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Clinical Studies on
Ardox-X® Technology
1997
1998
1998
1998
1999
Phase I
Phase I
Phase I
Phase II
Phase II
Location
Notox (NL)
Loma Linda
University
(USA)
Loma Linda
University
(USA)
Queen’s Univ.
Belfast (North
Ireland)
Royal London
School of
Medicine and
Dentistry (UK)
Purpose
Evaluation of
the mutagenic
activity of
Ardox-X®
toothpaste
Free radical
generation
study
Cytotoxicity
and
mutagenicity
study on
Ardox-X®
whiteninggel
Chemical
mechanism
analysis
Efficacy,
Chemical
model studies
of neutralising
oral malodour
by Ardox-X®
whitening gel
Doctor
Leading Trial/
Department
Mr Verspeek
Rip,
Microlaboratory
Prof. Y. Li,
Department of
Chemistry,
Prof. Y. Li,
Department of
Chemistry
Prof. E.
Lynch/Dr M.
Grootveld,
Medicine and
Dentistry
Department
Prof. E.
Lynch/Dr M.
Grootveld/
Medicine &
Dentistry
Department
Compound
Tested
[Ardox-X ®] =
0,5 eq;
toothpaste
Ardox-X®
Whitening gel
Ardox-X®
Whitening gel
Several
Ardox-X®
technologies
Several
Ardox-X®
technologies
Results
Ardox-X®
toothpaste is
not mutagenic
in the
salmonella
typhirium
reverse
mutation assay
and in the
Escherichia
coli reverse
mutation assay
The whitening
gel does not
contain or
produce
hydrogen
peroxide and it
generates only
a neglible
amount of
harmful free
radicals
The whitening
gel is not
mutagenic and
does not
impose risks
associated with
the cytotoxity
The study
revealed the
mechanistic
action of the
Ardox-X®
technology in
revealing the
complex
structure and
reaction
adducts
Chemical
structure of
Ardox-X®
whitening gel
indicates
potential
efficacy
against oral
malodour
cysteine and
methionine
species
Study
Number
Study nr. 97006
Study nr. 98004
Study nr. 98006
Study nr. 98003
Study nr. 02005, 02-006
Date of Trial
Type of
Clinical
Trial/Study
Clinical Studies on
Ardox-X® Technology
Date of Trial
2001-2004
2002
2002
2002
2003
Type of
Clinical
Trial/Study
Phase II, III
Phase I
Phase II
Phase II
Phase I
Location
Red Cross
Hospital,
Beverwijk (NL)
University of
Leiden (NL)
Amsterdam
Medical Centre
(NL)
University of
Nijmegen
(NL)
Mubio products
BV (NL)
Purpose
Treatment of
Ardox-X® on
patients with
chronic ulcers
The effect of
Ardox-X®
toothgel and
skin gel on
viral DNA
Efficacy on
Ardox-X®
onychomycosis
gel on 19
therapy resistant
patients on
Lamisil
In vitro
activity of
Ardox-X®
against
clinical fungi
Effect of
oxygen donors
on DNA
damage
Doctor
Leading Trial/
Department
Prof. Dr. R.
Kreis,
Department of
Woundcare
Dr Salimans/
M. Silvius
Laboratories
Dr Meinardi,
Dermatology
P. Verwij, M.
Lotgerink,
Department
of medical
microbiology
Prof. F.
Ramaekers,
the University
of Maastricht
Compound
Tested
[Ardox-X®] = 4
eq; woundgel
[Ardox-X®] =
0,5 eq
[Ardox-X®] = 13
eq
Several
Ardox-X®
formulations
Ardox-X®
Whitening gel
Results
80% of treated
open wounds
showed faster
healing
Ardox-X® does
not damage
the DNA of the
herpes simplex
virus
After application
of Ardox-X® nail
changes among
nineteen
onychomicosis
therapy resistant
patients on
Lamisil reverted
Ardox-X®
showed invitro activity
against all
yeast and
molds;
Ardox-X® has
potential to
be used as
topical
treatments
for superficial
mycoses
The whitening
gel shows very
limited DNA
damage in
cells when
treated with
high
concentrated
Ardox-X® gel
Study
Number
Study nr. 03003
Study nr. 02001
Study nr. 02-027
Study nr. 02008
Study nr. 03008
Clinical Studies on
Ardox-X® Technology
2003
2004
2005
2005
Phase II
Phase II
Phase II
Phase III
Location
Schulke & Mayr
(D)
Schulke & Mayr
(D)
University of
Aberdeen (UK)
TNO, Leiden
(NL)
Purpose
Challenge test
Challenge test
In vitro antifungal test
Study of
Angiogenese: invivo application
in mice
Doctor Leading
Trial/
Department
Matthew Daulby,
Microbiology
laboratory
Matthew Daulby,
Microbiology
laboratory
Prof. F.C.
Odds/Inst. For
Med. Sciences
Pieter Koolwijk,
Ph. D.
Compound
Tested
Several
Ardox-X ®
concentrations
Several
Ardox-X®
concentrations
[Ardox-X®] = 20
eq; onychomycosis gel
Several
Ardox-X®
concentrations
Results
Ardox-X®
products showed
broad antibacterial
properties
Parts of the
technology
showed antibacterial
properties, but
only the
complete
technology
exhibits a full
anti-bacterial
spectrum
Ardox-X® gel has
a good clinical
potential to be
used as a topical
anti-fungal
agent. The
complex showed
efficacy against
a range of fungi
associated with
skin and nail
infections
Ardox-X®
technology
stimulates
angiogenesis
and thus
woundhealing
Study Number
Study nr. 03-010
Study nr. 04-001
Study nr. 05-001
and 05-002
Study nr. 05-006
Date of Trial
Type of
Clinical
Trial/Study
Clinical Studies on Ardox-X® for
Periodontitis
Date of Trial
1997
1997
2002
Type of Clinical
Trial/Study
Phase II, III
Phase II
Phase II
Location
Nijmegen University,
Nijmegen (NL)
Nijmegen University,
Nijmegen (NL)
Dentres Benelux,
Nijmegen (NL)
Purpose
To evaluate the
effectiveness of
Ardox-X® toothpaste
on periodontal bacteria
To evaluate
effectiveness of
Ardox-X® toothpaste on
Streptococcus mutans
To compare four
toothpastes for their
anti-plaque/ antigingivitis potential and
reducing periodontal
bacteria
Application
Process
Brushing teeth with
Ardox-X® based
toothpaste
Brushing teeth with
Ardox-X® based
toothpaste
Brushing teeth with
Ardox-X® based
toothpaste
Doctor Leading
Trial
Dr. Van den Bosch
Dr. Van den Bosch
Prof. Dr. K.G. Konig
Number of
Patients
55
31
206
Results
a) Bacteria causing
periodontitis almost
completely eliminated;
b) Bleeding of the
gums stopped; c)
gingiva looks healthy.
Streptococcus Mutans
is measurably reduced
(69,2%) after 1 week of
brushing with tooth-gel
a) Ardox-X®
technology has antigingivitis potential;
b) Adverse effect:
Ardox-X® toothpaste
(2%), Colgate total
(27%), Signal (30%),
Mentadent (67%);
c) Highest bleeding
index for Ardox-X®;
d) Lowest increase of
salivary levels of
mutans streptococci
Trial Design
Double blind
Double blind
Double blind
Study Protocol
According to university
protocol
According to university
protocols
According to clinical
trial protocol
Clinical Studies on Ardox-X® for
Periodontitis
Date of Trial
2007-2008
2009-2010 - PENDING TRIAL
Type of Clinical
Trial/Study
Phase II, III
Phase II, III
Location
Dental clinic, Venlo (NL)
Nijmegen University, Nijmegen
(NL)
Acta Amsterdam (NL)
Purpose
To evaluate the effectiveness of
the Ardox-X® adjunctive topical
application in reducing
periodontitis
a) To evaluate the in-vitro
efficacy of Ardox-X® gel on
periodontal and root caries
associated pathogens
b) Double blind placebo
controlled clinical test on
periodontal bacteria in human
Application
Process
Administration of Ardox-X® gel
into the pocket
In vitro testing on agar plates
Doctor Leading
Trial
Dr Berendsen, Dr. G.J. Meijer,
DMD, PhD
Prof W. Beertsen
Dr W A. Van der Rijden
M. Fernandez
Number of
Patients
33
To be determined after
completion of the in-vitro test
results
Results
a) After 3 months, a 66%
reduction of pocket depth in
male and 49% in female;
b) Age (40-44 yr) showed
greatest improvement;
c) No difference in smokers vs.
non smokers;
d) Gold standard CHX value
showed 4,2% reduction
To be determined
Case study, regular use
In vitro testing; lab scale
In-vivo double blind patient
testing
According to dental clinic
protocol
Will be conducted according to
university protocol
Trial Design
Study Protocol
Administration of Ardox-X® gel
into the periodontal pocket
Clinical Studies on Ardox-X® for
Peri-Implantitis
Date of Trial
2005-2007
Type of Clinical
Trial/Study
Phase II, III, IV
Location
Rijnstate Hospital Arnhem
(NL)
Purpose
To evaluate the
effectiveness of the
Ardox-X® adjunctive topical
application in peri-implantatis
Application Process
Oral administration of
Ardox-X® gel
Doctor Leading Trial
Dr. P. Blijdorp, Dr. G.J.
Meijer, DMD, PhD
Number of Patients
34
Results
a) Significant tissue recovery
after 3 and 6 weeks;
b) After 3 months 75% of the
peri-implantitis cases were
cured with definite reosseointegration in 15% of
the implants;
c) After 6 months reosseointegration of 3mm in
15% of the cases and of 2
mm in 60% of the cases
Trial Design
Study Protocol
Case study, regular hospital
use
According to hospital clinic
protocol
Before treatment with Ardox-X®:
severe redness of the gingiva,
infection, poor woundhealing.
After treatment with Ardox-X®:
healthier gingiva, reduced redness,
new tissue growth around implant.
Clinical Studies on Ardox-X® for
Oral Mucositis
Date of Trial
2002-2005
2000-2007
Type of Clinical
Trial/Study
Phase II, III
Phase II, III
Location
Rijnstate Hospital,
Arnhem (NL)
Rijnstate Hospital,
Arnhem (NL)
Various dental clinics
(NL)
Purpose
To evaluate the
effectiveness of
Ardox-X® towards
oral mucositis.
To evaluate the
effectiveness of
Ardox-X® towards
oral mucositis.
Application
Process
oral rinse
oral rinse
Doctor Leading
Trial
Dr. P. Blijdorp
Dr. P. Blijdorp
Number of
Patients
155
220
Results
a) Erosive forms of
oral mucositis: relief
of symptoms after 1
week in 90% of cases
b) Hyperkeratotic
forms: relief of
symptoms after 6
weeks in 75% of
cases.
In Hodgkin/nonHodgkin oncology
treatment relief of
symptoms in 80% of
both cases during
cytostatic and
radiation courses.
Oral mucositis symptoms
are significantly reduced
Regular hospital use
Regular hospital use
In feasibility studies with
Ardox-X ® more than 80%
of patients experienced a
relief of symptoms.
According to hospital
clinic protocol
According to hospital
clinic protocol
Trial Design
Study Protocol
Patient with oral mucositis:
persistent harmful bacteria
with painful lesions.
Various dental
surgeons