Lecture 15 Flashcards
define biocompatilibity?
the ability of a material to do its job without eliciting any adverse affects from the pt
what are the ways to evaluate biocomp.?
- compositional analysis
- surface degradation tests
- cell culture tests
- ex vivo (blood)
- animal models test
- clinical testing in humans
what are the factors biocompatibility depends on?
- chem nature of components
- physical nature of the components
- types and location of pt tissue exposed to a biomaterial
- duration of exposure
- surface characteristics
- amount and nature of eluted substances
define adverse rxn?
any unintended, unexpected, harmful response of the pt to a biomaterial
what is critical adverse effect?
first event that is observed at the lowest exposure level
what is critical tissue/organ
location of the adverse effect
what is critical concentration?
conc that produces the adverse effect
what are the regulatory classes of materials?
class I: low risk (eg. ortho wires)-- do not need 510 (K) submission class II: moderate risk (e.g. bone screws) (need 510 K submission) class III: high risk e.g. drugs
what are potential adverse effects of dental amalgam?
- contact dermatitis or sensitization to metal elements
- lichenoid lesion
- adverse pulpal rxn or sensitivity
- thermal sensitivity (ag transfer heat)
- acute/systemic Hg toxicity
potential adverse effects of resin-based composed?
- contacts dermatitis sensatization to methacrylates
- lichenoid lesion
- estrogenic effects of bis phenol A
- cytotoxicty systemic effect
- systemic effects of free monomer or leaches substance
potential adverse effects of cast metal and condensed foil
- contacts dermatitis sensatization to metals (e.g. Ni, Cu, Be)
- lichenoid lesion
- thermal sensitivity of pulp
- systemic effects of leached metal ions
potential adverse effects of ceramic
- resp effects from silica dust, excessive wear of opposite teeth
- susc. to chipping
define estrogenicity
potential of a chem to act in the body in a manner similar to that of estrogen
define lethal dose fifty
calc. dose of a substane expected to kill 50% of the experimental animal population
what is LOAEL?
lowest observed adverse effect level –> lowest tested dose of a substance that has been reported to cause harmful effects in animals or humans