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3DKF Report Summary

Project ID: 719985

Periodic Reporting for period 1 - 3DKF (PIX DENTAL SYSTEM: FEASIBILITY STUDY)

Reporting period: 2016-03-01 to 2016-08-31

Summary of the context and overall objectives of the project

7 out of 10 adults have lost at least one permanent tooth to an accident, gum disease, a failed root canal or tooth decay, and tooth loss increases with age. To replace a tooth, general dental practitioners (GDPs) can offer a traditional resin-bonded restoration (called a dental bridge) or a tooth implant. Although both are viable solutions, tooth implants are better than a bridge; as installing a bridge means grinding down adjacent teeth to use as anchors to form the bridge and hold up the false tooth, which leads to jaw bone decay 10 years down the road). Implementing an implant or Implantology consists of fixing an artificial root on the jawbone to hold a prosthesis, at no damage to the bone and which simply needs to be replaced regularly. However, complications in implant surgery can occur, due to improper planning and incorrect implant placement. This leads to aggravated pain and discomfort, a long recovery and significant (unpredictable) expenses incurred by the patient, in addition to stress for the GDP. Relying on 3D imaging technology and advanced software, as well as surgical guides, Image Guided Surgery Software for implantology has made the practice much more predictable. But in spite of its fundamental advantages and the tremendous progress achieved in dental implant surgery in the past 25 years, currently available guided surgery software that form the core of Implantology continue to have limitations that restrict its use significantly.
3DKreaform has developed an entire system : Pix Dental System (PDS) is an solution to perform image-guided surgery for Implantology. PDS provides unprecedented accuracy that guarantees results, whilst removing the need for decades of expertise, collaborative features to enable cross-disciplinary online collaboration, delivered through and a very competitive pay per use pricing model.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Our goal is, now, to extend our market to Europe and many countries all over the world.
During this European phase one, we have conducted test trials in 4 european countries to validate our business model. We have validated our price list and thanks to our customer’s feedback during test-trials, here are the improvements we have made on Pix Dental System:
• Pix model envelope
Pix model envelope is a design software and file generation for pre-surgical model for the design and manufacture of dental prosthesis before the clinical phase. Files are generated with the same accurate precision as Pix Surgery.
For this software, we have improved indexing algorithm.

We have designed a model with Indexation (indexation is useful and mandatory when implants are strongly inclined between each other). The special abutment is not straight and therefore must be placed in a fixed position around its axes. Otherwise the prosthesis could not be positioned. The difficulty is to position the implant in the right position as the one decided during the planning and used to build the prosthesis that is why we have add arrow in the software which correspond to the small nick on the printed model

• Nano Pix Marker
In order to facilitate the use of our Pix Markers, we have reduced them.
So it is easier now, for the practitioner, to put it in a mouth.
We have also enhanced the use of PixMarker for full edentulous cases. The protocol became to fix PixMarker on the duplicate of the prosthesis. We also have adapted the size as shown in the picture below

• New Pix Tray
As our system is to be use by many GDPs, we have seen they have different types of Cone-beam. And some of it have a little field.
So sometimes, if the practitioner pays not enough attention, the 3D file obtained does not contain all the 3 Pix Markers and we cannot realize the data merging. We have improved ours Pix Trays to be sure to have the 3 Pix Markers in the field and put these Pix Markers inside the Pix Trays.
More, we have designed two types of Pix Trays, one for maxillary and one for mandible

• Software improvement
a) Pix project in English
In order to proceed to our international development, we have translated our project manager software.

Note: PDS was already in English at the beginning of phase1

b) Pix surgery
- We have improved merging algorithm.
- We have made functionality improvements on workflow fluidity.
- We added functionality improvements, with special regard to the selection, display and positioning of abutments by anticipating the position of the prosthesis and available soft tissues to anticipate the shape of the prosthesis for manufacturing prior to surgery.
- We have improved our software in order to add many surfaces.
The practitioner can see more details and can better prepare surgery and prosthesis

- We have developed a viewer
Our practitioners wanted to see their planning once it was validated without the possibility to modify it and for two main reasons:
To see it before or during surgery in order to remember their planning
To share this planning with other professionals (laboratory, for example)
So we have developed a new version of our software for that.
• New services
a) Do it 4 me
During our test-trials, some practitioners said us they have no time and no value to do themselves the merging and planning. So, we have created “Do it 4 me”, a new service allowing the practitioner just to validate our merging and planning for guide design and manufacturing.

b) Starter-Box
Practitioners wanted a “kit” to begin with our solution. So, we have developed our “Starter-Box” with everything necessary for practitioners to obtain correct 3D files and be sure to obtain after that a very precise guide.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

3DKF addresses the needs of the GDPs (practitioners, clinics and laboratories, as well as mutual insurance companies).
Why are users interested now? The aging population engenders a longer consumption of products, and because seniors wish to age well, it leads to an increasing interest in self-perception, thus to more investment in dental restoration. In addition, better dental hygiene has led to a decrease in demand for basic healthcare, for the benefits of implantology. This factor is correlated with the emergence of low-cost dental centres, with dentists who have stopped performing basic health care services to focus on implants, which are more durable investments. Indeed, the new generation of GDPs entering the market are seeking to offer better, cutting edge services and build long-lasting relationships with their customers and who typically follow a specialised training in implant surgery (at some point in their career); and will try implant surgery with the help of surgical guides as they exhibit higher skills levels.
Impacts for each group
GDPs: 50% reduction in surgery time duration and operating stress reduction. Our system allows an increased competence.
Safety: reassuring operative solution and predictable aesthetic
Comfort: quick intervention, less post medication, no oedema, less stress and less time, pain duration reduced by 60% et Resumption of daily life 3 times faster
Investment: Predictable cost
Treatment: precise placement increase ability to place implant in sites with little quantity of bone.
Civil society: reduction and cost containment
Measures to maximise impact.
a. Dissemination and exploitation of results: As mentioned, 3DKF seeks to reach customers/end-users through B2B2B relationships.3DKF has a competitive advantage over other companies and our clients will be committed to our service.
Dissemination. 3DKF will undertake several complementary actions in order to maximise its market success. These are structured across 3 lines. First, it will maintain a close relationship with Implantology or Odontology professors. 3DKF currently has prominent ambassadors within dental sector in France who are actively involved in regularly testing our solution and that we have called to guarantee our solution. Second, in the scientific world and particularly in dental care sector, scientific publications on a product are very important for a good market penetration and they are a good way to increase the brand’s notoriety. Finally, as already mentioned above, 3DKF will take active part in several high-level congresses to maximise its outreach, by organising workshops and seminars which will also provide the opportunity to our re-sellers and distributors to perform joint targeted marketing and communication actions.
3DKF will take active part in the most important fairs in our field.

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