EBD II Flashcards

1
Q

How can biomaterials be classified?

A

MART

By material
By application
By risk
By tissue interaction

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2
Q

Examples diff types materials

A

Polymers - denture bases/ impression material
Ceramics and glass
Composites

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3
Q

What factors are considered when thinking about risk?

A

Risk of type of exposure -
surface/skin contact, blood contact?
Risk length exposure - temporary, days, permanent

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4
Q

What are categories of risk?

A

I- low
II - intermediate
III - high risk

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5
Q

Why is a dental implant IIb?

A

Higher risk as contact with bone

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6
Q

What are ways of testing biocompatibility?

A

In-vitro - cell-free model
In-vivo- testing in animals
Clinical testing and trial. (pre-market)
Post-market surveillance

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7
Q

Why are biocompatibility test important?

A

Lead to process of awarding CE mark

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8
Q

What is used for post-market surveillance?

A

Adverse reaction reporting project

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9
Q

Adv and disadv of in-vitro testing?

A

Adv: rapid, cost-effective, reproducible, ethically non-controversial
Didadv: poor model of complex situation

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10
Q

Adv and disadv in-vivo testing?

A

Adv: whole complex animal model
Disadv: expensive, ethical controversy, not always reliable model of human body

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11
Q

What is often required by law when testing biocompatibility?

A

In vivo-testing

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12
Q

Adv and disadv clinical trials?

A

Adv: humans used
Disadv: expensive, ethical issues, may not represent real clinical practice

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13
Q

Why may clinical trials not represent general practice?

A

Specialist clinicians often used
Pt selection
Time/financial restraints vary

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14
Q

Adv of post-market surveillance?

A

Can provide early warning of hazzard/ side effects
Can highlight rare adverse reactions
Strengthen evidence base

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15
Q

Is post-market surveillance required by law?

A

Yes- implementation can be hard

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16
Q

Is pre-market testing required by law?

A

Yes for all new biomaterials

17
Q

What tests are used in pre-market testing

A

Cytotoxicity, haemolytic, irritation, systemic toxicity, genotoxicity

18
Q

What are in-vitro conclusion of titanium compatibility?

A

Surface biocompatible
Readily colonised by osteoblast
Rough modified surface superior in term of cell response

19
Q

What are in-vivo conclusion of titanium compatibility?

A

HaP superior to titanium alloy in terms of osteointegration

20
Q

Key points remember about material safety?

A

No amount testing guarantees absolute safety

No material risk free