Sargenti paste, N2, RC2B etc.
Ulf Bengtsson
“ Does it exist, in the US or elsewhere, any dental material that is
banned by any regulatory body because of inferior quality, toxicity or
for other reasons?”
One of the reasons for asking that question was N2 and all different
names/ techniques linked to it (N2 Normal, N2 Medical, N2 Universal, N2
Apical, RC2B, RC2W, Sargenti Paste, TCM, White One-Step Endodontic
Formula, Endodilato etc.) Endomethasone is another related
paraformaldehyde containing material.
Leading endodontic specialists condemn the use of this material for
toxicological / immunological / technological reasons.
Toxicological. A number of different ingredients have been found in N2
including phenyl mercury borate, paraformaldehyde and lead oxide
(Pb3O4). Both the ingredients and the amount vary between analyses. For
example Harndt and Kaul found almost 27% of lead oxide! When confronted
with the frequent changes in composition Sargenti replied that the
important ingredient is paraformaldehyde – the rest did not matter what
they were! N2 is also recommended by Sargenti to be used in deciduous
teeth.
Immunological. Paraformaldehyde is a polymer derived from formalin which
is the gas formaldehyde in solution with water. The American Endodontic
Society argues that a lot of food – pork, milk etc. – contains as much
formaldehyde as a root canal filled with N2. This is a very common
argument from N2 promoters showing their limited knowledge of the
problem. They compare a chemical implanted into the body with an
ingredient in food. Route of exposure does not seem to have any
significance to them. Teeth filled with N2 can cause an immunization of
the host. If this occurs, the subjects will be allergic to formaldehyde
due to N2. This means that these persons will show an allergic response
to milk, pork etc. Since formaldehyde is so wide pread in food and in
our environment these patients will experience all kinds of trouble.
Paraformaldehyde containing materials are also mutagenic.
Technological. The Sargenti method also includes the “N2DONTICS
Engine-Driven Root Canal Preparation System”. Intentionally broken
instruments forms an integrated part of the root canal filling. Sargenti
says: “Enough N2 material finds place in the reamer segment flutes to
guarantee a sealing of the apical third, like a cork of a bottle”
In 1977 the ADA and the American Endodontic Society agreed to use a
specific formula of Sargenti paste to be used in research (Zinc oxide
74%, Bismuth salts 17%, Titanium oxide 2%, paraformaldehyde 6,5%,
Excipients 0,5%) The reason was that scientific studies could not be
performed on a dental material that frequently alter in composition.
This frequent change in composition was explained by Sargenti:
“The material is basically a zinc oxide eugenol cement bearing a dosated
amount of paraformaldehyde. To increase wall adhesion and radiooacity,
metal salts like titanium oxide, barium sulfate bismuth subcarbonate,
LEAD OXIDE, bismuth oxide, bismuth phosphate etc. are added. An
additional antiseptic component – not absolutely necessary – is a small
quantity of PHENYL MERCURIC BORATE (capital letters by me). Experiments
have shown that it is possible to significantly vary the percentage,
quantity and number of the ingredients without influencing the
effectiveness of the material, provided that paraformaldehyde is not
left out and the method is correctly used this explains the varying
results of analyses found by different authors” (Sargenti A. Debate on
N2. Is N2 an acceptable method of treatment. Transactions of the fifth
international conference on endodontics. Ed. LI Grossman University of
Pennsylvania., Philadelphia, p. 176, 1973)
After this explanation by Sargenti the ADA still refuses to ban the use
of N2. As far as I know scientific experiments with the ADA N2 has not
yet taken place. N2 is however still used daily in patients in the US.
Why?
See also
http://www.fda.gov/fdac/departs/096_irs.html (Unapproved Dental Drug
Goes Up in Smoke)
http://www.aesoc.com/
Ulf B