 The Sargenti Opposition Society (SOS) was created in 2008 to inform the American public and our dental professionals of the continued
use of a dangerous, FDA rejected root canal drug, Sargenti Paste. This drug, as such classified by the FDA, is used by a minority number of general dentists who perform root canals. History has shown that Sargenti using dentists often do not tell their patients that the material that they are using is considered below the standard of care and not approved for use in the United States. Injuries are random and damage can be life altering.
The Sargenti Opposition Society wants you to know the right questions to ask so that you do not become a victim. The questions that we, the founders of the SOS, did not know. That question is "Are you putting anything with formaldehyde in any form (powder or liquid) into my mouth?"
Since a frequent response from dental professionals has been "I didn't think anyone used that stuff anymore", the Sargenti Opposition Society and its members have alerted every state dental board to the fact that this material is still in use and that patients continue to be harmed. We have alerted the FDA, ADA and the official root canal regulation board in America, the American Association of Endodontics (AAE).
This site is intended for the general public. Feel free to send us any questions.
ARE YOUR PETS SAFE?
 Even veterinarians agree that the use of this type of root canal material is not acceptable for our pets! You should be prudent and ask if your pet is ever in need of a root canal. Click here to read an excerpt from the book, "Veterinary Dentistry: Principles and Practice", authored by Robert B. Wiggs and Heidi B. Loprise, 1997.
ARE OUR TROOPS SAFE?
 Confirmed by the current (2008) Chief of Dental at the Veterans Administration, Sargenti Paste is not FDA approved and has never been used in a VA medical center. This article from 1975, documents such position. Thankfully, we keep our veterans out of harm's way while in the dental chair.
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Before reading about Sargenti Paste, you may want to read about the root canal procedure. For a detailed description, please visit Dr. Spiller's website (scroll down). Visit this ADA link for a less detailed description.
WHAT IS SARGENTI PASTE? |
Sargenti Paste is a material that is used to fill the canals that are created during a root canal procedure. This material is permanently sealed within the tooth. Sargenti paste always contains paraformaldehyde and sometimes contains lead and mercury. Paraformaldehyde is a powder form of formaldehyde and is highly toxic and causes severe and irreversible damage to tissues, nerves, and bones that it contacts. When mixed with liquid eugenol and then enclosed in the tooth, the formaldehyde emits gasses that permeate what is inside and sometimes outside of the tooth. If the paste is extruded out the bottom of the tooth (called an overfill) or seeps out of the porous structure of the tooth, it can cause severe and devastating results, many times becoming permanent life-altering conditions and can be fatal.
Sargenti Paste contains peanut oil, which, along with formaldehyde can cause an allergic person to go into anaphylatic shock. If you can die from anaphylactic shock (and you can), you can die from a Sargenti root canal. Not all dentists ask their patients about peanut allergies.
Many independent studies, including this one, demonstrate that anyone with an overfill of Sargenti Paste should seek immediate surgical removal. The formaldehyde continues to "disinfect" for 7-10 days, as reported by even the proponents. This "disinfecting" action means that the formaldehyde is continuing to permeate and destroy the tissue, nerve and/or bone that it has come in contact with.
Sargenti Paste is known by many names - Sargenti Cement, N-2, N-2 Normal, N-2 Medical, N-2 Universal, N-2 Apical, RC-2B, RC-2W, One Step Endodontic White, TCM and Endodilato. There are many formulations but all contain approximately 6.5% paraformaldehyde. Some contain lead and mercury.
There is no valid reason for using Sargenti Paste over the widely used and accepted gutta percha.
Not a single accredited dental school in the US teaches to use Sargenti Paste. Instead, they teach that it is below the standard of care and have done so for decades.
The American Association of Endodontics (AAE) has a strong position paper stating NOT to use this material. The AAE is an administrative board that sets the standards for endodontic care in the U.S. They are the only endodontic board recognized by the American Dental Association.
An excellent article, written by Dr. Stephen Barrett, of quackwatch.com provides a history of Sargenti Paste and the US dental and regulatory organizations. Click here.
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 The "disinfecting" property of Sargenti Paste occurs from the fumes off-gassed from the paraformaldehyde. This activity deactivates and destroys debris left in an improperly cleaned canal. It makes for quicker, sloppier and cheaper root canals. Dentists who use it believe that it causes no damage, even when extruded outside of the tooth and the patient's complaint is immediate. They refuse to accept responsibility for the devastation that it sometimes causes. Knowing that Sargenti type formulations are shunned by all of mainstream dentistry and considered below the standard of care throughout the US, the dentist will often conceal its use and leave it to the injured patient and their treating doctor(s) to hopefully not discover. Problems can even show up months after the procedure and the connection never made. Their is no valid reason to use Sargenti Paste over the widely accepted and used gutta percha.
Ask your own dentist about it.
ARE YOU SAFE?
No patient is protected from the use of Sargenti Paste. Damages are random. Peanut and formaldehyde allergies be ware! You MUST ask your dentist if they use this type of material and say NO. Unfortunately, many Sargenti injured patients were not given the opportunity to make their own choices and now live with permanent life altering health conditions. Don't walk in their shoes. Most dentists would not use this material on their patients. Unfortunately, that is not true for all.
Dr. Stephen Cohen, DDS and one of the authors of the most widely used endodontic textbook, Pathways of the Pulp, writes about the substandard and risky Sargenti Paste and other paraformaldehyde root canal sealers. An excerpt from his acticle -
"It is shocking that in the 21st century there are still some dentists who choose to use a paraformaldehyde containing sealer.
Simply put, there is no circumstance where it would be appropriate to use a paraformaldehyde paste for sealing a root canal. Why would any dentist choose to use this dangerous paste? I don’t know the answer to this question, but I do know that a few of our colleagues court disaster by continuing to use a dangerous paste instead of gutta-percha and sealers that are, according to the Food and Drug Administration, “generally recognized as safe and effective.”" Full Article begins on page 14, paraformaldehyde on page 16.
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WHAT INJURIES CAN RESULT? |
 An Alabama patient suffers permanent 24/7 numbness and burning pain in the chin/lips/gums after an overfill of Sargenti Paste (RC-2B) into the Inferior Alveolar Nerve (IAN) canal which runs under the bottom back molars (see diagram). The first xray, on the left, shows tooth #18 before the root canal procedure. Note that there is no material under the circled tooth. The xray below this on the left, shows the tooth after the root canal. There is a significant amount of paste outside the bottom of the tooth and inside the IAN canal. This overfill, approximately 6-7 mm is considered, by all standards, a gross overfill. The dentist, upon overfilling the root canal with Sargenti paste into the underlying inferior alveolar nerve canal, should have told the patient that the Sargenti paste overfill penetrated the nerve canal. An immediate referral to an oral surgeon to remove the overfill with microsurgery at a surgical center or hospital would likely have stopped the spread of Sargenti Paste's toxic chemical effects along the nerve pathways. Instead, the dentist's concealed that the toxic Sargenti paste inside the nerve canal was the cause of the patient's feeling numbness and burning pain in the lip, chin and gums. The dentist blamed local anesthetic injections for the root canal as the cause. Consequently, microsurgical removal of Sargenti paste was delayed until it was too late to make a difference. Thus constant numbness and disabling burning pain persist to this day and will remain so for life.
A
. Pogrel, DDS, MD published research in January 2007 in the Journal of the American Dental Association which showed that root canal overfills into the nerve canal if microsurgically removed within 72 hours completely reversed the nerve numbness and/or pain. Both doctor and patient should not delay surgical removal of Sargenti overfills into the canal. A patient should seek the help of an Oral Surgeon, not general dentist, for removal. Cone Beam 3D dental x-rays provide proof positive if Sargenti paste entry into the nerve canal is the cause of post-operative numbness or burning pain after a root canal.
 The CT scan to the right is that of a New Jersey patient who suffers from chronic osteomyelitis (bone infection). This scan was taken early into the patient's treatment. The yellow arrow points to the initial bone loss after an overfill of RC-2W. This patient's infection has been uncontrollable for 8+ years and has eaten away the jawbone and floor of the sinuses, requiring rebuilding from other parts of the patient's body. The second scan to the right (below) shows some of the pins (inside the red box) that are now present in the patient's jaw after many, many surgeries to attempt to correct and stop the damage. This patient's medical bills are in excess of $600,000 and climbing. Her dentist never disclosed that he had used Sargenti paste. For five years she was searching for the answer to her problems. She did not know the truth about what was used for her root canals.
This New Jersey patient's case is similar to the most horrendous reported case of Sargenti damage which occurred in 1984 (Link). The story of this patient was part of aPrimeTime Live show that aired on February 8, 1990. 60 Minutes has also done a story on the perils of Sargenti Paste at least a decade ago. It is time to realert the public to help them stay out of harm's way.
Injuries from Sargenti Paste and other paraformaldehyde materials can include chronic sinus infections, temporary or permanent numbness and burning nerve pain, serious chronic bone infections, and even anaphylactic shock. Many formulations of Sargenti Paste include peanut oil, which can also send an allergic person into anaphylactic shock. Neither of the above mentioned patients were asked if they were allergic to peanuts before, during, or after their root canals. It is also believed that the toxins in Sargenti Paste can travel throughout the body and affect distant organs. Many believe that the formaldehyde in this material is a carcinogen. Damage can be a life changing disaster. And, it is random. These two patients had nothing unique about their dental care that warranted deviating from the standard of care material, gutta percha. They simply chose the wrong dentists and did not know the right questions to ask. These two patient's dentists did not disclose that Sargenti Paste was used before or after the root canal, until confronted.
The public must know what these patients had to learn the very hard way. No one should have to walk in their shoes, not even them.
WHAT ARE (OR AREN'T) OUR REGULATORY BOARDS DOING ABOUT THIS? |
Pointing at each other for accountability!
The ADA and AAE point to the FDA. The FDA points to the State Pharmacy Boards. The State Pharmacy Boards point to the State Dental Boards. The State Dental Boards point to the FDA and ADA. NO ONE is accepting responsibility for enforcement of the sale and use of this unapproved and dangerous material. Any action that is taken is only in response to a patient complaint AFTER the damage is done. THIS MUST CHANGE!
The SOS has been in contact with all regulatory boards that are involved with this issue. Unfortunately, for the public, these boards have implemented a reactive form of enforcement. Only when a patient is injured, discovers it is Sargenti, and then reports it, is anything done. Then they only act upon the dentist that is involved with that particular injury. Our regulatory boards must become proactive in their enforcement and stop patients from being harmed instead of waiting until after they are harmed. There is not much that can be done for the injured patient once the damage from Sargenti Paste is done.
In 1996, the FDA confiscated and destroyed Sargenti Paste as toxic waste. They have recently confirmed that their position has not changed. What has changed, is the dysfunction of the FDA and the failure of their mandate to protect the public. On their own website, is a troubling article "A Troubling Trend", about the lack of FDA enforcement of compounded drugs. Sargenti Paste is a compounded drug. Enforcement is lacking. |
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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.