Tigran™ PTG [Porous Titanium Granules] for Bone Regeneration and Implant Osseointegration

2 T IGR AN™ PTG (Porous Titanium Granules)

The Tigran method for preserving and regenerating bone is based on the unique ultra-porous titanium granules. Tigran™ PTG (Porous Titanium Granules) is made of body-friendly titanium, known for more than 40 years as a superior material for dental implants. This novel bone regeneration material combines the superior biocompatibility, mechanical strength and osteocon-ductivity of titanium with an ultra-porous architecture that acts as an excellent scaffold for growth of new bone. Tigran™ PTG has many applications for dental bone regeneration, the most common are sinus lift, regeneration of bone in peri-implantitis defects and post-extraction socket fillings.

The Tigran Titanium Method

3BONE REGENER AT ION AND IMPL ANT OSSEOINTEGR AT ION

Tigran™ PTG (Porous Titanium Granules)

80% air and 20% pure titanium • Unique scaffold for bone in-growth • Optimal osseointegration• Normal drilling procedure can be used− soft titanium grade 1

Non-resorbable• Permanent volume fill• Predictable and long-term results• Optimal function and esthetics

Irregular shape, interconnected poresand trombogenic properties• Immediate mechanical stability• Quickly forms a blood clot− easy to handle• Superb biological performance• Stick together− firm initial stability due to capillary forces

Titanium−used in dental

implants for over 40 years

Photos courtesy of Dr. WohlfahrtPhoto courtesy of Dr. Steveling

4 T IGR AN™ PTG (Porous Titanium Granules)

Tigran™ PTG for Bone Regeneration and Implant OsseointegrationTigran Technologies has its origins in orthopedics. The first use of Tigran™ PTG was in 1987-88, when it was used for the fixation of hip prostheses, whereas the first dental application was in 1995. The titanium granules have been found to be a superb scaffold for bone regenera-tion and provide effective initial mechanical stability and excellent long-term clinical results.1

A number of clinical and experimental trials have been completed, and Tigran runs several on-going studies. For the latest scientific updates, please visit www.tigran.se.

Tigran Clinical Advisory BoardComposed of scientists and dentists throughout Europe, Tigran’s Clinical Advisory Board serves as an advisory body for Tigran’s clinical program and product development.

Histological section shows new bone incorporating the granules and re-osseointegration of the implant.

12 months after treatment.

Soft tissue

Tigran™ PTG

Implant

Bone

Scientific Evidence– www.tigran.se

Photos courtesy of Dr. Wohlfahrt

µCT of human biopsy 12 months after treatment, showing bone in-growth through granules, between granules and between granules and implant.

Bone In-growth and Implant Osseo-integration

Tigran™ PTG

Bone

SEM-image showing bone growing through the porosities and along the surface of an osteoconductive titanium granule.

Tigran™ PTG

Implant

Bone

1. Bystedt H, Rasmusson L. Porous titanium granules used as osteoconductive material for sinus floor augmentation: a clinical pilot study. Holmberg L, Forsgren L, Kristerson L. Porous titanium granules for implant stability and bone regeneration—a case followed for 12 years.

ImplantBone

Tigran™ PTG

5BONE REGENER AT ION AND IMPL ANT OSSEOINTEGR AT ION

Bone Regeneration Cases with Tigran™ PTG

5. Follow-up one year after surgery shows a stable graft and implant.

4. Tigran™ PTG is applied. After 6 months of healing, second stage surgery is performed and the crown re-seated.

1. Pre-op. 2. Mesio-buccal 11 mm PPD with profuse bleeding.

3. Bone defect during debridement with Tigran™ Brush No 1.

Peri-implantitis (Submerged)Tigran is conducting a number of studies assessing surgical treatment with Tigran™ PTG of bone defects caused by peri-implantitis. Tigran is the first to show in human biopsies that new bone can grow in direct contact in and around the titanium granules and osseointegrate the ailing implant, thereby restoring bone volume.

Professor Andrea Pilloni, Department of Periodontology at Sapienza University, Rome, Italy.Patient: Male, age 46

1. Pre-op. 2. Clinical situation pre-op.

3. Tigran™ PTG White applied.

5. Follow-up six months af-ter surgery shows a stable graft and implant.

4. Image post-op shows a healthy soft tissue.

Doctor Caspar Wohlfahrt, specialist in Periodontology and PhD student at the Department of Biomaterials, University of Oslo, Norway.Patient: Male, age 65

6 T IGR AN™ PTG (Porous Titanium Granules)

Bone Regeneration Cases with Tigran™ PTG

3. Follow-up five years after new prosthetics shows a healthy soft tissue.

4. Follow-up five years af-ter new prosthetics shows a stable graft and implant.

2.The fixture is removed and the cavity of the fixtu-re widened and filled with Tigran™ PTG. A new fixture is then screwed into place. At the same time, a sinus lift is performed in regio 14 and a new fixture is installed.

1. Five years after the den-tal prosthesis, the fixture in regio 13 has become mobile, likely due to excess strain.

Sinus LiftThe study ”Porous titanium granules used as os-teoconductive material for sinus floor augmenta-tion: a clinical pilot study” by associate professor Hans Bystedt and professor Lars Rasmusson was published in Clinical Implant Dentistry and Re-lated Research 2/2009 and shows that TigranTM PTG works effectively for bone regeneration in conjunction with immediate placement of an implant. The study is followed up by an inter-national multi-center study that further aims to show the capacity of the titanium granules for dental bone regeneration in connection with im-mediate placement of dental implants.

Associate professor Hans Bystedt, Sweden, has long ex-perience in bone regeneration with TigranTM PTG in sinus lift applications. Patient: Male, age 70

1. Tooth extraction. 2. Socket filled with Tigran™ PTG.

3. Implant insertion 2.5 months after bone regeneration procedure.

4. 18 month follow-up (1 year after implant inser-tion) shows a stable graft and implant.

Post Extraction Socket FillingTigran has conducted a number of experimental studies showing that when an extraction socket is filled with Tigran™ PTG, the volume of the ridge of the jaw bone is maintained, making the dental implant treatment more predictable and the result more esthetically attractive. A current Israeli study started in early 2010 under the di-rection of Dr. Adi Lorean and Dr. Ziv Mazor and involving 60 patients aims to further show the capacity of the titanium granules to preserve and regenerate dental bone in extraction sockets.

FIVE YEAR FOLLOW-UP!

Doctor Shlomo Lazarovitch, Israel, has conducted a num-ber of interesting procedures involving extraction socket fillings.Patient: Male, age 42

7BONE REGENER AT ION AND IMPL ANT OSSEOINTEGR AT ION

To ensure successful treatment results, please pay attention to these instructions and precautions. For further details, please see Instruction for Use in the product package and at www.tigran.se.

How to use Tigran™ PTG

Do not overfill. Material does not resorb at all, i. e., there is no volume change over time.

In wide cavities, cavities > 35º or with less than three walls consider membrane for improved primary graft stability.

Do not mix with other materials− may clog poro-sities and act as lubricant and hinder clot formation.

Radioopaque − can easily be seen on x-ray.

Ensure that the surgical wound is completely closed and the granules properly co-vered. Primary wound stability is important.

Normal drilling procedure can be used. Use sharp burr.

Easy to commu-nicate to patients − titanium has been used in dental app-lications for over 40 years.

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35º

Ensure that the surgical wound is completely closed and the granules properly covered. Primary wound stability is important.

Do not overfi ll. Material does not resorb at all, i. e there is no volume change over time.

Do not mix with other materials – may clog porosities and act as lubricant and hinder clot formation.

Ensure suffi cientblood fl ow for granules to adhere and to form a stable blood coagulum. If necessary, make puncture holes in bottom of defect.

Normal drilling procedure can be used. Use sharp burr.

Radioopaque – can easily be seen on x-ray.

Easy to com-municate to patients – tita-nium has been used in dental applications for over 40 years.

No risk of disease transfer from graft material.

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OTHERMATERIAL

In wide cavities, cavities > 35º or with less than three walls, please consider membrane for improved primary graft stability.

35º

Pack granules gently, but enough to ensure optimal interlocking and primary stability.

Ensure that the surgical wound is completely closed and the granules properly covered. Primary wound stability is important.

Do not overfi ll. Material does not resorb at all, i. e there is no volume change over time.

Do not mix with other materials – may clog porosities and act as lubricant and hinder clot formation.

Ensure suffi cientblood fl ow for granules to adhere and to form a stable blood coagulum. If necessary, make puncture holes in bottom of defect.

Normal drilling procedure can be used. Use sharp burr.

Radioopaque – can easily be seen on x-ray.

Easy to com-municate to patients – tita-nium has been used in dental applications for over 40 years.

��OTHER

MATERIAL

In wide cavities, cavities > 35º or with less than three walls, please consider membrane for improved primary graft stability.

35º

Pack granules gently, but enough to ensure optimal interlocking and primary stability.

Ensure that the surgical wound is completely closed and the granules properly covered. Primary wound stability is important.

Do not overfi ll. Material does not resorb at all, i. e there is no volume change over time.

Do not mix with other materials – may clog porosities and act as lubricant and hinder clot formation.

Ensure suffi cientblood fl ow for granules to adhere and to form a stable blood coagulum. If necessary, make puncture holes in bottom of defect.

Normal drilling procedure can be used. Use sharp burr.

Radioopaque – can easily be seen on x-ray.

Easy to com-municate to patients – tita-nium has been used in dental applications for over 40 years.

No risk of disease transfer from graft material.

��

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�

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OTHERMATERIAL

In wide cavities, cavities > 35º or with less than three walls, please consider membrane for improved primary graft stability.

35º

Pack granules gently, but enough to ensure optimal interlocking and primary stability.

Ensure that the surgical wound is completely closed and the granules properly covered. Primary wound stability is important.

Do not overfi ll. Material does not resorb at all, i. e there is no volume change over time.

Do not mix with other materials – may clog porosities and act as lubricant and hinder clot formation.

Ensure suffi cientblood fl ow for granules to adhere and to form a stable blood coagulum. If necessary, make puncture holes in bottom of defect.

Normal drilling procedure can be used. Use sharp burr.

Radioopaque – can easily be seen on x-ray.

Easy to com-municate to patients – tita-nium has been used in dental applications for over 40 years.

No risk of disease transfer from graft material.

��

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��OTHER

MATERIAL

In wide cavities, cavities > 35º or with less than three walls, please consider membrane for improved primary graft stability.

35º

Pack granules gently, but enough to ensure optimal interlocking and primary stability.

Achten Sie darauf, dass die Wunde komplett verschlossen und das Granulat vollständig bedeckt ist. Primäre Wundstabilitat ist wichtig.

Nicht überfüllen. Material wird nicht resorbiert, d.h. das Volumen bleibt langfristig erhalten.

Nicht mit anderen Materialien mischen – kann die Poren ver-stopfen und somit die Bildung eines Blut-koagels behindern.

Eine adäquate Blu-tung muss sicherges-tellt sein, so dass das Granulat aneinander haftet und ein stabiles Blutkoagel bildet. Falls notwendig perforieren Sie den Knochen im apikalen Bereich.

Normale Bohrtechniken können angewendet werden, auf scharfen Bohrer achten.

Radioopak – deutlich sicht-bar auf Röntgen-bildern.

Einfache Patien-tenkommuni-kation – Titan wird seit mehr als 40 Jahren in der Zahnmedizin angewendet.

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MATERIAL

Bei ausgedehnten Kavitäten, Kavitäten >35° und Kavitäten mit weniger als drei Wänden empfi ehlt sich die Anwendung einer Membran zur Verbes-serung der Primärstabilität des Ersatzmaterials.

35º

Das Granulat vorsichtig dichtpacken ohne zu viel Druck, aber dennoch aus-reichend, um das optimale Ineinandergreifen des Granulats und die Primär-stabilität zu gewährleisten.

Ensure sufficient blood flow for granu-les to adhere and to form a stable blood coagulum. If necessary, make puncture holes in bottom of defect.

Pack granules gently, but enough to ensure optimal interlocking and primary stability.

tigran technologies ab • medeon science park, se-205 12 malmö, sweden

• info@tigran.se • www.tigran.se • phone +46 40 693 92 70 • fax +46 40 650 16 66

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About Tigran Technologies Tigran Technologies AB (publ) is a dental sales- and development company based in Sweden. Tigran offers a system for bone regeneration and implant osseointegration in the mouth. The technology is based on porous titanium granules acting as scaffolding for the body’s bone cells in the process to rebuild jawbone in order to place and stabilize implants and prevent further bone loss. Tigran also develops instruments for optimized treatment and increased patient comfort in dental bone regeneration procedures. Tigran runs an extensive development program and has a number of published, submit-ted and on-going experimental and clinical studies. The company’s products, methods and technologies are covered by a strong intellectual property portfolio. The products are CE-marked. Tigran’s products are distributed through an international distribution network and the company’s own sales force. “Tigran” is a registered trademark of Tigran Technologies AB.

For further information and distribution network, please visit www.tigran.se

Patent: US, EP, GB, DE, FR, IT, NL, ES, CH/LI, PL, RU, CN, KR, AU, HK, ZA, IL, IN, SE, NO, MX, CA

Patent pending: JP, BR

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