The corrosion properties of the archwires may be different (Chapter 4). Estimates of intake levels from air (in micrograms per day) are 0.12 for Hg, Numerous studies have attempted to determine whether mercury exposure from dental restorations or other sources contributes to any documentable health problem. Still other studies have attempted to look at blood cell types and cell numbers in dentists, who are presumably exposed to higher levels of mercury because of their daily occupational exposure. Which tests can provide conclusive evidence to identify the specific cause of an allergic or toxic response to a restorative material? Class I: Low risk—General Controls [generally exempt from 510(k)], 2. Inflammation adjacent to the metal margin of a metal-ceramic crown. Biocompatibility, in a tissue engineering sense, may be defined as the integration of an implanted biomaterial, into (and/or interaction with) the host tissues, in order to facilitate tissue regeneration, without provoking an adverse local, or systemic, host response (Williams, 2008). Thus, the intake of mercury is a complex issue with many sources and forms of exposure. Materials that allow osseointegration have very low degradation rates, and they tend to form surface oxides that enhance bony approximation. Figure 7-14 shows a graph of the amount of tumor necrosis factor alpha (TNF-α) secreted by monocytes after exposure to hydroxyethyl methacrylate (HEMA) in different concentrations. Concerns about mercury stem from its toxicity and its relatively long half-life in the body. Erythematous reaction sites. Biocompatibility of devices is investigated using analytical chemistry, in vitro tests, and animal models. Biomaterials. The response of the body to a material can change over time (i.e., it is dynamic), because the body may change through disease or aging; the material may change through corrosion or fatigue, or the loads placed on the material may change through changes in the occlusion. Classically, this concern has focused on nickel allergy. Which factors come into play to explain these differences? Today, the choice of the test method is based on risk assessment, which is also divided into separate stages of analysis. 1. adverse reactions reported to all classes of dental materials 2. hypersensitivity, contact sensitivity, and estrogenicity Allergies to substances, foods, and solid materials are well recognized by the public, but specific allergens are difficult for health care professionals to diagnose. Examples of inflammatory reactions that may be caused by allergens leached as ions. Although several interfaces may be present in these restorations, the dentin–cement or dentin–resin interfaces are the most important in transition areas for transfer of leached substances into dentinal fluid. sockets have much greater weight and cause wear of the titanium alloy. These tests are quite diverse, but generally place cells or bacteria in contact with a material. The lowest known level for any observable toxic effect is 3 µg/kg. The absorption of ionic mercury is also poor (approximately 1% to 7%). The gingiva is attached to the tooth’s cementum surface just below the enamel with a specialized epithelium, which is called the, An allergic reaction induces an inflammatory response that cannot easily be distinguished from reactions caused by a nonallergic inflammatory process or by low-grade toxicity. The controversy over the biocompatibility of amalgam has waxed and waned several times in the 170-plus year history of its dental use in the United States. 14.2 The color of a material depends upon the interaction of the material with light and the observer’s interpretation of the affected light. The dental restorative materials described in this textbook are a special subgroup of what are more generally known as biomaterials. The biocompatibility of a material is similar in the sense that it depends on its environment as well as the nature of the material. 3. These values place the 1 to 3 µg/day of absorbed Hg0 vapor from amalgams in perspective. Some materials, such as latex, can cause allergy directly by activating antibodies to the material. This outward fluid pressure from the pulp chamber toward the enamel is not sufficient to eliminate the inward diffusion of bacteria, bacterial products, or material components into the pulp. Subsequently, risk assessment continues and decisions are made on whether or not further tests (e.g., animal tests or human clinical tests) are needed. Histologically, the inflammatory response is characterized by edema of the tissue caused initially by an infiltration of inflammatory cells such as neutrophils and, later in the chronic stage, to the action of monocytes and lymphocytic cells. These effects are controlled by the substances that are released from the material and the biological responses to those substances. The scheme differs from (a), because it emphasizes many cellular reactions in addition to toxicity. Two key-words “dental amalgam” and “toxicity” were used to search publications on dental amalgam biocompatibility published in peer-reviewed journals written in English. Most of the controversy stems from the known toxicity of mercury and the question of whether mercury from amalgam restorations has toxic effects. However, even with the enormous number of peer-reviewed publications that have resulted from investigations of alleged toxic and immunological reactions to mercury in dental amalgam, the evidence, thus far, has been regarded by some groups as inconclusive. There are extremely sensitive methods for detecting mercury in parts per trillion; these methods have made it possible to analyze the sources of mercury exposure for humans. One of the major accomplishments of the ADA was the development and acceptance of ANSI/ADA Specification No. Environmentalists fear that these substances will alter reproductive cycles and developmental processes in wildlife, and there is evidence to support these concerns with regard to humans. biocompatibility: [ bi″o-kom-pat″ĭ-bil´ĭ-te ] the quality of not having toxic or injurious effects on biological systems. The issue of bisphenol A in dentistry is covered more extensively at the end of this chapter. The Clean Air Act is the law that defines the responsibilities of the U.S. Environmental Protection Agency for protecting and improving air quality and the ozone layer. Since ancient times, a wide variety of relatively inert materials have been placed or implanted in humans to replace or repair missing, damaged, or defective body tissues. One study in Sweden reported that 15% of dentists (vs. 9% in the general population) had itching on the hands in response to gloves, particularly latex gloves. These adverse effects can be from cumulative irritation or from allergenic responses. Mercury leaves the body by excretion through urine and feces. Thus, these chemicals are probably xenoestrogens. In vitro biocompatibility tests are performed in a test tube, cell-culture dish, or otherwise outside of a living organism. For some materials, such as ceramics and resin-based composites, cyclical stresses contribute to the breakdown of the material and release of components. General biocompatibility–On this most basic level, we have to look at how the material reacts generally with human tissue. 2 International Dental & Medical Journal of Advanced Research Vol. The biocompatibility of a device depends on several factors, including: the chemical and physical nature of its component materials In this sense, biocompatibility is like color (Fig.14.2). Safety—The absence (freedom) from unacceptable risks. “Biocompatibility of Dental Implants: Literature Review”.EC Dental Science 20.1 (2021): 113-119. In a manner similar to local effects, systemic effects from dental materials are also a function of the distribution of substances released from dental materials. Mercury is also ingested as particles produced by wear, and about 45 µg/day of mercury may reach the gut either as the amalgam form or as dissolved and released Hg2+ ions. No effects of mercury have been noted. Biocompatibility—(1) General definition: The ability of a biomaterial to perform its desired function with respect to a medical (or dental) therapy, without eliciting any undesirable local or systemic effects in the recipient or beneficiary of that therapy, but generating the most appropriate beneficial cellular or tissue response in that specific situation, and optimizing the clinically relevant performance of that therapy (Williams, 2008); (2) Long-term implantable device: Ability of the device to perform its intended function, with the desired degree of incorporation in the host, without eliciting an undesirable local or systemic effect in that host (Willliams, 2008); (3) Scaffold material for tissue engineering product: Ability to perform as a substrate that will support the appropriate cellular activity, including the facilitation of molecular and mechanical signaling systems, in order to optimize tissue regeneration, without eliciting any undesirable local or systemic responses in the eventual host (Williams, 2008). Any of these changes may alter the conditions that initially promoted an appropriate and desired biological response. Several types of beverages have caused degradation of two types of dental ceramics. As indicated previously, teeth with cervical restoration margins can release ions or other substances into the gingival sulcus, and adverse reactions can affect the periodontal attachment and the periodontal ligament (Figure 7-3, with no restoration). Usage tests are equivalent to clinical trials. Allergy—(1) A hypersensitivity reaction initiated by specific immunological mechanisms (Johansson et al., 2004); (2) abnormal antigen–antibody reaction to a substance that is harmless to most individuals; (3) antigen-inducing an allergic reaction. However, to overcome any concerns, products free of bis-DMA can be used. The hydrodynamic theory of pulp pain is related to the movement of dentinal fluid and its influence on the odontoblastic processes. In some cases, observation for 2 weeks or more, when possible, can lead to a resolution of the response because the effect was caused either by trauma, another noninflammatory process, or a self-limiting allergic condition. A potential allergy to one of the metal components should be explored, since such tissue responses to leached metal ions is one of the most prevalent adverse effects reported by national adverse effect registries. In a manner similar to local effects, systemic effects from dental materials are also a function of the distribution of substances released from dental materials. In some cases, observation for 2 weeks or more, when possible, can lead to a resolution of the response because the effect was caused either by trauma, another noninflammatory process, or a self-limiting allergic condition. Reference dose (RfD)—An Environmental Protection Agency (EPA) estimate, with uncertainty or safety factors built in, of the daily lifetime dose of a substance that is unlikely to cause harm in humans (U.S. Agency for Toxic Substances and Disease Registry). It is used in load-bearing hip prostheses and dental implants, because of its combination of excellent corrosion resistance, high wear resistance, high strength, and good biocompatibility. Chronic exposure—The contact with a substance that occurs over a long time (more than 1 year) (U.S. Agency for Toxic Substances and Disease Registry). This debate has spurred considerable research in methods to eliminate particulate and elemental mercury from dental waste. Acute symptoms are neurologically based or kidney based, ranging from paresthesia (at 500 µg/kg or above) to ataxia (at 1000 µg/kg or above), joint pain (at 2000 µg/kg or above), and death (at 4000 µg/kg or above). by lipopolysaccharide. An evaluation of biocompatibility is one part of the overall safety assessment of a device. The area of biocompatibility of materials is also relevant to the practitioner from the standpoint of the health of the dental team. Their migration to other sites can occur by diffusion through tissues or by flow through lymphatic channels or blood vessels. In air, the concentrations of mercury range from about 0.01 to 0.02 µg/m3. Inflammatory response or possible allergic reaction adjacent to a class V resin-based composite. Figure 7-5, D, illustrates positive responses to patch-test substances on a patient’s back. Their routes of entry into the body include the following sources: (1) ingestion and absorption; (2) inhalation of vapor; (3) leakage through the tooth apex; and (4) absorption through the oral, Different types of biological responses to substances can occur in humans. Also in 1930, the Council established the ADA’s Seal of Acceptance program to promote the safety and effectiveness of dental products. These include inflammatory, allergic, toxic, and mutagenic reactions. Substances that accumulate in these areas can lead to inflammatory reactions, allergic reactions, periodontal pathology, and periapical lesions. Histologically, the inflammatory response is characterized by edema of the tissue caused initially by an infiltration of inflammatory cells such as neutrophils and, later in the chronic stage, to the action of monocytes and lymphocytic cells. Thus, it is not always appropriate to label the Ti-6Al-4V alloy as “biocompatible” and the cobalt-chromium alloy as “incompatible” because this classification depends upon the interaction of the material with its environment. However, these types of issues are also relevant to the orthodontist. Hypersensitivity—(1) The objectively reproducible symptoms or signs initiated by an exposure to a defined stimulus at a dose tolerated by normal persons (Johansson et al., 2004); (2) abnormal clinical reaction or exaggerated immune response to a foreign substance that is manifested by one or more signs and symptoms, such as breathing difficulty, erythema, itching, sneezing, swelling, and vesicles. adj., adj biocompat´ible. The practitioner must consider the particular clinical application and patient, and not assume that, because a certain alloy is biologically acceptable as an archwire, it will be acceptable as a bracket or a band or a spring. If it is not time limited, one can assume that the erythema may have been caused by an allergic reaction. SE to a predicate device (pre-amendment or post-amendment) for which PMA is not required, FDA’s determination of SE serves as the classification process for new devices, Most of the submissions to the Dental Branch are 510(k) types of submissions. Still other studies have attempted to look at blood cell types and cell numbers in dentists, who are presumably exposed to higher levels of mercury because of their daily occupational exposure. The first is the hypersensitivity of the patient to dental biomaterials. Absorption of specific metals through the oral mucosa, gastrointestinal tract, or respiratory tract can vary considerably for different chemical forms of a metal. A metal such as mercury can be exposed to tissues as a solid binary phase (Ag2Hg3), as dissolved ions in saliva, and as atoms in the vapor form. Instead, a decision was made to publish a product evaluation newsletter for ADA member dentists that focused on a specific category of professional products in each article. Thus, if substances leached from a biomaterial change the monocyte’s ability to secrete these substances, the biological response can be greatly influenced and this may greatly impair cellular defense mechanisms against bacteria (Schmalz et al., 2011). Primary tests measure basic biological properties such as toxicity or mutagenicity of the material. If the resin material does not penetrate the collagenous network or debonds from it as the resin shrinks during polymerization, a microscopic gap will form between the resin and dentin. Paracelsus (1493−1541) correctly proposed that only the dose of a substance differentiates a toxic agent from a remedy (, Biological testing of materials has evolved significantly over the past 50 years. The environment–metal interface creates the conditions for corrosion. A critical adverse effect is the first event that is observed at the lowest exposure level. Biocompatibility tests Swetha, et al. A Type II response is a cytotoxic hypersensitivity reaction, Type III is an immune complex hypersensitivity reaction, Type IV is a delayed or cell-mediated hypersensitivity, and Type V is a stimulating-antibody reaction, which is rare and sometimes classified as a subcategory of Type II (Rajan, 2002). Reduction in secretion of tumor necrosis factor alpha (TNF-α) by monocytes after exposure to different concentrations of hydroxyethylmethacrylate (HEMA). Even if all 32 teeth were restored on all surfaces with amalgam, the total number of surfaces (counting incisal edges) would be only 160. In 1930, the American Dental Association (ADA) formed a Council on Dental Therapeutics to oversee the evaluation of dental products. Latex rubber and its associated proteins are capable of causing severe and sometimes life-threatening allergic reactions in patients. For this metal, one must be concerned about exposure levels, absorbed dose, body burden, and critical target-tissue concentrations. Tooth-supported dental restorations consist of one or more prepared teeth, a monolayer or multilayer restorative material, and auxiliary dental biomaterials such as dental adhesives, cements, and sealing agents. Testing of dental materials also includes tests for pulp irritation responses, pulp capping effects, endodontic applications, and dental implant performance. Biocompatibility It is the ability of a material to elicit an appropriate biological response in a given application in the body. Although amalgams do not release anywhere near toxic levels of mercury, the long half-life of mercury in the body raises concerns among some individuals. Biocompatibility is also a property of a material interacting with its environment. Although it is unlikely that the practicing orthodontist will need to evaluate results of these tests directly, it is important that he or she understands how materials are approved for use, since ultimately it is the practitioner who must assume the direct legal risks of using materials in the patient. The relationship of dental materials to inflammatory reactions is important because of chronic inflammatory responses such as pulp inflammation and periodontal disease. Materials used in dentistry come into direct contact with the hard tissues of the teeth,theoralmucosa,thepulp&theperiapicaltissues. For metals, a rough surface promotes corrosion, which increases the release of ions that may lead to adverse effects. Biocompatibility is related to the behavior of biomaterials in various contexts. A patch test with dental test substances administered by an allergist may provide additional evidence of a potential allergy to one of the components of the material. The ultimate systemic response depends on four key variables: (1) concentration of the substance; (2) time of exposure; (3) excretion rate of the substance; and (4) organ of importance or site at which exposure occurred. These adverse events involved all classes of dental materials and occurred locally and systemically. The half-life ranges from 20 to 90 days, depending on the form, with methyl mercury exhibiting the longest half-life and inorganic forms the shortest. Many individuals have sensitivities to certain chemicals and other environmental factors that need to be taken into account before using a specific dental … It is an overview of biocompatibility concepts, terminology, outcome data from national registries of adverse effects, and principles of established test methods. Biocompatibility is a dynamic, ongoing process, not a static one. Risk—The combined probability of a harmful effect and the severity of the effect. Because the cervical margins of many dental restorations are near the periodontal attachment area (see, If the resin material does not penetrate the collagenous network or debonds from it as the resin shrinks during polymerization, a microscopic gap will form between the resin and dentin. Biocompatibility has also been described as the ability of a material to perform with an appropriate host response in a specific application. Since 2001 the Governing Council/Global Ministerial Environment Forum of UNEP has discussed the need to protect human health and the environment from the releases of mercury and its compounds. evidence-based dentistry to be passed on to the next generation of dentists. The types and locations of patient tissues that will be exposed to the device, 5. Any biomaterial that is placed adjacent to a natural tissue in the body can induce local or systemic biological effects. Nevertheless, when these problems occur, they are at best emotionally and financially stressful, and at worst devastating to the practitioner. (a) The oldest scheme used “unspecific” toxicity tests first, followed by “specific“ toxicity tests, and then by clinical trials. These are classified as Type I, II, or III reactions, according to the Gell and Coombs classification of immune responses (Gell and Coombs, 1963; Rajan, 2003). Because dental materials can affect the well-being of patients or dental auxiliaries, the practitioner assumes a legal risk when using these materials. What is the difference between osseointegration and biointegration? Toxic—Capable of causing injury or death, typically by a chemical agent. Because the cervical margins of many dental restorations are near the periodontal attachment area (see Figure 7-3), the biocompatibility of these materials may influence the body’s ability to defend against bacteria that cause periodontal disease. The TNF-α secretion shown on the y-axis is plotted against HEMA concentration on the x-axis for cells that were either stimulated by lipopolysaccharide (+LPS) or not stimulated by lipopolysaccharide (−LPS). Specific tests such as urinary mercury concentration can help clinicians complement their differential diagnoses. Figure 7-13 shows a plot of cellular glutathione from monocytes that were exposed to mercury or palladium ions in a cell culture. Also in 1930, the Council established the ADA’s Seal of Acceptance program to promote the safety and effectiveness of dental products. Very few implant materials or implant coatings promote osseointegration. There is fairly convincing evidence that BPA and BPA dimethacrylate may act on the estrogenic receptors in cells. Microorganisms and various natural processes can convert metallic mercury to inorganic mercury compounds, inorganic mercury compounds to organic mercury compounds, and organic to inorganic compounds. 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