Introduction
Biocompatibility of Dental Materials
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Biomaterial: A (nonviable) substance utilized in a medical device, purposed to interact with biological systems.
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Host Response: The response from a living organism to the introduction of a material.
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Biocompatibility (or Biological Performance): The capability of a substance to function cohesively with an appropriate host response in a specific situation.
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Toxicity: The ability to damage a biological system by chemical means [12••].
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Cytotoxicity: The ability of a substance to harm or kill cells by disrupting their function or causing cell death.
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Health Effects: Consequences of substance exposure, including local reactions (due to substances, bacteria, or physical stimuli), systemic toxicity (adverse reactions away from the application site), and other effects, like allergies, which can occur at lower substance concentrations than systemic toxicity.
Testing for Biocompatibility
In Vitro Testing for Biocompatibility
In VivoTesting for Biocompatibility
Clinical Testing for Biocompatibility
Threshold Values in Biocompatibility
Examples in Biocompatibility of Dental Materials
Toxicity of Dental Materials
Health Effects and Toxicity
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Local reactions: These are caused by the release of substances, bacterial presence, or mechanical/physical stimuli.
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Systemic toxicity: This refers to adverse reactions occurring distant from the application site.
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Allergies and others: This encompasses various health effects. Interestingly, a difference between systemic toxicity and allergies and others is based on the concentration of the substance to induce adverse effects. Allergic effects require less doses to induce health effects, than the systemic toxicity.
Testing Toxicity
Testing Toxicity Today
Threshold Values in Toxicity
Examples in Toxicity of Dental Materials
Toxicity of Dental Alloys
Toxicity of Dental Polymers
Toxicity of Dental Composite Resins
Toxicity of Dental Ceramics
Nanoscience and Toxicity of Dental Materials
Regulations of Medical Devices
Product description | Class | Comments | |
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Adhesives | IIa | Rule 8 | Placed “in teeth” |
All-ceramics | IIa | Rule 8 | |
Alloys (for crowns, bridges, inlays, prosthetics) | IIa | Rule 8 | |
Bone replacement materials | IIa IIb | Rule 8 Rule 8 | Not resorbable Resorbable |
Dental implants and abutments | IIb | Rule 8 | Long-term use, not placed “in teeth” therefore not class IIa |
Dental implants, biological coated | III | Rule 8, 3rd indent | If biological action is claimed |
Filling materials (composite, glass-ionomer-cements, ceramic inlays, galvano inlays) | IIa IIa | Rule 8 Rule 19 | If nanomaterial, internal exposure negligible |
Materials for guided tissue regeneration | IIb IIb | Rule 8 Rule 9 | Not resorbable Resorbable |
Suture materials | IIa III | Rule 7 Rule 7, 14 or 18 | Not resorbable Resorbable |