Sargenti Opposition Society - Who is Behind It

Sargenti Paste is named for a Swiss dentist, Dr. Angelo Sargenti, who introduced formaldehyde to endodontics. His method was controversial from early on and abandoned by mainstream dentistry. Dr. Sargenti died some years ago but proponents and users remain in the US. History has shown that most do not inform their patients that the material they are using is considered dangerous and below the standard of care. Neither Dr. Sargenti nor his followers have ever received FDA approval. A meeting between Dr. Sargenti and the FDA did not resolve favorably for the Sargenti proponents.

A meeting between the FDA and US proponents also did not resolve favorably for them (pg 14) and resulted in a denied approval for manufacturing and sale in the US.

Stephen Barrett, MD, of quackwatch.org and dentalwatch.org, recently wrote an excellent article on the history of Sargenti Paste. An excerpt from that article, below, describes the organization behind this dangerous root canal drug. For the full article, click here.

"In 1969, Sargenti followers formed the American Endodontic Society (AES), which now offers training, a Web site, a newsletter, and political support. Its mission is "to provide educational and scientific information on simplified endodontic procedures; to protect and preserve the right of the general dentist to perform those procedures for which he is qualified by education and experience." The current dues rate for "active/dentist" members is $195. Since at least 1988, the Encyclopedia of Associations has reported that AES's membership as "10,000." However, the income from "membership dues and assessments"reported in its 2006 Form 990 tax return is only $76,070, so the total number of active members appears to be less than 400. In a recent telephone conversation, I asked AES Secretary-Treasurer Alvin H. Arzt, D.D.S. how many active members AES has. He said about 2,900 to 3,000 [16]. When I pointed out the discrepancy, he replied that there were honorary members and others who were actively supportive, and that that's the number that the accountants put down.

Arzt, who is president of the N2 Products Corporation, also told me that the company's N2 had passed Phase II testing based on a submission that compiled 5,000 cases [16]. A recent AES newsletter reported that the application process had stalled because AES had not been able to find a company to manufacture N2 and gather data on its use [17]. However, Arzt said that AES has found a suitable manufacturer and hoped to go forward with a 1-year study that would persuade the FDA to approve the company's paste [16]. When I asked whether a report on the 5,000 cases had been published, Arzt said that no dental journal would consider publishing it. When I expressed surprise that AES itself had not made the data publicly available, he replied that a summary had been given to members, but the important thing was that the data were accepted by the FDA. He also alleged that endodontists oppose use of the N2 paste solely because it enables general dentists to do root canal treatment at lower cost. Although the dentists who use N2 tend to charge less than endodontists, I believe that opposition—which is not limited to endodontists but includes other dentists and dental educators who do not perform endodontic treatment—is based on safety concerns rather than economic reasons."

-- Dr. Stephen Barrett, MD, www.quackwatch.org
December 14, 2007

Proponents of Sargenti Paste, members of the American Endodontic Society, solicit patient cases from their dentist members as a requirement for achieving fellowship status in their club. The AES states in their submittal guidelines (documented in each of their newsletters), "No gross overfills". During the 1993 meeting with the FDA seeking approval (which was denied), the following statement was made by an FDA consultant for the Panel, Sheila McGuire, D.D.S., D.M.Sc. - "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." So, again, only look at the good and ignore the real dangers of Sargenti Paste.

An overfill occurs when the root canal filling material extrudes beyond the root tips and into surrounding tissue outside the bottom of the tooth (link). A dentist doing a properly done root canal treatment tries to keep the root canal filling material inside the tooth. Filling of the root canal is done after the nerve inside the tooth is removed. The hollow space where the nerve was previously located is cleaned, filed, shaped and disinfected to accommodate the root canal filling material.

When the root canal is completed the dentist should take a final x-ray to be sure no harmful overfill occurred. If one did occur, the patient should be followed that evening and the next day for persistent numbness and/or burning pain suggesting an overfill into vital structures such as the inferior alveolar nerve canal. If the patient complains of numbness and/or burning pain, an IMMEDIATE referral to an Oral Surgeon is warranted. Volumes of literature exists today that recommends immediate surgical intervention to remove a Sargenti Paste overfill.

With the omission of these problematic overfill cases, it is not surprising that the AES underestimates safety risks. Overfills are a common concern with root canals, and therefore a necessary part of any comprehensive study program. At the 1993 FDA meeting where Sargenti Paste was denied approval, members of the dental products panel noted that they could not evaluate the safety of Sargenti Paste without evaluating the failures. Overfilling, particularly if the overfill penetrates the main sensory jaw nerve (inferior alveolar nerve) underlying lower posterior teeth or perforates the sinus overlying upper posterior teeth, would fall into the failure category.

There are many general dentists who perform root canals using the standard endodontic material, gutta percha. Gutta percha, now synthetically made, was originally made of inert tree sap. In its synthetic form, gutta percha is still inert. The FDA recognizes gutta percha as generally safe and effective.

If the problem with Sargenti approval is an endodontic conspiracy, then why aren't the endodontist's also against gutta percha? Far, far more general dentists use gutta percha than the minority group of dentists who use Sargenti paste. It's not about an endodontic conspiracy, its about patient safety.