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The Trefoil™ system: Genesis of a project

by: Dr. Kenji W. Higuchi

A look behind the scenes at the origin and development of what may be the next big thing in implant dentistry.

The Trefoil system
Dr. Kenji Higuchi

Dr. Kenji W. Higuchi is a Diplomate of the American Board of Oral and Maxillofacial Surgery. He is widely respected in academic circles and recognized as an early pioneer in the field of osseointegration. Dr. Higuchi has authored or co-authored 36 publications in the implant literature and has lectured internationally for the past 30 years.

He holds Fellowships in the American Association of Oral and Maxillofacial Surgeons, the American and International Colleges of Dentists, and the Academy of Oral-Facial Rehabilitation.

He is also the driving force behind the highly anticipated Trefoil system.

At the recent Nobel Biocare Global Symposium in New York, the Trefoil system was introduced to an international audience. This treatment approach offers the possibility of same-day rehabilitation of the edentulous mandible or a failing dentition in the lower jaw with a definitive implant supported prosthesis. The use of an innovative compensation mechanism incorporated into a prefabricated framework, which allows adjustment to a precision fit on three implants, makes the Trefoil system unique.

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To help fellow human beings

I was fortunate to have experienced a long and close relationship with Professor Per-Ingvar Brånemark. Since attending the first international training course in August 1982, I had the privilege of collaborating with P-I for over 32 years.

On the occasion of his 70th birthday in Gothenburg, he made the following observation: “The concept of osseointegration has developed into as much a philosophy as a technique for rehabilitation.” (P-I Brånemark, May 3, 1999.)

Over several decades I observed P-I and Barbro Brånemark travel the globe in order to provide care to hundreds of patients suffering from acquired or congenital craniomaxillofacial defects, something they did without direct financial compensation.

Their humanitarian motivation was inspired by a compassion “to help fellow beings.” From the beginning, Brånemark exhibited an empathetic sensitivity for the edentulous patient, whom he considered comparable to an amputee.

Brånemark recognized the high global incidence of edentulism and the universal problem of affordability for implant rehabilitation. In 1999, as a potential solution for this predicament—as well as an expression of the philosophy of osseointegration—he introduced Novum, which was the forerunner and progenitor of the Trefoil concept.

Initially Brånemark referred to Novum as the “China Bridge” imagining the large number of patients throughout the world who could benefit if costs and duration of treatment were reduced. Novum was a pioneering landmark using immediate loading of implants combined with analog-guided surgery.

Favorable short-term results of implant and prosthesis survival rates were reported by multiple centers; however a concerning incidence of post-surgical prosthetic complications was also documented. These restorative problems, coupled with the unforgiving nature of the surgery, resulted in a decision by Nobel Biocare to discontinue Novum in 2007.

Early thoughts on misfit

Professor Brånemark emphasized the absolute need for precision in the Novum system. Guided implant placement is associated with varying degrees of implant misalignment, which interfered with the effective use of prefabricated frameworks in the past.

Based upon positive clinical results with over 70 patients treated using the Novum procedure in my private practice and similar experiences from other surgeons—including Dr. Ruben Rosenberg in Santiago, Chile—it became clear that the unforgiving surgical requirements of Novum and the high incidence of post-surgical restorative problems being reported were often related to misfit between the prefabricated framework and the three misaligned implants.

The dental implant literature documents that screw loosening and screw and framework fracture occur at a higher rate as a consequence of misfit. It was my belief that if a standardized mass-produced adjustable framework could be devised in conjunction with updated component design changes, the goal of providing more affordable full-arch implant-supported treatment could be realized.

Related article: Trefoil™ – A full-arch restoration with adaptive joints

The Trefoil system: collaborative innovation

Over a four-year period, 2012-2016, the Trefoil team implemented an intense process of collaborative innovation, which included multiple engineers and clinical specialists. The Trefoil team focused on rectifying the deficiencies of Novum using engineering and clinical technology not available in the mid-1990s.

By the early spring of 2015, the present Trefoil framework with three internal compensation mechanisms was developed and tested over a period of 70 weeks. This groundbreaking adjustable framework has the capability of correcting meaningful horizontal, vertical and angular misalignment of the three implants placed with guided surgery to achieve a precise fit.

This collaborative development required three years of bi-weekly meetings during which 25 framework iterations and over 100 component design changes were evaluated.

An international 5-year multicenter post market trial commenced in April 2016. By the end of December 2016, completed enrollment of 90 patients in the study is anticipated. To date, excellent early results have been reported in this prospective longterm study.

The use of innovation is the lifeblood of any medical device company and necessary for the advancement of healthcare. A successful innovation involves a new idea, device or method and must satisfy specific needs of the market. In the field of implant rehabilitation, the most common roadblock to proceeding involves the high financial cost of care. This reality of life has restricted the number of patients able to afford treatment.

The Trefoil system embodies the Nobel Biocare objective, “to treat more patients better,” by offering a reduction in cost using a simplified clinical work flow, a standardized prefabricated framework, and minimized componentry that reduces treatment time.

A brand-new approach

The Trefoil system was conceived and developed to extend the benefits of osseointegration to a new patient population. The Trefoil system is not intended to replace any of the current edentulous solutions presently available, but offers a more affordable premium alternative for an entirely new patient population instead.

Appropriate clinical treatment should involve patient-specific planning. This system is consistent with the “philosophy of osseointegration” and our common healthcare goal of addressing the needs of the many.

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