SARGENTI PROPONENTS The proponents of Sargenti Paste are two fold. The American Endodontic Society (AES), a non-profit organization that solicits dentists for membership dues, contributions, and patient cases/clinical tests where Sargenti Paste was used. The second proponent, N2 Products, deals directly with the FDA to obtain the New Drug Approval (NDA) which would permit manufacturing and sale of this dangerous material in the United States. The AES newsletters state that a mastership level in their club requires participation in N2/FDA Clinical Studies, thus indicating that it is participating in such. However, they openly acknowledge that they do not tell their patients that they are using this toxic material so no clinical trial protocols are being followed. While they may advertise participating in a clinical trial, they are not. Clinical trial protocols were not followed for the thousands of cases submitted to the FDA and consideration in the 1993 approval request which was denied. During that meeting, the FDA questioned whether patient approval was obtained and said that many were not. The representatives of N2 Products, stated that the dentist may have signed it, i.e. not the patient. AES CANCELS 2009 ANNUAL CONVENTION The AES cancelled their 2009 annual convention which would have been held in conjunction with the Am Dental Assoc's convention in Honolulu, Hawaii. This is the first time in years that this has happened and it has been confirmed by the AES that they no longer advertise meetings through the ADA because they do not want the SOS to obtain information. What do they have to hide? This cancellation notice was in the AES newsletter and was confirmed by the ADA. IS YOUR DENTIST A MEMBER OF THE AES? ASK! Do your homework before you let them do a root canal on you. Check with your state dental board to see if disciplinary action has been taken against your dentist. Check with your local court house to see if malpractice suits have been filed. Although lawsuits have been won by Sargenti using dentists, it is often a technicality of the law that allowed them to be successful, not the determination that the dentist was in the right. We will be updating our site with the list of dentists known to be members of the American Endodontic Society. You can also contact the AES at N2dontics@gmail.com, but getting a straight answer is unlikely.

Correspondences between the AES and Government Agencies Although FDA activities with drug manufacturers are generally proprietary, some information is available through the Freedom of Information Act and from Government websites. We have posted some of that information at the "Correspondence between the AES and Govt Agencies" link above. As we obtain pertinent information, we will post it on this site. The information discusses a perceived change in N2 approval path from the FDA Center for Drug Evaluation and Research (CDER) New Drug Approval (NDA) to the FDA Center for Devices and Radiological Health (CDRH) 510K pre-market approval path. The 510K clearance is generally less stringent and allows for the comparison to a predicate device, an already approved device. However, as you read the information, you will see why we believe the change to this path is no more likely to obtain approval than through the NDA. Patient approved studies must still be submitted that demonstrate the safety and efficacy of N2. Since the studies are provided by the AES fellowship and mastership programs, the data will not meet the study requirements. In the fellowship requirements, the AES clearly states "No gross overfills" should be submitted. In the mastership requirements, 105 cases must be submitted with no moer than 5 failures? Are the submittals being handpicked as they were for the 1993 attempt? AES 2008 ANNUAL MEETING POORLY ATTENDED Members of the SOS witnessed that the attendance at the 2008 convention in San Antonio, Texas was a mere 12 or so dentists. All but one or two were board members and officers. While there were other persons at this meeting, they were spouses and office personnel of the few dentist in attendance. This again confirms that their activities are NOT supported by 99% of our dental community, and international dental organizations. AES REMOVES NEWSLETTERS FROM WEB SITE The SOS' efforts to expose the activities of the AES and the use of Sargenti Paste have resulted in the removal of Newsletters from their website thus reducing the risk of dentists being swayed by the misinformation published in those newsletters. Because of the scrutiny by the SOS, the AES now hides both their newsletters and meetings from the public and other dental professionals. What do they have to hide? We continue to ask them to post information on their website that backs up the claims of FDA approval and legitimate scientific studies that are based upon clinical guidelines where patient knowledge and consent is included.

DR. ANGELO SARGENTI 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. WHAT CAN HAPPEN WITH YOUR PATIENT RECORD? 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.

"Be Wary of Sargenti Root Canals" 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