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R.T.R.ÂŽ Resorbable Tissue Replacement

Global Marketing – May 2009

For Internal Use Only


Contents

• Market Overview • Product – – – –

Positioning Presentations Indications Instructions For Use

• Pricing – Retail/Dealer/Transfer Price

• Q&A • Marketing & Clinical Support

• Features & Benefits – FAB table

• Competitive Set

For Internal Use Only


Market Overview


Categories of Bone Grafting Materials Synthetic origin

Biological origin

Calcium Carbonate

Osseous derivatives

Autograft

Allograft

(Alloplast materials)

Xenograft

Calcium sulfate

Polymers

Bioglasses

Calcium Phosphate Ceramics

Biocoral® HTR®

Capset®

Synthetic hydroxyapatite

Biological hydroxyapatite

Perioglas®

Biphased ceramics

Composite materials

Β-TCP

R.T.R.®


Biological Bone Grafting Materials

Osseous Derivatives

Autograft : bone taken directly from the patient

Allograft : bone coming from a human tissue databank and treated. DFDBA - Demineralized Freeze-Dried Bone Allograft FDBA - Freeze-Dried Bone Allograft

Xenograft = Heterograft : non-human bone (bovine origin mostly) Biological Hydroxyapatite

Risk of transmission of Creutzfeldt-Jacob disease


Synthetic Bone Grafting Materials

Calcium Phosphate Ceramics ß-TCP

Composite materials

Biological hydroxyapatite (not a xenograft,since fritting >1000°C)

Synthetic hydroxyapatite

Biphased Ceramics

Ceros Biosorb

Cerasorb R.T.R.® syringe/granules

PepGen P-15 Calciresorb-collagen Biostite

R.T.R.® cone Bio-Oss collagen Bonit Matrix

Bio-Oss

Cerapatite

Ostim

Calciresorb 35 Cera form 400 Alaska

MBCP Cross Bone SBS 70/30


Bone Grafting Market 4.5 Mio US$ (2008)

4%

RTR

3%

ALLOGRO NUOSS RCM6

10%

RCP

FOUNDATION

32%

CONFORM RCT

RCF BARRIER MEMBRANE

18% PERIOGLAS NOVABONE

ACE SURGICAL KERR SUNSTAR

MORITA SEPTODONT

33%

Source: SDM 2008

BIOPLANT

ALLOSOURCE


Product


What is R.T.R.® ?

A resorbable synthetic bone grafting material containing ß-TCP (ß tricalcium phosphate) that promotes new dense bone growth

Available through dealer distribution channel like the other Septodont products


R.T.R.® delivers the Benefits of ß-TCP Bone Grafting Materials  Promotes new bone formation through release of calcium and phosphate ions during its progressive resorption  Fosters dense new bone growth thanks to its osteoconductive micro and macroporous structure  Restores bone volume renewing the integrity of the alveolar ridge within 3 to 6 months


Available in 3 Presentations …  R.T.R.® cone Box of 2 cones each containing 0.3 cm3 (Ø 6 mm, H 10 mm) of ß tricalcium phosphate + collagen granules in sterile individual packaging.

 R.T.R.® syringe 0.8 cm3 of ß tricalcium phosphate granules (diameter 0.5 to 1mm) in sterile syringe, individually packaged.

 R.T.R.® Granules Box of 1 bottle containing 2 cm3 of ß tricalcium phosphate granules in sterile single unit package.


… For many Bone Grafting Procedures R.T.R.® cone: ideal for post extraction socket grafting, ridge augmentation  for general practitioner, implantologist

R.T.R.® syringe: ideal for periodontal defects, peri-implant

defects

for periodontist, implantologist

 R.T.R.® Granules: ideal for large defects (e.g. following apical endodontic surgery), Sinus lift for stomatologist, implantologist, endodontist


Features, Advantages & Benefits


FAB Table Features

Advantages

Benefits

Synthetic ßTCP granules

Resorbable

Allows new bone formation

Micro and macroporous

Maximises alloplast colonization by osteogenic cells

Allows bone augmentation

Hydrophilic material

Adapts to the surgical site

Easy contouring when filling bone defects

High level of purity +

ßTCP>99%, Biocompatibility and Safety

No risk of rejection

Double sterile packaging

Meets the asepsis standards required in implantology

Ensures the success of the bone grafting and therefore improves prognosis for the future implant

Exists in 3 different

Choice of best suited presentation for a given procedure

Ease of use

Ease of use

Cone is easy to handle and stays in place thanks to highly purified collagen of bovine origin that also promotes haemostatic healing.

• Syringe presentation

Precision of placement

Allows an easy direct placement without external mixing thanks to an easy aspiration of patient’s blood or physiological solution

• Granules presentation

“Bulk” packaging

Volume of granules adapted for large defects

sterilization

presentations • Cone presentation

(contains collagen)


Competitive Set


Calcium Phosphate Ceramics vs other Bone Grafting Materials Biological Osseous derivatives Porosity Resorbability

Clinically tested Risk of disease contamination

Synthetic

Calcium Carbonate (Biocoral®)

Polymers (HTR®, Fisiograft)

Bioglasses (Perioglas®)

Calcium Sulfate

Calcium Phosphate Ceramics

(Capset®)

(ex.: RTR®)

Like bone porosity

Macro and microporous

Macroporous

No

Low

Yes

Yes

Complete

No

No

Yes

Depends on the category

Yes

Yes

Yes

Yes

Yes

Yes

Yes

No

No

No

No

No


ß-TCP vs other Calcium Phosphate Ceramics Calcium Phosphate Ceramics Biological hydroxyapatite

Synthetic hydroxyapatite

Biphased Ceramics

Composite materials (ex.: R.T.R.® cone)

Contains Hydroxyapatite

Yes

Yes

Clinically tested Granule presentation

(ex.: R.T.R.® syringe/granules)

Yes

Depends on the product

No Yes (several months)

Resorbability

Porosity

ß-TCP

No or Incomplete

No

Incomplete

Incomplete to total

Like bone porosity

Macro and micro porous

Macro and micro porous

Depends on the product

Macro and micro porous

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Yes


Pricing


Q&A  What are the ingredients in R.T.R.®? R.T.R.® is a resorbable synthetic bone grafting material containing ß-TCP (ß tricalcium phosphate). R.T.R.® cone also contains collagen of bovin origin. 

What about the resorption of R.T.R.® ? R.T.R.® is resorbed very slowly in 3 to 6 months. Studies show that the amount of R.T.R.® in the augmentation material declines steadily. We used to believe that a bone substitute had to be resorbed as quickly a possible. But these days, it is known that the slow breakdown of RTR gives the bone augmentation material volume stability.

What is the role of the collagen in the R.T.R.® cone? The collagen allows the cohesion between the granules as to maintain the shape of the cone as well as maintaining the granules in place when suture is impossible. Besides, the collagen helps the formation of the clot and the fixation of the growth factors that are realased by the system. Thereby, the collagen promotes the healing.

Is it safe to use the collagen of bovine origine contained in R.T.R.® cone? The collagen comes from 6-month-young bovines, bred in the USA. Its purification and sterilization comply to the european security regulations.


 Can R.T.R.® be re-sterilized? R.T.R.® is already sterilized. It should not be re-sterilized as it is not approved for re-sterilization in dental practice. Septodont, as the manufacturer, cannot accept product liability in this case.  For which grafting indications can I use R.T.R.®? R.T.R.® can be used for post extraction socket grafting, ridge augmentation, periodontal defects, peri-implant defects, large defects (e.g. following apical endodontic surgery), sinus lift. 

Why is R.T.R.® better than other synthetic grafting materials? R.T.R.® (syringe & granules) is pure-phase β-TCP and does not contain other components. Thus, its resorption occurs completely, allowing a new bone growth. Also, as R.T.R.® is available in 3 different presentations, it can be used in many different bone grafting procedures.

 Why is R.T.R.® preferable to biologically-derived grafting products? With R.T.R.®, there is: 1) No risk of transmission of disease such as Creutzfeldt-Jacob 2) No problem of supply.


How to use R.T.R.® ? - Cone : R.T.R.® cone is inserted in the dental socket after waiting that the socket has been filled with Blood. - Syringe : All the granules must be soaked with some blood or physiological solution absorbed through the filter tip of the syringe. The excess liquid is released, the tip removed and the mixture injected into the surgical site. - Granules : R.T.R.® Granules is mixed in a sterile Dappen dish with the patient’s blood or physiological solution before being placed onto the clinical site using a dental spatula.

 Should I use R.T.R.® in all extractions or only for sockets where implants will be placed? R.T.R.® should also be placed whenever alveolar ridge preservation is needed (eg, aesthetic reason for a bridge).  Is it mandatory to close the surgical site with sutures? It is always better to suture the operative site. However, should suturing be impossible, R.T.R.® cone is particularly recommended.


 Can R.T.R.® also be used without membrane? A membrane is usually used as a barrier against the growth of soft tissue in the event of postoperative wound dehiscence. Otherwise, as long as it is possible to close the operatory site and as lons as the granules stay in place, it is not mandatory to use a membrane with R.T.R.®.  Should R.T.R.® be mixed with antibiotics? The use of antibiotics is generally unnecessary when employing R.T.R.®. If antibiotic therapy is indicated, it should usually be given systemically. 

Is it better to use autologous bone than R.T.R.® for sinus lift procedures ? A prospective multicentre randomized clinical trial* comparing autogenous bone and ßTCP in the case of sinus lifting showed no significant histologic or histomorphometric difference between the two techniques. * Szabo G et al,Int J Oral Maxillofac Implants 2005;20:371-371


Cone + syringe presentation

Trade Advertisings

All presentation


Sales Leaflet


Dentist Brochure


Poster - 508 x 762 mm


Clinical & Scientific References/Abstract update

 About β-TCP  About R.T.R.®


About ß-TCP 2008

Brkovic B, Prasad H, Konandreas G, Milan R, Antunovic D, Sandor G, Rohrer M, Simple preservation of a maxillary extraction socket using beta-tricalcium phosphate with type I Collagen : preliminary clinical and histomorphometric observations, Journal of the Canadian dental association, july/august 2008, vol 74 n°6:523-8 This case-report suggests that a cone of a biomaterial composed of ß-TCP combined with type I collagen, can prevent alveolar crest resorption following tooth extraction without the use of a barrier membrane or a mucoperiostal flap. Formation of new bone of acceptable quality and quantity permitted the placement of an osseointegrated dental implant. Further study of this material and this protocol is needed and a case series is currently underway. 2006 Jensen O, Use of alloplasts sinus floor grafting in: the sinus bone graft. Chicago: Quintessence 2006:201+209 (Second Ed) Pure-phase β-TCP offers ready availability in unlimited supply of a material that is free of allergens and foreign proteins and avoids second-site surgery for bone harvest. The material is resorbable, easy to handle, predictable, and compatible with the barrier membrane. It also reduces surgical treatment time.


Princ, G, Bert M, Ifi JC, Utilisation du substitut osseux ß-TCP, résultats à trois ans. Le ChirurgienDentiste de France n°1250/1251, 23-30 March 2006 After encouraging short-term results, the ß-TCP as bone grafting material shows a good stability in the results. Bone grafting in the porosities of the material proves that a colonisation by bone cells is possible, developing with time. Ormianer Z, Palti A, Shifman A, Survival of immediately loaded dental implants in deficient alveolar bone sites augmented with beta-tricalcium phosphate. Implant Dent. 2006 Dec;15(4):395-403. This study assessed the survival of immediately loaded dental implants placed in deficient alveolar bone sites at bone grafting. In all cases, beta-tricalcium phosphate was mixed with blood from the surgical site to augment the ridge level or fill spaces between the implant and socket wall. When indicated, the same materials were used for sinus floor augmentation. Within the limitations of this study, immediate loading of splinted implants in augmented sites is a predictable procedure.


About R.T.R.® Pending

Not published yet

Brkovic B, Prasad HS, Konandreas G, Agrogiannis G, Antunovic D, Rohrer M, Histologic evaluation of human post extraction sockets grafted with ß-TCP associated with collagen type I (R.T.R.® cone) : report of five cases New trial - Dimensional changes and aesthetic outcome after socket preservation using β-tricalcium phosphate or bovine porous bone mineral following tooth extraction

Brkovic B, Treatment of Apicomarginal Defect in Periradicular Surgery A Case Report supporting the efficiency of R.T.R.® Syringe as a grafting material for the apicomarginal bone defects


2007 Micheau C, Kerner S, Jakmakjian S, l’intérêt du phosphate tricalcique ß en parodontologie et en implantologie, Le chirurgien-dentiste de France n°13085, 14 Jun 2007 Through literature and clinical applications, R.T.R proved to have an osteo-inductive potential in the infrabony lesions and an excellent tolerance during cicatrisation, thus allowing better prognosis for teeth with severe periodontal lesions. Macesic M, Brkovic B, Antunovic D, Rohrer M, Prasad H, Healing of the human extraction sockets using ß-TCP in combination with collagen type I : clinical and histomorphometric report of 2 cases, Clinic of Oral surgery University of Belgrade, Serbia, Osteology Monaco, 2007 10-12 May The results of the present reports support the efficiency of ß-TCP in combination with collagen type I as a grafting material for pre-treatment of extraction sockets in implant surgery.


2006 Cariou F, RTR, Protocole clinique du comblement alvéolaire avec de l’os synthétique alloplastique, Clinic, nov 2006, vol 27,519-524 Reliability of ß-TCP as bone grafting material and its resorbability have been proved in the studies. Thanks to a combination with collagen, RTR cone allows an easy use of ß-TCP in a daily practice. RTR is recommended every time an implant is considered, especially in areas with bone defect or in ridge preservation for aesthetic purposes (bridges). Aleksic Z, Jankovic S, The clinical impact of PRP and ß-TCP in the treatment of infrabony defects, Journal of clinical periodontology, 2006, 33, supp7, 104 6 months after surgery both treatment (combination of PRP / ß-TCP / GTR and a combination of PRP / ß-TCP) resulted in significant probing depth reduction and clinical attachment gain. Brkovic B, Milan R, Jurisic M, Danilovic V, Bone augmentation with titanium mesh and ß-TCP, Clinical Oral Implants Research, volume 17 issue 4 page xvii - August-2006 Results of the present report support the efficacy of ß-TCP as grafting material for minor ridge preservation in combination with titanium mesh.


Clinical & Scientific Publications

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Septodont RTR