Clinical Studies & Amalgam Information

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1 Clinical Studies & Amalgam Information

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8 DENTAL AMALGAM Do amalgam fillings contain mercury? Yes. Does mercury escape from amalgam fillings? Yes. Have the levels of mercury released by amalgam fillings been shown through controlled scientific study to be dangerous? No. Clearly, we need to be sensible about the information we provide to the public. Anecdotal information and simple facts quoted out of context without qualification and without correct interpretation can be misleading and alarming. Mercury is a component of the amalgam used in silver-colored fillings. The other major ingredients are silver, tin, copper, and zinc. When mixed, these elements bond to form a strong, stable substance. The average content of mercury in an amalgam restoration is slightly less than 50 percent. For more than 150 years, billions of amalgam restorations have been placed and a National Institutes of Health report states that only 50 documented cases of allergy to mercury have been reported in scientific literature since One hundred million people in the United States have amalgam fillings and 100 million amalgam fillings are placed each year. Studies show that no filling material has been proven superior to amalgam in safety, durability, and cost effectiveness. Amalgam has been researched worldwide and no study has ever caused a professional dental organization or agency to recommend a ban of amalgam. The amount of mercury ingested by someone with amalgam restorations is miniscule well below established health safety standards. Mercury also enters the body through the ingestion of food (i.e., fish) and water, and through breathing air. Eventually, the body rids itself of mercury, but there is always a very low level of mercury present in the body.

9 In 1995, following a meeting of government health officials from nine European nations, the United States and Canada, the U.S. Public Health Service released a statement reiterating that there are "no scientifically compelling reasons either to discontinue or to curtail the clinical use of dental amalgam or to recommend removal of existing amalgam fillings," without clear evidence of allergy or intolerance in individual patients. A 1999 article in the Journal of the American Dental Association, reported that researchers found "no significant association of Alzheimer s Disease with the number, surface area or history of having dental amalgam restorations." Other claims that the removal of amalgam fillings leads to recovery from multiple sclerosis or that the use of amalgam leads to arthritis are unsubstantiated and without scientifically established cause and effect. The CDA does not believe that a dentist should prey upon the fears of people who have serious medical conditions by selling them dental treatment that may cost thousands of dollars and for which no cure has been proven. In 1997, the World Health Organization stated that no controlled studies have been published demonstrating systemic adverse effects from amalgam restorations. The long-term cost of two- or three-surface gold or composite restorations in permanent teeth is about four times greater than for amalgam restorations. There is no sound scientific evidence to support any health benefits from the removal of amalgam. The ADA Council on Ethics, Bylaws and Judicial Affairs has stated that "Based on available scientific data, the ADA has determined that the removal of amalgam restorations from the nonallergic patient for the alleged purpose of removing toxic substances from the body, when such treatment is performed solely at the recommendation or suggestion of the dentist, is improper and unethical." Replacing dental amalgam for aesthetic purposes has its own risks and the dentist should discuss all of the risk/benefits with the patient before replacing serviceable amalgam restorations. The Dental Board of California is currently finalizing a Dental Materials Fact Sheet that describes the various restorative materials available to the dental profession for restoration of an oral condition or defect. The relative benefits and detriments of each group of materials are also provided. This information is being provided by an independent, qualified scientific consultant and will be available to all licensed dentists in California to make available to their patients. Copyright California Dental Association. All Rights Reserved. June 14, 2001

10 THE OREGON HEALTH SCIENCE UNIVERSITY School of Dentistry 6 th Southwest Campus Drive. Portland. Oregon (503) Department of Dental Materials Science Mr. Bruce Richmond Silmet USA Corp18909 NE Fifth Avenue North Miami Beach, FL Dear Mr. Richmond: The results for the four alloys you sent to me for testing are enclosed. The differences between alloys are clearly shown. David B. Mahler, Ph.D. Professor and Chairman of the Department DBM:s Enclosure School of Dentistry Medicine and Nursing University Hospital Doembecher Memorial Hospital for Children. Crippled Children s Division Dental Clinics

11 RESULTS OF TESTS CONDUCTED ON DENTAL AMALGAM ALLOYS COMPARISON OF SPHERADON (BN11089) VS TYTIN (BN111488) (FEBRUARY 1989) 24 HOUR DIMENSIONAL CHANGE (u/cm) Spheradon Tytin AVE: ADA Requirement: ± 20 u/cm 7 DAY CREEP (%) Spheradon Tytin AVE: ADA Requirement: 3.0%

12 ONE HOUR COMPRESSIVE STRENGTH Spheradon Tytin AVE: 242 MPa 278 Mpa 35,100 psi 40,320 psi ADA Requirement: 80 Mpa MARGINAL LEAKAGE Spheradon Tytin AVE: 1.24 ml/min 3.00 ml/min Potential for postoperative sensitivity when Marginal Leakage > 3.00 ml/min

13 RESULTS OF TESTS CONDUCTED ON DENTAL AMALGAM ALLOYS COMPARISON OF NOGAMA 2 (BN011089) VS DISPERSALLOY (no batch #) (FEBRUARY 1989) 24 HOUR DIMENSIONAL CHANGE Nogama 2 Dispersalloy AVE: u/cm u/cm ADA Requirement: ± 20 u/cm 7 DAY CREEP Nogama 2 Dispersalloy AVE: 1.13 % 0.48 % ADA Requirement: 3.0%

14 ONE HOUR COMPRESSIVE STRENGTH Nogama 2 Dispersalloy AVE: 130 MPa 156 Mpa 18,860 psi 22,630 psi ADA Requirement: 80 Mpa MARGINAL LEAKAGE Nogama 2 Dispersalloy AVE: 0.20 ml/min 3.98 ml/min Potential for postoperative sensitivity when Marginal Leakage > 3.00 ml/min

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25 Material Safety Data Sheet 1. Product Identification Dental Amalgam (powder, capsules & tablets form ) Trade name: Nogama, Spherodon M, Spherodon+, Dentacore Manufacturer s name: Silmet Ltd. Address: 12 Hassadna St. Industrial Park City/Country: Or-Yehuda Israel Emergency telephone: Date prepared: February 1, Composition (information on ingredients) Silver 45-72% Copper 5-25% Tin 25-32% Zinc 0-1% Powder to Mercury ratio : app. one to one 3. Hazards Identification Exposure to mercury may cause irritation to skin, eyes, respiratory tract and mucous membrane. In individual cases, hypersensitivity reactions, allergies, or electrochemically caused local reactions have been observed. Due to electrochemical processes, the lichen planus of the mucosa may develop. Mercury may also be a skin sensitizer, pulmonary sensitizer, nephrotoxin and neurotoxin. After placement or removal of amalgam restorations, there is a temporary increase of the mercury concentration in the blood and urine. Mercury expressed during condensation and unset amalgam may cause amalgamation or galvanic effect if in contact with other metal restorations. If symptoms persist, the amalgam should be replaced by a different material. Removal of clinically acceptable amalgam restorations should he avoided to minimize mercury exposure, especially in expectant mothers. 4. First Aid Measures If skin or eyes are contacted, wash off well with water immediately. 5. Fire Fighting Measures Extinguishing media:

26 6. Accidental Release Measures Personal precautions: Avoid contact with skin. Disposal: Dispose of according to local or state regulations. Others: In case the material is released or spilled, clean up with inert absorbent material and dispose of in an approved manner. 7. Handling and Storage Avoid extreme heat. Keep in temperature of about 25 C. Packing materials: 8. Exposition Restrictions and Personal Protective Equipment. Personal Protective Equipment: Dental office or laboratory working clothes. Breathing protection: Do not breath or inhale vapor Hand protection: Use of protective gloves is recommended. Protective and hygiene measures: Washing of hands 9. Physical and Chemical PropertiesAppearance and Odor Appearance and Odor Powder: ordorless dark gray alloy of Silver, Tin and Copper Liquid: Mercury is a silvery, mobile odorless liquid Density g/cm 3 Solubility in water g/100g 68 F Solubility in organic solvents unsoluble 10. Stability and Reactivity Avoid extreme heat, keep closed. 11. Toxicological Information LD50/LC50: 150mg/M³/46 days inhalation-woman TCLO : 29/ M³/30 hours inhalation-rabbit. 12. Ecological Data Environmental toxic effects: aquatic toxicity: organism test period test method results

27 13. Disposal Instructions recommendation: obey local regulation 14. Particulars on Transport land carriage: warning label: risk no.: material no.: further particulars: no hazardous goods within the meaning of transport regulation. 15. Regulation marking: according to the MDD 93/42/EEC 16. Other Particulars The number of amalgam restorations for one patient should be kept to a minimum. Inhalation of mercury vapor by dental staff may be avoided by proper handling of the amalgam, the use of masks, along with adequate ventilation. Avoid contact with skin and wear safety glasses and gloves. Store amalgam scrap in well sealed containers. Regulations for disposal must be observed. Caution: U.S. Federal law restricts this device to sale by or on the order of a dentist. For dental use only. All information above has been given according to our present state of knowledge. It has been compiled to the best of our knowledge. The above mentioned data do not represent a guarantee on characteristics. They only describe the safety requirements with regard to our products. They do not represent an assurance of product characteristics in the meaning of guaranties.