African Journal of Oral Health Sciences AJOSHS 2015 V2 (2) IS THE SAFETY OF DENTAL AMALGAM STILL IN QUESTION: A LITERATUE REVIEW Maina S.W, Nyaga J.M, Kisumbi B, Kassim A.B, Dienya T.M, Simila H.O Department of Conservative and Prosthetic Dentistry, School of Dental Sciences, University of Nairobi Abstract: Objective: To review the scientific evidence on the adverse effects of dental amalgam in adults. Study design and method: The key words “adverse effects” and “safety “of “dental amalgam” were used to search for publications in peer reviewed journals on adverse health effects of dental amalgam. Results: Forty three papers were accessed and reviewed. Several researchers have reported that mercury released from dental amalgam restorations have not been demonstrated to contribute significant systemic effects on the immune system or neurological diseases. The available scientific data are not sufficient to relate various complaints and mercury release from dental amalgam especially due to other sources mercury like fish consumption. Moreover there are no controlled studies that have demonstrated adverse effects on health from amalgam fillings. Remarkably, the literature reviewed stated that amalgam restorations remain safe. Conclusion: There is no validated scientific evidence that dental amalgam causes adverse health effects in adults. Key words; - dental, amalgam, safety, Introduction Dental amalgam is made by mixing approximately equal parts of elemental liquid mercury (43 to 54 %) and an alloy powder (57 to 46 %) composed of silver, tin, copper and sometimes smaller amounts of zinc, palladium or indium. This material has been extensively used as a tooth filling material for many decades (170 years). In the United States alone, the American Dental Association estimates that amalgam fillings have restored the teeth of 100 million Americans (1). Dental amalgam has, beyond doubt, saved millions of teeth that otherwise would have been extracted. The fact that dental amalgam contains and releases elemental 3 mercury, concerns have been raised over the years with respect to its potential health effects to the dental personnel, the patient and lately to the environment (2). Amalgam is the most thoroughly studied and tested filling material in use. After decades of research projects undertaken around the world, no controlled studies have ever been published demonstrating adverse effects from amalgam fillings (3). Compared to other restorative materials, it is among those which have been regularly improved in terms of its mechanical properties and presentation. It is durable, easy to use, inexpensive and its longevity in a wide range of clinical application has been tested and reported to be 10-20years with an average survival of 15years (4). Despite the increasing use of tooth coloured materials with advantages of adhesion and aesthetics, amalgam is still one of the most widely used dental restorative materials (1). However, the anti-amalgamist claims that "sensitive" individuals can develop neurological disorders, various emotional problems, cardiovascular problems, collagen diseases and immunologic disorders. To support their argument, several tests have been used; breath, urine, blood, skin, stool, electro-dermal testing and air analysis (5-7). These tests have been found to be inconclusive due to the difficulties in demonstrating that the A Publication of the School of Dental Sciences African Journal of Oral Health Sciences AJOSHS 2015 V2 (2) source of mercury is from amalgam fillings or exposure from foods, water and air. It is, therefore, not known if the amount of mercury released from dental amalgam is enough to cause illness, even in the most exposed or the most sensitive minority of the amalgam-bearing population. The Scientific Committee of the European Commission in 2008 concluded that dental amalgams are effective and safe, both for patients and dental personnel. It also noted that alternative filling materials are not without clinical limitations and toxicological hazards (8). This is supported by the World Health Organization (WHO), FDI World Dental Federation and United Nations Environment Program (UNEP) report on the Future Use of Materials for Dental Restoration (2) and the U.S. Food and Drug Administration (FDA) which stated that elemental mercury levels released by dental amalgam fillings are not high enough to cause harm in patients (9). Material and Methods The key words “adverse effects” and “safety “ of “dental amalgam” in adults were used to search for publications from peer-reviewed journals and key dental organization statements, declarations and resolution The abstracts of the listed papers in English were reviewed to determine the relevance of the articles to the topics. Using the online library of the University of Nairobi and the internet 43 relevant articles were down -loaded and reviewed. Results 4 Exposure to mercury from dental amalgam can occur during placement, removal and in function. The evaporation of mercury from amalgams is affected by several factors: the concentration of tin in the Ag-Hg (ƒÁ1) grains, which make up the matrix of the amalgam structure and are the main mercury-releasing phase (10) , corrosion process (11), the atmosphere in which the amalgam is placed (12) the incorporation of indium into the triturated mercury or alloy powder (13-15), alloying a small amount of palladium with the alloy powder (16), alloy powder shape (17) among others. Ohmoto et al (18) examined the relationship between mercury content and mercury evaporation from amalgams during setting using high-copper amalgams single composition and admixed types (Table 1). They further stated that most of the factors influencing the mercury evaporation from amalgam are incorporated during the alloy manufacturing processes. When preparing amalgam with more resistance to condensation, caution is needed to prevent irregularities and cracks by carefully monitoring the amount of mercury used in trituration. In an earlier study, Haikel et al (19) Table 1 demonstrated a significant direct correlation between Hg vapor concentrations in intra-oral air and the sizes of amalgam restorations during each procedure: removing, setting, and polishing although there was no statistic significant difference. It is important to note that no control group was used in this study and other factors may have affected the result. The amount of Hg released from the mouth during function has been reported to be 0.03 μg / day (20, 21). Björkman and Lind (21) showed that while the age of the amalgam and the amalgam type influence the extent of mercury release during the initial non-steadystate conditions, the steady-state value of mercury daily dose due to a single amalgam filling is 0.03 μg / day, which is well below the calculated threshold-limiting value (TLV) of 82.29 μg/day considered dangerous for occupational exposure in the United States. The release of mercury from restorations in the mouth has been shown to be extremely slow. Berglund et al (22) found that the amount of mercury released from the oral cavity was time-dependent and reported that, the amount of mercury released with the time kept constant was almost independent of the pumping flow rate up to 8 litres per minute. In a later study (23), the same authors tested the release of mercury over a 24hr period under conditions that were as normal as possible (Table 1). The estimated average daily dose of mercury vapor inhaled from the amalgam restorations was 1.7 μg. Jones (24) reported that it would take 1,680 years for a 0.65g amalgam restoration to lose all of the combined mercury based on the established rate of release. The very slow release of a very small amount of mercury from amalgam restorations can be put into perspective by the fact that a patient with 10 amalgam A Publication of the School of Dental Sciences African Journal of Oral Health Sciences AJOSHS 2015 V2 (2) Table 1: The findings of different investigations on evaporation of mercury from dental amalgam. Author /year Population/sample Investigation Findings/Conclusion Ohmoto et al (18) High-copper amalgams single composition and admixed types. The relationship between mercury content and mercury evaporation amalgams during setting. Mercury content influenced mercury evaporation from admixed-type amalgam Haikel et al (19) 242 subjects Berglund (23) Halbach et al (26) WHO *Accepted daily mercury intake surfaces in his/her mouth would have a mercury intake into the blood which would be only 2% (0.8 μg/ day) of the World Health Organization’s Acceptable Daily Intake (WHO ADI 40 μg/day) for mercury, with no adverse health effects (24, 25). Further Halbach et al (26) evaluated the internal exposure and absorbed dose of mercury related to amalgam (Table 1).They concluded that the estimates obtained are below the tolerable dose set by WHO. Therefore the amount of mercury released from amalgam restorations and absorbed by the body is minuscule and unlikely to cause adverse health effects. The exposure to mercury vapor is of greater concern for dentists and their staff than for patients. Several re5 Analyzed the level of mercury vapor of intra-oral air before and after removing, setting and polishing dental amalgam using atomic absorption spectrometry. Mercury vapor released measured at intervals of 30-45 min using atomic absorption spectrophotometry. The integrated mercury absorbed from amalgam restorations randomized controlled trial. Acceptable Daily Intake of mercury with no health effects. searchers have reported that most people with fillings have less than 5 micrograms of mercury per liter of urine. Nearly all practicing dentists have levels below 10 micrograms per liter, even though they are exposed to mercury vapor when placing or removing amalgam fillings Thus, even with that exposure, the maximum levels found in dentists are only slightly higher than those of their patients and are far below the levels known to affect health, even in a minor way (27-31). Hence based on this data and the WHO maximum acceptable daily intake with no health effects (ADI) of 40 μg Hg/ day, a dentist could carry out 1000 amalgam procedures a week and keep within the WHO ADI limits. The results of investigations on amalgam and its effects on health for Surface texture immediately after condensation affected mercury evaporation. Vapor was released during any procedure. Estimated average daily dose of mercury vapor inhaled from the amalgam restorations was 1.7 μg. Reported estimates of up to 3 μg per day for an average number of restorations 7.4 μg per day for a high amalgam load. WHO ADI 40 μg/day* dental personnel and the general populations are shown in Table 2. Mercury is found in the earth's crust and is ubiquitous in the environment. Hence even without amalgam fillings, small but measurable blood and urine levels are found. Amalgam fillings may raise these levels slightly, but this has no clinical significance. The legal limit of safe mercury exposure for industrial workers is 50 micrograms per cubic meter of air for 8 hours per day and 50 weeks per year. Regular exposure at this level produce urine mercury levels of about 135 micrograms per liter. These levels are much higher than those of the general public but produce no symptoms and are considered safe (34). Other investigators, Kingman et al (35) (Table 2), Clarkson et al (36) and Brownwell et A Publication of the School of Dental Sciences African Journal of Oral Health Sciences AJOSHS 2015 V2 (2) al (37) have found no significant associations between amalgam exposure and clinical neurological signs or clinically evident peripheral neuropathy or other health effects (Bates et al (38) Table 2. Some dentists and other health professionals advise people to avoid amalgam and to have their amalgam fillings replaced with other materials and taking vitamins and other supplements to prevent trouble after amalgam. "Amalgam toxicity" or "amalgam illness” has been diagnosed in patients who suffer from multiple common symptoms. Berglund and Molin (39) (Table 2) and Herrstrom and Hogstedt (40) found that patients and people with symptoms they related to amalgam fillings had no significant higher mercury levels in blood and urine than those of a control group. Discussion For the past decades the public has been bombarded by sensational, confusing and misleading reports about health issues related to dental amalgam. Mobilization of irrational public fear is the strategy used by lobby groups to pressure governments to change public policy (41, 42). It is important that governments adhere to scientific principles and base health policies on sound scientific knowledge on dental amalgam. No systematic scientific studies have ever shown that dental amalgam poses a health hazard to patients, dentists, or to the dental assistant when professionally used and safely handled. Instead overwhelming scientific evidence has shown that dental amalgam is a safe dental restorative material (1-3, 8, 9, 23, 24, 34). Most of the tests that have been used such as breath, urine, hair, skin and blood have been found to be inconclusive or misinterpreted. Mercury is Table 2: The investigations on dental amalgam and its effect on health. ubiquitous and the body absorbs and excretes tiny amounts and hence is commonly found in urine and blood. Large-scale studies (33, 38) have shown that the general population has urine-mercury levels below 10 micrograms/liter. Industrial workers, and dentists, who have regular exposure to mercury vapor also, have low values (25, 27, 28). Urine testing gives a fairly reliable indicator of chronic exposure when performed on a 24-hour urine specimen. Urine mercury levels can be temporarily raised by administering a chelating agent such as DMSA or DMPS, which concentrates them to be excreted. This results in artificially raised urinary mercury levels. The use of a chelating agent before testing mercury levels should be considered invalid and unreliable. Some of the alleged allergic reactions associated with dental amalgam are concluded from skin testing (patch test) done with a dilute solu- Author Population /sample Investigation Health effects Ritchie, et al (25) 180 dentist against a control group Svenden et al (32) Dentist and dental nurses in Norway Well-controlled using a questionnaire the health and cognitive effects Exposure level and mercury level in urine Urinary mercury concentrations Dentist report having a disorder of the kidney more than control group but the difference was not significantly Levels of exposure seemed low Kingman al (35) et 1663 dentate Vietnam veterans Bates et al (38) 20,000 Defence Force persons New Zealand Berglund and Molin (39) 18 Patients referred physicians and control group 6 Exposure to amalgam and its effect to clinical neurological signs, vibrotactile thresholds and peripheral neuropathy. Association between amalgam restorations and disorders related with nervous system and kidney Any correlation between subjective symptoms and amalgam restorations- mercury levels in plasma, erythrocytes, and urine No significant association with reported memory disturbance no significant associations between amalgam exposure and clinical neurological signs or clinically evident peripheral neuropathy No significant correlation between amalgam restorations and chronic fatigue syndrome or kidney disease was observed. The symptom group had neither a higher estimated daily uptake of inhaled mercury vapor, nor a higher mercury concentration in blood and urine than the control group. A Publication of the School of Dental Sciences African Journal of Oral Health Sciences AJOSDS 2015 V2 (2) 7 tion of corrosive mercury salts that cause the skin to redden and possibly swell (5). The reaction is misinterpreted as a sign of mercury allergic reaction or toxicity. The other test used is hair which contains trace amounts of mercury from food, water, and air, regardless of whether the person has amalgam fillings. Because hair can absorb mercury from external sources, the amount of mercury it contains may not necessarily reflect the amount of mercury within the body. In addition, hair mercury testing cannot be standardized because hair thickness, density, shape, surface area and growth rate may vary from person to person. Further the laboratory reporting process has been stated to be invalid (6). amalgam as the main source of mer- 7. Zimmer, H., Ludwig, H., Bader, cury exposure. Studies have shown M., Bailer, J., Eickholz, P., even in the sick individuals who reStaehle, H.J and Triebig, G. lated their illness to mercury from Determination of mercury in amalgam (7, 38) their mercury levels blood, urine and saliva for the in blood and urine was similar to biological monitoring of an those of the general population. Thus exposure from amalgam fillings the alleged symptoms are common to in a group with self-reported ad other ailments, are self reported usverse health effects. Int J Hyg ing questionnaires which have been 8. E nvi r o n H ea l t h. 2 0 0 2 ; 20 5 found to be subjective and in some (3):205- 11. U.S. Food a n d cases psychosomatics. Drug Administration (FDA). Issues Final Regulation on Dental Amalgam. July 2009;pg Conclusion There is no validated scientific evidence that dental amalgam causes 9. Ferracane, J.L., Adey, J.D., Nakajima, H. and Okabe, T.: Mercury adverse health effects in adults even vaporization from amalgams with with the minimal amount of mercury varied alloy compositions, J Dent released from it. Res 1995; 74: 1414-1417. Autopsy studies are the most valuable and most important for examining the amalgam-caused mercury body burden. Guzzi et al (43) reported that total mercury levels were significantly higher in subjects with a greater number of occlusal amalgam surfaces (9) compared with those with fewer occlusal amalgams (0-3).They also stated that mercury levels were significantly higher in brain tissues compared with thyroid and kidney tissues in subjects with more than 12 occlusal amalgam fillings. Mutter (43) stated that dental amalgam is by far the main source of human total mercury body burden as proven by autopsy. This has, however, been disputed by the fact that humans are mainly exposed to methymercury from seafoods and fresh water fish. This source of mercury exposure has not been controlled for by researchers who have reported References 1. Dental amalgam factsheet, American Dental Association, revised 2009. 2. World Health Organisation Report: Future Use of Materials for Dental Restoration 2010. 3. Original FDI Policy Statement/ WHO Consensus Statement on Dental Amalgam issued in September 1997. 4. 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