Bone Grafting Materials and Techniques Update is dry-heat sterilized (3X) to a SAL of 10(-6), ......

Dental Management Coalition Annual Conference Dental Management Coalition Annual Conference July 21, 2008 Port St. Lucie, FloridaJuly 21, 2008 Port St. Lucie, Florida

Bone Grafting and Bone Grafting and Implant Dentistry UpdateImplant Dentistry Update

Jeffrey L. Turchi, DDSJeffrey L. Turchi, DDSDirector of Educational and Clinical Affairs Director of Educational and Clinical Affairs

Senior Product Manager Senior Product Manager J. Morita USAJ. Morita USA

Irvine, CAIrvine, CA

ObjectivesObjectives

Understand the evolution of bone grafting Understand the evolution of bone grafting techniques and materialstechniques and materials

Identify the different types of bone grafts, their Identify the different types of bone grafts, their characteristics, and the benefits/risks of eachcharacteristics, and the benefits/risks of each

Overview of the latest trends in implant hardware Overview of the latest trends in implant hardware and the technology for diagnosis and planningand the technology for diagnosis and planning

My BackgroundMy Background

B.A. HistoryB.A. History-- UCLA UCLA

Teaching Credential ProgramTeaching Credential Program-- CSU Dominguez HillsCSU Dominguez Hills

D.D.S.D.D.S.-- University of the Pacific, AAD SODUniversity of the Pacific, AAD SOD

18 years private practice18 years private practice

3 years with J. Morita USA3 years with J. Morita USA

Member ADA, CDA, OCDS, AO, IADMFRMember ADA, CDA, OCDS, AO, IADMFR

““FamilyFamily”” of dentistsof dentists

MotivationMotivation…………

What is a Bone Graft?What is a Bone Graft?

Historically, bone grafting has consisted of:Historically, bone grafting has consisted of:

A surgical procedure to harvest the A surgical procedure to harvest the patients own bone from a secondary sitepatients own bone from a secondary site

Utilization of an organic or artificial Utilization of an organic or artificial material to replace missing bone material to replace missing bone

Bone GraftingBone Grafting-- A Brief HistoryA Brief History

16681668-- Dutch Surgeon, Job Janszoon van Meekeren:Dutch Surgeon, Job Janszoon van Meekeren:

Described the use of canine bone to repair a cranial wound Described the use of canine bone to repair a cranial wound

Who did it?Who did it?

Did it work?Did it work?

Russian church Russian church

The The ““amazingamazing”” Dr. Van Meekeren???Dr. Van Meekeren???

Thanks, destructive nature of warfare in the 20Thanks, destructive nature of warfare in the 20thth century century

Bone Grafting TodayBone Grafting Today

Surpassed only by blood transfusions as the most Surpassed only by blood transfusions as the most transplanted human tissue transplanted human tissue

77--10 days of antibiotic coverage is routine with 10 days of antibiotic coverage is routine with allall bone grafting techniquesbone grafting techniques

Bone grafting has become a Bone grafting has become a veryvery hot dental topichot dental topic

Bone grafting applicationsBone grafting applications

Socket preservationSocket preservation

Periodontal defectsPeriodontal defects

Third molar extraction sites to support 2Third molar extraction sites to support 2ndnd

molarsmolars

Ridge augmentationRidge augmentation

Defects following cyst removal / apicoectomiesDefects following cyst removal / apicoectomies

Sinus liftsSinus lifts

Distraction osteogenesisDistraction osteogenesis

Nerve repositioningNerve repositioning

IMPLANT DENTISTRY!!!IMPLANT DENTISTRY!!!

Why Preserve the Alveolar Ridge?Why Preserve the Alveolar Ridge?

Bone loss is continuous and inevitable Bone loss is continuous and inevitable

Chewing pressure from roots or implants stimulate bone cells Chewing pressure from roots or implants stimulate bone cells

Alveolar bone in edentulous areas resorbs 0.5 to 1 mm per yearAlveolar bone in edentulous areas resorbs 0.5 to 1 mm per year

Why Preserve the Alveolar Ridge?Why Preserve the Alveolar Ridge?

Dr. Jon Suzuki, Director PostDr. Jon Suzuki, Director Post--Graduate Graduate Periodontics at Temple University:Periodontics at Temple University:

“…“…placing some type of graft material in the placing some type of graft material in the socket following every extraction is rapidly socket following every extraction is rapidly approaching standard of care status.approaching standard of care status.””

Characteristics of Graft MaterialsCharacteristics of Graft Materials

Most bone graft materials fall into two main Most bone graft materials fall into two main categories:categories:

OsteoconductiveOsteoconductive::A framework for new bone to grow into at its A framework for new bone to grow into at its

normal healing rate.normal healing rate.

OsteoinductiveOsteoinductive::Stimulate bone to grow at an advanced rate. Most Stimulate bone to grow at an advanced rate. Most

have added ingredients, (Growth Factors or have added ingredients, (Growth Factors or Bone Morphogenetic Proteins).Bone Morphogenetic Proteins).

Types of Bone GraftsTypes of Bone Grafts

AutograftsAutografts

AllograftsAllografts

XenograftsXenografts

SyntheticsSynthetics


Also referred to as Also referred to as ““autogenousautogenous”” or or ““autologousautologous”” grafts.grafts.

Source: patientSource: patient’’s own bone, usually harvested from s own bone, usually harvested from their palate, hip, chin, or pelvic crest.their palate, hip, chin, or pelvic crest.

““Gold StandardGold Standard””


ProsPros: contain living elements for bone : contain living elements for bone growth, no risk of rejectiongrowth, no risk of rejection

ConsCons: requires a second surgery, not : requires a second surgery, not recommended for patients with low bone recommended for patients with low bone densitydensity

AllograftsAllografts

Human bone, usually harvested from cadavers. Human bone, usually harvested from cadavers.

Risk of morbidity and mortality due to poorly screened sourcesRisk of morbidity and mortality due to poorly screened sources

April, 2008: California DPH required a separate license if a April, 2008: California DPH required a separate license if a dental office stores an allograft for more than 24 hours.dental office stores an allograft for more than 24 hours.

Commercially available Commercially available allograftsallografts: : -- DFDBDFDB by Biometby Biomet-- PurosPuros by Zimmer Dentalby Zimmer Dental

Allograft examplesAllograft examples

DFDB crystals (Biomet) Puros block (Zimmer)DFDB crystals (Biomet) Puros block (Zimmer)

PBSPBS-- Masterpiece TheaterMasterpiece Theater

Alistair Cooke (1908Alistair Cooke (1908--2004)2004)

PBSPBS-- Monsterpiece TheaterMonsterpiece Theater

Cookie Monster (1969Cookie Monster (1969--????)????)

Alistair Cooke body snatch leader pleads guiltyAlistair Cooke body snatch leader pleads guilty (March 19, 2008 London Telegraph)(March 19, 2008 London Telegraph)

The leader of a bodyThe leader of a body--snatching network which stole the bones of the snatching network which stole the bones of the broadcaster Alistair Cooke and illegally plundered more than 1,4broadcaster Alistair Cooke and illegally plundered more than 1,400 other 00 other corpses between 2001corpses between 2001--2005 has pleaded guilty.2005 has pleaded guilty.

Dr. Michael Mastromarino, the head of Biomedical Tissue SerDr. Michael Mastromarino, the head of Biomedical Tissue Services, made vices, made more than $4.6 million by selling the body parts to about 20,000more than $4.6 million by selling the body parts to about 20,000 transplant recipients throughout the US, Canada and Europe. transplant recipients throughout the US, Canada and Europe.

Funeral home owners in New York, Pennsylvania and New JerseFuneral home owners in New York, Pennsylvania and New Jersey were y were paid $1,000 for each corpse to harvest bones, skin, arterial valpaid $1,000 for each corpse to harvest bones, skin, arterial valves, ves, ligaments and tendons ligaments and tendons -- some of them diseased.some of them diseased.

Mastromarino, a 44Mastromarino, a 44--yearyear--old former oral surgeon, (whose license was old former oral surgeon, (whose license was suspended prior to running BTS), was convicted and will spend 18suspended prior to running BTS), was convicted and will spend 18--54 54 years in prison. More than 900 civil law suits have been filed ayears in prison. More than 900 civil law suits have been filed against him.gainst him.

Faux bone????Faux bone????

XenograftsXenografts

Bone or other tissue from animals, usually bovine or porcine Bone or other tissue from animals, usually bovine or porcine

Must be manufactured in a specific manner to ensure sterility Must be manufactured in a specific manner to ensure sterility and biocompatibility and biocompatibility

Most materials act as a Most materials act as a ““scaffoldscaffold”” for new bone to grow into at for new bone to grow into at its normal rate.its normal rate.

Some examples include: Some examples include:

BioOssBioOss by Osteohealth by Osteohealth PepGen15PepGen15 by Dentsplyby Dentsply

Xenograft examplesXenograft examples

Bio Oss (Geistlich)Bio Oss (Geistlich)

Powder (minerals of bovine bone) and sterile saline

Xenograft examplesXenograft examples PepGen P15 (Dentsply)PepGen P15 (Dentsply)

Liquid (Sterile saline)Powder (Collagen, Bovine minerals & synthetic analog of a peptide chain)

Synthetic (Alloplast) MaterialsSynthetic (Alloplast) Materials

Alternative materials to avoid the drawbacks of Alternative materials to avoid the drawbacks of autografts or autografts or allograftsallografts

Examples include coral and TCPExamples include coral and TCP

Very little risk of morbidity or mortality Very little risk of morbidity or mortality

Some are nonSome are non--resorbable and act as replacement bone resorbable and act as replacement bone

Others are resorbable frameworks or scaffolds for bone Others are resorbable frameworks or scaffolds for bone to grow into at itto grow into at it’’s normal rates normal rate

Some commercially available products are: Some commercially available products are: BioplantBioplant by Kerr Dental by Kerr Dental Gem 21SGem 21S by Osteohealth.by Osteohealth.

Examples of AlloplastsExamples of Alloplasts

Bioplant (Kerr) Gem 21S (OsteohealthBioplant (Kerr) Gem 21S (Osteohealth))

B-TCPgranules

rh-PDGF solution(Platelet Derived Growth Factor)

Polymethyl MA + Polyhydroxyethyl MA

BMPBMP’’s and Growth Factorss and Growth FactorsBone Morphogenetic Proteins:Bone Morphogenetic Proteins:

Discovered 1965 Discovered 1965 –– Dr. Marshall Dr. Marshall UristUrist UCLAUCLA

Found in human blood and bones Found in human blood and bones that stimulate that stimulate osteoinductionosteoinduction

20 have been identified, 2 have FDA approval for use in bone gra20 have been identified, 2 have FDA approval for use in bone grafting (2 & 7)fting (2 & 7)

Extracted from human tissue or fabricated in the labExtracted from human tissue or fabricated in the lab

Interact with receptors on surface of bone cellsInteract with receptors on surface of bone cells

Expensive, but stimulate bone to grow fasterExpensive, but stimulate bone to grow faster

Suspicion of carcinogenicity? (June 2008 Journal of American AcaSuspicion of carcinogenicity? (June 2008 Journal of American Academy of demy of Orthopaedic Surgeons)Orthopaedic Surgeons)

BMPBMP’’s and Growth Factorss and Growth Factors

Products containing BMPs:Products containing BMPs:

InfuseInfuse: : ((MedtronicsMedtronics Corporation)Corporation)

OPOP--11: : (Stryker Biotech)(Stryker Biotech)

AccelAccel ConnexusConnexus: : ((IsoTisIsoTis OrthobiologicsOrthobiologics))

AccelAccel DBM 100DBM 100: : ((IsoTisIsoTis OrthobiologicsOrthobiologics))

Grafton DBMGrafton DBM: : ((BioHorizonsBioHorizons))

RegenafilRegenafil: : ((ExactechExactech))

BMPBMP’’s and Growth Factorss and Growth Factors

PlateletPlatelet--derived growth factor (PDGF):derived growth factor (PDGF):

One of numerous One of numerous proteinsproteins regulating regulating cellcell growth and growth and divisiondivision

Role in Role in embryonicembryonic development, cell proliferation, cell development, cell proliferation, cell migration migration

Stimulates bone to grow fasterStimulates bone to grow faster

PRPPRPPlatelet Rich Plasma Centrifuge TechniquePlatelet Rich Plasma Centrifuge Technique

Platelet functions:Platelet functions:

HemostasisHemostasis

Scaffold for tissue Scaffold for tissue regenerationregeneration

Increase level of Increase level of GFGF’’ss

Attract stem cellsAttract stem cells

PPP

PRP

Barrier MembranesBarrier Membranes

Are there other grafting options?Are there other grafting options?

YES!!!YES!!!CollagenCollagen--based products are also now available.based products are also now available.

FOUNDATIONTMCollagen-Based Bone Filling Augmentation Material

for Use in the Filling of Extraction Sockets

What is Collagen?What is Collagen?

Insoluble, extraInsoluble, extra--cellular protein found in all animals cellular protein found in all animals

Most abundant protein in the human bodyMost abundant protein in the human body

Essential component of all connective tissues such Essential component of all connective tissues such as cartilage, bone, tendons, ligaments, and skinas cartilage, bone, tendons, ligaments, and skin

The History of FoundationThe History of Foundation

TerudermisTerudermis TeruplugTeruplug(approved in Japan 1993(approved in Japan 1993--skin grafting) (approved in Japan 1997skin grafting) (approved in Japan 1997-- dental)dental)

Terumo Medical Corporation, Tokyo, JapanTerumo Medical Corporation, Tokyo, Japan

FDA 510(K) Clearance #K040783FDA 510(K) Clearance #K040783

““FOUNDATION is a collagenFOUNDATION is a collagen--based bone filling augmentation material based bone filling augmentation material for use in the filling of extraction socketsfor use in the filling of extraction sockets”” (2004)(2004)

ManufacturedManufactured-- Terumo Corp.Terumo Corp.-- Japan, (now OlympusJapan, (now Olympus--Terumo Biomaterials) Terumo Biomaterials)

ApprovedApproved-- Japanese Ministry of Health as Japanese Ministry of Health as ““TeruplugTeruplug”” -- July 1997July 1997FDA as FDA as ““FoundationFoundation”” -- October 2004October 2004

LaunchedLaunched-- ““FoundationFoundation”” in U.S. Market by J. Morita USAin U.S. Market by J. Morita USA-- February 2006February 2006

Foundation ResearchFoundation Research

There are There are five published studiesfive published studies done in Japan by the following institutions:done in Japan by the following institutions:

Nihon University School of Dentistry at MatsudoNihon University School of Dentistry at Matsudo

Kanagawa Dental College, Department of PeriodontologyKanagawa Dental College, Department of Periodontology

School of Medicine, Yokohama City University, Dept. of OMFSSchool of Medicine, Yokohama City University, Dept. of OMFS

Osaka Dental UniversityOsaka Dental University

Terumo CorporationTerumo Corporation

There is another study currently in progress at the UniversityThere is another study currently in progress at the University of Rochester of Rochester

Bovine collagenBovine collagen-- Type IIIType III(skin only)(skin only)

Telopeptide(this protein acts as an antigen in

a different species)Protease (pepsin) treatmentto remove telopeptides (pH 3)

““AteloAtelo--collagencollagen””

Neutralized (pH 7)

Heat-denatured atelo-collagenFibrillar atelo-collagen

Telopeptide

Stimulates infiltration of cells into the scaffoldScaffold for surrounding cells

Heated over 37℃/100 °F

FoundationFoundation’’s Manufacturing Processs Manufacturing Process

Fibrillar atelo-collagen (scaffold)

Heat-denatured atelo-collagen

FOUNDATIONTMCollagen-Based Bone Filling Augmentation Material

Cross-linked by heat and formed into a bullet shape

S size M size

25 mm

8 mm 15 mm

How Does How Does ““Heat DenaturedHeat Denatured”” Atelocollagen stimulate bone to grow?Atelocollagen stimulate bone to grow?

HAC has an inherent quality called HAC has an inherent quality called ““chemotaxischemotaxis””

““A A responseresponse of of motilemotile cellscells where the direction of where the direction of movementmovement is is affectedaffected by the by the gradientgradient of a of a diffusiblediffusible substancesubstance””

The HAC creates a chemical stimulus that causes bone The HAC creates a chemical stimulus that causes bone growth cells to be drawn into the plug at a rapid pacegrowth cells to be drawn into the plug at a rapid pace

Only product on the market that speeds up the healing Only product on the market that speeds up the healing process without BMPs or PDGFs process without BMPs or PDGFs

Why Bovine Collagen?Why Bovine Collagen?

Abundant supplyAbundant supply

Highly compatible with alveolar boneHighly compatible with alveolar bone

Attracts fibroblasts and osteoblasts which Attracts fibroblasts and osteoblasts which accelerate new bone formation accelerate new bone formation

Hypersensitivity to Bovine CollagenHypersensitivity to Bovine Collagen

JapanJapan::October 1998October 1998-- March 2005, over 450,000 units sold March 2005, over 450,000 units sold Three cases of Three cases of ““rashrash”” have been reported from users. have been reported from users.

U.S.A./CanadaU.S.A./Canada::February 2006February 2006-- presentpresentNo cases reportedNo cases reported

Safety Precautions for Prevention of BSE Exposure Safety Precautions for Prevention of BSE Exposure (Bovine Spongiform Encephalopathy), or (Bovine Spongiform Encephalopathy), or

Mad Cow DiseaseMad Cow Disease

All documented cases of BSE have been in animals older than All documented cases of BSE have been in animals older than 12 months. All bovines used for FOUNDATION are less than 6 12 months. All bovines used for FOUNDATION are less than 6 months old.months old.

Only Only skinskin is extracted from the bovine.is extracted from the bovine.

99% of cases have been in Europe.99% of cases have been in Europe.

European Medical Examination Agency (EMEA) classifies each European Medical Examination Agency (EMEA) classifies each organ into 4 risk categories for potential BSE infection, organ into 4 risk categories for potential BSE infection, ““HighHigh””, , ““MiddleMiddle””, , ““LowLow””, and , and ““No riskNo risk””. Skin is defined as . Skin is defined as ““No riskNo risk””..

The FDA and the U.S. Dept. of Agriculture (USDA) also state The FDA and the U.S. Dept. of Agriculture (USDA) also state that skinthat skin--derived bovine products present derived bovine products present ““No riskNo risk”” for BSE.for BSE.

Foundation Safety Foundation Safety During ManufacturingDuring Manufacturing

Sterility Assurance LevelSterility Assurance Level (SAL):(SAL):

Estimates the Estimates the probabiliprobability of any medical device being ty of any medical device being nonnon--sterile after sterile after sterilizationsterilization. .

Foundation is dryFoundation is dry--heat sterilized (3X) to a SAL of 10(heat sterilized (3X) to a SAL of 10(--6), 6), or a 1 in 1 million chance on nonor a 1 in 1 million chance on non--sterility prior to sterility prior to packaging. packaging.

Same SAL as sterile surgical gloves. Same SAL as sterile surgical gloves.

Foundation vs. CollaplugFoundation vs. Collaplug Confusion, but no comparisonConfusion, but no comparison

CollaplugCollaplug (Zimmer Dental)(Zimmer Dental)

Bovine collagenBovine collagen

Bullet shaped plugBullet shaped plug

““Wound healerWound healer”” onlyonly

Used in combination with Used in combination with other productsother products

FoundationFoundation

Bovine collagenBovine collagen

Bullet shaped plugBullet shaped plug

No membrane No membrane

Accelerates bone growthAccelerates bone growth

Maintains alveolar ridgeMaintains alveolar ridge

Implants placed as soonerImplants placed as sooner

Tooth Extraction

Insertion of FOUNDATION

Surrounding cells and capillaries infiltrate into FOUNDATION.Peripheral gingiva extends onto it.

The extraction socket closes and is filled with augmented bone.

The socket is filled with FOUNDATION and it also covers the extraction surface.

Extraction socket is created and bone is exposed.

The Basics for using The Basics for using FoundationFoundation

Photos Courtesy of Dr. Edward Marcus Photos Courtesy of Dr. Edward Marcus Yardley, PAYardley, PA

““ToothTooth”” #12#12

Beginning the extractionBeginning the extraction

Atraumatic root tip removalAtraumatic root tip removal

Proper handling of FoundationProper handling of Foundation

Small size FoundationSmall size Foundation

Shaping the plugShaping the plug

Plug now mimics shape of root tipPlug now mimics shape of root tip

Extraction of intact root tipExtraction of intact root tip

Curetting the socketCuretting the socket

Inserting the plugInserting the plug

FurtherFurther……....

FurtherFurther……

Foundation in placeFoundation in place

Gentle condensation of the plugGentle condensation of the plug

Compression of buccal and lingual platesCompression of buccal and lingual plates

Done, ready for passive sutureDone, ready for passive suture

2 weeks post2 weeks post--op healingop healing

Implant placementImplant placement-- 12 weeks post12 weeks post--opop

Implant in place Implant in place -- 12 weeks post12 weeks post--opop

Digital panoramic surveyDigital panoramic survey-- 12weeks 12weeks postpost--opop

Indications for UseIndications for Use

The following cases The following cases demonstrate the use of demonstrate the use of Foundation in strict adherence Foundation in strict adherence to the FDAto the FDA--approved approved ““Indications for UseIndications for Use”” guidelines. guidelines.

Extraction of #8 due to advanced perio disease in a 65 year old female

Before extraction

Application of FOUNDATION

Immediately after extraction

Sutured

1 week later

18 weeks later (from low angle)

2 weeks later

18 weeks later (front)

PrePre--op / Postop / Post--opop

Oro-antral fistula (58 year-old male)

1 week later

Application of FOUNDATIONTooth extraction

2 weeks later

Routine extraction in a diabetic patient

Tooth extraction Application of FOUNDATION

3 days later 1 week later 2 weeks later

FAILURE CASEExtraction Sockets by Marginal Periodontitis

(78 year-old male)

Four days post-opImmediate post-op, socket not well curetted

Health Canada LicenseHealth Canada License

Health Canada issued license #71546 on June 7, Health Canada issued license #71546 on June 7, 2006 for Foundation as follows:2006 for Foundation as follows:

““A collagen based bone filling materialA collagen based bone filling material””

Missing teeth

Decorticating the bone

Full-thickness flap Pre-Op

Application of FOUNDATION

Pre-Op

Suture placedMembrane placed

3 months Post-Op

Pre-Op

(3mm wide)

3 months Post-Op

(6mm wide)

Foundation viewed by J. Morita Accuitomo Foundation viewed by J. Morita Accuitomo 3D Imaging demonstrating bone growth3D Imaging demonstrating bone growth

Day of extraction 12 weeks postDay of extraction 12 weeks post--opop

Keys to SuccessKeys to Success1. Curette the socket and remove any unhealthy tissue to expos1. Curette the socket and remove any unhealthy tissue to expose bone. e bone.

2. Place FOUNDATION in the socket using forceps or clean glove2. Place FOUNDATION in the socket using forceps or clean gloves.s.

3. FOUNDATION 3. FOUNDATION must be saturated with bloodmust be saturated with blood..

4. Select a slightly larger size of FOUNDATION than the socket4. Select a slightly larger size of FOUNDATION than the socket to be to be filled. filled. FOUNDATION must be in contact with bone to stimulate new FOUNDATION must be in contact with bone to stimulate new growthgrowth.

5. If a bony wall is missing make sure FOUNDATION is firmly 5. If a bony wall is missing make sure FOUNDATION is firmly supporting the soft tissue in that area. supporting the soft tissue in that area.

6. Secure FOUNDATION by suturing to prevent its dislodgement f6. Secure FOUNDATION by suturing to prevent its dislodgement from rom the extraction socket. Primary closure is the extraction socket. Primary closure is notnot required.required.

What others are saying:What others are saying:

Gordon Christiansen, (Clinical Research Associates) Gordon Christiansen, (Clinical Research Associates) reported a reported a ““96% Clinical Success Rate96% Clinical Success Rate”” in their September in their September 2007 CRA Newsletter2007 CRA Newsletter

Dr. Joe Blaes, Editor of Dr. Joe Blaes, Editor of Dental EconomicsDental Economics wrote an article in wrote an article in the July 2007 issue called the July 2007 issue called ““From Footings toFrom Footings to FinishesFinishes”” in his in his ““Pearls for your PracticePearls for your Practice”” column column

Foundation was named as a Foundation was named as a "Top 100 Product"Top 100 Product”” by by Dentistry Dentistry Today Today in 2007in 2007 andand 20082008

ROIROI-- A Win / Win for you and your patientA Win / Win for you and your patient

Preserves ridge/socket after anyPreserves ridge/socket after any permanent tooth extraction permanent tooth extraction

33rdrd molarsmolars

Higher level of patient careHigher level of patient care

Increase production Increase production

Insurance CodeInsurance Code-- U.S.U.S.

ADAADA––CDT Code #7953:CDT Code #7953:““Ridge Preservation Bone GraftRidge Preservation Bone Graft””

Insurance CodeInsurance Code-- CanadaCanada

7243172431-- Alveolar Bone PreservationAlveolar Bone Preservation-- Xenograft Xenograft (first socket)(first socket)

7243972439-- Alveolar Bone PreservationAlveolar Bone Preservation-- Xenograft Xenograft (each additional socket)(each additional socket)

* * As per Dr. Jim Gray, Director Member ServicesAs per Dr. Jim Gray, Director Member Services-- BC Dental AssociationBC Dental Association

SummarySummary

Bone grafting for socket/ridge preservation has become a key Bone grafting for socket/ridge preservation has become a key part of the exploding practice of implant dentistrypart of the exploding practice of implant dentistry

Older grafting techniques and materials are no less successful Older grafting techniques and materials are no less successful

New materials are making the process more efficient without New materials are making the process more efficient without sacrificing any of the predictability of the pastsacrificing any of the predictability of the past

Socket/ridge preservation will soon become a routine procedure Socket/ridge preservation will soon become a routine procedure not only for the specialist, but also for the general practitionnot only for the specialist, but also for the general practitioner er

OsseointegrationOsseointegration

Osteoblast

Titanium

SEM

Implant DentistryImplant Dentistry

EdentulismEdentulism

PrimaryPrimary Etiology?Etiology?

U.S. stats:U.S. stats:

20M totally edentulous20M totally edentulous15M edentulous in one arch 15M edentulous in one arch 100M partially edentulous100M partially edentulous

Kalorama Information, 2005Kalorama Information, 2005


2004 BRFSS2004 BRFSS** study on Edentulous Seniors (65+), Rhode Islandstudy on Edentulous Seniors (65+), Rhode Island

FemaleFemale

MinorityMinority

High school diploma or lessHigh school diploma or less

Low incomeLow income

SingleSingle

RenterRenter

Urban dwellerUrban dweller

*Behavioral Risk Factor Surveillance System- A component of the CDC


Other characteristics (Edentulous 65+):Other characteristics (Edentulous 65+):

DonDon’’t exerciset exercise

OverweightOverweight

SmokerSmoker

Regular alcohol useRegular alcohol use

No regular dental or medical visitsNo regular dental or medical visits

Physically or mentally unhealthyPhysically or mentally unhealthy

Depressed or anxiousDepressed or anxious

Poor sleepPoor sleep

No energyNo energy


Patients with no dental insurance:Patients with no dental insurance:

ElderlyElderly

MinorityMinority

High school diploma or lessHigh school diploma or less

Low incomeLow income

Unemployed or retiredUnemployed or retired

Also has no health insuranceAlso has no health insurance


YetYet……..

People are living longer and developments People are living longer and developments in bone grafting and implant techniques in bone grafting and implant techniques are providing better options for the are providing better options for the edentulous and the partially edentulousedentulous and the partially edentulous


““Big FourBig Four””Nobel Biocare, Straumann, Biomet 3i, ZimmerNobel Biocare, Straumann, Biomet 3i, Zimmer

2006= 73.7% 2006= 73.7%

2007= 70.1% 2007= 70.1%

100+ implant companies worldwide100+ implant companies worldwideWhy???Why???

Per Ingvar BranemarkPer Ingvar Branemark

19521952-- Titanium implants in rabbitsTitanium implants in rabbits

Swedish Swedish oorthopaedic surgeonrthopaedic surgeon-- initially focused on knee and hip applicationsinitially focused on knee and hip applications

High rate of edentulism changed his focusHigh rate of edentulism changed his focus

19651965-- Gosta LarrsonGosta Larrson

Partnership with Partnership with ““Bofors ABBofors AB””——NobelpharmaNobelpharma——Nobel BiocareNobel Biocare

““OsseointegrationOsseointegration””

Dr. Leonard LinkowDr. Leonard Linkow

Blade implants, Blade implants, implantologistimplantologist to the to the ““starsstars””??????

Dr. Gerald NiznickDr. Gerald Niznick

Paragon/CoreParagon/Core--Vent from 1982Vent from 1982--20012001

Sold to Sulzer 2001 (later acquired by Zimmer) for $102MSold to Sulzer 2001 (later acquired by Zimmer) for $102M

Agreed to a 5 year Agreed to a 5 year ““NonNon--competecompete”” clauseclause

Started Implant Direct LLC with 7 new patentsStarted Implant Direct LLC with 7 new patents

Osseoperception Osseoperception as per P.I. Branemarkas per P.I. Branemark

Osseointegration: A living processOsseointegration: A living process

Fixtures are connected to a prosthesis and forces Fixtures are connected to a prosthesis and forces are transmitted to surrounding boneare transmitted to surrounding bone

The fixture becomes part of the body The fixture becomes part of the body andand the mindthe mind

Prosthetics somehow communicate with the brain Prosthetics somehow communicate with the brain to restore functionto restore function

OsseoperceptionOsseoperception

Original Branemark SystemOriginal Branemark System


Traditional implant systemsTraditional implant systems

CrownCrown

AbutmentAbutment

FixtureFixture


SLActive

BICON

Straumann

Zimmer One piece3i

Nobel Active

NanoTite Ca Ph coated

3i


Straumann SLActiveStraumann SLActive::SSandblasted with andblasted with LLarge grit followed by arge grit followed by AAcid etching, cid etching, then conditioned in then conditioned in nitrogennitrogen and preserved in saline. and preserved in saline. Surface becomes hydrophilic, attracting blood and Surface becomes hydrophilic, attracting blood and proteins, potentially promoting faster osseointegration.proteins, potentially promoting faster osseointegration.

3i NanoTite3i NanoTite::High energy beams bombard HA coated target, creating High energy beams bombard HA coated target, creating a molecular cloud which bonds to implant. The implant is a molecular cloud which bonds to implant. The implant is then coated with Ca Ph for enhanced integration.then coated with Ca Ph for enhanced integration.

The The ““firstfirst”” implant?implant?


Zirconium

Titanium

BICON

SYBRON Endopore

Coated ImplantsCoated Implants

HA coated

HA + Plasma coated

Simpler Implants

Bone Screws Milled from Cow Metatarsals

OverdenturesOverdentures

Implant TrendsImplant Trends

Market shift? (cost vs. big name)Market shift? (cost vs. big name)

Traditional C&B vs. single tooth implantTraditional C&B vs. single tooth implant

DxDx and Tx Planning Standard of Careand Tx Planning Standard of Care

Endodontists (2008 AAE meeting)Endodontists (2008 AAE meeting)

GPGP’’s vs. specialistss vs. specialists

Delayed placement vs. Immediate placement vs. Immediate loadDelayed placement vs. Immediate placement vs. Immediate load

Roughened surface preferred over coatingRoughened surface preferred over coating

Dental Tourism Dental Tourism ((272,000 medical & dental 272,000 medical & dental ““touriststourists”” spent $656 million in India in 2007. This total is expected spent $656 million in India in 2007. This total is expected to hit $2.5 billion by 2012.to hit $2.5 billion by 2012.

ImagingImaging

OMFR is a specialtyOMFR is a specialty

Only about 80 OMFRs in the U.S.Only about 80 OMFRs in the U.S.

Only 5 programs (Iowa, Conn, UMKC, SA, UNC)Only 5 programs (Iowa, Conn, UMKC, SA, UNC)

Opportunities???Opportunities???

Digital ImagingDigital Imaging

According to Dentalcompare.com:According to Dentalcompare.com:

20 percent to 35 percent of dentists have incorporated 20 percent to 35 percent of dentists have incorporated digital xdigital x--ray systemsray systems

Majority are general dentistsMajority are general dentists

Digital radiography is fast becoming the standard of care Digital radiography is fast becoming the standard of care for diagnostic imaging in dentistry for diagnostic imaging in dentistry


DICOM DICOM ((DDigital igital IImaging and maging and CoCommunications in mmunications in MMedicine) is a standardized format for handling, storing, edicine) is a standardized format for handling, storing, printing, and transmitting information in printing, and transmitting information in medical imagingmedical imaging. .

DICOMDICOM standards are developed by standards are developed by American College of American College of RadiologyRadiology (ACR) and (ACR) and National Electrical Manufacturers National Electrical Manufacturers AssociationAssociation (NEMA).(NEMA).

DICOMDICOM enables the integration of scanners, servers, enables the integration of scanners, servers, workstations, printers, and network hardware from workstations, printers, and network hardware from multiple manufacturers into anmultiple manufacturers into an archiving and archiving and communication systemcommunication system..


Digital panoramic xDigital panoramic x--ray units are the fastest growing ray units are the fastest growing capital equipment market in the worldcapital equipment market in the world

2006 compared to 20072006 compared to 2007::

Digital pan sales grew by 27% Digital pan sales grew by 27%

Film based pan sales dropped by 49%Film based pan sales dropped by 49%

DigitalDigital--Film based sales ratio went from 6Film based sales ratio went from 6--1 to 141 to 14--11

WHY???WHY???


Higher resolutionHigher resolution

Lower dosageLower dosage (as much as 80(as much as 80--90%)90%)

AAs s LLowow AAss RReasonablyeasonably AAchievablechievable

Electronic claimsElectronic claims

Better patient communication, case acceptanceBetter patient communication, case acceptance

Elimination of poor imagesElimination of poor images

Environmentally responsibleEnvironmentally responsible (No chemical disposal)(No chemical disposal)


Causes of poor images with FilmCauses of poor images with Film--based systems:based systems:

Patient movementPatient movement

Improper Improper KvKv or or mAmA settingssettings

Poor patient positioningPoor patient positioning

DARKROOM ISSUESDARKROOM ISSUES (80% of problems)(80% of problems)

3D Cone Beam CT Imaging3D Cone Beam CT Imaging

Axial Coronal Sagittal


A radiograph is a 2D representation of a 3D object

That 3rd dimension is what radiologists/clinicians have been searching for

The Changing World of 3D ImagingThe Changing World of 3D Imaging

•• LinearLinear tomography tomography -- mid 1930smid 1930s

•• Computed Tomography (CT) Computed Tomography (CT) -- 19701970’’ss

•• Cone Beam CT (CBCT) Cone Beam CT (CBCT) -- late 20late 20thth CenturyCentury

The Changing World of 3D ImagingThe Changing World of 3D Imaging

Linear Tomography Computed Tomography Cone Beam CT

Cone Beam CT vs. Medical CTCone Beam CT vs. Medical CT

Cost of CBCT scan is much less than medical CT Cost of CBCT scan is much less than medical CT

The equipment is substantially lighter and smaller. The equipment is substantially lighter and smaller.

CBCTs have better image resolution (CBCTs have better image resolution (smaller pixelssmaller pixels) )

Very easy to operate and to maintain; little Very easy to operate and to maintain; little technician training is required technician training is required

Some cone beam manufacturers are dedicated to the Some cone beam manufacturers are dedicated to the dental market dental market

Cone Beam CT vs. Medical CTCone Beam CT vs. Medical CT

In CBCT patient is seated, as compared with lying down In CBCT patient is seated, as compared with lying down in a medical CT unit in a medical CT unit

Open design of the cone beam CT units virtually Open design of the cone beam CT units virtually eliminates claustrophobia eliminates claustrophobia

The upright position is also thought to provide a more The upright position is also thought to provide a more realistic picture of condylar positions during a TMJ examrealistic picture of condylar positions during a TMJ exam

Radiation dose is considerably less than a medical CT Radiation dose is considerably less than a medical CT

Computed Tomography (CT)- 1970’s

Cone Beam CT (CBCT)- late 20th century

2D reconstruction

X-ray Source

2D (pixel)Reconstruction

Row of X-ray Detectors

Flat panel X-ray

Detector

Cone Beam reconstruction

3D (Voxel)Reconstruction

X-ray Source

Medical CTMedical CT vvs CBCT s CBCT

Voxel?Voxel?

““volumevolume”” and and ““pixelpixel””


Applications:Applications:

Implant planning (Now the S.O.C.???)Implant planning (Now the S.O.C.???)

EndoEndo-- as per Steve Buchananas per Steve Buchanan

Identifying pathologyIdentifying pathology

TMJTMJ

ENTENT

Ortho evaluationOrtho evaluation

Pre/Intra/PostPre/Intra/Post--Op assessment of traumaOp assessment of trauma

Locating foreign bodiesLocating foreign bodies

Cleft lip/palateCleft lip/palate

Caries detectionCaries detection

３D Accuitomo ８０

Imaging Areas

40mm φ

x 40mm H

60mm φ

x 60mm H

80mm φ

x 80mm H

Voxel Sizes

ｍ

ｍ

ｍ

Φ40×H40mmSmall Area

Φ40×H80mmFull view of Antagonistic Teeth

Φ80×H80mmFull Mouth

Field of View

FOVFOV

Field Of ViewField Of View

How big is too big?How big is too big?

LiabilityLiability

Implant Tx Planning SystemsImplant Tx Planning Systems

Materialise (Simplant)Materialise (Simplant)

world's first interactive 3D Implant Planning System 1998world's first interactive 3D Implant Planning System 1998

precise preoperative planning software precise preoperative planning software

allows clinician to find the ideal position of the implants allows clinician to find the ideal position of the implants

compatible with every implant brandcompatible with every implant brand

After vital structures are located, the After vital structures are located, the ““SurgiGuideSurgiGuide”” is fabricated to drill exactly to is fabricated to drill exactly to the planned implant location the planned implant location

Implant Tx Planning SystemsImplant Tx Planning SystemsNobelGuideNobelGuide

Introduced 2005Introduced 2005

Only works with NB Only works with NB implantsimplants

Uses Uses ““ProceraProcera”” softwaresoftware

Materialise vs. Nobel BiocareMaterialise vs. Nobel Biocare

June 1998 – Materialise is awarded a U.S. Patent

August 1998 – Materialise is awarded a European Patent

June 2005 – Nobel Biocare launches its NobelGuide product in Germany.

November 2006 – Materialise files a patent infringement action in Germany

June 25 2005 - Nobel Biocare files a nullify action in Germany

August 2007 – Nobel Biocare files civil action in California seeking a declaration of patent non-infringement

August 2007 – German court rules that Nobel Biocare is indeed infringing on Materialise’s European patent

September 2007 – Nobel Biocare files an appeal against the decision of the District Court of Düsseldorf with the Düsseldorf Court of Appeals (pending)

October 2007 – Materialise files a counterclaim for U.S. patent infringement in California

“The Main Event”

NB MATERIALISE

Thank You For Your Attention!Thank You For Your Attention!

Contact Information:Contact Information:

[email protected]@jmoritausa.com

(800) 818(800) 818--77887788

9 Mason9 MasonIrvine, CA 92688Irvine, CA 92688

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