How does the preclinical testing of dental implants at INNOPROOF work?

Below, we present our capabilities for the preclinical testing of dental implants and related instruments. The most important mechanical test is the fatigue test according to ISO 14801:2017. This testing method can also be adapted for bridge constructions. More information can be found below by clicking on the respective sections. In addition to the ISO 14801 test, we offer accredited torsion tests on dental implants according to ISO/TS 13498.

What about surgical instruments? Are you aware of how long torque wrenches last and how precise the torque display remains after numerous uses? To answer these questions, we provide corresponding accredited tests according to ISO 11953.

If you are interested in tests related to endodontics, please also check our “Surgical Instruments” section, where we offer testing of dental files according to ISO 3630-1.

Please contact us or use the call-back function so we can prepare a tailored offer for you.

The methods accredited within our scope are marked with *.

Procedures for the mechanical testing of dental implantology

  • ISO/TS 13498 Torsionsprüfung enossale Implantate*The torsion test according to ISO/TS 13498 evaluates the torsional strength and maximum torque of implants or articulated connecting components of dental endosseous implant systems. This test is especially suitable for evaluating novel joint types, connectors, and new materials. The test is conducted at room temperature in air and should, as far as possible, simulate the clinical use of the implant. That is, specimens representative of the finished product are tested and sterilized as required according to the manufacturer's instructions.

    The maximum torque is determined on at least six identical specimens by clamping the sample into the testing machine and applying torque at a rate of one to ten degrees per minute. The torsional strength is determined at a rotation angle of 2°. During the test, a curve is recorded showing torque as a function of rotation angle, from which the maximum torque and torsional strength can be graphically determined. Broken or deformed parts of the implant are subsequently examined under a low-magnification microscope and documented in the test report.

  • ISO 14801 Ermüdungsprüfung enossale Implantate* DIN EN ISO 14801 describes a test method for fatigue (failure) of single-piece endosseous dental implants of various sizes and designs. The test should, as far as possible, simulate the clinical use of the implant, meaning that specimens representative of the finished product are tested and sterilized as required according to the manufacturer's instructions. For testing, the specimen is rigidly clamped in the testing machine depending on the design (angled or non-angled abutments) and subjected to a uniaxial load for a defined number of cycles. To create a worst-case scenario, the implant is tilted by 30° during testing.

    Additionally, the critical failure point and location are determined, which characterize permanent deformation, loosening of the implant assembly, or fracture of a component. If the implants contain corrosion-prone components or polymers, testing must be conducted in physiological saline solution at 37°C. For all other implant compositions, testing is performed in air at room temperature. All results are documented in a test report according to the standard.

  • Using this method, we determine the extent of screw loosening at the connection between the implant body and abutment by applying cyclic torsional loading. The loosening torque of the abutment screw is measured both before and after the cyclic loading.

  • The standard ISO 22683 defines test methods to determine the rotational fit (rotational freedom angle) between the implant body and the implant abutment. This ensures that manufacturing tolerances and clinical requirements are met and helps prevent premature loosening of the connection, especially when components from different manufacturers are combined.

  • For the fatigue testing of bridge constructions, INNOPROOF GmbH has established an in-house procedure, as this is currently not covered by international standards. The in-house procedure was developed by the manufacturer Nobel Biocare, Switzerland. The bridge is fixed onto two dental implants, which are embedded in a metal block.

    We offer this testing procedure similar to ISO 14801 tests, conducted in medium at 37°C.

  • DIN EN ISO 11953 describes a test concerning torque wrenches used for placing dental implants. The goal is to check the repeatability of the torque display or the triggering of the torque wrench. The working principle of the torque wrench can be based on various mechanisms, such as a bending beam with a scale display or a ratchet that signals reaching the desired torque by clicking. In clinical practice, the key question for practitioners is how precise the torque values remain after a certain number of uses. With our torque testing setup combined with endurance tests and reprocessing equipment, we simulate these applications in an accelerated timeframe.

  • In addition to testing dental implants, we offer testing methods in the field of tooth preservation. These relate to endodontic instruments and root canal sealing materials. We test the mechanical requirements for root canal instruments according to DIN EN ISO 3630-1 and are accredited for torsional strength and twist angle tests (Section 7.4) as well as bending resistance (Section 7.5). The second part of this standard, DIN EN ISO 3630-2, covers reamers, which are tested for fatigue strength in a rotary bending test. For tooth preservation, we also test root canal sealing materials according to DIN EN ISO 6876. We are accredited for the following procedures: flow, working time, setting time, film thickness, foreign matter, and solubility.