Bio Vitality Dental: ISO 10993-3 Mutagenicity Test
Consolidated report summary: AMES-PH-24/0562.
Consolidated report summary: AMES-PH-24/0562.
Consolidated report summary
This page covered the same source and has been consolidated into the analysis below. Its original URL remains available.
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Perguntas Frequentes
What is the mutagenicity test and why is it important for dental resins?
The mutagenicity test evaluates a substance's ability to cause changes in DNA, which can lead to genetic mutations and, potentially, diseases like cancer. For dental resins, it is crucial that they are non-mutagenic, as they will be in prolonged contact with oral tissues. Smart Print Bio Vitality has been tested and proven non-mutagenic, ensuring patient safety and compliance with international biocompatibility standards.
Which international standards were followed in the mutagenicity test of Smart Print Bio Vitality?
The Smart Print Bio Vitality test followed the rigorous standards ISO 10993-3 (evaluation of genotoxicity, carcinogenicity, and reproductive toxicity), ISO 10993-12 (sample preparation), ISO/TR 10993-33 (guidance for genotoxicity tests), and OECD guideline n°471 (bacterial reverse mutation test). Compliance with these standards ensures the scientific validity and global acceptance of the results.
What does it mean for the test to have been performed 'in the absence and presence of metabolic activation'?
It means that the test evaluated the resin's mutagenic potential under two conditions: directly (in the absence of metabolic activation) and after being processed by the body (in the presence of metabolic activation, simulated by S9-mix). This ensures that the resin does not cause mutations either by itself or after being metabolized, covering a complete spectrum of safety. Smart Print Bio Vitality has proven safe under both conditions.
What is the importance of using different extraction vehicles (NaCl and Cottonseed oil) in the test?
The use of different extraction vehicles, such as saline solution (0.15M NaCl) and cottonseed oil, simulates different scenarios of material contact with the body. NaCl represents an aqueous environment, while oil simulates a lipophilic environment. This ensures that any potentially mutagenic substance present in the resin is extracted and tested, regardless of its solubility, reinforcing the comprehensiveness and reliability of the Smart Print Bio Vitality test.
How do the results of the Smart Print Bio Vitality mutagenicity test impact the clinical practice of dentists?
For dentists, the results confirm that Smart Print Bio Vitality is a biocompatible and safe material, minimizing risks of adverse reactions or genetic damage to patients. This allows the resin to be used with greater confidence in various applications, such as surgical guides, models, and temporaries, contributing to the safety and quality of treatments in digital dentistry.
What are the Salmonella typhimurium his- and Escherichia coli WP2(uvrA-)(pKM101) strains used in the test?
These are mutant bacterial strains, specifically developed for the Ames Test. Salmonella typhimurium his- is unable to produce histidine, and Escherichia coli WP2(uvrA-)(pKM101) is unable to produce tryptophan. They only grow in a medium without these amino acids if they undergo a reverse mutation. The absence of extra growth in the Smart Print Bio Vitality test indicates that it does not induce these mutations.
What is the relevance of GLP (Good Laboratory Practice) certification for this study?
GLP (Good Laboratory Practice) certification ensures that the study was planned, executed, monitored, recorded, archived, and reported in accordance with rigorous quality principles. This guarantees the integrity, reliability, and traceability of the generated data, making the results of the Smart Print Bio Vitality test acceptable to regulatory authorities worldwide.
Where can I purchase Smart Print Bio Vitality resin and what is its cost?
The Smart Print Bio Vitality resin can be purchased directly from the Smart Dent online store. The current price is R$ 1859. For more details and to purchase, visit: loja.smartdent.com.br/resina-smart-print-bio-vitality. Invest in a material with proven safety for your procedures.
Besides mutagenicity, what other properties of Smart Print Bio Vitality make it ideal for dentistry?
Beyond mutagenicity, Smart Print Bio Vitality also stands out for its nanohybrid technology with Advanced Nanosilicate Particles, offering high flexural strength (147 MPa), flexural modulus (5490 MPa), and excellent radiopacity (1.048 mm Al). These physical-mechanical properties, according to ISO 4049, ensure durability, dimensional stability, and precision for various clinical and laboratory applications.
What are the implications of a material being considered 'non-mutagenic' for the longevity of restorations and prostheses?
A 'non-mutagenic' material significantly reduces the risk of adverse biological reactions in surrounding tissues over time. This contributes to the longevity and clinical success of restorations and prostheses, as it minimizes the chance of chronic inflammation, irritation, or other complications that could compromise the integrity of the work and the patient's health. The safety of Smart Print Bio Vitality is a key factor for clinical durability.