Safety and Clinical Efficacy of Dental Materials Quiz

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What is the purpose of in vitro assays in dental materials testing?

To assess materials at the cellular level (correct)

To test materials in small animals

To conduct tests on humans directly

To evaluate materials using larger animals

Which animals are typically used in secondary tests for dental materials?

Pigs

Monkeys (correct)

Dogs

Rabbits

What determines the number of tests needed in dental materials testing?

The geographical location where the tests are conducted

The phase of testing and material elimination (correct)

The cost of conducting each test

The size of the animal used in testing

What type of tests are conducted in in vivo usage tests for dental materials?

Tests for dermal irritation and bony implantation Signup and view all the answers

Which organization's approval is needed to conduct in vivo usage tests on humans for dental materials?

Food and Drug Administration (FDA) Signup and view all the answers

What type of test involves applying materials in animals as they would be applied to a patient?

In Vivo Tests Signup and view all the answers

Which material was found to have the most severe inflammatory reaction?

The silicate Signup and view all the answers

What was the reaction level for the composite material?

Moderate to slight Signup and view all the answers

Which material had little or no effect?

The ZOE Signup and view all the answers

What is the purpose of the references provided in the text?

All of the above Signup and view all the answers

Which of the following is NOT mentioned as a key reference in the text?

Sakaguchi and Powers (2012) Signup and view all the answers

What is the main focus of the text?

Comparing the inflammatory reactions of different dental materials Signup and view all the answers

What is the main purpose of postmarket surveillance?

To monitor the safety and performance of dental materials after they are introduced to the market Signup and view all the answers

What do the ISO 7405 and ISO 10993 standards cover?

Biological evaluation of dental materials and medical devices Signup and view all the answers

What is the purpose of the four levels of testing described in the ISO 7405 standard?

To evaluate the cytotoxicity, tissue compatibility, and safety of new dental materials Signup and view all the answers

What is the primary responsibility of a dental material manufacturer when selecting tests for biological evaluation?

To select the appropriate tests based on the intended use and known/assumed toxicity of the material Signup and view all the answers

Why is it important to consider the manufacturer's stated use for the material when evaluating test results?

To interpret the test results in the context of the material's intended use Signup and view all the answers

What is the importance of following strict guidelines and humane animal use ethics when conducting in vivo testing on dental materials?

To minimize the suffering of animals used in the testing Signup and view all the answers

According to the cell culture tests, which material had the most severe effect on cultured cells?

ZOE (zinc oxide eugenol) cement Signup and view all the answers

At the 30-day observation point in the implantation test, which material caused a more severe reaction than silicate cement?

ZOE (zinc oxide eugenol) cement Signup and view all the answers

Which statement is true about the inflammatory reactions at 90 days in the implantation test?

ZOE and silicate caused slight reactions, while resin composite caused a moderate reaction Signup and view all the answers

In the usage test, where the materials were evaluated in class V cavity preparations, how did the results compare to the other evaluation methods?

The results were quite different from the other methods Signup and view all the answers

Which of the following evaluation methods was NOT used in this study?

Clinical trial Signup and view all the answers

In the implantation test, at what time point could the reactions NOT be determined?

7 days Signup and view all the answers

What is a limitation of human clinical trials mentioned in the text?

No histology is performed Signup and view all the answers

Why are teeth from young orthodontic patients considered for usage tests?

They have open apices Signup and view all the answers

What type of animals are typically chosen for usage tests?

Dogs, monkeys, and sheep Signup and view all the answers

What is a major disadvantage of animal tests based on the text?

Difficult interpretation, high cost, and ethical concerns Signup and view all the answers

Why are animal models with anatomy similar to humans preferred for usage tests?

To ensure clinical relevance Signup and view all the answers

What can be impossible to evaluate from clinical symptoms alone in human clinical trials?

Pulp damage Signup and view all the answers