creos™ syntogain

Biomimetic bone graft substitute for efficient regeneration.¹

A biocompatible synthetic porous (bone) substitute, with a multidirectional interconnected porous structure, similar to that of human cancellous bone, designed for use in periodontal, oral and maxillofacial surgery.

What makes the difference?

creos™ syntogain is the latest generation of synthetic bone graft. Its advanced manufacturing process¹ in an aqueous environment and at low temperature enables to get a bone graft with key differentiators.

Unique round shape of the granules^1,2

Makes it easy to apply in situ.³

Avoids stacking effect.⁴

High-hydrophilicity⁴

Allows an easy hydration and granule handling.³

Non-sintered¹

Micropores and osteoconductivity are not reduced by heat treatment.^5,6

UNIQUE COMPOSITION OF THE MATERIAL^1,7,8

80% of Calcium Deficient Hydroxyapatite (CDHA) and 20% of BTCP (beta-tricalcium phosphate).

MICROSCOPIC SURFACE MADE OF NANOCRYSTALS^1,9

High specific surface area^1,10,11 and high microporosity^1,12.

BONE STABILITY^1,2

The bone is stable and it maintains the volume of the defect starting from day one, based on clinical case series^1,13

Advanced manufacturing process¹

IT'S BIOMIMETIC^1,7,8

creos syntogain advanced manufactured process enables to get a unique composition of the material that mimics human bone that is also made of CDHA.^1,7,8

The closer a material resembles human bone, the better it is for bone formation.¹⁴

Traditional calcium phosphate (HA / B-TCP) synthetics
High-temperature manufacturing process: passivates materials and reduces the potential of the host to interact with it.

creos syntogain biomimetic calcium phosphate (CDHA / B-TCP)
Low-temperature manufacturing process: hydroxyapatite crystals grow slowly to mimic the structure and composition of human bone.

High specific surface area^1,10,11

Thanks to the biomimetic manufacturing process, hydroxyapatite crystals grow on the surface of the granules. This increases the surface area and enables cell attachment for the bone generation.¹²

The specific surface area was measured by nitrogen adsorption

Pore entrance size distribution associated to the nano-, micro- and macrostructure in CDHA (1.): Barba et al 2016

High nano-/microporosity^1,12

A nano-/microporosity similar to the natural bone’s structure allows good inflow of blood, cell colonization and reliable bone formation.

The solution mimics the natural porosity of bone.¹²

creos™ syntogain demonstrated non-inferiority when compared to the reference DBBM in terms of dimensional preservation of the alveolar ridge

In one of the largest randomized clinical trials (RCT) performed in dental bone regeneration¹⁵, 102 patients were randomized to receive bone augmentation using creos syntogain or the reference deproteinized bovine bone matrix (DBBM). Six months post grafting, the mean bone change in width and height was respectively -1.78% and 1.35% for creos syntogain (n=42) and -2.16% and 2.99% for the reference DBBM (n=41). The differences between the two materials were not statistically significant. The mean implant insertion torque was 36.2 Ncm at sites regenerated with creos syntogain and 35.1 Ncm at sites regenerated with the reference DBBM. For creos syntogain, 71.1% of the implants were placed with an insertion torque above 35 Ncm and 62.8% for the reference DBBM.

The bone is stable and it maintains the volume of the defect.² When compared to reference product (DBBM), no statistically significant difference in the vertical and buccolingual dimensional change has been observed.¹⁵

Dimensional variation of the alveolar ridge at 6 months post bone grafting: measurements were made on CBCT, based on anatomical reference points (sinus floor or mandibular canal).

Implant stability and insertion torque: measured at the time of implant placement, 6 months post bone grafting. NobelParallel™ CC implant was used.

creos syntogain Instructions For Use

Important information on, and instructions for, creos syntogain.

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Questions about creos syntogain?

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When is creos syntogain used?

The solution is able to cover indications from the most common to the most challenging.

Further indications may include:

Vertical and horizontal ridge augmentation

Bone dehiscences and fenestrations around implants

Resources

Clinical case

Horizontal GBR with simultaneous implant placement in anterior maxillary teeth by Dr. Ginebreda

EDUCATION

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References

See Instructions For Use for full prescribing information, including indications, contraindications, warnings and precautions.

1. Hoornaert A, Maazouz Y, Pastorino D, et al. Vertical Bone Regeneration with Synthetic Biomimetic Calcium Phosphate onto the Calvaria of Rats. Tissue Eng Part C Methods. 2019 Jan;25(1):1-11. doi: 10.1089/ten.TEC.2018.0260. PMID: 30501579.

2. Raymond Y, Pastorino D, Ginebreda I, et al. Computed tomography and histological evaluation of xenogenic and biomimetic bone grafts in three-wall alveolar defects in minipigs. Clin Oral Investig. 2021 Dec;25(12):6695-6706. doi: 10.1007/s00784-021-03956-y. Epub 2021 May 1. PMID:33931811.

3. Data on file: Granules handling Voice of Customer from 2017-2018 + GKEM Handling Questionnaires Results from 2022.

4. Data on file: Milestone 2 report (chapter 2.5.1)

5. Henkel KO, Gerber T, Lenz S, Gundlach KK, Bienengräber V. Macroscopical, histological, and morphometric studies of porous bone-replacement materials in minipigs 8 months after implantation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Nov;102(5):606-13. doi: 10.1016/j.tripleo.2005.10.034. Epub 2006 May 19. PMID: 17052636.

6. Weibrich G, Trettin R, Gnoth SH, et al. Bestimmung der Größe der spezifischen Oberfläche von Knochenersatzmaterialien mittels Gasadsorption. (Alternate title: Analysis of the size of the specific surface area of bone regeneration materials by gas adsorption). Mund Kiefer GesichtsChir (2000) 4:148-152 Springer-Verlag 2000.

7. Barba A, Diez-Escudero A, Espanol M, et al. Impact of biomimicry in the design of osteoinductive bone substitutes: nanoscale matters. ACS Appl. Mater. Interfaces 2019. DOI:10.1021/acsami.8b20749.

8. Data on file: Mimetis XRD analysis report using the RIR quantification method. Medical device composition certificate.

9. Barba A, Diez-Escudero A, Maazouz Y, et al. Osteoinduction by foamed and 3D-printed calcium phosphate scaffolds: effect of nanostructure and pore architecture. ACS Appl. Mater. Interfaces 2017.DOI:10.1021/acsami.7b14175.

10. Sadowska JM, Guillem-Marti J, Montufar EB, Espanol M, Ginebra MP. * Biomimetic Versus Sintered Calcium Phosphates: The In Vitro Behavior of Osteoblasts and Mesenchymal Stem Cells. Tissue Eng Part A. 2017 Dec;23(23-24):1297-1309. doi: 10.1089/ten.TEA.2016.0406. Epub 2017 Feb 21. PMID: 28107811.

11. Data on file: Milestone 2 study (page 18)

12. Ginebra MP, Espanol M, Maazouz Y, Bergez V, Pastorino D. Bioceramics and bone healing. EFORT Open Rev 2018;3 DOI: 10.1302/2058-5241.3.170056.

13. Data on file: Clinical cases from 2022.

14. Rufino Senra M, de Fátima Vieira Marques M. Synthetic Polymeric Materials for Bone Replacement. J. Compos. Sci. 2020,4, 191;doi:10.3390/jcs4040191.

15. Ginebra Cairó I., Roig Cayón M., Velasco-Ortega E. et al., Biomimetic synthetic bone graft in alveolar ridge preservation: 1-year RCT results, Abstract N°EAO-647 EAO Geneva 2022.