ISO/TS 11405:2015
Dentistry — Testing of adhesion to tooth structure
ISO/TS 11405:2015 gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A.
ISO/TS 11405:2015 does not include requirements for adhesive materials and their performance.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sampling
5 Test methods
5.1 Bond strength tests
5.1.1 General
5.1.2 Tooth substrate and storage
5.1.3 Treatment of results
5.1.4 Tensile bond strength
5.2 Gap measurement test for adhesion to dentine
5.2.1 General
5.2.2 Tooth substrate and storage
5.2.3 Cavity preparation
5.2.4 Filling procedure
5.2.5 Storage of specimen
5.2.6 Gap measurement
5.3 Microleakage test
5.3.1 General
5.3.2 Tooth substrate and storage
5.3.3 Cavity preparation
5.3.4 Filling procedure
5.3.5 Storage of specimens
5.3.6 Measurement of microleakage
5.3.7 Treatment of results
5.4 Clinical usage tests
5.4.1 Introduction
5.4.2 Method
5.4.3 Restorations
5.4.4 Study duration
5.4.5 Sample size
5.4.6 Clinical procedures
5.4.7 Evaluation
5.4.8 Treatment of results
Annex A (informative) Examples of test methods for measurement of bond strength
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Sampling
5 Test methods
5.1 Bond strength tests
5.1.1 General
5.1.2 Tooth substrate and storage
5.1.3 Treatment of results
5.1.4 Tensile bond strength
5.2 Gap measurement test for adhesion to dentine
5.2.1 General
5.2.2 Tooth substrate and storage
5.2.3 Cavity preparation
5.2.4 Filling procedure
5.2.5 Storage of specimen
5.2.6 Gap measurement
5.3 Microleakage test
5.3.1 General
5.3.2 Tooth substrate and storage
5.3.3 Cavity preparation
5.3.4 Filling procedure
5.3.5 Storage of specimens
5.3.6 Measurement of microleakage
5.3.7 Treatment of results
5.4 Clinical usage tests
5.4.1 Introduction
5.4.2 Method
5.4.3 Restorations
5.4.4 Study duration
5.4.5 Sample size
5.4.6 Clinical procedures
5.4.7 Evaluation
5.4.8 Treatment of results
Annex A (informative) Examples of test methods for measurement of bond strength
Bibliography