The nextfull-arch revolution

Trefoil™

nobelbiocare.com

A revolutionary fixed solution to treat more patients better

Nobel Biocare has led innovation in full-arch solutions for over 50 years. By continually challenging existing treatment methods we aim to drive efficiency and make high-quality implant treatment a viable choice for more patients.

The Trefoil system is a breakthrough in efficiency for treating the mandible. Using a pre-manufactured bar with a unique fixation mechanism, it can adjust to compensate for inherent deviations from the ideal implant position. This is a new fixed solution for definitive teeth in one day.*

*Depending on clinician preference and close cooperation with the laboratory.

The Trefoil Bar is delivered pre-assembled

PATENT PENDING for fixation mechanism

More patients benefit from a fixed solution

Removable overdentureLocator®, Ball abutments, ERA

Removable overdentureBars

Trefoil™ All-on-4® treatment concept

Other fixed, implant supported options

Low cost / versatility High cost / versatility

Removable Fixed

Mandible & Maxilla Mandible Mandible & Maxilla

Treating more patients better – a broader portfolio of fixed treatment solutions

The Trefoil system offers a high-quality efficient fixed solution for more edentulous patients and patients with failing dentition.

“The Trefoil system embodies the Nobel Biocare objective – treat more patients better. With this improved efficiency comes the opportunity to bring the benefits of osseointegration to a whole new patient population.”Dr. Kenji Higuchi, US

Several studies confirm implant-assisted complete prostheses are more advantageous than conventional dentures. The benefits of fixed solutions can outweigh the cost of a fixed-removable for many patients when considering implant-supported solutions.

Fixed solutions offer:1

Ϩ improved function with a higher bite force

Ϩ better retention and stability

Ϩ avoidance of some disadvantages of removable solutions including more mucosal problems and the wear of components.

As an elective surgery, clinicians must take into account many patient preferences and circumstances.

A breakthrough in workflow efficiency

An innovation in comparison to the conventional treatment method that brings new efficiencies at almost every step – from manufacture of components to definitive restoration.

The Trefoil system can offer reduced chair time and shorter time-to-teeth compared to conventional treatment by combining:

Ϩ A pre-manufactured definitive bar

Ϩ A prosthetic workflow

Ϩ An acrylic prosthesis

Ϩ Reduced restorative componentry

Estimation of active working time based on median time observed in clinical use.

6HOURS

Prosthodontist

Surgeon

Lab

*Data on file from use by experienced clinicians and labs.

Definitive teeth in a day*

Dental implant patients are increasingly demanding immediate restorations.2,3

To meet those demands, dental professionals are seeking solutions with fewer surgical steps, shorter treatment time, high success rates, high patient satisfaction and function on the day of surgery.2,3

The Trefoil system is a cost-efficient solution that allows Immediate Function and makes fixed and definitive teeth on the day of implant surgery* an option for more patients.

*Depending on clinician preference and close cooperation with the laboratory.

Definitive teeth in

1day*

*Depending on clinician preference and close cooperation with the laboratory.Conventional treatment: in cases where bone grafting needs to be performed, the total treatment time may take up to nine months. The comparison above demonstrates possible treatment methods with approximate treatment times.

Shorter time-to-teeth: the Trefoil system enables a fixed and definitive prosthesis to be placed up to six months earlier than conventional treatments with provisional prosthetics.

1 day*

Trefoil™

Implant placement and fixed definitive restoration in one visit.*

Conventional treatment

Implant placement: implants and provisional denture are placed.

Fixed and definitive restoration is placed.

1 day*

3 - 6 MONTHS

Straightforward prosthetic workflow

*Depending on clinician preference and close cooperation with the laboratory.**Data on file from use by experienced clinicians and labs.

Straightforward prosthetic workflow

The Trefoil Bar simplifies the creation of the definitive acrylic prosthesis and saves substantial time for the restorative clinician and the lab.

The Trefoil system’s unique fixation mechanism compensates for deviations in implant placement. With passive fit possible for a pre-manufactured bar, there is no need for CAD/CAM and chair time is reduced.

Prosthodontist

1 hour

Surgeon

2 hours

Lab

3 hours

Estimation of active working time based on median time observed in clinical use.**

Reduced chair time and restorative work

The restorative workflow is simplified thanks to the pre-manufactured bar. An experienced clinician and lab will require approximately six hours of active working time.

The first pre-manufactured bar with a passive fit

The ingenious fixation mechanism is a breakthrough in treatment for treating the mandible.

The pre-manufactured bar, anatomically designed for the natural arch of the mandible, contains adaptive joints that adjust to compensate for horizontal, vertical and angular deviations from the ideal implant position.

Angular deviation ±4.0° Horizontal deviation ±0.4 mm Vertical deviation ±0.5 mm

Proven strength when pushed to the limit4

The Trefoil system maintains its strength when pushed to the extreme of its compensation capability. In fact, tests prove almost no difference in fatigue limit when the maximum configuration is applied compared to when there is none.

150

200

250

300

350

No compensation(n=6)

Med

ian

Fati

gue

Lim

it

Maximum compensation(n=6)

p = 0.292

Patent pending for fixation mechanism

Each mechanism has five self-adjusting joints that help correct the position of the pre-manufactured bar, enabling the passive fit of the definitive prosthesis.

The first pre-manufactured bar with a passive fit

The Trefoil™ Implant

Machined tissue collar for easy access

The prosthetic platform is placed at soft tissue level, which allows easy access and leaves the soft tissue undisturbed throughout the entire workflow.

High implant survival with TiUnite

The TiUnite implant surface is proven for high survival rates and low prevalence of peri-implantitis, as shown by the largest ever study of a single implant brand.6

Conical connection for compatibility

The proven conical connection platform ensures compatibility with the Trefoil implants using the current prosthetic offering.

An integral part of the Trefoil system is the Trefoil Implant. It combines the proven5 parallel-walled implant design, a machined soft tissue collar and a conical connection.

The Trefoil™ PureSet

Organized to save your time

The Trefoil system also introduces a new high-grade stainless steel tray to support your dedication to uncompromising hygiene. The Trefoil PureSet surgical tray is designed for reuse in clinical environments, and keeps your components organized to save you time. Instruments stay together throughout cleaning and sterilization.

Clinical case: Mandibular full-arch restoration using the Trefoil system

Clinical case summary

Case description: Mandibular edentulism Patient: Male, 77 years old, hypertension, atrial fibrillation, medication -Warfarin Clinical situation: Failing lower dentition Surgical solution: Trefoil™ Restorative solution: Restorative solution includes a temporary maxillary denture and the Trefoil protocol for the mandible. Surgery date(s): August 24, 2017 Total treatment time: 24 hours

A/Prof. Glen Liddelow BDSc, MScD, DClinDent Prosthodontist, Perth, Western Australia Surgery and Prosthetics

Michael Standish CDT Perth, Western Australia Laboratory procedures

Mandibular residual ridge. Pre-treatment panoramic radiograph.

Initial clinical situation

Preparation of the central implant site. The central implant is inserted using the Positioning template.

Implant placement

The central implant is in position.

All three Trefoil Implants CC RP with 4.5 mm collar are in place.

Verification of implant placement

The Transfer Abutments and a non-engaging temporary abutment are placed to construct the verification index. The Transfer Abutments are luted with light-cured resin to fix the verification index.

Placement of the Healing Abutments. The site is sutured.

Impression for verification index Tissue site preparation

“The Trefoil system provides an outstanding option for the edentulous patient and will provide an affordable, quality solution.”Dr. Glen Liddelow, Australia

Conventional wax-up and processing for a wrap-around hybrid acrylic / titanium fixed prosthesis.

Conventional wax-up and processing for a wrap-around hybrid acrylic / titanium fixed prosthesis.

Delivery of the final bridge on the day of surgery. Occlusion is checked for even contact and anterior guidance. Accessibility for cleaning is verified and screws are tightened to 35 Ncm. Access holes are sealed with Teflon and composite.

Happy patient after the treatment.Post-op radiograph.

Completed prosthesis with polished rounded intaglio surface to facilitate cleaning.

Final prosthesis.

Laboratory procedure

Clinical case: Mandibular full-arch restoration using the Trefoil system

See the full clinical case on nobelbiocare.com/trefoil

Verifying the fit of the Trefoil bar. Fixation ofthecompensationmechanism can be either laser welding or resine. The bar shown here is laser welded.

Articulation of the bar to the opposing arch may be done in a traditional way using a wax rim on the bar or with a cut out duplicate denture prosthetic guide.

Treatment success

In an ongoing five-year, multi-center study across four continents, results are already being reported for implant and prosthetic survival rates.5

This important study7 has now expanded to include 110 patients at the request of participating clinicians to meet the needs of their patients.

5years

4continents

110patients

Dr. Kenji Higuchi, United States

Dr. Rubén Rosenberg, Chile

Dr. Rubén Davó, Spain

Prof. Dr. Massimo Albanese, Italy

Dr. Glen Liddelow, Australia

Treating more patients better with a more affordable solution

For edentulous patients and patients with a failing dentition, a removable implant-supported solution may offer a lower price compared to a fixed prosthesis. However, more aspire to a fixed prosthesis, proven to significantly improve their quality of life.8

As one study 8 shows, patients hoping for a fixed solution but only receiving a fixed removable are dissatisfied with their treatment outcome.

For patients held back by finances from their treatment of choice, the Trefoil system offers a faster and more affordable fixed treatment solution.

References

1. Emami E et al. Implant-assisted complete prostheses. Periodontol 2000. 2014 Oct;66(1):119-31. doi: 10.1111/prd.12041.

2. Chung S, McCullagh A, Irinakis T. Immediate loading in the maxillary arch: evidence-based guidelines to improve success rates: a review. J Oral Implantol 2011;37:610-621 https://www.ncbi.nlm.nih.gov/pubmed/22004059

3. Romanos G, Froum S, Hery C, Cho SC, Tarnow D. Survival rate of immediately vs delayed loaded implants: analysis of the current literature. J Oral Implantol 2010;36(4):315-24. https://www.ncbi.nlm.nih.gov/pubmed/20735268.

4. Carretta R, Geisendorf M, Spinnler A, Heuberger P, Higuchi KW, Brunski JB. A Novel Prefabricated Final Fixed Solution for the Edentulous Mandible. J Dent Res 96(Spec Iss A):3348, 2017 (www.iadr.org).

5. Higuchi K. et al. An adaptive prefabricated full-arch framework on three implants in the mandible- preliminary results. Oral poster presenta¬tion accepted to be presented at the 26th Annual Scientific Meeting of the European Association for Osseointegration. Saturday 7th October, 2017. IFEMA Feria de Madrid, Spain.

6. Karl, M. and Albrektsson, T. Clinical performance of dental implants with a moderately rough (TiUnite) surface: A meta-analysis of prospective clinical studies, Int J Oral Maxillofac Implants. 2017 Jul/Aug;32(4):717-734. doi: 10.11607/jomi.5699.]

7. Clinicaltrials.gov. The TREFOIL concept 5-year clinical investigation (NCT02940353). https://clinicaltrials.gov/ct2/show/NCT02940353. Accessed June 22, 2017.

8. Allen PF, McMillan AS. A longitudinal study of quality of life outcomes in older adults requesting implant prostheses and complete removable dentures. Clin Oral Implants Res. 2003 Apr;14(2):173-9.

nobelbiocare.com/trefoil

GMT 63127 GB 1906 © Nobel Biocare Services AG, 2019. All rights reserved. Nobel Biocare, the Nobel Biocare logotype and all other trademarks are, if nothing else is stated or is evident from the context in a certain case, trademarks of Nobel Biocare. Please refer to nobelbiocare.com/trademarks for more information. Product images are not necessarily to scale. Disclaimer: Some products may not be regulatory cleared/released for sale in all markets. Please contact the local Nobel Biocare sales office for current product assortment and availability. For prescription use only. Caution: Federal (United States) law restricts this device to sale by or on the order of a licensed dentist. See Instructions for Use for full prescribing information, including indications, contraindications, warnings and precautions. As such, provided patient criteria are met and adequate primary stability is achieved, Nobel Biocare implants allow a fixed provisional restoration to be loaded on the day of surgery