dental 1.3 dental Requirements Flashcards
what is dental materials
substance /s specially prepared for the use of an authorized person in the practice of dentistry and related procedures
requirements of dental materials
knowing dental materials is safe in patients
material can withstand forces of mastication
must be biocompatible or Bioacceptable
what is biomaterial
material designed to be implanted for the repair or replacement of damaged tissue,
it interacts with tissues producing changes in both the material and surrounding tissues,
must be biocompatible
checks required for new products
must be presented to gov agencies don't have adhesive effects materials history chemical composition test for biocompatibleility see if it has a temp or long term contact with body
check for recycled drugs
new ver of old drugs are checked with FDA (federal drug admin)- requires less testing
what is biocompatibility
quality of being Accepted in a specific living environment without adverse side effects
what influences biocompatibility
interactions between materials and body e.g PH, application of force
depends on composition, location and interaction with oral cavity
what is Bioacceptability
quality of which is Tolerable in living environment in spite of some adverse side effects
aims for biocompatibility
no toxins in cells or allergic reactions
division of exposure to toxins
acute- under 24 hours
subacute- repeated 1 month or less
subchronic- 1 to 3 months
chronic longer than 3 months
when did the ADA establish the guidelines for dental materials
1926
in 1972
ADA council of scientific affairs approved of specification no 41
what is The Index of Federal Specifications and Standards
they have specifications that are used to maintain quality control of dental material
2 international organizations that prepare specifications and standards
FDI (Fédération Dentaire Internationale)
ISO (International Organization for Standardization)
who prepares European standards
CEN since 1995
test methods for dental materials
preclinical evaluations of biocompatibility of medical devices in dentistry.
test for biological evaluation
in vitro test
in vivio test
usage test
test for toxins on living organisim
Ad and Disad for in vitro tests
ad-quick to perform, cheapest, can be standardized, large scale screening, great excellence of interaction
Disad- relevance is questionable
Ad and Disad in vivo test
Ad- allows complex systems, responds more comprehensive, more relevant
Disad- expensive, time consuming, ethical concern, difficult to control, difficult to interpret
Ad and Disad of usage test
Ad- relevance to use of the material is used
Disad- all of in vivo but more
usage must be done in conditions the drug would be used in
what is cytotoxicity
access cell death by materials by measuring no of cells before and after exposure to material
tets for cell metabolism
in vitro tets
what is mutagenesis assay
effect of biomaterial on cell gentics
what are implantation tests used for
used to evaluate material that will contact bone
skim sensitization tets
tests for skin hypersensitivity - done by pads
hemolysis assay
tests the materials potential to damage red blood cell membranes
what is a median lethal dose
the amount of test material which lethal in 50% of the infinite population of the test species
