Injured patients should file an adverse event report with the FDA.
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.
THIS WEBSITE IS UNDER REDESIGN. PLEASE EXCUSE OUR BROKEN LINKS. Best viewed in Internet Explorer.
*NEW* Florida dentist, Raymond Della Porta, files million dollar slander/libel lawsuit against SOS founder, Lorrie (Hellier) Kruse, after her interactions with Florida dental board and Department of Health. The suit backfires and Della Porta agrees to drop the case and pays SOS founder "a confidenial amount" to avoid a lawsuit for malicious prosecution (della porta release) (kruse release). Read articles written by Stephen Barrett, founder of quackwatch - Florida dental board actions. (board complaint, settlement, final order). Della Porta agrees to permanently stop using sargenti paste, considered below the standard of acceptable care in the state of Florida (link). Lawsuit information can be found in 2nd to last paragraph (with references below) at this link. Read news report written by local reporter, Eileen Kelley, after finding filing in local court (link).
VIDEO - NBC 10 in Philadelphiareports on SOS Founder. Aired September 24, 2009,Embalming Fluidcontains 5-29% formaldehyde, not the 40% 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.
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.
New Jersey dentist, Dominic Cicero, surrenders license to state dental board. This dentist was found guilty of gross negligence in the treatment of SOS Founder, Claudia Megaro (see video below). Had it not been for Claudia's constant efforts to stay on the board, they would have allowed this case to go unpunished, even after stating that her case was the worse that they have seen in NJ. See quackwatch for more information.
Cincinnati Financial of Ohio & Medical-Protective Insurance Companies cancel malpractice insurance for Sargenti using dentists. Cincinnati Financial was the insurance company sued by one of the SOS Founders after suffering severe permanent pain and numbness.
2010 AES Annual Meeting in Orlando poorly attended. As with the 2008 meeting, a mere dozen or so dentists were in attendance, almost all were officers and board members. This again confirms our belief that there is little support for this group of disrespected dentists.
US Government officially declared formaldehyde a carcinogen. (link)
Chicago Dental Society cancels clinic tables at 2011 Midwinter Meetings, including American Endodontic Society.
N2 UNIVERSAL [aka Sargenti Paste] DATA DO NOT SUPPORT APPROVAL, FDA's DENTAL PRODUCTS PANEL, 1993(link).
Read entire meeting transcript at this link.
Contrary to the information published by the Sargenti proponents stating that Dentist's Advantage malpractice insurer covers dentists who use sargenti paste/cement, they do NOT.Confirmation of their position against this material came to us directly from Dentist's Advantage. This company mentions Sargenti Paste overfills in a list of risk management case studies & a recent high dollar lawsuit from its use (search "sargenti").
2009 Ninth World Congress on Preventive Dentistry reiterates: Paraformaldehyde-containing products should not be used in treating patients, Sept 2009 (link). Based upon our research, we believe that the use of Sargenti Paste is not widely supported or used worldwide.
Poland National Medicines Institute, Medical Devices Department, 2009 ... the use of paraformaldehyde-containing filling materials or root canal sealers is undoubtedly below the standard of care for endodontic treatment (link).
Guinea Pigs Then (1976), Still Guinea Pigs Now (2010) (link)
A 1974 death of a California woman in a dentist office was connected to Sargenti Paste/N2. Many patients have suffered anaphylactic shock from the formaldehyde which can be fatal. Peanut oil is frequently used when mixing the paste so those with allergies should be especially aware. See article here.
41 Y/O PATIENT SUFFERS ANAPHYLACTIC SHOCK FROM SARGENT ROOT CANAL
The prominent endodontic textbook, Endodontics, by John Side Ingle, Leif K. Bakland, states, "The Sargenti method has become a cult and, like most cults, is based more on testimonials than on facts.... [Dr.] Sargenti himself indicated a double standard of endodontic treatment when he public ally stated 'If I had endodontic problems myself, and I wished to have an exact endodontic treatment, I would certainly ask Dr. Herbert Schilder to treat me'". Dr. Schlider was an expert on endodontic treatment and did not use Sargenti Paste.
Proponents of Sargenti Paste advertise that the effects of the formaldehyde can not cause systemic damage. Cases where a patient has suffered from anaphylactic shock demonstrate that the formaldehyde in the paste does travel beyond the confines of the porous tooth. (link)
ADA ENDODONTIC SPECIALTY BOARD
SARGENTI ANNUAL MEETING HAS POOR ATTENDANCE
The American Association of Endodontics (AAE) has REAFFIRMED, in 2013, a strong position against the use of Sargenti Paste and other paraformaldehyde materials. 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.
In 2008, the AES meeting was attended by a mere dozen or so dentists despite being held at the same time & place as the well attended American Dental Association annual convention. Nearly all in attendance were AES officers or board members. This was confirmed by members of the SOS who had long believed that there was little support for the activities of this rogue group of dentists. The meeting was cancelled in 2009.
US ENDODONTISTS STRONGLY AGAINST THE USE OF SARGENTI PASTE
18 YEARS LATER & STILL NO ANSWER
Sargenti Paste is strongly denounced by the only Am Dental Assoc accredited endodontic (root canal) specialty board, the American Association of Endodontics (AAE). It is widely believed that using this material is negligent and below the standard of care. We encourage you to read this reaffirmed position statement before reading more of our site. (link)
The Ohio Dental Licensing Board all but begs the FDA for guidance on Sargenti Paste in 1991. Ohio claims to have never received this. To this day, state dental boards look to the FDA for guidance and since there is none, they continue to ignore a significant problem. At least one person has apparently died with the death being linked to this material. (link to Ohio Letter article).
ALABAMA'S ATTEMPT AT SARGENTI ROOT CANAL INFORMED CONSENT
Due to gross negligence during a Sargenti root canal, as a part of a dental practice's disciplinary action, three Madison, AL dentists are now required to obtain patient consent before performing the procedure. The consent form provided here is what the dental board approved. After nearly 3 years of repeated attempts by the patient to get a copy, it was finally provided by the Attorney General's office. It is a generic consent for any and all dental procedures and is not suitable for informed consent for using Sargenti Paste. There is no place for the patient to consent to the additional risks from Sargenti Paste, it uses medical terms that patients will not know, it omits anaphylactic shock (evidence that systemic problems do occur), omits that the FDA rejected it in 1993 for safety concerns and is still not approved, omits that every accredited dental school teaches NOT to use it including Alabama's, omits that the ADA does not recommend it and among others, omits to include the AAE statement.
By signing this, the patient is not consenting to the risks of a Sargenti root canal and even if they were, a patient cannot consent to negligent treatment and using Sargenti Paste is negligence. Don't let this keep you from contacting an attorney if you find yourself injured. Dentists need to know that this is unacceptable.
WHY DO DENTISTS USE SARGENTI PASTE?
WHAT THE EXPERTS SAY?
The "disinfecting" property of Sargenti Paste occurs from the fumes off-gassed by the para formaldehyde. This activity deactivates and destroys debris left in an improperly cleaned canal. It makes for cheaper, 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.
Dr. Stephen Cohen, DDS who is a primary author of the most widely used endodontic textbook, Pathways of the Pulp, writes about the continued use of Sargenti Paste. He says - "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.
ABOUT ROOT CANALS
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.
The Sargenti Opposition Society was founded in 2008 by 2 severely injured patients to inform the American public and our dental regulators of the continued
use of a dangerous, FDA rejected root canal drug, Sargenti Paste. Sargenti Paste contains the powder form of formaldehyde known as paraformaldehyde as its active ingredient.. It contains levels of this chemical equal to what is used in embalming fluid. Dentists claim to use it for canal disinfecting. It is a cheaper, shortened and sloppier way to perform root canals. The vast majority of dentists worldwide are strongly against its use. The use of this material is considered below the standard of acceptable care and its use is the basis of malpractice lawsuits, regardless of whether the patient consented to its use or not. Sargenti using dentists often do not tell their patients that the material they are using is not approved for use in the United States. Injuries are completely random and damage can be life altering.
Since a frequent response from dental professionals has been "I didn't think anyone used that stuff anymore" or "that is only used in 3rd world countries", 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 standards boarda, the American Association of Endodontics (AAE).
WHAT IS SARGENTI PASTE?
Sargenti Paste is a material that is used to fill the canals that are created during a root canal procedure and 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. It can cause severe and irreversible damage to tissues, nerves, and bones that can be detected immediately after the procedure or months later.. The formaldehyde emits gasses that can escape from the confines of the tooth. It enters the blood stream during the root canal procedure. 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, often becoming permanent life-altering conditions and even fatal.
Sargenti Paste contains peanut oil, which, along with formaldehyde can cause an allergic person to go into anaphylactic shock (Journal of Endodontics, Sept 2000 article) This indicates that the formaldehyde does not remain only within the confines of the tooth. 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. There are many formulations but all contain 6.5% paraformaldehyde. Some contain lead and mercury. The Material Science Data Sheet (MSDS) for the powder portion of the N2 formulation which does not contain lead and mercury can be found at this link. A review of this information clearly demonstrates why it is NOT a safe material to be used.. The formulation containing lead and mercury, according to the FDA, should NOT be made or sold anywhere within the US. Unfortunately, that is not the reality of today. The MSDS for the liquid component can be found at this link. The liquid and powder are mixed by the dentist just prior to the root canal procedure.
ENDODONTISTS ENCOURAGED TO
REPORT SARGENTI INJURIES
The American Association of Endodontics (AAE) has initiated a databank to collect adverse reactions from their members when Sargenti Paste formulations (N2, RC2B, RC2B White, RC2W) are used. Any patient injured by the use of these materials should encourage their dentist/endodontist to report their situation to this databank. If they do not or cannot, we encourage the patient to make the contact. Sargenti injuries are under reported as many dentists conceal its use from their patients. Link
ALL US DENTAL SCHOOLS SAY NO
Not one accredited dental school in the US teaches to use Sargenti Paste. Instead, they teach that it is below the standard of care & have done so for decades. Dentists who use it claim that their instructors were biased because Sargenti using dentists are taking business away from the endodontics so they ignored what was taught. The truth is that dental schools have both general dentists and endodontists on their faculty and there is no big monetary conspiracy. The fact is that Sargenti Paste is recognized as the toxic material that it is.
PERMANENT NERVE DAMAGE
(numbness and chronic burning/stinging pain)
UNCONTROLLABLE BONE INFECTION
(entire upper right jawbone eaten away by infection,
rebuilt from leg parts which is also being eaten away
A Huntsville/Madison, Alabama patient, Lorrie Hellier (founding member of the SOS) suffers permanent 24/7 numbness and burning/stinging 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. A gross overfill is typically a 4mm overfill.
The dentist upon overfilling the root canal with Sargenti paste, was obligated to tell the patient that the overfill penetrated the nerve canal (regardless of the material). An immediate referral to an oral surgeon to remove the overfill with microsurgery would likely have stopped the spread of Sargenti Paste's toxic chemical effects along the nerve pathways. Instead, the dentists concealed that the toxic Sargenti paste inside the nerve canal was the cause of the patient's feeling numbness and burning/stinging pain in the lip, chin and gums. The dentist blamed local anesthetic (novacain) injections as the cause. Consequently, microsurgical removal of Sargenti paste was delayed until it was too late to make a difference.The photo of the patient's teeth was taken during the surgery and shows how the Sargenti Paste is spattered throughout the jaw as it is put in under pressure (white specs are pieces of the paste). The surgeon was able to remove most of the pieces but some still remain in the jaw and have not resorbed after nearly 4 years.. The rolled up piece of paste (under the tooth) had been wrapped around the Inferior Alveolar Nerve and is the reason for the irreversible damage.
Because the surgery was delayed, the constant numbness and disabling burning/stinging pain persists to this day and will remain so for life. The Alabama Dental Board disciplined these dentists and the patient filed a dental malpractice lawsuit that was settled out of court (patient complaint, board charges, consent orders). As a part of the dental board settlement, these dentists are forever required to use this board approved uninformed informed consent. This consent form is lacking widely known information by our dental community, including that Sargenti Paste was rejected (1993) by the FDA for failure to prove safety and remains unapproved to this day. The FDA states that "patients can not assume that these products are safe and effective".
Dr. M. Anthony Pogrel, DDS, MD published research in January 2007 in the Journal of the American Dental Association (JADA) which shows that root canal overfills into the nerve canal if micro surgically 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 nerve canal or anywhere else that results in patient complaints of pain and/or numbness. 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. They can likely be done at your state dental school for a small fee, possibly as low as $300 (before insurance).
The CT scan to the right is that of a New Jersey patient, Claudia Megaro (founding member of the SOS and subject of news story above), who suffers from chronic osteomyelitis (unstoppable bone infection). This scan was taken early into her treatment that began in 2000. The yellow arrow points to the initial bone loss after an overfill of RC-2W (formaldehyde but reportedly no lead and mercury). Her experience trying to get medical help are discussed at this link. Her experience with the legal system was equally painful and never should have been necessary.
Claudia was so severely damaged with life threatening injures at the hands of her dentist she has almost died more than once. Her life continues to be threatented by recurring infections. She lives on antibiotics and still has frequent infection flare-ups, likely because her problems were not treated timely. Her dentist concealed his use of Sargenti Paste and she did not come to know about it until 5 years after she left the care of Dr. Cicero..
Claudia's infection has been uncontrollable for 9+ years and has eaten away the jawbone and floor of the sinuses, requiring rebuilding from leg bone, tissue, skin and blood vessels. Her situation has been so horrific that when she discovered that she had hair growing on the roof of her mouth from using leg skin, all she could do was laugh. Just one more thing in the day in the life of her horrific story.
The second scan to the left (below) shows some of the pins (inside the red box) that are now present in her jaw after many, many surgeries to attempt to correct and stop the damage. Her medical bills are in excess of $600,000 and climbing. Although she settled a lawsuit, most of the money was spent to pay her attorney, reimburse her health insurance company, and to pay off outstanding copays and other out of pocket expenses from her 33%. There was little left for the future costs that she will incur for life.
Her dentist never disclosed that he used Sargenti paste until confronted in depositions and then claimed he did not know what it was, just that it was his favorite. For five years Claudia searched for the real answer to her problems. It turned out to be Sargenti Paste. If only she had known early on, immediate surgery would have helped mitigate the severity and relentlessness of the infection. Claudia filed a dental malpractice lawsuit against her dentist and settled the case just before trial.
Claudia's case is similar to the most horrendous reported case of Sargenti damage which occurred in 1984 in Florida (Link). The story of this patient was part of a PrimeTime Live show that aired on February 8, 1990. Good Morning America and 60 Minutes have also done stories on the perils of Sargenti Paste over a decade ago. It is long past time to realert the public to help them stay out of harm's way.
OTHER HEALTH RISKS ASSOCIATED WITH SARGENTI
PASTE, EVEN DEATH
WHAT ARE (OR AREN'T) OUR REGULATORY
DOING ABOUT THIS?
Many formulations of Sargenti Paste also include peanut oil, which can also send an allergic person into anaphylactic shock and even cause death. The lead and mercury in the pink formulation can also have serious negative effects on the patient.
We had nothing unique about our dental problems that warranted deviating from the standard of care material, gutta percha. We simply chose the wrong dentists and did not know the right questions to ask. None of the dentists involved in our care divulged that Sargenti Paste was used until confronted. That concealment cost both of us valuable recovery, recovery that would not have left us with life altering and life threatening damage. Had our overfills been with the standard of care material, gutta percha, we both believe our dentists would have divulged the problem immediately.
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 manufacturing 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. The next patient in that same dental chair is NOT protected. 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.
ASK - "ARE YOU PUTTING ANYTHING WITH FORMALDEHYDE IN MY MOUTH?"
DON'T ASSUME, IT ISN'T WORTH THE RANDOM RISK.
It is the policy of the Sargenti Opposition Society to post only the most current and verified information obtained from credible sources. If you have documentation that conflicts with any information on our site or demonstrates a violation of any type, please contact us and we will correct our site as necessary.
Copyright 2008, 2009, 2010. Sargenti Opposition Society. All rights reserved.