Adverse Rxn to Dental Materials Flashcards
What does the clinician expect of their dental materials?
Ease of use Appropriate physical/mechanical properties Cost effective biomaterials and devices Efficacy Safety - for the pt and the dental team
What is meant by safe?
Biomaterial materials do not irritate the surrounding structures, do not provoke an inflammatory response, do not incite allergic reactions and do not cause cancer
Types of toxicity?
Cytotoxicity/genotoxicity/mutagenicity/carcinogenicity/
neurotoxicity/
Types of allergic reactions?
Immediate (type 1)
Delayed (type 2)
What did a case study find on adverse reactions to biosynthetic hyaluronic acid gel?
3% of pts experience allergic reactions to implanted bovine collagen
HYA is believed to be non-immunogenic
Case study pt developed allergic type reaction after 3rd tx
Not known if this reaction to a modified HYA or a contaminant
= CASE STUDIES FREQUENTLY PROVIDE LITTLE/NO INFO REGARDING LIKELIHOOD OR NATURE OF ADVERSE EVENT
Allergic reactions and adverse reactions evidence?
Most studies = case reports
Care reports are at best based on patch testing for allergens, but often lack detailed investigation
Some adverse rxns are a response to the physical form of a material
Local inflam is a normal reaction to common degradable medical polymers and some biological materials (not allergic reaction) - can be chronic in some cases
How have synthetic biomaterials failed?
Chronic inflammation
Foreign body response to physical presence of particulate debris (irritant)
Amalgam disease?
Dental amalgam contains mercury (Hg) = toxic metal
Accumulation of higher concentrations of Hg in the body associated with specific clinical symptoms
Human expose to Hg is inevitable
Some believe Hg in dental restorations = amalgam illness or disease
How common are real adverse reactions to biomaterials?
Generally allergy rates are increasing
Innovation means dental materials are increasing in range and complexity
Exposure increases risk
Adverse reaction reporting project findings?
Rubber products most common
Clincial has greater risk of developing an adverse reaction than a pt
Exposure increases the risk associated with any one material
Adverse reactions are uncommon and not of a serious nature
Why are dental materials so safe given their hazardous contents?
Risk reduction
- European regulations = pre-market testing and CE mark
- Improved packaging
- Non-contact operative techniques = no drip packaging
- Post market surveillance = early warnings of previously unsuspected adverse reactions - can identify factors associated with adverse reactions
Pre-market testing
- Test determined by evaluation of risks associated with the materials and its clinical application
- Tests include cytotoxicity, haemolysis, irrigation, systemic toxicity and genotoxicity
What is the CE mark?
Enables goods to be sold throughout the EEA
The result of a risk management exercise including scientific, pre-clinical and sometimes clinical testing
