Why is MimetikOss UNIQUE?

MimetikOss Granules is the only synthetic graft with statistical data demonstrating equivalence to gold standard Geistlich's Bio-Oss

Synthetic Bone Grafting is a highly diverse field where a deep knowledge of the technology, processing and design of bone grafts is required to discern and spot the differences among commercial products. Clinicians are trained in bone grafting, but differentiating a good bone grafting from an excellent one can be a challenging task! This is the reason why all dental and maxillofacial surgeons involved in the design of this solution decided to pursue the ultimate test a Randomized Controlled Trial able to correctly, statistically evaluate the efficacy of MimetikOss versus the control group, gold standard in this field: Geistlich's Bio-Oss.
The study presented hereunder is of special relevance considering very few synthetic grafts reached this level of clinical evidence. Most of synthetic materials as of today do not compete with alofenic or xenogenic solutions in terms of clinical performance, but rather are presented as second-level options for simple, safe regeneration cases such as sinus lifts for instance. MimetikOss aims at performing at least as well as animal-derived solutions via mimicking the mineral phase of bone synthetically.

Design of the Randomized Controlled Trial

The objective is to assess the efficacy of MimetikOss in an alveolar ridge preservation procedure followed by the placement of an implant and its prosthesis. The following hypothesis were used: 

  • H0: The performance of MimetikOss is equivalent to the one of Bio-Oss after ridge preservation procedure
  • H1: The performance of MimetikOss is interior to the one of Bio-Oss after ridge preservation procedure
The summarized surgical protocol was:
  • Extraction of the tooth if the patient meets inclusion criteria
  • Alveolar preservation with a bone graft
  • (6 months) Biopsy extraction during implant placement
  • (6-18 months) Implant stability follow-up
The Outcomes measured were:
  • The ridge dimensional changes (horizontal and vertical) between implantation time and implant placement (6 months)
  • The bone vertical level
  • Implant stability (ISQ, Osstel)
  • Histologial and histomorphometric evaluation
The radiological analysis has been realized by Dr Hans-Göran Grondahl, Emeritus Professor of the University of Lund, Malmö Dental School, Sweden.
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MimetikOss is not a usual synthetic bone graft. Check yourself:

SEM Scanning Electron Microscopy image of a Regular synthetic product processed at high temperature

SEM Scanning Electron Microscopy image of a Biomimetic synthetic MimetikOss processed at low temperature (<200ºC)

Results of the Randomized Controlled Trial

The bone volume preservation, measured by micro-CT is the most critical and the most clinically-relevant outcome. The results of this measurement show that MimetikOss and Bio-Oss lost 1,78% and 2.16% respectively in ridge width over 6 months while they gain 1.35% and 2.99% respectively in ridge height.

The statistical analysis of these results leads to the conclusion that Bio-Oss and MimetikOss have equivalent performance in terms of height and width preservation. 

This conclusion is extremely relevant, as no other synthetic biomaterials so far had reached this milestone of volume preservation comparable to that of Bio-Oss, in a statistically meaningful trial.

 

The histomorphometric evaluation of the biopsy taken prior to implant placement, 6 months after implantation of the graft in the socket, led to interesting results. Indeed, the proportion of hard tissue, computed as the sum of newly formed bone and remaining biomaterial, was higher for MimetikOss compared to Bio-Oss. After 6 months, this result has shown statistical significance. Consequently, the proportion of Stroma is inferior for MimetikOss compared to Bio-Oss and also statistically significant. This could explain that primary outcome result: the excellent volume stability as measure by micro-CT.

Again, this results shows that MimetikOss is the first synthetic graft with a competitive clinical performance compared to Bio-Oss.

 

In terms of implant insertion and stability, both the ISQ and the Implant Insertion Torque have similar, non-statistically significant value for both MimetikOss and Bio-Oss.

Again, this result further supports the equivalence in terms of clinical performance and outcome between MimetikOss and Bio-Oss.

 

Conclusion

The statistical analysis of these results leads to the conclusion that Bio-Oss and MimetikOss have equivalent performance in terms of height and width preservation.​

HOW DOES MIMETIKOSS COMPARE TO SYNTHETIC GRAFTS?

Synthetic bone grafting hasn’t historically reached the expectations of the dental surgeons. The gold standard is and remains the xenograft Bio-Oss from Geistlich for many reasons including predictability and volume preservation. This is why we designed a synthetic bone graft, based on more than 20 years of Research and Development at the Polytechnical University of Catalonia, Barcelona, Spain, using Bio-oss as the reference point.

Still, many clinicians, in quest of understanding, ask us how to compare MimetikOss to regular synthetic products. First and foremost, MimetikOss uses a biomimetic technology, meaning its processing steps does not involve high-temperature processing. MimetikOss’ structure is unique, as it mimics the nano-, micro- and macro features of natural bone. Manufactured in a humid, low-temperature environment, the crystals grow into plat-like aggregates of calcium-deficient hydroxyapatite. The same hydroxyapatite as other synthetic? Absolutely not!

All material identified as relevant players in the sythetic market are composed of sintered calcium phosphate phases such as hydroxyapatite or beta-tricalcium phosphate. Becuse of the high-temperature treatment, the structure of the graft, especially its nano- and micro- structure and thus, properties, do not replicate the natural physiological bone structure. This leads to a graft being degraded chemically, via a progressive dissolution in the surgical site. MimetikOss is manufctured below 200ºC and replicates well the structure ant composition of the natural bone. This leds to the graft being recognized as natural bone by the bony cells and progressive remodelling and coupled new bone formation.

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3rd Generation Synthetic Grafts

Artoss

BoneCeramic

MaxResorb

Ethoss

Biomietic Synthetic

4th Generation Synthetic Grafts

MimetikOss

FAQ

What’s so special about MimetikOss?

MimetikOss is the first synthetic bone graft that actually works, not only better than older generation synthetics but also as well as Bio-Oss.

Why would I choose MimetikOss?

  • Unlike any other synthetic product, it is manufactured hydrothermally, which gives it the capacity to mimic the natural bone mineral structure and composition. Consequently, it triggers bone cells to recognize it as natural bone.
  • The shape of the granules allows extremely high adsorption of proteins and cell adhesion. This is thanks to the high nano-, micro- and macro-porosity and hight specific surface area of the material.
  • The fact that the granules are highly porous results in significant support of the vascularization process and consequently, the growth of new bone.
  • MimetikOss helps achieve quick bone regeneration, leading to highly vascularized bone tissue.
  • MimetikOss integrates exceptionally well with the surrounding soft tissue, avoiding soft tissue inflammation.
  • MimetikOss does not stack with time, meaning it will always maintain a high bone volume even after a long period of time. Additionally, there is no need to over-packing at the time of implantation, to make up for potential volume loss.
  • On X-ray, MimetikOss looks as radiopaque as natural bone. The reason for that is its similarity in structure and composition.

Questions about Nanobone

ArtOss has a high performance thanks to its nanostructure.

MimetikOss has micro, nano, and macro-porosity . The nanostructure has a needle-like shape, characteristics of biomimetic calcium deficient hydroxyapatite

References: Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al. Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

ArtOss allows rapid bone formation and complete remodeling.

The rapid bone regeneration is also accompanied by an inflammatory response

Questions about Boneceramic (Straumann- Switzerland)

Boneceramic is bifunctional.

Thanks to its composition, MimetikOss is osteoconductive1,2  thanks to its calcium phosphate aspect being enhanced with CDHA 

Boneceramic has an optimized morphology.

Thanks to its granular shape and biomimetic composition, MimetikOss allows maintaining the volume of the defect since day 1, giving high predictability on the clinical the outcome

A nano-, micro- and macro-porosity similar to the natural bone’s structure allow good inflow of blood, cell colonization and reliable bone formation. The solution mimics the natural porosity of bone

References: 

Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

 
 

Boneceramic is safe and biocompatible.

Thanks to its synthetic nature, MimetikOss is equally safe and biocompatible. 

Boneceramic has a homogeneous composition.

MimetikOss is made of 80% Calcium deficient hydroxyapatite (also named biomimetic hydroxyapatite) and 20% Beta Tricalcium Phosphate

Questions about MBCP+ (Biomatlante- France)

MBCP+ is osteoconductive

Thanks to its composition and production process, MimetikOss is osteoconductive.

 References:

 Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

 

 

 

MBCP+ molecular mixture is 20% HA and 80% TCP.

MimetikOss’ composition is 80% Calcium deficient hydroxyapatite (also named biomimetic hydroxyapatite) and 20% Beta Tricalcium Phosphate

MBCP+ has a 70% porosity, with an interconnected network of macropores and micropores

MimetikOss has a nano-, micro- and macro-porosity similar to the natural bone’s structure allow good inflow of blood, cell colonization and reliable bone formation. The solution mimics the natural porosity of bone.

 

 References:

 Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

 

 

 

MBCP+ allows volume Stability

Thanks to its granular shape and biomimetic composition, MimetikOss allows maintaining the volume of the defect since day 1, giving high predictability on the clinical the outcome.

References:

 Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

 
 

MBCP+ has an efficient architecture

Thanks to the biomimetic manufacturing process, hydroxyapatite crystals grow on the surface of the granules, allowing to achieve a high specific surface area and a high level of multiscale porosity. 

 

 

Biomatlante has a clinical experience of +30 years

MimetikOss is the fruit of 20 years of research.

MBCP+ is safe

As is MimetikOss, being synthetic

 

Questions about MagnetOs (Kuros Biosciences)

Magnetos is autoclaved at 135ºC for 99 min to achieve the sub-micron scale surface topography (Method described by Kokubo et al)

MimetikOss is not sintered at high temperatures. Instead, it is manufactured hydrothermally in order to achieve the production of a bone graft that’s similar to the bone mineral structure and composition, resulting in a specific surface area that is way higher than any sintered product.

-The consequence of treating the material in the way stated by EthOss, is that it is only the surface that is elaborated with a biomimetic approach (with composition and microstructure very similar to MimetikOss) however, the core of the material is still a classical sintered biphasic product. –

 

References:

Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

2 Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

 

 

MagnetOs has a Specific Surface Area = 2.77 m2/g

MimetikOss has a specific Surface Area MimetikOss = 9.861 m2/g

-Higher Specific Surface Area means higher protein adhesion and cellular exchange, leading to a higher vascularized bone, therefore stronger bone. –

 

Questions about EthOss

EthOss is a combination of 65%Tricalcium Phosphate and 35% Calcium Sulphate.

MimetikOss has a structure similar to the natural bone1,2 : it is 80% biomimetic calcium-deficient hydroxyapatite (CDHA)

20% biomimetic beta-tricalcium phosphate (β-TCP) 

-The composition of the bone graft Biphasic 65% b-TCP / 35% Calcium sulfate, it’s a cement (2nd generation). There is no novelty for this material as it has not changed in 30 years.-

 

 

EthOss comes in a syringe applicator, in two sizes: 0.5cc and 1cc.

MimetikOss Granules is readily available in (1 cc for now, and starting Q4 2021, 0.5cc, 1cc, 2cc, 5cc, 10cc) the granules sizes, being: 

S (0.2 – 1 mm) 

M (1 – 2 mm)

-When a bone graft comes in the form of a paste (that sets after implantation), it can only be used for indications with a well defined defect, like a four- wall defect. This limits the indications.

 
 

 

EthOss can achieve 50% of bone (histology) after 12 weeks.

There is no statistical support for this claim. The quote is from one clinical case. 

While MimetikOss’ fastest re-entry has been at 8 weeks, it is not a significant piece of data. The reason is that bone regeneration capacity is shorter or longer depending on the age and health status of the patient.

 
 
 

 

Ethoss has got several publications that prove the efficacy of the product.

All Ethoss publications are done by Peter Fairbairn. He’s the founder, member of the board and majority partner of EthOss, which is usually a conflict of interest for such publications (being the only ones Ethoss has done) 

 

 


EthOss has osteoinductive properties

We failed to find any support for this claim.

MimetikOss has solid proof on the osteoinductive properties of the material

References:

Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189

 Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs – Clinical oral implant research_Publication submitted, under review

Ethoss have a pre-clinical study in rabbit calvaria (the only publication presenting statistical results) where they have a control (empty defect), Bio-oss and EthOss. They measure the newly formed bone (BV/TV) and what they obtain is (mean): Ethoss 33.70 Bio-Oss 24.07 Control 27.36

We did not find any statistical difference between the groups, nor the difference between using EthOss and nothing at all. 

 

 

Questions about Maxresorb


Maxresorb composition is 60% hydroxyapatite (HA) and 40% beta-tricalcium phosphate (β-TCP).

MimetikOss is make of 80% biomimetic calcium-deficient hydroxyapatite (CDHA) and 20% biomimetic beta-tricalcium phosphate (β-TCP)

 
 

 

 

 

 

 
 
 

 

The peculiar composition of Maxresorb® promotes the fast formation of new vital bone, ensuring a long-term mechanical and volume stability.

MimetikOss promises volume stability based on clinical validation: 

Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Alain Hoornaert et al.  Tissue Engineering Part C: Methods, Mary Ann Liebert, 2019, 25 (1), 10.1089/ten.tec.2018.0260.hal-02103189