Predicting Biocompatibility Flashcards
Incidence adverse reactions in dentistry?
Low - despite dental materials having hazardous components
Why are incidence adverse reaction so low?
Materials tests for safety/ efficacy prior release on market
How is risk classified?
I = low II = intermediate III = high
What is risk based on?
Type exposure - surface, indwelling, blood
Length exposure - <24 hours, days, permanent
What does classification of risk determine?
Tests need to be carried out to obtain evidence gain CE mark
What is risk?
Possibility of +1 outcome from given set of circumstance
What does ALARP mean?
As low as reasonably possible
What is biocompatibility?
Ability of a material to perform in specific application w/ appropriate host response
What is law for dental materials?
Pre-market testing
What tests are used for dental materials?
Cytotoxiciity Haemolysis Irritation Systemic toxicity Genotoxicity
What parts of material are tested?
Material, its components and extracts
Difference between in vitro and in vivo testing?
In vitro = cell-free models
In vivo = cell testing
Adv and disadv in vitro testing
Adv = cheap, quick, reproducible, ethically straightforward Disadv = poor model complex being
Adv and disadv in vivo testing?
Adv = whole animal model Disadv = expensive, reproducibility, ethical debate, not always reliable model
Adv and disadv clinical trial?
Adv = humans used Disadv = expensive, risks, ethical issue, not always real representation
