NovaMin®:
The NovaMin Technology was developed by
Dr. Len Litkowski and Dr. Gary Hack at the Department
of Restorative Dentistry at the University of
Maryland and by Dr. David Greenspan at NovaMin
Technology Inc. There are currently 5
products on the market that include NovaMin:
|
Product: |
Sold By: |
Launched: |
|
SootheRx®-
Dentist Dispensed Take Home Tooth Sensitivity
Therapy System |
OMNII
Oral Pharmaceuticals (West Palm Beach.,
FL) |
October
2004 |
|
DenShield™-
Same as above |
NovaMin
Technology Inc. (through independent
distributors) |
December
2004 |
|
NuCare®
Root Conditioner with NovaMin®-
In-chair product for treatment of sensitivity
post periodontal surgery |
Sunstar-Butler
Co. (Chicago, IL) |
November
2004 |
|
NuCare®
Prophylaxis Paste with NovaMin®-
In-chair
product used during prophylaxis
(tooth cleaning) procedures by your
hygienist
|
Sunstar-Butler
Co. (Chicago, IL) |
March
2005 |
|
Oravive®-
Consumer toothpaste that whitens
and desensitizes teeth (www.oravive.com)
Dr. Collins
Restore Toothpaste
|
NovaMin
Technology Inc. (mainly through internet
sales) |
December
2002 |
NovaMin is made
of synthetic mineral containing sodium, calcium,
phosphorous and silica (sodium calciumphosphosilicate)
which are all elements naturally found in the
body. When NovaMin particles come in contact
with saliva or water, they rapidly release sodium,
calcium and phosphorous ions into the saliva
that are available for remineralization of the
tooth surface. Unlike the other calcium
phosphate technologies, the ions that NovaMin
release form hydroxycarbonate apatite (HCA)
directly, without the intermediate amorphous
calcium phosphate phase detailed above
10. NovaMin particles also attach
to the tooth surface and continue to release
ions and remineralize the tooth surface after
the initial application. These particles
have been shown, in in-vitro studies, to release
ions and transform into HCA for up to two weeks
11. Ultimately these particles
will completely transform into HCA which is
the mineral your teeth and bones are made of.
NovaMin has been
shown, in in-vitro and clinical studies, to
be a significant tubule occluder and desensitizer.
In a number of in-vitro studies NovaMin has
been shown to occlude by over 80%. In
a clinical on tooth hypersensitivity a NovaMin
containing toothpaste (Oravive®) was shown to
decrease sensitivity significantly greater that
a strontium chloride toothpaste which is the
favored tubule occlusion ingredient in Europe
12. In another clinical study
on tooth hypersensitivity a NovaMin containing
toothpaste (SootheRx®) was shown to decrease
sensitivity by 90% which was highly significant
versus placebo 13. In an open
label study on a NovaMin product used to treat
sensitivity post scaling and planning (NuCare®
Root Conditioner), the product was shown to
reduce sensitivity by up to 52 % 24 hours post
procedure. Nearly 80% of the patients
reported significant relief from sensitivity
at the 24-hour post treatment time point
14. NovaMin has also been shown
to have significant anti microbial properties
and can kill up to 99.999% of oral pathogens
associated with periodontal disease and caries
15. In a gingivitis study,
A NovaMin containing toothpaste (Oravive®) was
shown to reduce gingivitis by up to 58% used
twice per day for 6-weeks which is equivalent
to chlorhexadine used 3 times a day for 6-months
16.
NovaMin Technology
Inc. has 510(k) approvals from the FDA on the
above products for the treatment of tooth hypersensitivity.
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About Recaldent®
Recaldent®:
The Recaldent technology was developed by Prof
Eric Reynolds of the University of Melbourne
and supported by the Australian Milk Council.
Recaldent was first
used in Trident Chewing
Gum, introduced in February 2002, and more
recently in GC America’s
MI Paste,
introduced in mid 2004 in the US.
Recaldent
(also referred two as CPP-ACP) is a complex
of casein phosphopeptide (CCP), a protein
found in milk, and amorphous calcium phosphate
(ACP). This complex is said to adhere
to plaque on the tooth surface and release calcium
and phosphorous during a “normal acid challenge”
in the mouth which can then be use for tooth
remineralization 1,2 . Most
of the scientific research conducted on
Recaldent relates
to its anti-caries benefit.
Recaldent has been
shown in several laboratory studies and in one
clinical study to be effective in remineralizing
carious lesions and to interfere with the adhesion
of some bacteria to the tooth surface.
There are no clinical studies available that
address the ability of
Recaldent to reduce
tooth hypersensitivity. The GC America
web site and literature do show a graph of “Inhibition
of Dentin Permeability” which is a measurement
of how effective a material is at occluding
tubules. It is generally believed that
materials which occlude dentinal tubules will
reduce clinical sensitivity 3,4.
In this graph the
MI paste
achieves a 100% reduction in flow immediately
after application but before rinsing and
a 30% reduction in flow only 5 minutes after
rinsing. This data indicates that the
CCP-ACP complex doesn’t strongly adhere to the
dentin surface and is readily rinsing off.
To read more about
Recaldent, Click here!
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to top)
About SensiStat®
SensiStat®:
The SensiStat Technology was developed by
Dr. Israel Kleinberg at the Department of Oral
Biology and Pathology at State University of
New York at Stony Brook. The technology
was first incorporated into Ortek’s Proclude®
desensitizing prophy paste that was launched
in March of 2003 and later in
Denclude®, a dentist
dispensed sensitivity paste for take home use
that was launched in November of 2004.
The SensiStat
technology is made of arginine bicarbonate,
an amino acid complex, and particles of calcium
carbonate, a common abrasive in toothpaste.
The arginine complex is responsible for adhering
the calcium carbonate particles to the dentin
or enamel surface. Although the calcium
carbonate is said to create an “alkaline environment
that react with tubule fluids to further enhance
particle attachment” the research and literature
on SensiStat characterize the calcium carbonate
as “poor solubility” 8. Calcium
carbonate is, in fact, not very soluble and
releases very low levels of calcium into the
oral environment. As a result, the SensiStat
technology does not increase calcium levels
in saliva as significantly as the other calcium
phosphate technologies do to enhance remineralization.
The in vitro data
on the Proclude in-office product indicates
it is an effective tubule occluder and a clinical
study on the Proclude prophy paste indicates
that a 90% reduction in sensitivity was achieved
for up to 28 days in a non-placebo controlled
study 8,. A non placebo controlled
clinical study on sensitivity reduction for
the Proclude in-office product resulted in significant
reduction of tooth sensitivity 9.
Although the Ortek website claims that a clinical
study of the Denclude
take-home product resulted in a 60% reduction
in sensitivity, no clinical data has been published
that details this study. Ortek does have 510(k)
approval from the FDA on both the Proclude and
Denclude products
for the treatment of tooth hypersensitivity.
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to top)
About
ACP (Amorphous
Calcium Phosphate)
Amorphous Calcium Phosphate
(ACP): The ACP technology was
developed by Dr. Ming S. Tung at the American
Dental Research Associations
Paffenbarger Research
Center. The technology was first incorporated
into a consumer toothpaste product called Enamelon
that was launched in 1999 but failed in the
market place as it competed directly with consumer
giants like Procter and Gamble and Colgate Palmolive.
The technology was reintroduced in the
Enamel
Care toothpaste brand by Church & Dwight
(the Arm & Hammer folks) in mid 2004.
The
ACP technology requires a two phase delivery
system to keep the calcium and phosphorous components
from reacting with each other before use (a
dual compartment tube is used for
Enamel
Care toothpaste). The current sources
of calcium and phosphorous are two salts, calcium
sulfate and dipotassium phosphate. When
the two salts are mixed, they rapidly form amorphous
calcium phosphate (ACP) that can precipitate
onto the tooth surface. This precipitated
ACP can then readily dissolve into the saliva
and can be available for tooth remineralization
5.
Arm & Hammer
claims the toothpaste is the only one with `liquid
calcium' and that it “fills the tooth surface
and restores luster”,
which are cosmetic claims and do not require
approval from the FDA. The “fights cavities”
claim is associated with the fluoride in the
toothpaste.
The
scientific research on ACP has addressed both
the anti caries and desensitization potential
of the technology. Although there has
been a significant amount of in vitro and some
clinical studies conducted by the Paffenbarger
Institute on a variety of two-phase ACP systems,
there is limited clinical data available for
the Enamel
Care toothpaste product. The current
product claims are associated with increased
gloss of the tooth surface. A recent clinical
study on the product claims a “23.4% increase
in tooth gloss and a 13.7 % decrease in tooth
roughness” 6. A recent study
on dentin permeability indicated that “successive
treatments of dentin with dual-phase calcium-containing
toothpastes can progressively reduce dentin
permeability by surface deposition of mineral”
7. There are no clinical studies
that support the use of
Enamel
Care toothpaste for reducing tooth hypersensitivity
and there are no FDA approvals for tooth desensitization
for the Enamel Care product at this time.
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to top)
More detailed information
on the above technologies can be found at the following
websites:
References:
-
Reynolds,
EC. “Remineralization of enamel subsurface
lesions by casein phosphopeptide – stabilized
calcium phosphate solutions”. J Dent
Res. 1997 Sep; 76(9):1587-95.
-
Shen P, Cai
F, Nowicki A, Vincent J, Reynolds, EC. “Remineralization
of enamel subsurface lesions by sugar-free
chewing gum containing casein phosphopeptide
–amorphous calcium phosphate”. J Dent Res.
2001 Dec; 80 (12): 2066-70.
-
Brännström
M, Astrom A. The hydrodynamics of the dentine;
its possible relationship to dentinal pain.
Int Dent J. 1972 Jun;22(2):219-27.
-
Orchardson
R, Gillam DG. The efficacy of potassium
salts as agents for treating dentin hypersensitivity.
J Orofac Pain. 2000 Winter;14(1):9-19.
-
C.A Munoz,
J. Stephens, A. Wilson, HM Proskin, A. Ghassemi,
L. Vorwerk, and T. Winston, Loma Linda University,
Howard M. Proskin & Assoc., Church & Dwight,
“Tooth surface restoration by a bicarbonate
– dentifrice containing calcium and phosphate”.
Abstract 2115.
-
A. Ghassemi,
T. Winston, A. Charig, L.Litkowski, K. Quinlan,
M. Flickinger, F. Saunders, and L.Vorwerk,
Church & Dwight, Univ. of Maryland. “Intra-Oral
evaluation of a two-phase containing bicarbonate
toothpaste”. Abstract 3597.
-
A. Charig,
A. Winston, and S. Gupta, Church & Dwight.
“Dentin permeability reduction due to two-phase
calcium-containing toothpaste”. Abstract
0954.
-
Ortek Website-www.ortekinc.com
-
M.S. Wolff,
and I. Kleinberg, “Duration of reduction
of dentinal hypersensitivity after prophylaxis
with a calcium/arginine bicarbonate carbonate
prophy paste”. Journal of Dent. Res.
2003; 82: Special Issue A, Abstract #0180
(AADR 2003).
-
Litkowski
LJ, Hack GD, Sheaffer HB, Greenspan DC,
“Occlusion of Dentin Tubules by 45S5 Bioglass®”
1997, Bioceramics, Vol 10
-
Jennings DT,
McKenzie KM, Greenspan DC, Clark AE. “Quantitative
Analysis of Tubule Occlusion Using NovaMin
(Calcium Sodium Phosphosilicate)” Journal
of Dental Research (#2416), Vol. 83 A March
2004
-
Report on
file at NovaMin Technology Inc. March 2004,
currently being prepared for publication.
-
Report on
file at NovaMin Technology Inc. May 2004,
currently being prepared for publication
-
Report on
file at NovaMin Technology Inc. February
2005, currently being prepared for publication
-
D.C. Greenspan,
A. Clark, and G.P. LaTorre, NovaMin Technology,
Inc., University of Florida, “In-Vitro antimicrobial
properties of a bioactive glass (NovaMin)
containing dentifrice”. Abstract 1586.
-
Report on
file at NovaMin Technology Inc. March 2005,
currently being prepared for publication
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to top)
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