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Biocomp Factoid 3

Biocomp Factoid 3

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Published by: moffittaj on Apr 01, 2011
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Charles F. Cox, DMD, PhDDirector, Research & DevelopmentPhoenix Dental Inc. Fenton, Michigan1
BIOCOMPATIBILITY OF DENTAL AGENTS:A SERIES OF VI FACT
OIDS 
 
PART-I:
DENTAL BIOCOMPATIBILITY
A HISTORICAL PERSPECTIVE
PART-II:
WHICH CAME FIRST?
 
IN VITRO 
OR
IN VIVO 
BIOCOMPATIBILITY ANALYSIS
PART-III:
IN VIVO 
BIOCOMPATIBILITY ANALYSIS
PART-IV
:
IN VITRO 
BIOCOMPATIBILITY ANALYSIS
PART-V:
WHICH BIOCOMPATIBILITY TEST IS MOST IMPORTANT ?
PART-VI:
A BACTERIOMETIC SEAL IS THE REAL DEAL
PART-V:
WHICH BIOCOMPATIBILITY TEST IS MOST IMPORTANT ?
N
ow that you’ve read FACT
OIDS 
 
#
Ithru
#
IV, you may think that the answer is
simple. But, if you’ve followed the
chronological comparison of
in vitro 
versus
in vivo 
 testing, you may realize that no simple answer has yet presented itself
a properscientific answer for biocompatibility testing is simply not easily reported by a simple yesor no response.A number of
in vivo 
animal & human usage studies (Kakahashi 1968, Brännström1968, Bergenholtz 1978, Cox et al 1982,1984,1987, 1992) each demonstrated
beyond a doubt
that certain bacteria & their toxins can easily infiltrate into enamellamella & restorative channels & rapidly penetrate down to the EDJ. From this point,the bacteria & toxins can easily spread along the EDJ interface, where they penetrateinto & through the dentine tubules. From this point, they may initiate a low-gradeirritation response to the odontoblast cells, whereby these cells may respond bydepositing a thin layer of
reactionary 
dentine. However, if the insult persists as achronic effect, the primary odontoblasts may die
whereby certain undifferentiated cellsof the pulp stroma may respond to form newodontoblast
oid 
cells that then deposit anew layer of
reparative 
dentine directly adjacent to the secondary dentine. However, ifthe bacterial insult is persistent, it may easily cause pulp inflammation & regional pulpnecrosis (Van Hassell). Such dynamic factors of microleakage & bacteria are extremelydifficult to control & even more so, they are difficult to simulate within
in vitro 
bench toptests
the ISO committee is still waiting for such well controlled &
in vitro 
tests to be
repeated by ―certified research laboratories‖.
 Lets now consider some additional research publications to allow you to make thedecision for yourself:
1
)
In vivo 
research data in dog teeth were first published in the1936 Brit Dent Jour by Dr. Manley of Birmingham, England. He reported that the
 
Charles F. Cox, DMD, PhDDirector, Research & DevelopmentPhoenix Dental Inc. Fenton, Michigan2
H
3
PO
4
component of silicate cement was the toxic factor to vital canine dental pulps.
2
)It was 2-decades later that
in vitro 
tissue culture tests were first published on silver-tindental amalgam by Dr. Kawahara & colleagues from Osaka University in 1955.
3
) In1968, Dr. Brännström demonstrated in controlled human studies, that silicate cementwas non-toxic to vital pulp cells
bacteria were the causative agents for inflammationthrough microleakage along the restorative interface.
4
) In 1977
after years ofpersonal efforts with colleagues
Dr. William Cotton organized the 1
st
IADR PBGSymposium in Copenhagen, which strongly advocated for the creation of harmonizedbiocompatibility standards
he was 1
st
to move towards harmonization ofbiocompatibility testing.
5
) After years of meetings the ISO committee published their1
st
Book of Harmonized Biocompatibility testing standards in 1999.
6
) In 2009, the ISOcommittee published revised testing standards that serve as suggested standards,
which may be chosen for evaluation by the ―developing group‖ for biocompatibility
validation.ARE TOXIC AGENTS PRESENT IN TODAYS DENTAL RESTORATIVE AGENTS?Today, the fact remains. There are certain agents that are minor & majorcomponents of restorative dental systems that range from irritational, mutagenic,carcinogenic & toxic to vital human tissues. For instance, research publications reportthat the toxic chemistry of formalin (OSHA Tech guide 2006),
aldehydes (O’Brien et al.
2005), glutaraldehyde (Sano et al. 2005), formocresol (Block 2010), phenol (Conning1970), hydroxy ethyl methacrylates (HEMA), (Mathias et al. 2006), bis-phenyl-A (BPA)(FDA 2010), & ketones (Breeze 1984); are
known irritants
that range from mild-to-toxic within the International Medical & Dental profession (Autian 1972, 1974).
Isn’t, it somewhat curious that due to that
rather infamous grandfather clausethat
still lingers in the dental industry since the 1950’s e
ra, that the dental profession is stillable to continue to employ many of these irritational & toxic agents as a minor
component of ―newly developed‖ dental products. And, in addition to the various
chemicals, certain metals (nickel, cadmium, zinc, copper) that are commonly found inmany cosmetics also are known to cause initial sensitizing reactions to humans. In1999, Yamanaka reported more intense irritational reactions to human dentine & vitalpulp tissues! Again, even with the current continued ISO acceptance of thesegrandfathered, yet known irritating dental products, many worldwide dental agenciescontinue to permit the clinical use of these agents
even though some are classified as
 
Charles F. Cox, DMD, PhDDirector, Research & DevelopmentPhoenix Dental Inc. Fenton, Michigan3
germicidal (glutaraldehyde, Sano 2005). In addition, studies have documented thathigh concentrations of alcohols, aldehydes & acetone may rapidly dehydrate &denature vital cells, collagen fibers & other proteins especially when improperly placedby the clinician. Today, there still remains on the commercial dental marketplace,endodontic & pædiatric restorative agents that contain lead, formaldehyde &glutaraldehyde, which are known irritants & are potentially toxic, not only to the patientbut more importantly to all office personnel who work in the clinic environment on adaily basis.WE NOW POSE AN APPARENT QUESTION: CAN
IN VITRO 
RESEARCHERS WHOOFTEN REPRESENT VARIOUS COMPANIES INTERESTS
HAVE IT BOTH WAYS ?SHOULD THEY BE ABLE TO CHOOSE THEIR OWN FAVORITE TEST ?
As we’ve reached this point, we can now understand
that the ISO
10993-5-2009committee
in vitro 
tests recommendationsare only suggestions. They only serve as the
first biocompatibility ―test gate‖, especially when a new dental restorative product or 
device is developed for use in the oral cavity. Once the developing group has passedtheir own personally chosen
in vitro 
biocompatibility test
they can then move to thenext
in vivo 
biocompatibility-testing gate
again an animal system of their choice.Animal tests involve the surgical placement of the agent into the connective tissues ofthe tissues of rats or rabbits for certain periods of time along with positive & negativecontrol agents such as ZnOE, silicate or ZnPh cements for evaluation of theirhistological responses.Still, we are now confronted by the fact that initial
in vitro 
tests are not completelyreliable to define a possible false positive or a false-negative test outcome. Forinstance, if you challenge those same
in vitro 
research laboratories who adhere to their
―own
 
suggested‖
in vitro 
test & then ask them if they have routinely employed a knowntoxic control agent e.g. glutaraldehyde in their system, they often respond that they donot concern themselves with such a control test
especially since those agent(glutaraldehyde, phenol, acetone, HEMA) have long been grandfathered as legallyacceptable restorative dental agents. If you ask those same
in vitro 
researchers who sit
on today’s Pulp Biology committees that discuss & define testing models & then
challenge them with the critical issue of bacterial infection use in their own
in vitro 
 
system, they quickly respond they ―are only required to follow the suggested BS EN

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