SARGENTI N2 – ALIVE AND KICKING
by Alvin H. Arzt, DDS, MAES
To mention N2 and the Sargenti Root Canal technique today, usually gets the response, “Is that material still around?”
It is over 50 years since Dr. Angelo Sargenti introduced N2 and Efficient Endodontics to the US from Europe. It is over 20 years since a New Drug Application (NDA) was submitted to the FDA and was accepted for review.
However, it was in 2007 that the N2 formula was updated by moving the paraformaldehyde from the powder to the liquid. By making this simple change, all the ingredients remain the same, but the shelf life has increased from 6 months to 3 years.
Once the powder and liquid are combined chairside, the same efficient results are accomplished: a sealer that allows complete sealing of the canal and the destruction of all active bacteria remaining in a canal after the mechanical preparation is completed.
The success rate of 98% remains at the top of the list for success of all sealers and cements available today. Even though the small change in formulation has been done, the FDA requires new data and research to substantiate the submission of this change. As everyone knows, the FDA does not act quickly and the final stages of acceptance by the FDA are expected shortly. All this data has now been submitted. N2 is now accepted by the European Nations (EU), Canadian FDA, Japanese FDA and all nations that do not have organized endodontic specialties. It is now in Phase III of the FDA NDA ladder, which is the final stage before full acceptance. No other root canal sealer or cement has ever applied to the FDA for an NDA.
Why do at least 30,000 dentists in the US continue to use the generic formulation of N2, until the new original formula is available? It is because:
1. it produces for their patients a root canal technique that reduces pain rapidly and continues with post-op pain free conditions.
2. it allows a successful root canal to be completed in one visit, whether it was vital or non-vital to start.
3. it is less traumatic to both the patient and the dentist and using the canal engineering being taught, every tooth treatment has
just about the same procedure.
4. it allows you to adapt any technique being taught today, using titanium or stainless steel instrumentation, hand or engine preparation to be included as a Sargenti N2 Technique.
5. and it is compatible with gutta percha or any other solid core.
There isn’t a sealer or cement out today that has lasted over 50 years like N2 has. Most sealers that many dentists use today will be out of existence within 5 years. They still cannot obtain a 98% success rate with any conventional root canal technique.
The successful generic formula of N2, available from pharmacies, is now used until the new formulation is obtainable.