The Biocompatibility of a New Type of 45S5 Bioactive Graft in a Sheep Model: A Pilot Study Erhan Okay 1, Ali Can Ozarslan 2, Özgür Başal 3, Hüseyin Cakıroglu 4, Sevil Yucel 2, Korhan Özkan 5, Mahmut Nedim Doral 6 7
- 45S5 biyoaktif greftler, uluslararası tıbbi cihaz standartlarına uygun olarak üretilmiş ve kemik rejenerasyonunu desteklemek amacıyla geliştirilmiştir.
- Koyun modelleri üzerinde yapılan 120 günlük klinik öncesi testler, materyalin biyouyumlu olduğunu ve herhangi bir patolojik reaksiyona yol açmadığını kanıtlamıştır.
- Çalışma sonucunda, bu biyoaktif camın kemik konsolidasyonunu artırdığı ve cerrahi müdahalelerde güvenilir bir dolgu materyali olarak kullanılabileceği doğrulanmıştır.
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Bone Regeneration and the Role of 45S5 Bioactive Grafts
Bone is a highly dynamic tissue with a remarkable capacity for regeneration and healing after trauma. However, extensive damage often requires intensive surgical management and the use of advanced biomaterials to ensure proper recovery. This study focuses on the development and evaluation of 45S5 bioactive grafts designed to enhance the bone repair process.
Production Standards and Regulatory Compliance
The 45S5 bioactive grafts used in this research were prepared using the melt-quenched method. To ensure the highest level of safety and efficacy, the production process strictly adhered to international medical product requirements:
- MDD Regulations: 93/42/EEC Annex-II sections 3 & 4.
- Quality Management: ISO 13485:2016 standards for medical devices.
These rigorous standards ensure that the bioactive materials are suitable for clinical bone regeneration applications.
Methodology: Preclinical Evaluation in Sheep Models
The biocompatibility of the scaffold was evaluated following the comprehensive principles of the ISO 10993 series. The experimental procedure involved creating defects in the tibia of the right hind leg of sheep. The methodology included the following steps:
- Implantation: Defects were filled with 3-mm bioactive granules.
- Control Group: A cylindrical polypropylene biocompatible material was utilized as a negative control.
- Observation Period: The sheep were monitored for 120 days to assess long-term biological effects.
- Analysis: After the period, the tibia were analyzed according to ISO 10993-6 (tests for local effects after implantation).
Results and Histological Findings
The results conclusively demonstrated the safety of 45S5 bioactive grafts. Histological evaluations confirmed that there were no signs of pathological changes within the implant area. Key observations from the Hematoxylin and eosin (H&E) sections included:
| Observation Type | Findings |
|---|---|
| Pathological Changes | None detected around the implant area |
| Cellular Response | Presence of a few multinucleated giant cells and macrophages |
| Surface Interaction | Non-irritant mild fibrotic changes on the biomaterial surface |
Conclusion: Future of Bone-Bonded Materials
In conclusion, 45S5 bioactive glass has proven to be highly biocompatible in a sheep model. The material demonstrates a significant capacity to promote bone consolidation, supported by the formation of a growing bone mineral layer. These findings justify the further development and preclinical application of 45S5 as a reliable bone-bonded material for surgical interventions.
Keywords: bioactive material, biocompatibility, experimental animal model, experimental sheep surgery, preclinical research.
