Scientific information

Introduction

The company works under strict ISO 13485:2016 medical devices quality system and operates within the framework of a controlled production environment. The conformity assessment procedure of bonyf products was carried out according to the rules of the Medical Device Directive 93/42/EEC.

OlivaFix First generation safety and performance evaluation

OlivaFix was developed with the user safety in mind and therefore undergoes strenuous biocompatibility testing before being brought to the market according to the norms (EN ISO 10993-5) and (EN ISO 10993-10). Cytotoxicity of OlivaFix was assessed according to ISO 10993-5 standard. Our results showed that this product is not cytotoxic. In addition, irritation and sensitization assays were performed according to ISO10993-10. OlivaFix did not induce irritant and sensitizing effects. All these tests were performed at a renowned laboratory situated in France.

A study was conducted in 2018 by Dental Advisor (USA) on the OlivaFix "first generation" which was evaluated by 28 consultants after 302 uses. Results showed that OlivaFix "first generation" is easy to use, effective, and has an excellent grip and a long adhesion. The product was confirmed to be natural, showed a good patient acceptance and was therefore nominated as "2018 Top Award Winner".(1) OlivaFix was developed with the user safety in mind and therefore undergoes strenuous biocompatibility testing before being brought to the market according to the norms (EN ISO 10993-5) and (EN ISO 10993-10). Cytotoxicity of OlivaFix was assessed according to ISO 10993-5 standard. Our results showed that this product is not cytotoxic. In addition, irritation and sensitization assays were performed according to ISO10993-10. OlivaFix did not induce irritant and sensitizing effects. All these tests were performed at a renowned laboratory situated in France.

A study was conducted in 2018 by Dental Advisor (USA) on the OlivaFix "first generation" which was evaluated by 28 consultants after 302 uses. Results showed that OlivaFix "first generation" is easy to use, effective, and has an excellent grip and a long adhesion. The product was confirmed to be natural, showed a good patient acceptance and was therefore nominated as "2018 Top Award Winner".(1)


ghraph-1.jpg  awarded.jpg



olivafix-gold-new-GOLD-color.png

The new generation clinical performance evaluation

Based on the characteristic performance of OlivaFix "first generation" tested by professionals of one of the most recognized US dental magazines "Dental Advisor" and tests conducted by an independent German laboratory, we are eager to inform you about OlivaFix® Gold.

Two studies were conducted by Dermatest GmbH (Germany) to evaluate the safety and performance of OlivaFix® Gold on denture wearers.

The first study was conducted on 20 healthy subjects and showed that the holding time of OlivaFix® Gold exceeds the 24h for full upper dentures. The results showed also that all participants tolerated OlivaFix® Gold very well during the course of the three-day application test under dermatological and clinical control. No adverse reactions were observed.

A second study, was conducted by Dermatest GmbH to confirm the holding time with 5 healthy subjects. The findings of this study confirmed that OlivaFix® Gold hold for up to 24 hours when the instructions of application are followed properly.



Why ORGANIC Extra Virgin Olive Oil ?

- Preservatives and additives free. - GMO-free (Genetically Modified Organism free).

Benefits of Extra Virgin olive oil in our newest formulation

  • Characteristics

Virgin olive oil, the most valuable olive oil category, is highly appreciated around the world for its healthy properties due to the presence of monounsaturated fatty acid (oleic acid) and antioxidant compounds (phenols, tocopherols, and chlorophyll pigments). (2)

Extra virgin olive oil (EVOO), produced exclusively by physical processes, contains high concentrations of antioxidants, mainly phenolic compounds.

  • Benefits

EVOO has been shown to possess antioxidant, antimicrobial, and anti-inflammatory properties, in vivo and in vitro. (3, 4)

  • Antioxidant activity

The health benefits of the phenolic compounds in olive oil include their antioxidant activity, which is related to the capacity to protect DNA, proteins, and lipids from damage caused by exposure to Reactive Oxygen Species (ROS). (5)
High consumption of extra-virgin olive oils rich in phenolic antioxidants (as well as squalene and oleic acid) afford considerable protection against cancer (colon, breast, skin), coronary heart disease, and ageing by inhibiting oxidative stress. (6)
Several epidemiological studies have demonstrated beneficial effects of olive oil ingestion on oxidative stress–related diseases, including cardiovascular diseases (5), cancer (7) and rheumatoid arthritis. (8)

  • Antibacterial activity

Olive oil phenolic compounds have antimicrobial properties by denaturing bacterial proteins and inactivating enzymes. (9, 10, 11)
Phenolic compounds in olives and olive oil such as oleuropein, hydroxytyrosol, vanillin, and aliphatic aldehydes have the ability to inhibit or delay the growth of a range of bacteria and fungi. (12)

  • Anti-inflammatory properties

Evidence has shown that regular consumption of foods rich in phenolic compounds may
decrease the risk for the development of chronic diseases. (13,14)



References

1. Dental Advisor. Clinical Evaluation of Olivafix.; USA 2017.
2. Tena N, Wang SC, Aparicio-Ruiz R, García-González DL, Aparicio R. In-depth assessment of analytical methods for olive oil purity, safety, and quality characterization. J Agric Food Chem. 2015;63(18):4509-4526. doi:10.1021/jf5062265.
3. Cicerale S, Conlan XA, Sinclair AJ, Keast RSJ. Chemistry and Health of Olive Oil Phenolics. Crit Rev Food Sci Nutr. 2008;49(3):218-236. doi:10.1080/10408390701856223.
4. Cicerale S, Lucas L, Keast R. Biological Activities of Phenolic Compounds Present in Virgin Olive Oil. Int J Mol Sci. 2010;11(2):458-479. doi:10.3390/ijms11020458.
5. Fki I, Sahnoun Z, Sayadi S. Hypocholesterolemic effects of phenolic extracts and purified hydroxytyrosol recovered from olive mill wastewater in rats fed a cholesterol-rich diet. J Agric Food Chem. 2007;55(3):624-631. doi:10.1021/jf0623586.
6. Owen RW, Giacosa A, Hull WE, et al. Olive-oil consumption and health: the possible role of antioxidants. Lancet Oncol. 2000;1:107-112. http://www.ncbi.nlm.nih.gov/pubmed/11905662. Accessed November 3, 2017.
7. Pelucchi C, Bosetti C, Negri E, Lipworth L, La Vecchia C. Olive oil and cancer risk: an update of epidemiological findings through 2010. Curr Pharm Des. 2011;17(8):805-812. http://www.ncbi.nlm.nih.gov/pubmed/21443483. Accessed November 1, 2017.
8. Berbert AA, Kondo CRM, Almendra CL, Matsuo T, Dichi I. Supplementation of fish oil and olive oil in patients with rheumatoid arthritis. Nutrition. 2005;21(2):131-136. doi:10.1016/j.nut.2004.03.023.
9. Rawel HM, Meidtner K, Kroll J. Binding of Selected Phenolic Compounds to Proteins. J Agric Food Chem. 2005;53(10):4228-4235. doi:10.1021/jf0480290.
10. Ortega-García F, Blanco S, Peinado MA, Peragón J. Polyphenol oxidase and its relationship with oleuropein concentration in fruits and leaves of olive (Olea europaea) cv. “Picual” trees during fruit ripening. Tree Physiol. 2008;28(1):45-54. http://www.ncbi.nlm.nih.gov/pubmed/17938113. Accessed November 3, 2017.
11. Cushnie TPT, Lamb AJ. Antimicrobial activity of flavonoids. Int J Antimicrob Agents. 2005;26(5):343-356. http://www.ncbi.nlm.nih.gov/pubmed/16323269. Accessed November 3, 2017.
12. Bisignano G, Tomaino A, Lo Cascio R, Crisafi G, Uccella N, Saija A. On the in-vitro antimicrobial activity of oleuropein and hydroxytyrosol. J Pharm Pharmacol. 1999;51(8):971-974. http://www.ncbi.nlm.nih.gov/pubmed/10504039. Accessed November 3, 2017.
13. Tresserra-Rimbau A, Guasch-Ferré M, Salas-Salvadó J, et al. Intake of Total Polyphenols and Some Classes of Polyphenols Is Inversely Associated with Diabetes in Elderly People at High Cardiovascular Disease Risk. J Nutr. 2016;146(4):767-777. doi:10.3945/jn.115.223610.
14. Tresserra-Rimbau A, Rimm EB, Medina-Remón A, et al. Inverse association between habitual polyphenol intake and incidence of cardiovascular events in the PREDIMED study. Nutr Metab Cardiovasc Dis. 2014;24(6):639-647. doi:10.1016/j.numecd.2013.12.014.