Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
  • A61Q11/00—Preparations for care of the teeth, of the oral cavity or of dentures; Dentifrices, e.g. toothpastes; Mouth rinses
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
  • A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
  • A61K8/466—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfonic acid derivatives; Salts
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K8/00—Cosmetics or similar toiletry preparations
  • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
  • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
  • A61K8/49—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing heterocyclic compounds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
  • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
  • A61K2800/51—Chelating agents

Definitions

• the invention relates to a method for removal from the oral cavity of elementary mercury (Hg°) released from amalgam in dental fillings affected by mechanical means, such as drills and other abrasive tools.
• the invention also relates to a composition for use in such method and to the its preparation.
• Exposure to mercury may be due to slow continuous emission of mercury vapour from amalgam fillings (Stock A, Die concurrentlichkei t des Quecksilber- da pfes und der Amalgams. Z. Angew. Chemie. 1926 39:984-9) .
• considerable exposure to mercury has been observed in association with insertion and removal of amalgam fillings leading to absorption as indicated by high concentrations of mercury m urine (Frykholm K O, Mercury from dental amalgam, i ts toxi c and al lergic effects and some comments on occupa ti onal hygiene . Acta Odontol . ⁇ cand. 1957:15, suppl. 22:1-108) . Recent studies have verified these early observations.
• Mercury vapour has been detected m the oral cavity of individuals with amalgam fillings. Its release from the occlusal surfaces of fillings is accelerated by a variety of mechanical actions on the amalgam. Such actions involve insertion, remodelling, polishing, chewing, brushing and removal of fillings. Oral breathing sweeps the vapour into the respiratory passages resulting in pulmonary absorption. Some mercury vapour might also diffuse through the tissues lining the oral cavity and enter the blood stream In addition the vapour may be dissolved in saliva and be oxidized to divalent inorganic mercury (Hg 2* ) . Hydrogen peroxide, often present on the surfaces of oral tissues due ro bacteria, mu be i volved in the ox;ci ⁇ t L on process.
• Inhaled mercury vapoi - is completely absorbed across the pulmonary membranes resulting in a net retention of about 80% of the inhaled dose. At least 50% of the retained vapour passes across the alveolar membranes directly into the blood stream where it dissolves in plasma and is distributed to all tissues m the body. In view of its lipid solubility, the dissolved vapour penetrates cell membranes, the blood brain barrier, and the placenta without hindrance. Once inside cells Hg° is oxidised to Hg 2 + .
• Metallic mercury vapour is highly toxic. Distinct effects on the central nervous system, lungs and the renal system may be demonstrated after exposure corresponding to average urinary mercury concentrations of 20-50 ng per inhalation Acute exposure to high concentrations of mercury vapour causes pneumonitis.
• the classical effects of chronic poisoning present as mental changes, tremor, gingivitis, nephritis and allergic dermatitis.
• Knowledge concerning carcinogenic effects of inorganic mercury is incomplete.
• amalgam The amount of mercury released from permanent amalgam fillings is unknown.
• Amalgam fillings thus constitute a serious health problem. Consequently, health authorities in various countries are considering a general ban on the use of amalgam in dentistry.
• amalgam fillings Although a sharp reduction in amalgam use may be anticipated in the future, millions of individuals are already bearers of amalgam fillings. Removal of their fillings to reduce mercury exposure is commonly performed today. Removal of amalgam fillings, however, involves steps in which substantial quantities of mercury vapour are released into the oral cavity, and thereby become available for inhalation. Moreover, polishing procedures of permanent amalgam fillings also result in the release of mercury vapour. Mechanical handling of intra-oral fillings and repair material resulting in heating of amalgam may further contribute to mercury release. Consequently, removal of dental fillings has been shown to cause a considerable increase in urinary mercury.
• intraoral suction which may have a similar effect as that of the cofferdam technique.
• the total content of saliva-born mercury may be reduced at any given time although gingival contact of remaining saliva still is likely to permit direct absorption through the mucosa of divalent metallic mercury.
• the suction per se may result in a certain removal, however incomplete, of mercury vapour from the oral cavity.
• This technique requires assistance by personnel or devices applied around the tooth which limit the intra oral spread of mercury-contaminated water from high speed drilling devices or instruments used for polishing.
• a further method in use is cooling and water flushing of the amalgam material during mechanical working by drills, abrasives, etc., leading to an increase in temperature of the amalgam and thus articulased mercury release.
• Various cooling techniques are known in the art. Efficient cooling necessitates the adduction of substantial volumes of cooling medium which has to be continuously removed from the oral cavity, a problem for which there is no adequate solution. Extra oral suction and external ventilation will reduce the exposure of dental health care personnel to mercury vapour. This technique requires the use of face masks and is expensive and cumbersome. Moreover, it does not protect the patient.
• EP-Bl 0 262 970 discloses a composition for absorbing mercury vapour formed from dental amalgam, comprising an iodide, a polyhydric alcohol, and a Lewis acid. For reasons of toxicity this known composition does not seem to be useful for application in the oral cavity of a patient. Similar compositions of this kind employing thiosulfate ion are also known, for instance from GB-A 2 122 916.
• the method according to the invention comprises administration to the oral cavity of the patient being treated of an effective amount of an agent having high affinity for mercury ion (Hg 2* ) , in the present context also called mercury scavenging agent.
• an agent having high affinity for mercury ion Hg 2*
• mercury scavenging agent in the present context also called mercury scavenging agent.
• EDTA ethylenediamine tetraacetic acid
• suitable pharmaceutically acceptable salts thereof such as the sodium, potassium and calcium salts, preferably in form of an aqueous solution thereof.
• EGTA ethylenediamine tetraacetic acid
• cysteine 2
• 3-dimercaptopropane-l- sulphonate DMPS
• D-penicillamine meso-2,3- dimercaptosuccinic acid
• NAP N-acetyl-D,L-penicillamine
• dimercaprol dimercaprol
• EDTA-calcium disodium 2, 3,dimercaptopropane-1- sulphonate, 2, 3-dimercaptosuccinic acid, deferoxamine, ditiocarbamate sodium, aluminum salts, sodium citrate, sodium glucuronate, tartaric acid or its sodium and potassium salts
• the application of the solution into the oral cavity may be achieved by several different means.
• administration may be achieved by direct flushing by means of a syringe during the dental procedure. It may also be administered by pre-soaked woven or non ⁇ woven tissue or some other type of scavenging agent reservoir being placed in close proximity of the intra-oral area where mercury emission is expected to occur. Such tissue may be based on paper or cotton swabs, etc.
• a pumping device for pumping the solution into the oral cavity at a slow rate or of passive flow of said solution administered directly via the drilling equipment (the drill head) in close proximity of the drill.
• Similar designs may be used for administration during procedures other than drilling, e.g., during polishing of amalgam materials or during filling or application of amalgam in the oral cavity.
• Reservoirs for the mercury-scavenging agents of the invention may also be applied at the rim of fixed suction devices in the oral cavity. Such devices comprise Clean Up (registered trade mark of AGDA phenomenon AB, Orsa, Sweden) .
• Other devices that may be used include cups fixed around one or several teeth in order to create a basin which may be filled with the agent according to the invention, thereby completely covering the amalgam surface during the drilling or polishing procedure.
• an aqueous composition for use in said method comprising EDTA or a pharmacologically acceptable salt thereof, in particular an alkali salt such as a sodium, potassium or calcium salt, dissolved in an appropriate amount of water or other suitable aqueous medium to make-up a solution containing from 0,01 % by weight to 5 % by weight of EDTA or said pharmacologically acceptable EDTA salt.
• the composition according to the invention may also contain agents increasing its viscosity, such as carrageenan or carboxymethyl cellulose, and agents improving its taste, such as peppermint oil or spearmint oil.
• EDTA by one or several agents selected from the group EGTA, cysteine, 2, 3-dimercapto- propane-1-sulphonate (DMPS) , D-penicillamine, meso-2,3- dimercaptosuccinic acid (DMSA) , N-acethyl-D-L-penicillamine (NAP), dimercaprol, and diethyldithiocarbamate.
• DMPS 2, 3-dimercapto- propane-1-sulphonate
• DMSA meso-2,3- dimercaptosuccinic acid
• NAP N-acethyl-D-L-penicillamine
• dimercaprol dimercaprol
• the pH of the aqueous composition by adding a pharmacologically acceptable acid, such as phosphoric acid or an acidic salt thereof, a pharmacologically acceptable base, such as sodium hydroxide, or a weak salt thereof, such as sodium carbonate or sodium bicarbonate, or by adding a suitable buffering agent, such as a combination of sodium dihydrogen phosphate and disodium hydrogen phosphate.
• a pharmacologically acceptable acid such as phosphoric acid or an acidic salt thereof
• a pharmacologically acceptable base such as sodium hydroxide, or a weak salt thereof, such as sodium carbonate or sodium bicarbonate
• a suitable buffering agent such as a combination of sodium dihydrogen phosphate and disodium hydrogen phosphate.
• the pH of the aqueous composition will be from 5.0 to 8.5, preferably from 6 to 7.5.
• an agent for scavenging mercury in an ionic state to prevent uptake of mercury in an atomic state by the human body for the manufacture of a medicament for the prevention of Hg° uptake by the human body.
• Agents, carriers, and additives useful in this context are mentioned above in connection with the composition according to the invention.
• the method according to the invention is surprisingly effective in reducing the concentration of mercury vapour in the oral cavity of a patient.
• EDTA is only known to strongly complex mercury ion whereas it is effective, according to the invention, to substantially reduce elementary mercury (Hg°) present in the oral cavity of a patient.
• An survey of the accumulation and biotransfer of mercury is given by M Nylander in Accumulation and Biotransforma tion of Mercury and i ts Rela tionship to Selenium after Exposure to Inorganic Mercury and Methyl Mercury.
• cavities were prepared by means of a high-speed drill in acrylic teeth shaped and sized similar to human teeth.
• the cavities were filled with dental amalgam (non-gamma two amalgam) which was allowed to set for at least 24 hours.
• dental amalgam non-gamma two amalgam
• composition of claim 6, c h a r a c t e r i z e d in that it contains an viscosity-modifying agent.
• composition of claim 6-8 c h a r a c t e r i ⁇ z e d in that its pH is from 5.0 to 8.5.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Birds (AREA)
• Epidemiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Cosmetics (AREA)

Applications Claiming Priority (2)

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Cited By (5)

Citations (2)

• 1995
  • 1995-11-28 SE SE9504259A patent/SE9504259D0/sv unknown
• 1996
  • 1996-11-26 WO PCT/SE1996/001548 patent/WO1997019670A1/en active Application Filing

Patent Citations (2)

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