One of the most promising treatments in modern history is root-canal therapy. Known technically as "endodontics" (from the Greek "within the tooth"), the treatment involves removal of the infected pulp inside the tooth. When successful, such therapy makes extraction and replacement with a false tooth unnecessary. Conventional root-canal therapy, except in simple cases, is considered a job for a specialist with years of training and experience. For the patient, it can be painful, time-consuming and costly. Now a controversy has developed in the field of endodontics over an alternative new kind of root-canal therapy called the Sargenti technique, which is touted as fast, inexpensive and simple enough for any dentist to learn at a one-day seminar.
Endodontists perform root-canal therapy when the pulp - consisting of blood vessels, nerves and connective tissue within the roots of a tooth (drawing) - is damaged by loss of circulation or decay. Left untended, the damaged pulp would become a breeding ground for bacteria, leading to abscess formation and loss of the tooth. In the conventional method, the endodontist drills a hole in the crown of the tooth and removes the dead pulp with various small instruments, designed to enter the narrow, often convoluted root canals. He usually fills the empty canal with gutta-percha, a gum-like material, and a sealer consisting largely of zinc oxide. Treatment of a single tooth may require two or three visits and cost from $125 to $250. For completion of the job, the patient may be referred to his own dentist to be fitted with a synthetic cap or crown, which may cost an additional $150.
Device: The Sargenti method of root-canal treatment, named for the Swiss dentist who devised it, has been spreading rapidly among U.S. dentists in recent years and differs from conventional therapy in two major ways. First, the dentist uses motorized devices, including one called the Giromatic, instead of the standard miniature handheld instruments usually used to clean out the root canal. The device is said to simplify the task of pulp removal. Second, Sargenti proponents fill the root canal with a special paste, variously designated N-2, RC2A and RC2B, to mention a few of its trade names. The paste contains compounds of lead and mercury along with steroid hormones and paraformaldehyde. These materials are supposed to sterilize and protect the root canal against bacterial growth.
A Sargenti treatment usually can be completed in just one visit and costs as little as $50 to $95, not including the cost of a crown. The Sargenti advocates conduct day-long training seminars around the U.S. where, for $105, any dentist can learn the technique, place an order for a Giromatic device - and become a member of the American Endodontic Society, the Sargenti practitioners' own dental specialty group.
Conventional endodontists, who may join the older, more select American Association of Endodontists only after stringent qualifying procedures, argue that root-canal therapy is simply too complex to be learned in a one-day seminar. They also say they are persuaded that the Sargenti method has never been proved effective by valid scientific studies and that it may, in fact, be downright dangerous. They claim that the mechanical pulp removers are not as thorough as other instruments, and might even bore all the way through a tooth. And the Sargenti paste, they contend, is even more hazardous.
Sargenti-method critics further insist that the lead and mercury compounds in the filler paste pose a toxic hazard if they leak out of the root canal. The paraformaldehyde, which resembles embalming fluid, is highly damaging to tissues, they charge. Several endodontists have reported seeing patients with injuries to bone and oral tissues following Sargenti root-canal treatment, and practitioners of the technique have been the targets of a growing number of malpractice suits, "I've been called as an expert witness in about a dozen of the cases in the last two years," says Dr. Dudley Glick, professor of endodonties at the University of Southern California.
In a recent malpractice case, a woman was hospitalized because part of the palate at the root of the mouth had dissolved away following treatment. The patient required plastic surgery to undo the damage. More commonly, the Sargenti method has been blamed for damage to the area around the tooth itself. "We've observed patients who've arrived with acute pain and root-end infection associated with bone loss," says Dr. Samuel Luks, director of dentistry at the Bronx-Lebanon Hospital Center in New York. "They routinely arrive in distress and it's usually impossible to save the tooth."
Pain: Sargenti proponents contend that the paste contains only small amounts of potentially toxic substances and that, properly applied, it should remain confined to the root canal. They also insist that the gutta-percha used by the more orthodox endodontists accounts for the postoperative pain often associated with conventional treatment. "There is," says Dr. Ramon Werts of Fullerton, Calif., a Sargenti-method dentist and executive director of the American Endodontic Society, "rarely, if ever, any pain experienced in the Sargenti technique."
The U.S. Food and Drug Administration has not approved the Sargenti paste for nationwide sale, and is now considering an outright ban. In California, health officials have forbidden the two major suppliers in the state to continue selling the paste, and the California Dental Association has advised all its members against its use. Until the paste is banned nationally, however, the Sargenti practitioners can ask any pharmacist to mix up a batch on presumption whenever they need some.
[Note: The FDA has not approved Sargenti Paste for use. They simply passed enforcement jurisdiction to the State Pharmacy Boards unless the material is being sold interstate in single patient prescriptions (5g) and without the heavy metals (lead, mercury). Today, compounding pharmacies (found by the American Endodontic Society) are selling in much large quantity, in prescriptions with the dentist's name on it, unlabeled, and with heavy metals, all against FDA regulations. The FDA is seriously in violation of their mandate to protect the public on this issue, as are State Pharmacy Boards who should be policing the dangerous material when sales fall within their jurisdiction. No dentists should be using this material. Period.