1 Department of Preventive and Paediatric Dentistry, Centre for Oral Health, University of Greifswald, Greifswald, Germany.
J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.
Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy. In vitro, self-assembling peptide P-4 enhances remineralization of early carious lesions. To investigate the safety and clinical efficacy of P-4 for treatment of initial caries, a randomized controlled single-blind study was conducted on children aged >5 y with visible active early caries on erupting permanent molars. Subjects were randomized to either the test group (P-4 + fluoride varnish) or control group (fluoride varnish alone). Caries were assessed at baseline and at 3 and 6 mo posttreatment per laser fluorescence, a visual analog scale, the International Caries Detection and Assessment System, and Nyvad caries activity criteria. Intention-to-treat analyses were performed, and safety and clinical feasibility of the treatment approaches were assessed. Compared with the control group, the test group showed clinically and statistically significant improvement in all outcomes at 3 and 6 mo. The laser fluorescence readings (odds ratio = 3.5, P = 0.015) and visual analog scale scores (odds ratio = 7.9, P < .0001) were significantly lower for the test group, and they showed regression in the International Caries Detection and Assessment System caries index (odds ratio = 5.1, P = 0.018) and conversion from active to inactive lesions according to Nyvad criteria (odds ratio = 12.2, P < 0.0001). No adverse events occurred. The biomimetic mineralization facilitated by P-4 in combination with fluoride application is a simple, safe, and effective noninvasive treatment for early carious lesions that is superior to the presently used gold standard of fluoride alone. By regenerating enamel tissue and preventing lesion progression, this novel approach could change clinical dental practice from a restorative to a therapeutic approach. This could avoid additional loss of healthy hard tissue during invasive restorative treatments, potentially enabling longer tooth life and thereby lowering long-term health costs ( ClinicalTrials.gov NCT02724592).
基于再生医学的龋齿治疗方法侧重于仿生再矿化初始龋齿病变，作为一种微创治疗。在体外，自组装肽 P-4 增强早期龋齿病变的再矿化。为了研究 P-4 治疗早期龋齿的安全性和临床疗效，对年龄>5 岁、萌出恒磨牙可见活动性早期龋齿的儿童进行了一项随机对照、单盲研究。受试者随机分为实验组（P-4+氟化物漆）或对照组（单独氟化物漆）。根据激光荧光、视觉模拟评分、国际龋齿检测和评估系统以及 Nyvad 龋齿活动标准，在基线和治疗后 3 个月和 6 个月评估龋齿。进行意向治疗分析，并评估治疗方法的安全性和临床可行性。与对照组相比，实验组在治疗后 3 个月和 6 个月时所有结果均显示出临床和统计学上的显著改善。激光荧光读数（比值比=3.5，P=0.015）和视觉模拟评分（比值比=7.9，P<.0001）显著降低，国际龋齿检测和评估系统龋齿指数呈回归趋势（比值比=5.1，P=0.018），根据 Nyvad 标准，活性病变向非活性病变的转化（比值比=12.2，P<.0001）。未发生不良事件。P-4 结合氟化物应用促进仿生矿化是一种简单、安全、有效的非侵入性治疗早期龋齿病变的方法，优于目前单独使用氟化物的金标准。通过再生釉质组织和防止病变进展，这种新方法可以使临床牙科治疗从修复方法转变为治疗方法。这可以避免在侵入性修复治疗过程中进一步丧失健康的硬组织，从而延长牙齿寿命，降低长期健康成本（ClinicalTrials.gov NCT02724592）。
