Notes on the 1971 Meeting of Dr. Angelo Sargenti with FDA Device Officials

Stephen Barrett, M.D.
October 25, 2007

In 1971, Angelo Sargenti, a Swiss dentist who had developed a conroversial root canal treatment, met with eight FDA officials, one of whom recorded what took place. Six of the officials were physicians and dentists from what was then called the Division of Surgical-Dental Drug Products (DSDDP), one was from the Drug Efficacy Study Implementation (DESI), and one was a compliance officer. Sargenti advocated using a paraformaldehyde-containing sealant that is capable of severely damaging soft tissues if it escapes from a tooth root during the root canal procedure. During the meeting, he was advised that the FDA would not approve use of the sealant without adequate studies to demonstrate that it is safe. The memo portrays him as evasive and mentally unstable.

Memorandum of Conference
(September 21, 1971, 9 a.m. to 9 :45 a.m.)

Between: Dr. Angelo. Sargenti, D.M.D., Lucarno, Switzerland and William J. Gyarfus, M.D., Director, DSDDP; Frederick J. Grigsby, M.D., Deputy Director, DSDDP; George W. Wade, D.D.S., Dental Officer, DSDDP; Clarence C. Gilkes, D.D.S., Dental Officer DSDDP; Joseph M. Renna, D.D.S., Dental Officer, DSDDP; Clarence M. Nealey, Food and Drug Officer, DSDDP; John R. Carr, D.D.S., DESI; Donald Plumb, Food and Drug Officer, Office of Compliance.

Subject: N-2 root canal sealer.

Dr. Sargenti thanked us for the opportunity to meet. He mentioned that he has just completed a tour during which he had lectured on his technique on the use of N-2. (Some of the places mentioned were Chlcago, Phlladelphla, Delaware, Boston, California. )

Dr. Sargenti then spent approximately 5 minutes shuffling papers (and reprints) on to Dr. Gyarfas’ desk, on surrounding chairs and on the floor.

He then proceeded to read portions of letters from dental organizations and from individual dentists across the country.

He said that he realized that this could be considered as mere testimony but added that this country (“U.S.A.) is a “dentally underdeveloped nation” in the treatment of root canal problems when compared to Switzerland.

He proceeded to give a lengthy dissertation on the need (as he saw it) to correct the problems (as he saw them) and proceeded to quote figures relating to the large number of edentulous people in the U.S.A. as contrasted to the few in Switzerland where his product is widely used.

He proceeded to give a long-winded (and somewhat irrational) criticism of the present state of Root Canal Therapy in the U.S. Some of the statements made by Dr. Sargenti were:

  • His material is for the obliteration of the root canal and is a hard material. (He passed around a sample of a hard pink substance in a plastic sac.)
  • That he has a solution for all our problems in root canal work.
  • That approximately 25 different formulations had been used and that they had all produced the same good results. He said that these were basically zinc oxide and that some date back to about 6 years ago.
  • FDA is influenced by falsified information.
  • That he has other connections.

He then asked if there were any questions.

Dr. Gynrfas gave him copies of the pertinent sections of the Food, Drug and Cosmetic Act and the Federal Regulations.

Dr. Sargenti showed some knowledge of the Food, Drug and Cosmetic Act and stated that he knows most of it from memory. He expressed the idea that we are denying the dentists in this country the use of a “new Product” (by these regulations).

Since Dr. Sargenti said that the N-2 stayed within the root canal, Dr. Wade asked what purpose the formaldehyde served. Dr. Sargenti’s answer was evasive and he could not be pinned down.

Dr. Gyarfas explained that we are not denying anything to dentists or to dentistry—that our purpose is to protect the public—that no clinical evidence was presented to show the safety and efficacy of the drug(s) aznd that this is a New Drug which requires such evidence.

Dr. Carr explained (among other things) that the Council of the American Dental Association (as well as many foreign countries) condemns the use of formaldehyde in such preparations.

Dr. Sargenti said that we have been misinformed and that he wanted to inform us on this important problem of Root Canal Therapy (no explanation of the formaldehyde was given by Dr. Sargenti).

Dr. Gyarfas again expressed the need for well conducted trials in order to demonstrate the safety and efficacy with controlled scientific data-and that be (Dr. Sargenti) would have to abide by the new drug regulations and procedures.

Dr. Sargenti got very emotional at this time and it became difficult to follow his line of thought. It appeared  that he was threatening some type of legal action.

Dr. Gyarfas attempted to restore order and to calm Dr. Sargenti down and adjourned the meeting when Dr. Sargenti became even difficult to understand.

Dr. Gyarfas then again reminded Dr. Sargenti that no evidence had been presented to support the product and that the drug cannot be imported into the U.S.A. or be in interstate commerce without an effective Notice.

                                                      —Joseph M. Renna, D.D.S.

This page was posted on October 25, 2007.