Your info is about 30 yrs old. TRY finding a dentist who still does these. Yeah, they have a group of guys who think they’re great. And you know what? In the right hands THEY ARE!!

People, get a life.

Besides, there’s a groundhog in Pennsylvania that’s about to be horribly abused on the 2nd- how can you sleep in a world with that kind of horror?

Small compounding pharmacies are selling iinterstate, in bulk, across state lines against FDA regulations yet the FDA looks the other way when their regulations are being broken. It strongly appears that today, sargenti using dentists are buying the material from a Florida based pharmaceutical company…..without a doubt against FDA regulations.

Proponents claim to be conducting a “FDA Clincial Study” yet they do not tell their patients that they are using this material and obtain the correct consent. What clinical study allows that?

The FDA has stated that there is no drug/device approved/cleared by the FDA that has (para)formaldehyde as its active ingredient, as does Sargenti Paste. So, what information is there that justifies using this on human beings? All animal studies have proven the toxicity properties. 17 years after a 1993 failed attempt to gain approval, nothing has been done to remedy the concerns of the FDA, yet dentists across this country still use it and conceal it from their patients, sometimes even after they have been harmed.

The numerous sargenti Paste formulations in use past and present, contain anywhere from 4-6.5% formaldehyde while embalming fluid contains 5-29%. Why is this ok? Why won’t our dental systems and regulatory boards alert the public so they have the same opportunity to make the same informed decisions that these dentist and regulators do?

After 30 years of proported attempts to get this material approved, with no success, why are they allowed to continue? What benefit does this material bring to the table that compensates for the risk to the patient? None.

Standard of care materials, such as gutta percha, have been used successfully for decades by both general dentists and endodontists. Yes, they have root canal failures but claims of Sargenti Proponents that they have virtually “no failures” just isn’t true. Proponents do not accept the responsiblity for the failures and injures that their material causes, instead they blame the patient or their treating doctors. Blame the victim. There are cases and studies from around the globe that document the harms of this material. There are ONLY self-serving testimonials from proponents that document the safety of it, of which are widely disputed by the our dental community.

Proponents, have for decades, claimed some form of FDA approval, including a 2003 claim that N2 (aka Sargenti Paste) had passed FDA “Phase III(final testing)”, when they had not then and still have not. Why would the FDA not immediately act upon someone who makes such false claims? FDA told proponents in the 1993 meeting that this material is NOT approved and basically to stop saying such, yet a decade later it still goes on. Why are these supporters immune from FDA regulations?

Below are some FDA quotes and information reported by the media from the failed 1993 attempt by N2 Products to gain approval for their formaldehyde paste. Is this the quality of the science that you want for materials that are used on you or your family?

FDA Medical Imaging, Surgical and Dental Drug Products Division Acting Director Paula Botstein MD, said that “N2 Products’ database, consisting of a clinical study of 109 root canals in 91 patients and case histories from 9,000 other patients, was “flawed” in several respects.”

“I have lingering problems based upon the package of material that was submitted by the sponsor that does not document adherence to an adequate…study”

“The clinical trial was not performed using a concurrent control group” but instead used a historical control which was not well characterized,”

“The case histories, Botstein said, “were not consecutive and were all chosen for successful outcome.”

The case reports “were limited to one page…which contained all the data that were collected, including X-ray data without accompanying analytic readings”, Botstein said.

“I notice that a great number of the case forms are not signed, which is like sending in something that has no data on it at all. Why were they accepted in a form where signatures were not required?” “The case report forms are not signed in a majority of the submissions.”

“there is some question as to whether or not the subjects were truly picked at random from the people who were presented to the 19 clinicians who participated in the study.”

Botstein remarked that the “scientific data presented were not enough to prove the safety and effectiveness of the drug”. N2 Universal is a root canal filler and sealer comprised of zinc oxide powder and liquid euginol components. Unlike other conventional sealers such as gutta purcha, N2 contains 6.5% paraformaldehyde. “According to product literature, paraformaldehyde “achieves its disinfecting purpose through chemical action within the root canal.”

Fountain called N2 a “new drug which presents a health hazard and should be banned.”

“The case reports submitted by the sponsor and the American Endodontic Society were considered in determining the efficacy of the N2 Universal. Notably, the Society only requests case reports on teeth that have been treated safely and effectively from its Fellows. That is a quote from the NDA submission.”

“As consumer representative, having listened very intently to the entire day’s conversation, one of the things that consumers expect, I think, is that their dental professional provider will do no harm, similar to a physician. The patient consumer needs to expect not to be harmed.” … “So, I feel very strongly that this material has not met the scientific standards that consumer groups would want to believe that their health care providers would use to judge efficacy and safety of a given product.”

Proponents justify their use of this material with testimonials from self-serving dentists who use non-standard formulations purchased from compounding pharmacies with no quality control. They divert attention from the dangers of their material by pointing the finger at other products which have no comparison to Sargenti Paste. They claim that approval has never been received because of a monetary turf war with endodontists who are upset that general dentists are taking away their business. Baloney since the vast majority of general dentists use gutta percha for their root canals and the AAE is not against gutta percha.

Proponents claim no evidence of systemic damage (proven wrong by documented world-wide cases of anaphylactic shock where elevated amounts of formaldehyde were found) and ignore the many cases and causes of what can be severe and life threatening local damage where nerve, bone and tissue can be assaulted.

They claim there is more formaldehyde in the foods that we eat than in their toxic material, which the FDA addressed by saying -

“The N2 presentation this morning made some note of the fact that pears and fruit have much higher formaldehyde content than N2 has. 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 where it is applied, and that local necrosis needs to be reorganized or it will be reinfected with a later breakdown. That is one of the problems when we are using formaldehyde for other type of tissue necrotizing agents—the observation period has to be rather long, especially if you are treating vital cases. I think the formaldehyde content here is a very specific issue and has to be looked at as very separate.”

This is the tip of the iceberg of the 3 decades long issues with using Sargenti Paste. It is baffling how such a serious assault, that uses a widely known to be toxic material, on the unknowing and unsuspecting dental patient can be ignored by the very organizations who tax payers pay to protect them. Again, the patient has the right to know that this material is being used and given the opportunity to decide for themselves if they want such a toxic material used on them. The dentists who use this and are eventually forced to tell their patients neglect to tell both sides of this story.

The public knows about the formaldehyde in FEMA trailers, we know about the lead in the toys from China and the age old issue of mercury in fillings, why don’t we know about the age old problem of formaldehyde, lead and mercury in root canals?

I invite you, whether a member of the general public or of the regulatory boards which we expect to keep us safe, to watch a recent story on Sargenti Paste done by a NBC Philadephia reporter. It can be found at our website by clicking on my name. The full transcript of this 1993 FDA meeting can be found on the FDA page at that site. The sargenti paste portion begins around page 12.

Please always ask if your dentist is using formaldehyde before you allow them to perform a root canal on you. Injuries are random and without educating yourself, you could be the next victim. Sadly, we can’t count on our dental industry to protect or tell us.

While I applaud the AAE for adopting the postion that they have against Sargenti Paste formulations, they have fallen short of using their influence to stop what the public deserves to know about and be protected from.

There is one kind of root canal that should be feared. It is a Sargenti type root canal which uses Sargenti paste as a filler or sealer. Perhaps that is what President Obama was referring to in his remarks.

Sargenti paste, aka RC2W, RC2B, N2 etc., contains paraformaldehyde and sometimes lead. It was rejected by the FDA years ago. It causes both bone and nerve damage as well as sinus problems when used in the maxilla.

It’s use is considered below the standard of care, yet some dentists still use it. Dentists that use it do not tell their patients. When a patient is harmed by the use of Sargenti paste the dentist accepts no responsibility or accountability. The patient’s life as they knew it is over, all because they trusted their dentist and their dentist abused their trust.

Thanks for your time,
Justin TI, Ottawa, Canada.