Trueformer-the newest dental implant in the market

Principally dental implants are anchored in bone by means of mechanical connection followed by osseointegration. Implant stability is considered to play a fundamental role in successful osseointegration. Vidyasagar et co. found a 32% implant failure rate implants caused by inadequate initial stability.

Dental implant stability, biomechanical stability, load transfer mechanisms and either success or failure of implants depends on the design parameters: length, diameter, geometry and threads. Bone resorption can be activated by surgical trauma or bacterial infection, as well as by the design parameters used. Masticatory forces acting on dental implants may result in unfavourable stress on the surrounding jawbone, which can cause bone rejection and eventual failure of the implant. A high percentage of bone-implant contact is necessary to create sufficient anchorage of the implant, which is a determinant factor in osseointegration.

Dental implant technology and design must be constantly upgraded, providing patients with ultimate levels of convenience, helpfulness and affordability. For those reasons we decided several years ago to improve implants design. Our concept evaluates design parameters, implantation requirements, bone condition, patient demands. We found a lack in short dental implants design: have same design like long implants with bigger diameter only. Short or narrow implants are preferred for the prosthetic solution of the extremely resorbed alveolar bone areas Specific design for resorbed dental ridges was not found.

Our new designed dental implants –TRUEFORMER-solve major problems in jaw rehabilitation:

– regarding primary stability after insertion of the implant in the edentulous area.

– permit implantation in boneless region of the upper and/or lower jaw.

– reduce surgical time procedures and healing period.

Our specific concept design of TRUEFORMER Implant includes:

TRUEFORMER Description:

The Trueformer Implant system includes root form endosseous dental implants with an expandable element which promotes stabilization of the implant after bone insertion.

The upper part of the implant has and internal hex abutment surface Trueformer Implants are made from titanium alloy with sand blasting surface finish to allow better contact and grip and tissue.

The Trueformer dental implant is similar to other dental implants commercially available in the market in terms of its basic intended use, material, surface, mechanical strength (fatigue) and basic shape.

1. Expandable elements: located in the apical part includes 4 wings like plateaus, one piece with the implant body. The wings are folded into the body of the implant and are deployed after implantation. After implantation they are deployed and opened into the site wall of the prepared bone using a special key provide by our company.

The internal mechanism in the implant body do not permit reverse sliding of the wings fixing the wings into the bone. The expandable element design will cause the tissue to be slightly ‘cut ‘ but will not cause injury.

2. Implant length: and diameter have an influence on the stress distribution at the bone-implant interface, as well as on success rates. Implant dentistry market research has shown that great success rate depends on high implant stability and large bone –implant surface contact. This is why longer implants guarantee better success rates and prognosis than shorter implants with statistically lower success rates due to reduced stability, due to less bone to implant contact and smaller implant surface. OUR SOLUTION: Trueformer 6-8 mm length has an expandable system to increase bone surface contact with the implant and also to provide more stabilization necessary for osseointegration.

3. Implant diameter: it is thought that wider implants allow for interaction with a larger amount of bone and because of this are more stable. OUR SOLUTION: Trueformer has a 3.4 mm diameter and its stability results from enlarged apical surface provided by opened wings into wall bone. A removable torque test cannot “extract” this implant. Narrower diameter implants can be used in small spaces. A primary Trueformer clinical applications: to yield optimal stability and to prohibit over-instrumentation.

4.Material: alloy Ti-6Al-4V (Ti-6 aluminum-4 vanadium), is the first modern material used for TRUEFORMER implants, because it is still one of the most used in contemporary dental implants.

5. Threads: are incorporated into implants and ” improve initial stability, enlarge implant surface area, distribute stress favorably, minimizing the amount of extreme adverse stresses to the bone-implant interface. The thread profile is characterized by the depth, pitch (number of threads per unit length), flank angle, the top radius of curvature, and the straight part at the bottom of the thread.” Pitch threads accentuate the effect of threads and induce a desired biomechanical behavior.

6. Roughness: the implant surface is roughened by projecting hard particles (alumina or TiO2) at high velocities at implants to alter the surface roughness. it improves adhesion, proliferation and differentiation of osteoblasts. The TRUEFORMER is provided in both threaded and a grooved (fmn-type) designs.

7. Finite element analysis: “FEA is becoming a common method in implant dentistry that allows engineers/scientists to study jawbone and implant properties, and bone-implant interface as well as to understand how to improve implant design in order to function within physiological acceptable limits. FEA consists on a computerized three-dimensional model that has been extensively used to predict the characteristics of stress distribution in bone surrounding implants, which are influenced by both the implant dimensions and the biomechanical bond formed between the bone and the implant”. The implant-15 degree abutment fatigue life simulation shows that TRUEFORMER Dental implant would achieve fatigue limit cycle suggested by ISO 14801 at 220N.

8. Sterility: As required for all medical devices provided sterile, the TRUEFORMER will be provided in SAL (Sterility Assurance Level) of 10-6 using Gamma Irradiation VDmax 22.5 kGy Method with accordance to AAMI TIR 33:2005 and in conjunction with ISO 11137-2:2012 for sterilization of healthcare products.

TRUEFORMER Expandable element features:

– provide more stability after insertion which contributes to patient’s safety since it may improve primary retention and stabilization;

-enlarge bone-implant contact, create sufficient anchorage of the implant, which is a determinant factor in osseointegration

-This is thought to be attributed to greater surface area available on non-self-tapping screws due the availability of more threads.

-Increase successful performance of TRUEFORMER due to minimized micromovement of the implant once loaded mechanical considerations must first be taken into account to.

-prevent the tissue from being injured if excessive insertion is unintentionally applied by the dentist during implant placement in the bone, as might occur if the implant has a sharp-edge design.

-apical impenetrable bound sealed the body of the implant.

-expandable system cannot be reopened after implant has been inserted into the bone tissue. The system closes hermetically the body of the implant and block communication between the mouth and inside bone tissue.

TRUEFORMER Intended Use:

It is intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, as a terminal or intermediary abutment for fixed or removable bridgework, and to retain over dentures.

The implants are intended for delayed and immediate implantation after extraction, on single tooth and/or multiple teeth. The implant can be immediate loaded only in delayed implantation (several months after extraction). Prosthetic restorations- crowns, bridges, prosthesis applications- are to be attached to the implant when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

Why we use Trueformer dental implant?

Because:

-Treatment procedure: without any bone augmentation, without any waiting periods, without complex or multiple re-entry procedures, can be used in combination with other implants (for example Trueformer implants in posterior jaw areas and long implants in anterior jaw areas).

-Implant design: external shape of TRUEFORMER with a conical end is similar to the other devices mentioned in this paper. The purpose of the expansion is to receive more initial implant stabilization and better mechanical integration which improve osseointegration

-Surgical procedures: using classical surgical kit and classical protocols followed by activation (opening) of the plateau system.

Prosthetic rehabilitation: similar with other implants using external hex abutment.

-Provide: minimally invasive procedures that offer improved aesthetic results and boast shorter treatment lengths.

The Trueformer design is driven by simplicityits innovation revolves around short implants with an expandable system capable to improve stability of the implant. The new system is simple to implant and dentists can use the same surgical procedure as for classic dental implants.

– Surgical procedures: using classical surgical kit and classical protocols followed by activation (opening) of the plateau system.

– Prosthetic rehabilitation: similar with other implants using external hex abutment.

The Trueformer design is driven by simplicityits innovation revolves around short implants with an expandable system capable to improve stability of the implant. The new system is simple to implant and dentists can use the same surgical procedure as for classic dental implants.

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