In-Kone®

Fromoutsideto inside The implant, from another angle

Technical and scientific informationIn-Kone®, the dental implant with an indexed conical connection.

We are grateful to - Dr. C. Bolle- Dr. B. Chapotat- Dr. E. Schneck- Dr. A. Simonpieri- Dr. K. Valavanisfor their collaboration

Table of Contents

Histological analysis of the bone integration process P 5

Properties of the material P 6

The In-Kone® connection P 8

Static and dynamic testing, ISO 14801:2007 standard P 10

In-Kone® implant concepts and clinical effects P 12

Mechanical advantages of the conical connection P 14

Biological advantages of the conical connection P 15

Benefi ts associated with 2 mm subcrestal placement of a self-locking conical connection P 16

Bibliography P 17

Modern implantology provides patients with treatment options that are predictable, permanent and reproducible on esthetic and functional aspects.Based on scientifi c and clinical experience, it embodies an understanding of the broad principles of tissue integration and tissue maintenance over time.In the scope of product development, Global D has gathered these broad principles into three inextricably linked components.

Modern implantology… by Global D

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Crestal bone preservation

Periodontal integration

In-Kone®

Implant encapsulated by bone at two years post-surgery

To have more information about In-Kone® dental implant, please contact Global D company or refer to the sales catalog. The In-Kone® dental implant is placed on the market since 2009.Risk classes: I, IIa, IIb according to 93/42/EEC directive. Please consult instructions for use.Indications: The In-Kone®Universal SA² consists of endosseous implants, compatible with tekka abutments and ancillary. In-Kone® Universal SA² dental implants are intended to be surgically placed in the bone of upper or lower jaw arches to support tekka prosthetic devices and to restore patient aesthetics and masticatory function, in single or multiple unit applications. The tekka implant In-Kone® Universal SA², may be used equally well in a single-stage or two-stage surgical procedure. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load. This technique is only contemplated when all other less invasive therapies are considered to be less appropriate. The In-Kone® Universal SA² implants are single-use and sterile, they are used to replace the root of a missing tooth to restore all or part of the functions of a nature tooth.The products are available subject to obtaining approvals in force in the countries concerned.

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Histological analysis of peri-implant bone remodeling on TA6V implants with an S surface. A study in beagle dogs

Global D has launched a preclinical study to analyze how its In-kone® and Twinkon® S implants integrate into bone after 3 and 12 weeks of healing.

Study performed by C. Bolle1,2, P. Exbrayat2, K. Gristch1,2 and B. Grosgogea1,2 in collaboration with D. Fau3.1- Laboratory of Multimaterials and Interfaces, UMR-CNRS 5615, Faculty of Odontology, University of Lyon 1.2- Faculty of Odontology, Dental Consultation and Treatment Unit, Hospices Civils of Lyon.3- Lyon Veterinary School, Marcy l’Etoile, France.(Analysis methods: histology, non-decalcifi ed bone, cutting/grinding technique)

Histological analysis of the bone integration process

Optical microscope images showing the interface of an S surface implant with bone tissue after 3 and 12 weeks of healing. Non-decalcifi ed bone, cutting/grinding technique, Paragon stain.

Peri-implant tissue response after three weeks of healing

After three weeks of healing in a beagle dog, the ridges of the threads are locked into the cortical bone within the bone margin that was present before the implant was put into place (OB- old bone).In the valleys of the threads, apposition of new bone trabeculae (NB- new bone) along the drill track (distance osteogenesis, white arrow) and in direct contact with the implant surface (contact osteogenesis, orange arrow) is visible.The threads have not yet been completely fi lled with new bone. The presence of numerous osteoblasts (blue) and osteoids shows that bone formation is ongoing.

Peri-implant tissue response after 12 weeks of healing

After 12 weeks of healing in a beagle dog, the implant/new bone contact area and the peri-implant bone density are greater.The valleys of the threads are fi lled with newly formed bone (NB), thus remodeling has begun: primary immature bone is replaced by secondary compact bone (OS), which is a sign of advanced bone maturation.

OB OB

OBNB

NBNB

OBOB

NB

NB NB

NB

OS

50 µm

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Bone integration

Properties of the material [1 to 13]

TitaniumTitanium alloy (grade 5 or TiAI6V4), which conforms to ISO 5832-3 and ASTM F-136 ELI standards, has excellent mechanical properties and modulus of elasticity. It is known to be biocompatible and it is the material of choice in the medical world: orthopedic implants, dental implants, maxillofacial surgery and orthognathic surgery.

All Global D products are designed and manufactured according to ISO 13485 and ISO 9001 (G-MED certifi cation) and conform to the 93/42/EEC and 2007/47/EC directives.

The Global D titanium dental implants are manufactured from TA6V ELI (grade 5) titanium alloy, which is a known implantable alloy

Surface fi nishTo obtain a surface fi nish that favors bone integration, te ka Global D took the following requirements into consideration: topography with appropriate macrostructure and microstructure obtained by sandblasting and acid etching, which results in a surface roughness between 0.5 and 4 microns (µm). This method leads to a more favorable cellular response than that obtained with implants that are only sandblasted or machined, which improves the quality of the bone integration. A surface roughness of 1 to 2 μm will guarantee a better cellular response for this type of surface.A study was performed to assess the surface morphology and measure the roughness of the SA² (sandblasting and dual acid-etching) implant surface.

Figure 1 shows the differences in surface morphology.

SA² processing results in a surface topography that is close to the desired roughness (SLA). In addition, the roughness measurements confi rm that SA² processing promotes a better cellular response for integration of the implant into bone.

Sandblasting SA²

Roughness (Ra) 1,6 to 3,2 1,6 to 2,6

Implant te ka Ti6AI4V ELI + SA2

Implant te ka Ti6AI4V ELI + sandblasting

Figure 1 : Scanning electron microscopy (SEM) images. Top: te ka implant with the SA² processing; bottom: te ka implant that was only sandblasted.

The surface fi nish of the In-Kone®Universal dental implant was subjected to SA² (sandblasting+ dual acid-etching) processing. The surface was submitted for biocompatibility testing according to current European standards. The CE mark for the In-Kone® Universal implant was assigned by G-MED, a French notifi ed body.

40 μm

2 μm

X-rays of two In-Kone® implants with the fi nal prosthesis at one and two years post-surgery.

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SA2

The In-Kone® connection

To demonstrate the sealing of the In-Kone® implant conical connection, a study was performed to measure the gap between the prosthetic component (abutment) and the implant (Figure 1).The goal of this study was to verify that the gap between the prosthetic component and the implant was less than the size of a single bacterium (Figure 2).Scanning electron microscopy (SEM) of an In-Kone® implant with an abutment and prosthesis screw.

In Figure 3, two measurements were taken at various locations in the contact area: the largest was 0.814 microns (μm) and the other was less than 0.2 microns.

The gap between the implant and abutment in the conical connection was 0.8 microns at its widest, while fl at-to-fl at (clearance fi t) connections are between 4 and 30 microns.

Note that a bacterium measures between 0.2 and 10 microns (1) and that a Porphyromonas gingivalis bacterium is 1 micron in size. The minuscule gap between the In-Kone® implant and abutment prevents bacterial contamination, since there is no infra-tissue recess present.

Based on these observations, the conical connection in the In-Kone® implant is impervious to the passage of bacteria that are known pathogens for periodontal tissues.

(1) Robert A. Freitas Jr., Ralph C. Merkle, Kinematic Self-Replicating Machines, Landes Bioscience, Georgetown, TX, 2004.

Figure 1: Appearance of contact between the pillar and the implant following a thread cut.

Epithelial and connective tissue emergence profi le of an In-Kone® implant after four months of healing.

Figure 2: Focus area on conical link between the implant and abutment.

Figure 3: Measurement of widest gap between the two components.

Abutment AbutmentImplant Implant

The In-Kone® implant connection was also tested in the laboratory of Professor Torres (Laboratory for Biology, Health and Nanoscience, Montpellier University, France). Its tight seal is comparable to that of other implant brands, notably those marketed by Straumann, Dentsply and Astratech, and is signifi cantly better than that of other brands.Its tight seal is signifi cantly better than for another brand.

Higher values indicate more leakage in the connection.

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0One system te ka Average

all implantsX-rays of an implant and fi nal prosthesis three years after surgery.

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Static and dynamic testing, ISO 14801:2007 standard

To satisfy the mechanical requirements that ensure the reliability of the implant/prosthesis system, Global D performed mechanical testing according to ISO 14801:2007. The goal of these tests was to evaluate the strength of the implants and abutments.Procedure: fi nite element modeling to visualize the load distribution and mechanical testing to determine the failure strength.

Methods 1) The fi nite element modeling was performed with 3.5 mm diameter implants to evaluate the worst case

scenario (most extreme mechanical loading conditions). The results showed that the stresses were concentrated at the junction between the abutment and implant, which resulted in better load distribution.

2) According to ISO 14801: 2007, a mechanical test was performed on a 3.5 mm diameter implant in a supracrestal location, to simulate 3 mm of bone loss. The goal was to place the implant in the least favorable position (longer moment arm). The load was applied at a 30° angle and at a frequency of 10 Hz for fi ve million cycles.

ResultsThe values calculated corresponded to the highest loads supported by the implant/abutment combination.

The mechanical tests showed that results with the In-Kone® implant were similar to those of commercially-available implants.

As the pitch is more acute, the stability, retention and imper-viousness are greater.The In-Kone® connection has these features: 8° pitch (4° half-pitch), 20 mm² contact area and 2.8 mm diameter connection.

X-rays three years after surgery: stability of bone and soft tissues.

Extraction, implantation + IFL

X-ray before Lefort surgery at two years

At two years

Day of surgery and placement of a short abutment

At two yearsAt one year

8°

2.5 mm

1 mm

Extraction, implantation and immediate functional loading.

X-rays before and after Lefort surgery. Clinical case two years after implantation.

X-ray of implant and abutment at one year, two years and with the fi nal prosthesis. Clinical case at two years.

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ISO 14801 : 2007

In-Kone®Universal implant and clinical effects

Effect of the morse tapered connection on peri-implant tissue preservationThanks to its technical features, the conical connection has many mechanical and biological advantages over fl at-to-fl at (clearance fi t) connections.

Biological advantages

Thick mucous membrane

Stable connective tissue embedding

Dimensions that fi t into the biological width

Increased bone plate Reduced stress on bone cortex

Insignifi cant bacterial infi ltration

Surface roughness (Ra) of 0.2 to 2 µm

Signifi cant primary stability

Implant features

Concave anatomical abutment

Stable and impervious connection

Roughened subcrestal beveled edge

Loads distributed along the implant

Progressive threads

Atraumatic apex

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Concepts

Mechanical advantages of the conical connection [14 to 18]

The conical connection, which is based on two interlocking cones, increases the contact area between the two components, which prevents micro-movements and results in greater stability at the implant/abutment connection. The widest gap between the two components is 0.8 microns for a conical connection, while fl at-to-fl at connection can be up to 30 microns. The conical connection has higher strength, and the risk of screw loosening and/or breakage is substantially lower.

The conical connection also allows for better stress distribution and optimal distribution of the loads on the peri-implant bone. Overloaded areas located at the fi rst few millimeters of the crestal level of the implant are replaced by a more even distribution along the implant, which allows for high functional loads on small-diameter or short implants (especially benefi cial in areas with signifi cant bone resorption). Thus, the choice of implant diameter is no longer based on the required prosthetic reconstruction, but on exploiting as much peri-implant bone as possible.

Increased contact area, greater stability at the implant/abutment junction.

Narrow gap between the implant and abutment: prevents micro-movements and bacterial infi ltration.

Better distribution of stresses: optimal load distribution along the implant without the risk of overloading the peri-implant bone.

Small-diameter or short implants can be used in areas with signifi cant bone resorption.

Implant diameter chosen based on bone volume, not prosthetic restoration.

Biological advantages of the conical connection [18 to 20]

The precise fi t of a conical connection prevents micro-movements and bacterial infi ltration leading to soft tissue infl ammation. The subcrestal placement and the fl ared shape of the prosthetic abutment contribute to a high number of hemidesmosomes by increasing the contact area, which creates a high-volume, mucosal membrane O-ring seal. Since the biological width is preserved, the peri-implant tissue integration is robust.

Tight seal prevents micro-movements and bacterial contamination. Preservation of peri-implant soft tissues, without infl ammation. Customized emergence profi le. Robust stability in the biological width due to the bond between epithelial and connective tissues.

X-Ray of 4 In-Kone® implants and healing screws. The day of surgery

X-Ray of implants with defi nitive single prosthesis at 2 years follow up.

Extraction-implantation: X-ray of an In-Kone® implant in subcrestal location.

Gingival stump with abutment and fi nal crown six months after surgery.

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Benefi ts associated with 2 mm subcrestal placement of a self-locking conical connection [19 to 23]

The fi rst benefi t of subcrestal placement of the In-Kone® implant is that less-vascularized cortical bone is not overloaded, thus the risk of mechanical cratering is reduced.

The second is the natural increase in peri-implant soft tissue volume, which allows for a neck diameter that is more suitable to the prosthetic tooth, and helps with the emergence profi le.

The third benefi t of a conical connection in the subcrestal bone is that better esthetic results can be achieved. The main reason is the difference between the size of the implant and the diameter of the cervical margin of the clinical crown.

Finally, it seems benefi cial in esthetic areas to use implants with different endosseous and transmucosal components, so they can be adapted to the peri-implant tissues if the latter are modifi ed after healing.

Reduction of excessive loads on the less-vascularized crestal bone. Substantial reduction in the risk of mechanical cratering. Natural increase in the volume of peri-implant tissues. Better esthetic results: freedom to choose implant size and diameter for the cervical margin of the

clinical crown.

X-rays of two implants, one being short (6 mm), on the day of surgery and at three years with the fi nal implant.

X-ray showing the bone level of two In-Kone® implants three years after the surgery.

Emergence profi le of the mucous membrane after four months of healing.

The In-Kone® implant has a conical connection with an 8° angle (friction taper), which preserves the integrity of the biological width. A 1.5 to 2 mm subcrestal placement favors the development of a large tissue volume, which ensures long-lasting periodontal health.

References

[1] Albrektsonn T., Wennerberg A. Oral implant Surface : Part I – Review focusing topographic and chemical properties of different surfaces and in vivo responses to them. Int. J. Posthodont. 2004;17:536-43

[2] Albrektsonn T., Wennerberg A. Oral implant Surface: Part II – Review focusing on clinical knowledge of different surfaces. Int. J. Posthodont. 2004;17:544-64

[3] Boyan B.D. et al. The titanium-bone cell interface in vitro : the role of the surface in promoting osteointegration. Titanium in medicine (ed Springer ISBN 3-54066936-1),561-585

[4] Buser D. Titanium for dental application (II) :Implant with roughened surfaces. Titanium in medicine (ed Springer ISBN 3-54066936-1), p875-888

[5] Buser, D. et al. Infl uence of surface characteristics on bone integration of titanium implant. A histomorphometric study in miniature pigs. J biom Mat. Res. Sept 2004, vol25-7,889-902

[6] Dohan Ehrenfest DM, Coelho PG et al. Classifi cation of osseointegrated implant surfaces: materials, chemistry and topography. Trends in Biotec. Apr 2010 vol 28-4: 198-206

[7] Kim H, Choi SH, Ryu JJ et al. The biocompatibility of SLA-treated titanium implants. Biomed Mater 2008 (3) 025011

[8] Le Guéhennec L et al. Surface treatments of titanium dental implants for rapid osseointegration. Dental Material 2007 (23) :844-54

[9] Marin C., Granato R. et al. Removal torque and histomorphometric evaluation of a bioceramic grit-blasted/acid-etched and dual acid-etched implant surfaces : An experimental study in dogs. J Preiodontol 2008 ;79 :1942-49

[10] Shalabi MM. et al. Implant surface roughness and on bone healing : a systematic review. J Dent. Res. , vol 85-6,496-500

[11] Schwartz Z. et al. Effect of Micrometer-Scale Roughness of the Surface of Ti6Al4V Pedicle Screws in Vitro and in Vivo. JBJS 2008; 2485-2498

[12] Vörös J, Wieland M. et al. Characterization of titanium surfaces. Titanium in medicine (ed Springer ISBN 3-54066936-1),p87-144

[13] Wennerberg A. Albrektsonn T.Effect of titanium topography on bone integration : a systematic review. Clin Or. Impl. Res. 2009 ;20(suppl 4) ;172-184

[14] Hansson S. Implant-abutment interface: biomechanical study of fl at top versus conical. Clin Implant Dent Relat Res 2000;2(1):33-41

[15] Norton MR. An in vitro evaluation of the strength of the conical implant-to-abutment joint in two commercially available implant systems. J Prosthet Dent 2000;83:567-571

[16] Norton MR. An in vitro evaluation of the strength of a 1-piece and 2-piece conical abutment joint in implant design. Clin Oral Implant Res 2000;11:458-464

[17] Merz BR, Hunenbart S, Belser UC. Mechanics of the implant-abutment connection: an 8-degree taper compared to a butt joint connection. Int J Oral Maxillofac Implants 2000;15:519-526

[18] Hermann JS, Schoofi eld JD,Schenk RK,Buser D, CochranDL. Infl uence of the size of the microgap on crestal bone changes around titanium implants. A histometric evaluation of unloaded non-submerged implants in the canine mandibular. J Periodontol 2011;72:1372-1383.

[19] Boskaya D,Mütfü S. Mechanics of the tapered interference fi t in dental implants. J Biomech 2003,36:1649-1658

[20] Weng D, Nagata MJ, Bell M, de Melo LG, Bosco AF. Infl uence of microgap location and confi guration on peri-implant bone morphology in nonsubmerged implants: an experimental study in dogs. Int J Oral Maxillofac Implants 2010;25:540-547.

[21] Bateli M, Att W, Strub JR. Implant neck confi gurations for preservation of marginal bone level: a systemic review. Int J Oral Maxillofac Implants 2011;26:290-303

[22] Chu CM, Hsu JT, Fuh LJ, Huang HL. Biomechanicals Evaluation of Subcrestal Placement of Dental Implants: In Vitro and Numerical Analyses. J Periodontal 2011;82:302-310.

[23] Chapotat B, Schneck E. Infl uence de la connectique cône morse dans le maintien des tissus péri-implantaires. Implant 2011 ;17 :203-214

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