The testing for biocompatibility of newly developed dental and medical devices is an essential preclinical requirement. Controlled clinical studies represent the final test prior to marketing of any material. The Biological/Clinical Core will provide support services to evaluate the safety and efficacy of material developed by the Center. It will assist in the design and conduct biocompatibility analyses of candidate materials. Furthermore, it will take part in the design and performance of the clinical trials. The biological assays will include four cell culture techniques, subcutaneous implantations tests for toxicity assessments, and the pulp and dentin usage test. The results obtained in the studies will be presented in collaboration with the scientists involved in the development of new materials for the replacement of amalgam, and with the Biostatistical Core. The clinical studies will, for budgetary reasons, be limited to small, short term feasibility studies. Established direct (USPHS criteria) and indirect (replicas/impressions and photography) clinical techniques will be used to evaluate the results. The clinical feasibility studies will include resin-based composites retained by the new adhesive/bonding technique developed by the Center as well as the new composite with minimal shrinkage during polymerization. Inlays for the treatment of primary caries and for replacement of failed amalgam restorations will be inserted using the luting cements and the ceramic materials developed by the Center. Shell crowns, partial and full, will be used to restore extensively broken-down teeth. These restorations will not follow established principles for crown preparations. The shell crowns require maintenance of maximum amounts of enamel. Thus, they conserve whatever tooth structure is left. The small, short term clinical trials do not lend themselves to detailed statistical analyses, but they are feasibility studies in the true sense of the term and will form the basis for future R01 Grant Applications.
| Richards, Nicola D; Soderholm, Karl-Johann; Batich, Christopher D (2004) Effect of molar mass of an experimental primer on shear bond strength to dentin. J Biomed Mater Res B Appl Biomater 70:384-8 |
| Mondragon, E; Soderholm, K J (2001) Shear strength of dentin and dentin bonded composites. J Adhes Dent 3:227-36 |
| Orefice, R L; Hench, L L; Clark, A E et al. (2001) Novel sol-gel bioactive fibers. J Biomed Mater Res 55:460-7 |
| Domingues, R Z; Clark, A E; Brennan, A B (2001) A sol-gel derived bioactive fibrous mesh. J Biomed Mater Res 55:468-74 |
| Antonson, S A; Anusavice, K J (2001) Contrast ratio of veneering and core ceramics as a function of thickness. Int J Prosthodont 14:316-20 |
| Mjor, I A; Moorhead, J E; Dahl, J E (2000) Reasons for replacement of restorations in permanent teeth in general dental practice. Int Dent J 50:361-6 |
| Tyas, M J; Anusavice, K J; Frencken, J E et al. (2000) Minimal intervention dentistry--a review. FDI Commission Project 1-97. Int Dent J 50:12-Jan |
| Wakabayashi, N; Anusavice, K J (2000) Crack initiation modes in bilayered alumina/porcelain disks as a function of core/veneer thickness ratio and supporting substrate stiffness. J Dent Res 79:1398-404 |
| Mjor, I A; Toffenetti, F (2000) Secondary caries: a literature review with case reports. Quintessence Int 31:165-79 |
| Mjor, I A; Dahl, J E; Moorhead, J E (2000) Age of restorations at replacement in permanent teeth in general dental practice. Acta Odontol Scand 58:97-101 |
Showing the most recent 10 out of 57 publications
