Biodentine

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Summary Introduction ................................................................................................................................................................. 4 ❶ Active Biosilicate Technology ............................................................................................... 5 1.1 - Setting reaction ..................................................................................................................................................... 6 1.2 - Formulation of Biodentine ...................................................................................................................... 7 ❷ Physico-chemical features ............................................................................................................... 8 2.1 - Setting Time ............................................................................................................................................................. 8 2.2 - Density and Porosity ...................................................................................................................................... 10 2.3 - Compressive strength .................................................................................................................................. 11 2.4 - Flexural strength ................................................................................................................................................ 12 2.5 - Vickers micro hardness ............................................................................................................................... 12 2.6 - Radiopacity ............................................................................................................................................................ 13 2.7 - Comparison with Glass Ionomers and ProRoot ® MTA ..................................................... 13 ❸ Biodentine Interfaces ...................................................................................................................... 14 3.1 - Resistance to acid ........................................................................................................................................... 14 3.2 - Resistance to microleakage .................................................................................................................... 16 3.3 - Electron Microscopy ...................................................................................................................................... 18 ❹ Outstanding biocompatibility .................................................................................................... 20 4.1 - Cytotoxicity tests (ISO 7405, ISO 10993-5) ............................................................................... 20 4.2 - Sensitization tests (ISO 7405, ISO 10993-1) ............................................................................ 21 4.3 - Genotoxicity tests (ISO 7405, ISO 10993-3, OCDE 471) ............................................... 22 4.4 - Cutaneous irritation tests (ISO 7405, ISO 10993-10) ........................................................ 23 4.5 - Eye irritation tests (OCDE 405) ............................................................................................................. 23 4.6 - Acute toxicity tests (ISO 7405, ISO 10993-11, OCDE 423) ......................................... 23 4.7 - Preclinical safety conclusion .................................................................................................................. 23 ❺ Evidence based bioactivity ............................................................................................................ 24 5.1 - In vitro test of direct pulp capping on human extracted teeth .................................. 24 5.2 - In vitro test for angiogenesis .................................................................................................................. 25 5.3 - Stimulation of reactionary dentine in indirect pulp capping : rat model ............................................................................................................................ 25 5.4 - Calcification as a result of Biodentine in a direct pulp capping and pulpotomy : pig model ................................................................................... 26 5.5 - Overall bioactivity ............................................................................................................................................. 28 ❻ Clinical efficacy ................................................................................................................................................. 29 6.1 - Biodentine is used as a dentine substitute under a composite .......................... 29 6.2 - Biodentine is used as a direct pulp capping material ................................................. 31 6.3 - Biodentine is used as an endodontic repair material .................................................... 32 References ................................................................................................................................................................ 33 3
4 Introduction Biodentine was developed by Septodont’s Research Group as a new class of dental material which could conciliate high mechanical properties with excellent biocompatibility, as well as a bioactive behavior. Several years of active and collaborative research between Septodont and several universities led to a new calcium-silicate based formulation, which is suitable as a dentine replacement material whenever original dentine is damaged. In addition to the chemical composition based on the Ca 3 SiO 5 – water chemistry which brings the high biocompatibility of already known endodontic repair cements (MTA based), Septodont increased the physico-chemical properties (short setting time, high mechanical strength…) which make Biodentine clinically easy to handle and compatible, not only with classical endodontic procedures, but also for restorative clinical cases of dentine replacement. Sealing ability of this biomaterial was also assessed to be equivalent to glass-ionomers, without requiring any specific conditioning of the dentine surface. Leakage resistance and mechanical strength will improve over the first weeks after placement. Biodentine turns out to be one of the most biocompatible of all the biomaterials in dentistry as demonstrated according to all the ISO standard tests, as well as in the different preclinical and clinical research collaborations. Moreover, reactionary dentine formation was demonstrated in rats, exhibiting high quality and quantity of protective dentine stimulation in indirect pulp capping. In the case of direct pulp capping and pulpotomy in pigs, the compatibility with the pulp enables a direct contact with fibroblasts, with limited inflammatory response compared to controls. Formation of a regular and dense dentine bridge is histologically demonstrated within one month. Besides the usual endodontic indications of this class of calcium-silicate cements (repair of perforations or resorptions, apexification, root-end filling), Biodentine has been evaluated for its restorative properties versus composite (Z100, 3M ESPE) in a three year follow-up, randomized, multicentre clinical study in 400 patients. It was suitable as a permanent dentine substitute and temporary enamel substitute. Restoration of deep or large crown carious lesions provides a very tight seal, without post-operative sensitivity and insures the longevity of restorations in vital teeth. Biodentine has also achieved 100% success in direct pulp capping in adults presenting healthy pulp.
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Page 9 and 10: 10 2.2 - Density and Porosity The m
Page 11 and 12: 12 (O’Brien 2008)). This maturati
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Biodentine

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