Novel Dental Adhesives to Prevent Recurrent Caries

 描述(申请人提供)：细菌相关边缘腐烂是树脂基复合修复体(RBC)失败和重新处理的首要原因。这些修复的再治疗每年花费患者和保险公司数十亿美元。该系统的弱点是被称为混合层的区域，在该区域，粘附剂将红细胞与牙本质结合。目前市场上还没有一种粘合剂显示或声称在防止这种边缘破裂方面具有长期治疗效果。Cure Innovation已成功制造出聚丙烯酸聚合的碘化铜颗粒(PAA-CUI)并获得专利，该颗粒旨在赋予牙科粘合剂和其他基于树脂的牙科技术长期的抗菌特性。初步数据表明，该添加剂对变形链球菌具有持续的抗菌活性，一年后与即时效果相似。具体地说，我们观察到PAA-Cui的加入抑制/杀死了99.9%的变形链球菌，这种能力可以持续长达1年，这是初步测试的终点。目前市场上产品的杀菌能力限制为14天。此外，观察到这种抗菌活性，没有证据表明细胞毒性或对剪切粘结强度的负面影响。为了使PAA-CUI添加剂具有真正的临床和商业潜力，CURE需要确认它对更广泛的致龋菌的杀菌能力，证明它能够防止红细胞周围的边缘腐烂，并确认它对长期结合完整性没有不利影响。这些目标总结了这项提案的目标，如果是积极的，可以通过抑制复发龋齿的形成和延长红细胞的寿命来显著推动牙科粘合剂技术领域的发展。这些结果将证明进一步的研究是合理的，重点是获得FDA的批准、扩大生产和人体临床试验。

 DESCRIPTION (provided by applicant): Bacterial related marginal decay is the top reason for failure and retreatment of resin based composite restorations (RBCs). Retreatment of these restorations costs both the patients and insurance companies billions of dollars per year. The weak point of the system is the zone known as the hybrid layer, where the adhesive bonds the RBC to the dentin. There are currently no adhesives on the market showing or claiming long-term therapeutic effectiveness at preventing this marginal breakdown. CuRE Innovations has successfully fabricated and patented copper iodide particles polymerized with polyacrylic acid (PAA-CuI) that are designed to impart long-term antimicrobial characteristics to dental adhesives and other resin based dental technologies. Preliminary data indicate that this additive has sustained antimicrobial activity against Streptococcus mutans with similar efficacy at the one-year mark when compared to the immediate results. Specifically, we observed that the addition of PAA-CuI inhibits/kills >99.9% of S. mutans and this ability is sustained for up to 1 year, which was the endpoint for the preliminary testing. The limit of bactericidal capacity for products currently on the market is 14 days. Furthermore, this antimicrobial activity was observed with no evidence of cytotoxicity or negative effects on shear bond strength. For the PAA-CuI additive to have true clinical and commercial potential, CuRE needs to confirm the bactericidal capability of it against a wider range of cariogenic bacteria, show that it is capableof preventing marginal decay around RBCs, and confirm that it has no adverse effects on long- term bond integrity. These goals summarize the aims of this proposal, and if positive, could significantly advance the field of dental adhesive technology by inhibiting the formation of recurrent decay and extending the lifespan of RBCs. These results will justify further studies focusing on gaining FDA clearance, scaling production, and a human clinical trial.