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Novel Dental Adhesives to Prevent Recurrent Caries

预防龋齿复发的新型牙科粘合剂

基本信息

批准号：
9139104
负责人：
Walter G. Renne
金额：
$ 21.14万
依托单位：
CURE INNOVATIONS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-03-15 至 2018-03-14
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9139104
关键词：
Adhesives Adult Adverse effects American Dental Association Antimicrobial Effect Carbomer-940 Characteristics Clinical Clinical Trials Copper Data Dental Bonding Dental General Practice Dental Materials Dental Technology Dental caries Dentin Development Environment Failure Formulation Frequencies Goals Human Hybrids In Vitro Incidence Infiltration Insurance Iodides Lead Legal patent Long-Term Effects Longevity Marketing Matrix Metalloproteinases Mechanics Modeling Oral Patients Phase Plant Resins Production Property Recurrence Resistance Retreatment Sales Small Business Technology Transfer Research Streptococcus mutans System Technology Testing Tooth structure Treatment Cost United States World Health Organization anticaries antimicrobial bactericide base cariogenic bacteria commercial application composite restoration cost cytotoxicity dental adhesive design innovation killings novel particle prevent public health relevance restoration success therapeutic effectiveness tooth filling

项目摘要

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.

描述（由申请方提供）：细菌相关的边缘腐烂是树脂基复合材料涂层（RBC）失效和再处理的主要原因。这些疾病的再治疗每年花费患者和保险公司数十亿美元。该系统的弱点是称为混合层的区域，在该区域中粘合剂将RBC粘合到牙本质。目前市场上没有粘合剂显示或声称在防止这种边际分解方面具有长期治疗效果。CuRE Innovations已成功制造并获得专利的碘化铜颗粒与聚丙烯酸（PAA-CuI）聚合，旨在为牙科粘合剂和其他基于树脂的牙科技术提供长期抗菌特性。初步数据表明，这种添加剂对变形链球菌具有持续的抗菌活性，与直接结果相比，一年后的效果相似。具体地，我们观察到PAA-CuI的添加抑制/杀死>99.9%的S。变形杆菌，并且这种能力持续长达1年，这是初步测试的终点。目前市售产品的杀菌能力极限为14天。此外，观察到这种抗微生物活性，没有细胞毒性或对剪切粘合强度产生负面影响的证据。为了使PAA-CuI添加剂具有真正的临床和商业潜力，CuRE需要确认其对更广泛的致龋细菌的杀菌能力，证明其能够防止RBC周围的边缘衰变，并确认其对长期粘合完整性没有不利影响。这些目标总结了该提案的目的，如果是积极的，可以通过抑制复发性衰变的形成和延长RBC的寿命来显著推进牙科粘合剂技术领域。这些结果将证明进一步的研究重点是获得FDA批准，规模化生产和人体临床试验。