. With titanium brackets costing more than stainless steel, ceramic brackets costing almost twice as much, and self-ligating brackets often costing double that, cost can indeed be a factor. Many doctors charge more for certain types of brackets and those not wanting to appear to be nickel and dimming their patients merely raise either their appliance fee or the overall fee to accomplish the same end result. For some patients, if given the option, the cost difference could be a real factor in appliance selection, which, depending on the specifics of the case as noted above, might or might not be contraindicated and, in the correct set of circumstances, could pose some standard of care and ethical concerns.

The last question asks whether we can identify patients at risk regarding certain metal toxicities secondary to orthodontic appliance usage. Although there probably are certain diagnostic tests that could be performed, does recommending or not recommending such laboratory tests fall within our current standard of care? One common test for minimal acceptance of a certain diagnostic test or clinical procedure is whether it is practiced by a respectable minority of one’s professional peers. I don’t want to start splitting hairs about what number constitutes a respectable minority, but I, like most of you (at least the reasonable doctors among us), know it when I see it. To my knowledge, routine screenings have not been recommended because, as the 2 articles noted above stated, the risks as we know them today are in the long run inconsequential and clinically insignificant.

Our reader ends his question with a comment espousing that, in the end, it is all about serving the best interests of our patients—hear, hear.

Commentary

It used to be acrylic, then it was latex, after that it was nickel, and now it is chromium. In time, a small segment of our patients will negatively react to other materials. As a specialty, how are we to respond to this type of clinical challenge? After all, in reality, that’s what it is, another professional hurdle that we must clear as we go about our daily ministrations. Do we merely proceed with business as usual and disregard the potential negative sequelae because of the small chance of its occurrence, or, because even if it does occur, it will usually not rise to the level of clinical significance? Do we take the issue totally out of the picture and recommend nonmetallic appliances for everyone? How much must we tell our patients? More importantly, from an ethical perspective, how much information should we tell our patients? Most seasoned practitioners know how easy it is to scare someone into not having treatment or to accept a different form of treatment, appliance used, and so on, based on how we inform them. There is an extremely fine line between education and coercion. Often, we cross that line without even knowing it.

I guess the bottom line is more research, translating into more data, giving us more information to first place on our triple-beam balance scale of orthodontic practice, which, after proper professional filtration, allows us to appropriately inform the patient of our recommendations given the totality of the circumstances. All this, and we’re only talking about braces—whew!

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Apr 8, 2017 | Posted by in Orthodontics | Comments Off on Materiality and materials
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