Brunton P A, Davies R P W, Burke J L, Smith A, Aggeli A, Brookes S J, Kirkham J
Restorative Dentistry, Leeds Dental Institute, University of Leeds, Clarendon Way, Leeds, LS2 9LU, UK.
Br Dent J. 2013 Aug;215(4):E6. doi: 10.1038/sj.bdj.2013.741.
We previously reported that a rationally designed biomimetic self-assembling peptide, P₁₁-4, nucleated hydroxyapatite de novo and was apparently capable of in situ enamel regeneration following infiltration into caries-like lesions. Our present aim was to determine the safety and potential clinical efficacy of a single application of P₁₁-4 on early enamel lesions.
Fifteen healthy adults with Class V 'white spot' lesions received a single application of P₁₁-4. Adverse events and lesion appearances were recorded over 180 days.
Patients treated with P₁₁-4 experienced a total of 11 adverse events during the study, of which two were possibly related to the protocol. Efficacy evaluation suggested that treatment with P₁₁-4 significantly decreased lesion size (p = 0.02) after 30 days and shifted the apparent progression of the lesions from 'arrested/progressing' to 'remineralising' (p <0.001). A highly significant improvement in the global impression of change was recorded at day 30 compared with baseline (p <0.001).
The results suggest that treatment of early caries lesions with P₁₁-4 is safe, and that a single application is associated with significant enamel regeneration, presumably by promoting mineral deposition within the subsurface tissue.
我们之前报道过，一种经过合理设计的仿生自组装肽P₁₁-4能够从头诱导羟基磷灰石形成，并且在渗入类龋损后显然能够原位再生牙釉质。我们目前的目的是确定单次应用P₁₁-4治疗早期牙釉质病变的安全性和潜在临床疗效。
15名患有V类“白斑”病变的健康成年人接受了单次P₁₁-4治疗。在180天内记录不良事件和病变外观。
在研究期间，接受P₁₁-4治疗的患者共经历了11次不良事件，其中两次可能与治疗方案有关。疗效评估表明，P₁₁-4治疗30天后显著减小了病变大小（p = 0.02），并使病变的明显进展从“静止/进展”转变为“再矿化”（p <0.001）。与基线相比，在第30天记录到的整体变化印象有高度显著改善（p <0.001）。
结果表明，用P₁₁-4治疗早期龋损是安全的，单次应用与显著的牙釉质再生相关，可能是通过促进表层下组织内的矿物质沉积实现的。
