Download Etiology of Caries 2004

CAMBRAtm a New System
CAMBRA, LLC.
(CONFIDENTIAL)
V. Kim Kutsch, DMD.
Doug A. Young, DDS. MS.
The Problem
Dental caries is a bacterial
infection that is expressed by
symptoms (cavities), for which
there is no system for the
screening, risk assessment,
diagnosis and treatment of.
Goal
To create a plug and play
system to accurately screen,
assess, diagnose and treat the
bacterial infections that causes
dental caries.
Etiology of Caries 2004
• Caries: an infectious microbiological
disease of the teeth that results in
localized dissolution and destruction of
calcified tissues. It is a bacterial infection
of Mutans streptococci and Lactobacilli.
Mutans streptococci
A pandemic infection in
humans most strongly
associated with the onset of
enamel caries.
CM Sturdevant 1995
Classifies caries into pit and fissure,
smooth surface and root surface
lesions with different rates of
progression and morphology. Pit and
fissure caries have a small site of origin
but a wide base at the DEJ. Initial
cavitation of the fissure walls cannot be
seen on the occlusal surface making
these lesions more difficult to detect.
John Featherstone 2003
The Caries Balance
“It is very useful and constructive clinically to
consider caries in its progression or reversal as
an ongoing and often changing balance between
pathologic factors and protective factors.”
Dr. Steven M Adair
“Dentistry must begin reorienting
its approach to caries from a
primarily surgical approach to a
medical-management approach.
Dental caries is a steady-state
disease with a variable expression
over time. A surgical approach to a
steady-state disease is inefficient,
creating a constant state of playing
“catch-up”.”
Caries Risk Assessment 2004
Risk is defined as the probability that
some harmful event will occur. Caries
risk assessment is the calculation of
of whether new carious lesions will
occur or incipient lesion will develop.
GV Black, 1924
“The idea that dental practice
is purely mechanical and not
dependent upon knowledge of
the pathology of dental caries,
should be abandoned forever.
It is an anomaly of science that
should not continue. It has the
tendency plainly apparent to
make dentists mechanics only.”
JDB Featherstone, 2003
“With so much disease, it is easy
to get caught up in an endless
treatment cycle to “fix” the
problem using traditional
surgical restorative approaches.”
Paradigm Shift
Dental caries as an infectious disease
model involves focusing on treatment
of the entire disease process not just
surgically treating cavities.
“The primary goal of operative
dentistry is to maintain primary
oral health, defined as the absence
of disease of the teeth,
periodontium and mucosa.”
Lutz F, Krejci I. Resin composites
in the post-amalgam age.
Compendium December 1999.
20(12):1138-1148.
Dental Caries is an Infection!
“Dental caries can be
considered an infection,
caused by the colonization
by Mutans Streptococci.”
Martens L, Surmont P,
D’Hauwers R. A decision tree
for the treatment of caries in
posterior teeth. Quintessence
Intl March 1990. 21(3):239-246.
“Dental caries is an infectious and
transmissible disease. Detailed
knowledge regarding the acquisition
and transmission of infectious agents
facilitates a more comprehensive
approach to prevention.”
Berkowitz RJ. Acquisition and
transmission of mutans
streptococci. JCDA February
2003. 31(2):135-138.
“The appearance of mutans
streptococci in the pits and
fissures is usually followed
by caries 6-24 months
later”.
Sturdevant CM. The Art and
Science of Operative Dentistry
Third Ed. 1995, Mosby.
“Caries risk assessment
should be one of the most
important goals of the child’s
initial dental examination.”
Fadvai S. Management of early
childhood caries. General Dentistry
Jan-Feb 2003. 51(1):38-40.
Caries Risk Assessment
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Medical history
Dental history and exam
Homecare habits
Dietary habits
Saliva rate / buffering capacity
CRT score
Medical History
• Medications reducing salivary flow
• Medications with sugar base
• Mental or physical handicaps
Dental History & Exam
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DMF score
Recare visits / last prophy
Fluoride use
Existing active lesions
Plaque index
Homecare Habits
• Brushing/flossing habits
• Fluoride rinses
Dietary Habits
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Timing of sugar intake
Frequency of sugar units
Type of sugar units
Chewing gum
Pepsi generation
“Cola soda consumption
increased from 22.2 gal/yr. in
1970 to 56 gal/yr. In 1999.
The average 12-19 year old
drinks 28 oz/day.”.”
Chase WD. Dentistry takes
a hard look at soft drinks.
Dentistry Today September
2001. 20(9):32.
“This increase in soft drink
consumption has been paralleled
by increasing rates of obesity in
children and reports of rampant
tooth decay.”
Shenkin JD, Heller KH, Warren JJ,
Marshall TA. Soft drink consumption
and caries risk in children and
adolescents. General Dentistry JanFeb 2003. 51(1):30-36.
“Daily between meal
consumption of soft drinks three
or more times a day increases the
risk of dental caries by 179%.”
Ismail AI, Burt BA, Eklund SA. The
cario-genicity of soft drinks in the United
States. JADA 1984. 109:241-245.
Saliva
• Buffering capacity
– pH 5 - 7 is normal
– pH < 5 is low
• Rate of flow:
– < 0.7 ml/minute is high risk
– 0.7 - 1.0 ml/min is moderate risk
– > 1.0 ml/min is low risk/normal
CRTbacteria
• MS, Lactobacilli CFU/ml saliva
– < 105 CFU/ml is low risk/normal
– 105 CFU/ml is moderate risk
– > 105 CFU/ml is high risk
Salivary and tongue
levels of Mutans
Streptococcus correlate
well with plaque levels.
Tanzer JM. Salivary and
plaque microbiology tests
and the management of
dental caries. J Dent Ed.
61:866-874.
Vivadent CRTbacteria
Vivadent Cultura Oven
CRT Materials
CRT Analysis
Low Risk Patient
Not taking medications that affect
saliva, regular check-ups, no
cavitations, good homecare, limited
sugar intake, saliva flow >1 ml/min,
pH 7, CRT < 105 CFU/ml.
Moderate Risk Patient
Not taking medications that affect
saliva, fairly regular check-ups, no
cavitations, average homecare, some
sugar intake, saliva flow 0.7-1.0
ml/min, pH 5-7, CRT 105 CFU/ml.
High Risk Patient
May be taking medications that affect
saliva, infrequent check-ups, at least
1 cavitation, poor homecare, frequent
sugar intake, saliva flow <0.7 ml/min,
pH <5, CRT > 105 CFU/ml.
Extreme Risk Patient
May be taking medications that affect
saliva, no check-ups, several
mandibular anterior cavitations, poor
homecare, frequent sugar intake,
saliva flow <0.5 ml/min, pH <5, CRT
>> 105 CFU/ml.
Treatment Protocols
Classify the patient as low,
moderate, high or extreme risk for
dental caries. Base treatment on
caries risk assessment.
“Antibacterial therapy
must be used to combat
high bacterial challenge.
Preventive factors must
outweigh the
pathological factors.”
Featherstone JD. The
science and prevention of
caries. JADA 2000 July.
131(7):887-99.
“At age 5, the DMF in
the xylitol group was
70% lower than the
fluoride or
chlorhexidine group.”
Isokangas P, Soderling E,
Pienihakkinen K, Alanen P.Occurrence
of dental decay in children after
maternal consumption of xylitol gum. J
Dent Res 2000 Nov. 79(11):1885-9.
“In this study glass ionomer
with fluoride showed superior
antibacterial action compared
to pit and fissure sealant
resins.”
Kozai K, Suzuki J, Okada M, Nagasaka N.
In vitro study of antibacterial activities of
sealants and glass ionomers. ASDC J Dent
Child 2000. Mar/Apr 67(2):117-22, 82-3.
“Iodine is among the most potent
of bactericidal agents. Its effect is
not time dependent; once bacterial
contact is made, its action is
immediately lethal.”
DenBesten P, Berkowitz R. Early
childhood caries: an overview with
reference to our experience in California.
JCDA February 2003. 31(2):139-143.
Recaldent: CPP-ACP
• CPP: Casein Phosphopeptides
– Milk protein
– Protects the ACP component
– Delivery vehicle, very sticky
ACP Amorphous Calcium
Phosphate
Functions:
Remineralization/Desensitization
Fugi Triage – new class of glass
ionomer
• Light initiated chemical
cured
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–
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Absolutely no resin
Highest Fl release
Limit bacterial growth
Ca and Fl from saliva
diffuse through
– Fl and Sr available from
Triage material
– Allows enamel maturation
while protecting
“Long term caries pathogen
suppression is feasible with
current products, can result in
significant caries inhibition.”
Hildebrandt GH, Sparks BS.
Maintaining MS suppression
with xylitol chewing gum. JADA
2000 July. 131(7):909-16.
Low Risk Patient
• Maintain primary oral health
• Counsel patient about risk factors
• Monitor risk factor changes
Moderate Risk
Patient
• Direct counseling to specific risk
factors as appropriate
• Treat bacterial infection
• Monitor infection control until
CRT is < 105 MS CFU/ml saliva
• Fluoride therapy to remineralize
any decalcification areas
High Risk Patient
• Direct counseling at
appropriate risk factors
• Restore cavitated lesions, treat
bacterial infection
• Treat until CRT is < 105 MS
CFU/ml, check monthly
• Monitor CRT annually
Extreme Risk Patient
• Direct counseling at
appropriate risk factors
• Treat bacterial infection
first
• Treat until CRT is < 105
MS CFU/ml, check
monthly
• Then restore cavitated
lesions with GIC
• Monitor CRT annually
Insurance Re-imbursement
• CDT III Codes
– D0415 Bacteriology studies
– D0425 Caries susceptibility test
• CDT IV Codes
– D0415 Bacteriology studies
– D0425 Caries susceptibility test
• Medical Codes CPT
Cariogram Malmo University
Previser Caries/perio Risk
Assessment: www.previser.com
Internet Cariology Sites
http://www.cdafoundation.org
http://www.wcmicrodentistry.com
http://www.db.od.mah.se/car/carhome.html
http://www.dentistry.uic.edu/courses
http:/www.dent.ucla.edu.com
National Institute Health Library
Google>Pubmed or Medline>NIHL
“He needed immediate caries control to
maintain his dentition. However this
would not have left him with sufficient
tooth structure to build on so full
coverage IPS Empress crowns were the
only possible restorative option.”
Myles W. Aesthetic dentistry: it’s more
than meets the eye. Aurum Ceramics
News. Feb 2002. 6(1):8.
“The overall objective of this document is to
provide the basis for a cross-disciplinary
approach among medicine, dentistry,
nursing, and other agencies that affect
dental health to reduce or eradicate dental
caries in children in every county,
community and culture in California by the
year 2010.”
Featherstone JDB, et al. Caries
Management by risk assessment:
consensus statement, April 2002. JCDA
March 2003. 31(3):257-269.
The Solution
CAMBRAtm, a New System
By CAMBRA, LLC
System Components
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Screening Test
Risk Assessment Form
Bacterial Culture
Antimicrobial Treatment
– Therapeutic Rinse
– Daily Maintenance Rinse
Component A: Screening Test
• ATP Bioluminescence
• Non-specific bacterial and somatic ATP levels
RLU’s from mouth at rest, selecting swab for
two teeth surfaces
• Somatic ATP presence
• MS ATP levels?
• Correlation between non-specific ATP levels
and CRT bacterial cultures
• Real time (15 second ) inexpensive test for
identifying high risk from low risk individuals
Hygenia ATP Bioluminescence
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$800 retail? handheld light meter
$1.75 ?retail per swab disposable
15 second real time test results
Identify with high sensitivity and
specificity for high vs. low risk caries
patients
• Needs university based clinical trial
validation UOP with Dr. Doug Young
Market Potential
• Dentistry is 80 B annual industry
• 300,000,000 dental check-ups per year
• Argument could be made as standard of care
for screening test and caries risk assessment to
be performed at each check-up appointment
• Total market size could be 300M tests/year
• Need to establish as standard of care
Strategic Plan First Year
• Beta test with 10-20 clinical trial sites at
Rendezvous complete June 2005
• 300-500 procedures in Beta test
• Introduce to 300 dentists at WCMID
• 3,000-5,000 procedures in Q3 and Q4.
• Introduce at 5 California Dental Schools
• Introduce to all 50 dental schools December
• Introduce to early adopters (6-10,000 dentists)
Component B: Risk Assessment
Form
Clinical Validated CAMBRA Form
Adopted by VKK from
Featherstone
CAMBRA Form
• Updated form weighing high, moderate
and low risk factors
• Clinical validation
• Indicates Bacterial culture for high risk
patients
Component C: Bacterial Culture
Rapid culture for MS
CAMBRAcult
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Rapid culture specific for MS
3-24 hours
Color change indicator?
Validates diagnosis of clinical caries
Identifies individuals for therapeutic
rinse regimen followed by maintenance
rinse
Component D: Therapeutic Oral
Rinse
Active antimicrobial treatment to
eliminate MS infection
CAMBRA Therapeutic Rinse
• Two component rinse for short term
antimicrobial treatment of MS infection
• Sodium Hypochlorite active ingredient
• Additional components include: fluoride
0.5%, polyphenols, xylitol
CAMBRA Maintenance Rinse
• Daily use to prevent MS numbers from
returning to >105 CFU’s
• Single component oral rinses
• Active ingredients: polyphenols, fluoride,
xylitol, anthocyanidins
CAMBRA Decision Tree
Component A
Screening test: positive
negative
Component B
Component C
CAMBRAcult
Positive
CAMBRA Risk Assessment Form
Positive
Negative
Negative
Component D
Therapeutic Rinse
Maintenance Rinse
Component C
CAMBRAcult
Positive
Negative
Recare
Appointment
USA Dental Demographics
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170,000 dentists in USA (primary market)
150,000,000 patients in USA
14 year adoption curve in dentistry
Early adopters account for 6-10,000 dentists
Typical J-curve adoption sequence with
chasm between early adopters and early
majority
Market Potential
• Dentistry is 80 B annual industry
• 300,000,000 dental check-ups per year
• Screening test could be performed at
each re-care appointment
• Bacterial culture could be recommended
in 25% of visits, or 75 M procedures
• Need to establish as standard of care
CAMBRAcult Market Potential
by Dollars
• Dentistry is 80 B annual industry
• 75 M procedures for CAMBRAcult per
year at 6-10 per procedure
• At $6 per procedure = $4.5 M
• At $10 per procedure = $7.5 M
CAMBRAcult Market Potential
by Dentist
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•
•
•
170,000 Dentists in US
30 check-ups per week times 50 weeks per year
255,000,000 dental check-ups per year
Screening test could be performed at each recare appointment
• Bacterial culture could be recommended in
25%, or 65 M procedures
• Procedure will be performed twice on the high
risk patients or 130 M procedures
CAMBRAcult Market Potential
by Patient
• 150,000,000 patients in US (50% of
population) two check-ups per year
• 300,000,000 dental check-ups per year
• Screening test could be performed at each recare appointment
• Bacterial culture could be recommended in
25% of visits, or 75 M procedures
• Procedure will be performed twice on high risk
patients for 150 M procedures
Strategic Plan
• Beta test with 10-20 clinical trial sites at
Rendezvous
• Validate clinical trials at UOP/Young
• Introduce to 300 dentists at WCMID
• Introduce to CAMBRA Coalition, significant
thought leaders, influencers (Featherstone,
Christensen, CRA)
• Introduce at 5 California Dental Schools
• Introduce to all 50 dental schools
• Introduce to early adopters (6-8,000 dentists)
Additional Strategy Issues
• Patent protection for system, trademarks for
CAMBRA
• Short term market strategies around early
adopters
• Establish as standard of care in 5 California
schools, then broaden to all US schools.
• Establish as standard of care in California
• Year two attack foreign markets, AU, NZ,
EEU, dental schools and early adopters
Strategic Plan First Year
• Beta test with 10-20 clinical trial sites at
Rendezvous complete June 2005
• 300-500 procedures in Beta test
• Introduce to 300 dentists at WCMID
• 3,000-5,000 procedures in Q3 and Q4.
• Introduce at 5 California Dental Schools
• Introduce to all 50 dental schools December
• Introduce to early adopters (6-8,000 dentists)
Q1 2006 through DentalTown
Strategic Plan Second Year
• Introduce to early adopters in California
2,000 dentists
• 100 CAMBRAcult procedures per dentist
per year
• 500 Screening swabs per dentist per year
• 200,000 cultures, 1,000,000 screening
swab procedures in Year Two
• At $15 per procedure = $3.0 M retail
Marketing Focus: California
• Legal standard of care since July 2004
• 22,000 dentists in California; 2,000 early
adopters
• Education DVD to market system to dentists in
California
• Support education with programs at major
meeting CDA Anaheim and San Francisco
• Advertise in CDA journal
Dental Schools
• By creating a standard of care issue in the
dental schools: dental students we may be able
to short circuit the 14 year adoption rate
• Need to make standard of care in the mind of
4500 annual dental school graduates
• Still a mission/education sell to the market at
large, needs to be a simplified system that is
plug and play
Initial Kit Components $1,500
Target Retail
• Screening Test: Light meter/200 swabs
• Risk Assessment: Kutsch/CAMBRA form at
low or no charge, electronic format
• Bacterial Culture: Culture oven/12 culture
tubes
• Therapeutic Rinse: 6 patient kits of
Therapeutic Rinse (12 - 8 oz. bottles)
• Maintenance Rinse (12 – 8 oz bottles)
Component Competitors
• Screening Test: none
• Risk Assessment: Featherstone/CAMBRA
Coalition/CDA Foundation at no charge
• Bacterial Culture: Vivadent CRT <1% after 15
years in market
• Therapeutic Rinse: There are no specific rinses
for the treatment and maintenance of dental
caries from a purely antimicrobial standpoint.
• Chlorhexidine, ACT fluoride rinses.
• No complete system
Risks
• Hygenia issues for private label
components, patent issues
• Bacterial culture issues
• Clinical trials on oral rinses
• Inability to convince dental market to
adopt medical approach to treating
caries, vs. the traditional surgical
approach