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The information below documents the position of foreign countries and International agencies on the sale and/or use of Sargenti Paste and other paraformaldehyde containing root canal materials. Unfortunately, we are finding that these countries also do not actively enforce their regulations until an injured patient files a complaint in response to an injury. The SOS' activities to educate the public expands beyond the US so that all dental patients world-wide will know the right questions to ask.
Unless otherwise noted, emails were sent to members of the Sargenti Opposition Society. Additional entries are pending as we gain confirmation from other countries and international dental agencies. Our goal is to provide accurate and up to date information. Should you see incorrect or missing information, please let us know. |
| DATE |
COUNTRY |
ORGANIZATION |
POSITION |
| March 09, 2008 6:00 PM |
International |
International Federation on Endodontic Associations |
Email Message from IFEA Secretary, Cal Torneck
I apologize for the delay in responding to you e-mail but as a new Secretary I thought it wise to consult with the other members of the IFEA executive before responding to you. Because of its mandate IFEA does not officially assume an opinion on this matter but does accept the position of the AAE which does not sanction their use. A fuller explanation of the AAE position can be obtained by going to their web site. |
| Current on website |
Britian |
British Endodontic Society |
|
Current on web site
|
Canada |
Canadian Academy of Endodontics(equivalent to American Assoc of Endodontics) |
Canadian Academy of Endodontics, Standards of Practice. page 6, 2006
Root canal obturation materials must be proven to be biocompatible. For example, the use of paraformaldehyde containing materials is below the standard of care for endodontic treatment. |
| March 3, 2008 |
Canada |
Health Canada(equivalent to US FDA) |
Email with letter from Roland Rotter, Director, Medical Devices Bureau
This is in response to your email of March 3, 2008 requesting further information on Sargenti paste for use in dental procedures in Canada.
Since Sargenti Paste would most likely be considered to be a Class III medical device here in Canada, the manufacturer would require a Class III medical device license in order to legally sell it in Canada. Upon search through our database of licensed devices, Sargenti Paste was not found and therefore cannot be sold legally in Canada (assuming a Class III classification). Please not that you can visit www.mdall.ca in order to search through a database of all the licensed Class II, III and IV medical devices in Canada. |
| October/November 2004, Dispatch Newsletter |
Canada |
Canadian Royal College of Dental Surgeons of Ontario |
Link - (page 28).
Members are reminded of the College’s
position that the use of paraformaldehyde containing
materials in root canal
therapy of permanent teeth is not a
standard of practice in this province. Accordingly, such materials must not be
used.
Members should also be aware that N2
is not authorized for sale in Canada
under Health Canada’s medical devices
regulations. |
| June 18, 2008 11:38 AM |
Canada |
Provincial Dental Board of Nova Scotia, Halifax NS |
Email from the Administrative Assistant, Office of the Registrar.
The Sargenti Paste is not an approved treatment product in NS. The same goes for other paraformaldehyde products. |
| June 12, 2008 1:08 PM |
Canada |
Canadian Dental Association
(equivalent to American Dental Assoc) |
Email with a statement from Dr Benoit Soucy, the Director of Membership and Professional services at the Canadian Dental Association.
The use of paraformaldehyde containing obturating materials in endodontics is an old controversy that will not go away, in spite of the accumulation of scientific evidence.
The hope is that pastes containing 4% paraformadehyde or paraformaldehyde derivatives would allow for the provision of endodontic treatment in a safe, simplified fashion. It has resulted in the introduction of a number of products based on the original recipe concocted by Dr. Sargenti in the 1950s under names such as N2 , Endomethosone and AH56.
The problem is that when it works, the Sargenti the technique works very well but when it does not, consequences are dramatic. The inescapable conclusion is that the risk is not worth the benefit and the use of paraformaldehyde containing pastes for endodontic purposes cannot be recommended
The evidence on paraformaldehyde is very well summarized in “Mishaps and serious complications in endodontic obturation” by ALAN H. GLUSKIN published in Endodontic Topics, Volume 12, Issue 1, Page 52-70, Nov 2005. For your convenience, I have pasted the relevant excerpt below.
Paraformaldehyde:
The use of paraformaldehyde pastes depends on the acceptance of concepts and therapies related to the principles of mummification and fixation of pulp tissue (45). In 1959, Sargenti and Richter introduced a method for endodontic therapy that included filling the root canal system with a paraformaldehyde paste (N2). Sargenti and other proponents for a number of paraformaldehyde paste formulations have touted the consistent antimicrobial activity of the paste when used in endodontic therapy (46). Although traditional zinc oxide and eugenol sealers are used in conjunction with solid core materials such as gutta-percha, N2, RC2B, endomethosone, and other paraformaldehyde paste formulations are recommended as the sole-filling material, greatly increasing the volume of material used in the canal system. Thus, absorbability and toxicity are serious considerations with paraformaldehyde pastes. In a large number of reports published regarding paresthesia and other complications of the inferior alveolar nerve following penetration of root canal filling material into the mandibular canal, in most cases, damage to the nerve was specifically attributed to the highly irritating components of various paraformaldehyde pastes (47–53). Brodin (54) and other investigators (36, 55–59), have experimentally and convincingly demonstrated the neurotoxicity of these paraformadehyde compounds. Furthermore, Brodin et al. (60) have shown that N2, among other root-filling materials with paraformaldehyde as a component, produced permanent disruption of nerve conduction in vitro. Others have demonstrated the systemic distribution of radioactively labeled paraformaldehyde incorporated within formocresol in pulpotomized dogs (61). Disintegration products were found in periapical and periodontal tissues remote from the pulpal wound site. The radiolabeled paraformaldehyde was additionally found in blood, regional lymph nodes, kidney and liver. It had been recognized early on by researchers that every effort should be made to confine these materials to the canal (49, 55–57), as more and more clinical reports of extreme complications were published (36, 50, 53, 62).
Because of the higher risks associated with paraformaldehyde-containing endodontic materials, the use of N2 or similar type pastes are contraindicated as permanent injury risk is substantially less with traditional-filling materials. When a safer, less hazardous alternative therapy exists, it is unreasonable to elect an unsafe methodology. This fact is highly relevant because it is contrary to patient safety to require an individual to assume inherently more dangerous treatment risks that are reasonably avoidable, with safer and more predictable methodologies.
In a second email from Public Information Coordinator, dated 7/21/08. the CDA stated -
Thank you for contacting the Canadian Dental Association (CDA). I sincerely apologize for the delay in my response and I thank you for your patience.
CDA answers general inquiries about oral health care and dentistry, but does not provide research information, advice related to individual dental problems, conditions, diagnoses or proposed treatments. Regrettably, CDA does not have a position regarding Sargenti paste as we do not regulate dental materials.
|
Current on website
|
|
European Society of Endodontology
*NEW* |
Quality guidelines for endodontic treatment: consensus report of the European Society of Endodotology, International Endodontic Journal, 39, 921-930, 2006, pg 926.
"The root canal filling should consist of a (semi-) solid
material in combination with a root canal sealer to fill
the voids between the (semi-) solid material and root
canal wall. Sealers containing organic materials such
as aldehydes are not recommended."
The countries below are members of the European Society of Endodonology, which does not recommend the use of Sargenti Paste and similar type materials. The perils of Sargenti paste are known internationally.
http://www.e-s-e.org/cms/index.php?article_id=36&clang=0
|
Wed, 16 Jul 2008 18:25:55
|
India |
Indian Endodontic Society |
As of Today, the organisation, Indian Endodontic Society, position on use of Sargenti Paste/Cement or any other Paraformaldehyde containing material is *STRICT NO *in the practise of Dentistry in India. |
August 22, 2008
2:49 AM
|
Mexico |
Mexican Dental Association |
According to a Mexican endodontist, THIS PASTE WAS USED 30 YEARS AGO BUT THE MEXICAN DENTAL ASSOCIATION CANCEL[LED] THE USE OF IT BECAUSE [OF] VERY DANGEROUS SIDES EFECTS.
|
January 23, 2009
*NEW* |
Poland |
National Medicines Institute, Medical Devices Department, Warsaw, Poland |
|
Monday, November 03, 2008 4:30 AM
|
Portugal |
INFARMED - National Authority of Medicines and Health Products, I.P. |
For medical devices there is no specific limitation or restriction regarding the use of formaldehyde and paraformaldehyde. However, during the medical devices manufacture, the risk and the benefit have to be analysed, to take into account all risk factors including toxicity to human body.
Please be also informed that the products abridged in the definition “any instrument, apparatus, equipment, material or other article, used separately or jointly, including logical supports for its functioning, aimed by the manufacturer to be used in human beings for purposes of:
• diagnosis, prevention, monitoring, treatment or palliation of a disease;
• diagnosis, monitoring, treatment, palliation or compensation of an injury or deficiency;
• study, substitution or alteration of the anatomy or of a physiological process;
• conception control and of which the main claimed effect in human body is not attained by pharmacological, immunologic or metabolic means, although its function may be supported by those means.”, are considered medical devices.
If the [Sargenti] Paste is used to fulfil the tooth canal, this product has to be classified as medical device. Any Distributor of Non-active Medical Devices that operates within the Portuguese territory must also notify INFARMED of all the medical devices they distribute. So far this product has not been notified to Infarmed as a medical device. |
Current on website
|
Singapore |
Singapore Society of Endodontists |
|
| 1986 |
Sweden
|
Swedish Health Authorities |
K. U. B. ALLARD (1986) International Endodontic Journal 19 (4) , 205–208 doi:10.1111/j.1365-2591.1986.tb00479.x
Paraesthesia—a consequence of a controversial root-filling material? A case report
Summary. This is a report of a case where a patient suffered paraesthesia following root filling of her lower left second molar. The Swedish health authorities considered that as a formaldehyde containing root filling cement had been used, the dentist had not worked in accordance with science and proven experience. |
Current on website |
Sweden
|
Swedish National Board of Health and Welfare
Endodontiska material,
Publication dated Feb 22, 2008 |
English Translation -
Root fillings material governed, as other dental materials, the European directive on medical devices. Products Monday Tuesday authorities have not been selling in Scandinavia, now with the CE mark. This also applies to the N2, a zink oxide eugenol cement with the addition of para-formaldehyde. The material, as such, has now crossed the legal framework of the EU, but the arguments used against its use earlier, remains relevant today. Formaldehyde is strongly sensitising and a possible carcinogen and N2 are marketed together with a treatment that is contrary to generally accepted principles of modern endodontin. |
July 30, 2008
*NEWLY POSTED* |
Switzerland |
|
Home of Dr. Sargenti, inventor of this material, follows the guidelines of the ESE European Society of Endodontology, which recommends against the use of formaldehyde type formulations. The European position is -
"The root canal filling should consist of a (semi-) solid
material in combination with a root canal sealer to fill
the voids between the (semi-) solid material and root
canal wall. Sealers containing organic materials such
as aldehydes are not recommended." |
August 08, 2008 10:09 PM
|
Thailand |
Endodontic Society of Thailand |
We don't use that [Sargenti Paste or other paraformaldehyde root canal materials] at all. |
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Injured patients should file an adverse event report with the FDA.
Absent
reports from the public, the FDA will not realize the extent
of the dangers
of Sargent Paste. Click here to file report. Also ask
your doctor to file a
report on your behalf. Since reports are
voluntary over 90% of adverse events go unreported.
