Sargenti Opposition Society
WHAT YOUR DENTIST MAY NOT TELL YOU
but you need to know before your next root canal
FDA MedWatch LinkInjured 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.
 
SARGENTI PASTE IN THE MEDIA

Since most patients and doctors are not aware of the magntitude of this problem, there is little to nothing about it in the media.  After nearly 3 decades of silence from the FDA, state dental boards, ADA, AAE, it's time for a change.   If those in charge are not going to stop the use of this material, the very minimum they should do is tell the public.   We have the right to be informed about something that the vast majority of our dental community believes is dangerous.  One of the missions of the SOS, is to alert the public.  Please help us by alerting your family, friends, coworkers, etc... to be aware of the materials used in their root canals.  ASK.

  • Sargenti paste still widely used despite controversy, DrBicuspid.com (link). Years of research by the SOS, indicates that this material is not widely used, even worldwide, and many national and international dental and drug regulatory agencies are firmly against its used.

  • *NEW* 2010 News article from Guyana recognizes dangers of Sargenti Paste formulations (link)

  • NBC 10 in Philadelphia Report on SOS Founder Aired September 24, 2009

View more news videos at: http://www.nbcphiladelphia.com/vide

Wikipedia and the Department of Drug Enforcement defines emblaming fluid as containing 5-29% formaldehyde. Not 40% as claimed by Dr. Piacine. The most widely used formulations of Sargenti Paste include 6.5% formaldehyde.

There is no doubt that Sargenti Paste (RC2W) was the cause of Claudia's damage.  Her dentist testified to using it on her under oath. What happened to Claudia is the same medical condition that occurred in the late 1980's to a Florida woman whose life was ruined by her family doctor's use of this material on her. Her cases prompted the Florida Dental Board to adopt a rule that the use of it is below the standard of acceptable care.

Viewer's comments:
(1) the 40% formaldehyde is found in Formalin which ... is not commonly used in embalming but in the preservation of anatomical specimens. 
(2) Scary Story.  4% formaldehyde is used to fix tissue in labs.
(3) "I just can't believe that dentists are putting ANY amount of formaldehyde into people's mouths. It is all toxic... it's like saying a small amount of mercury won't hurt you, or a small amount of ionizing radiation won't hurt you. BALONEY! Any amount will kill the cells it comes in contact with. These so called scientists are just criminals in lab coats. To think that supposedly intellegent people are formulating these toxins for human use is simply astounding. "

 

We had a record numbers of visitors the day this news story aired, Thursday, and the following 5 days after, as shown in a visitor map below.  Visitors were on our site within minutes of the story airing.  Thank you to NBC 10 Philadelphia and reporter, LuAnn Cahn, for helping us educate the public and bring awareness to this injustice to dental patients. 


In a recent malpractice case, a woman was hospitalized because part of the palate at the root of the mouth had dissolved away following treatment. The patient required plastic surgery to undo the damage.

 

October 6, 1975, UNITED STATES EDITION
At the Root of the Trouble


BYLINE: MATT CLARK with DAN SHAPIRO in New York

One of the most promising treatments in modern history is root-canal therapy. Known technically as "endodontics" (from the Greek "within the tooth"), the treatment involves removal of the infected pulp inside the tooth. When successful, such therapy makes extraction and replacement with a false tooth unnecessary. Conventional root-canal therapy, except in simple cases, is considered a job for a specialist with years of training and experience. For the patient, it can be painful, time-consuming and costly. Now a controversy has developed in the field of endodontics over an alternative new kind of root-canal therapy called the Sargenti technique, which is touted as fast, inexpensive and simple enough for any dentist to learn at a one-day seminar.

Endodontists perform root-canal therapy when the pulp - consisting of blood vessels, nerves and connective tissue within the roots of a tooth (drawing) - is damaged by loss of circulation or decay. Left untended, the damaged pulp would become a breeding ground for bacteria, leading to abscess formation and loss of the tooth. In the conventional method, the endodontist drills a hole in the crown of the tooth and removes the dead pulp with various small instruments, designed to enter the narrow, often convoluted root canals. He usually fills the empty canal with gutta-percha, a gum-like material, and a sealer consisting largely of zinc oxide. Treatment of a single tooth may require two or three visits and cost from $125 to $250. For completion of the job, the patient may be referred to his own dentist to be fitted with a synthetic cap or crown, which may cost an additional $150.

Device: The Sargenti method of root-canal treatment, named for the Swiss dentist who devised it, has been spreading rapidly among U.S. dentists in recent years and differs from conventional therapy in two major ways. First, the dentist uses motorized devices, including one called the Giromatic, instead of the standard miniature handheld instruments usually used to clean out the root canal. The device is said to simplify the task of pulp removal. Second, Sargenti proponents fill the root canal with a special paste, variously designated N-2, RC2A and RC2B, to mention a few of its trade names. The paste contains compounds of lead and mercury along with steroid hormones and paraformaldehyde. These materials are supposed to sterilize and protect the root canal against bacterial growth.

A Sargenti treatment usually can be completed in just one visit and costs as little as $50 to $95, not including the cost of a crown. The Sargenti advocates conduct day-long training seminars around the U.S. where, for $105, any dentist can learn the technique, place an order for a Giromatic device - and become a member of the American Endodontic Society, the Sargenti practitioners' own dental specialty group.

Conventional endodontists, who may join the older, more select American Association of Endodontists only after stringent qualifying procedures, argue that root-canal therapy is simply too complex to be learned in a one-day seminar. They also say they are persuaded that the Sargenti method has never been proved effective by valid scientific studies and that it may, in fact, be downright dangerous. They claim that the mechanical pulp removers are not as thorough as other instruments, and might even bore all the way through a tooth. And the Sargenti paste, they contend, is even more hazardous.

Sargenti-method critics further insist that the lead and mercury compounds in the filler paste pose a toxic hazard if they leak out of the root canal. The paraformaldehyde, which resembles embalming fluid, is highly damaging to tissues, they charge. Several endodontists have reported seeing patients with injuries to bone and oral tissues following Sargenti root-canal treatment, and practitioners of the technique have been the targets of a growing number of malpractice suits, "I've been called as an expert witness in about a dozen of the cases in the last two years," says Dr. Dudley Glick, professor of endodonties at the University of Southern California.

In a recent malpractice case, a woman was hospitalized because part of the palate at the root of the mouth had dissolved away following treatment. The patient required plastic surgery to undo the damage. More commonly, the Sargenti method has been blamed for damage to the area around the tooth itself. "We've observed patients who've arrived with acute pain and root-end infection associated with bone loss," says Dr. Samuel Luks, director of dentistry at the Bronx-Lebanon Hospital Center in New York. "They routinely arrive in distress and it's usually impossible to save the tooth."

Pain: Sargenti proponents contend that the paste contains only small amounts of potentially toxic substances and that, properly applied, it should remain confined to the root canal. They also insist that the gutta-percha used by the more orthodox endodontists accounts for the postoperative pain often associated with conventional treatment. "There is," says Dr. Ramon Werts of Fullerton, Calif., a Sargenti-method dentist and executive director of the American Endodontic Society, "rarely, if ever, any pain experienced in the Sargenti technique."

The U.S. Food and Drug Administration has not approved the Sargenti paste for nationwide sale, and is now considering an outright ban. In California, health officials have forbidden the two major suppliers in the state to continue selling the paste, and the California Dental Association has advised all its members against its use. Until the paste is banned nationally, however, the Sargenti practitioners can ask any pharmacist to mix up a batch on presumption whenever they need some.

[Note: The FDA has not approved Sargenti Paste for use. They simply passed enforcement jurisdiction to the State Pharmacy Boards unless the material is being sold interstate in single patient prescriptions (5g) and without the heavy metals (lead, mercury).  Today, compounding pharmacies (found by the American Endodontic Society) are selling in much large quantity, in prescriptions with the dentist's name on it, unlabeled, and with heavy metals, all against FDA regulations. The FDA is seriously in violation of their mandate to protect the public on this issue, as are State Pharmacy Boards who should be policing the dangerous material when sales fall within their jurisdiction.    No  dentists should be using this material.  Period.

 


   
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