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 Paraformaldehyde, always the active ingredient in the many formulations of Sargenti Paste, is a powder form of formaldehyde. When the powder is mixed with liquid eugonel, it emits toxic gasses that mummify and deactivate whatever it comes in contact with, whether that occurs inside or outside of the tooth. Paraformaldehyde, like liquid formaldehyde, is widely considered a carcinogen. There is no justifiable reason for any dentist to permanently seal Sargenti Paste, and its formaldehyde, into any patients mouth.
The information below will help you understand more about the issues related to using this chemical in dentistry.
Emergency Overview
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DANGER! MAY BE FATAL IF SWALLOWED, INHALED OR ABSORBED THROUGH SKIN. CAUSES IRRITATION TO SKIN, EYES AND RESPIRATORY TRACT. SENSITIZER. SUSPECT CANCER HAZARD. EMITS FORMALDEHYDE WHICH MAY CAUSE CANCER. Risk of cancer depends upon duration and level of exposure. COMBUSTIBLE SOLID.
SAF-T-DATA(tm) Ratings (Provided here for your convenience)
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Health Rating: 3 - Severe (Cancer Causing)
Flammability Rating: 3 - Severe (Flammable)
Reactivity Rating: 1 - Slight
Contact Rating: 3 - Severe
Lab Protective Equip: GOGGLES & SHIELD; LAB COAT & APRON; VENT HOOD; PROPER GLOVES; CLASS B EXTINGUISHER
Storage Color Code: Red (Flammable)
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Potential Health Effects
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Inhalation:
Highly irritating to upper respiratory tract. May cause inflammation of lining of nose, throat, and lungs with bronchopneumonia and edema possible from extremely irritating exposure.
Ingestion:
Causes severe irritation and inflammation of mouth, throat, and stomach. Severe stomach pains will follow with possible loss of consciousness.
Skin Contact:
Contact with dust causes drying, cracking, and scaling.
Eye Contact:
Exposure to high vapor concentrations or contact with dust causes tearing and severe irritation. Contact with dust causes severe burns.
Chronic Exposure:
Prolonged and repeated contact may cause allergic dermatitis or asthma. May harm the kidneys.
Aggravation of Pre-existing Conditions:
No information found.
- Although not a dental case, the following demonstrates that formaldehyde should not be put into any part of a living body and also shows the medical and legal implications of of its inappropriate use in medicine. A woman was injected in her foot with Formalin (formaldehyde) that had inadvertently been mixed with other agents and consequently was left with permanent numbness and pain. A lawsuit was filed.
- Several European countries restrict the use of formaldehyde, including the import of formaldehyde-treated products and embalming, and the European Union is considering a complete ban on formaldehyde usage (including embalming), subject to a review of List 4B of the Technical Annex to the Report from the Commission to the European Parliament and the Council on the Evaluation of the Active Substances of Plant Protection Products by the European Commission Services. Countries with a strong tradition of embalming corpses, such as Ireland and other colder weather countries, have raised concerns.
The European Union has decided on the date September 22 2007 to ban formaldehyde use throughout Europe, because of its carcinogenic properties. (Link)
The Personal Cost of Formaldehyde in Root Canals
Sargenti Paste is inflammatory by nature since it contains paraformaldehyde, a powder form of formaldehyde. When a Sargenti root canal is done in the upper jaw, the floor of the maxillary sinus is right above it. If the paste is not contained within the root, either by leakage or an overfill, the paste can touch the membrane of the sinus floor. The paste causes a continuous irritation to all tissue it comes in contact with. This sets up the body's response of frustrated repair, which is destructive in nature. When this happens, the patient will experience chronic sinus problems. There are also documented cases of gross overfills of Sargenti Paste in bottom molars causing damage to the underlying inferior alveolar nerve (IAN), altered sensation, including pain and numbness. Often these injuries are irreversible unless immediate surgical intervention is performed and the Sargenti material removed.
Sargenti users often argue that regular food products that we eat, such as pork chops, milk, green onions, fruit, contains less formaldehyde than a root canal filled with Sargenti Paste. In the words of the FDA Dental Product Panel Advisory member, Dr. Larz Spangberg*, D.D.S., Ph.D, during the 1993 failed attempt to obtain FDA approval for Sargenti Paste N2 -
"I think that is a misunderstanding of what the problem with formaldehyde is. Formaldehyde exists in our environment to quite some extent in small amounts. The problem with the formaldehyde in N2 is the fact that it causes a local necrosis [death] where it is applied, and that local necrosis needs to be reorganized or it will be re infected with a later breakdown. That is one of the problems when we are using formaldehyde for other type of tissue nercotizing agents - the observation period has to be rather long, especially if you are treating vital cases."
Sargenti proponents also fail to address the route of exposure. They are comparing a chemical implanted permanently into the body with an ingredient in common food products. Route of exposure seems to have no significance to them and seems to show their limited scientific knowledge.
Teeth filled with Sargenti Paste can cause an immunization of the host. When this happens, the person will be allergic to formaldehyde due to the use of Sargenti Paste. They can begin to have allergic reactions to food that does contain formaldehyde. Since formaldehyde is widely used in food and in our environment patients can experience all kinds of allergy troubles.
Paraformaldehyde containing root canal materials have also been shown to be mutagenic (Paraformaldehyde MSDS, Special Remarks on Chronic Effects on Humans).
*At the time of the 1993 FDA meeting, Dr. Larz Spangberg was Professor and Chairman, Department of Restorative Dentistry and Endodontology, the School of Dental Medicine, University of Connecticut Health Center
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Injured patients should file an adverse event report with the FDA. Absent reports from the public, the FDA will not realize the extent of the dangers of Sargent Paste. Click here to file report. Also ask your doctor to file a report on your behalf. Since reports are voluntary over 90% of adverse events go unreported.