背景:需要对龋齿进行简单的非侵入性循证干预,以克服修复范式中的局限性。自组装肽P11-4是非侵入性干预,可在初始龋齿病变中再生釉质。
方法:作者对P11-4产品Curodont修复(Credentis;现在由vVARDIS制造)(CR)和Curodont修复氟化物(Credentis;现在由vVARDIS制造)对初始龋齿病变的有效性进行了系统评价和荟萃分析。主要结果是24个月后病变进展,龋齿逮捕,和空化。次要结果是合并的国际龋齿检测和评估系统评分类别的变化,定量光诱导荧光(QLF;Inspektor研究系统),美学外观,和病变大小。
结果:6项临床试验符合纳入标准。本综述的结果代表2个主要结果和2个次要结果。与平行组相比,使用CR可能导致龋齿停滞大幅增加(相对风险[RR],1.82[95%CI,1.32至2.50];45%归因风险[95%CI,24%至60%];治疗所需数量[NNT],2.8),并且可能将病变大小平均(SD)减少32%(28%)。证据还表明,使用CR会导致空化大量减少(RR,0.32[95%CI,0.10至1.06];NNT,6.9),并且不确定降低合并的国际龋齿检测和评估系统评分(RR,3.68[95%CI,0.42至32.3];NNT,19).没有研究使用Curonot修复氟化物Plus。没有研究报告不良的美学变化。
结论:CR可能对龋齿停止和病变大小减小具有临床重要影响。两项试验都有未蒙面的评估员,所有试验的偏倚风险均升高.作者建议进行更长的试验。CR是用于初始龋齿病变的有希望的治疗方法。本系统评价的方案在PROSPERO(304794)中事先注册。
Simple noninvasive evidence-based interventions for caries are needed to overcome limitations in the restorative paradigm. The self-assembling peptide P11-4 is a noninvasive intervention that regenerates enamel in initial caries lesions.
The authors conducted a systematic
review and meta-analysis on the effectiveness of the P11-4 products Curodont Repair (Credentis; now manufactured by vVARDIS) (CR) and Curodont Repair Fluoride Plus (Credentis; now manufactured by vVARDIS) on initial caries lesions. Primary outcomes were lesion progression after 24 months, caries arrest, and cavitation. Secondary outcomes were changes in merged International Caries Detection and Assessment System score categories, quantitative light-induced fluorescence (QLF; Inspektor Research System), esthetic appearance, and lesion size.
Six clinical trials met the inclusion criteria. Results of this
review represent 2 primary and 2 secondary outcomes. When compared with parallel groups, use of CR likely results in a large increase in caries arrest (relative risk [RR], 1.82 [95% CI, 1.32 to 2.50]; 45% attributable risk [95% CI, 24% to 60%]; number needed to treat [NNT], 2.8) and likely decreases lesion size by a mean (SD) of 32% (28%). The evidence also suggests that use of CR results in a large reduction in cavitation (RR, 0.32 [95% CI, 0.10 to 1.06]; NNT, 6.9) and is uncertain about lowering merged International Caries Detection and Assessment System score (RR, 3.68 [95% CI, 0.42 to 32.3]; NNT, 19). No studies used Curodont Repair Fluoride Plus. No studies reported adverse esthetic changes.
CR likely has clinically important effects on caries arrest and decreased lesion size. Two trials had nonmasked assessors, and all trials had elevated risks of bias. The authors recommend conducting longer trials. CR is a promising treatment for initial caries lesions. The protocol for this systematic
review was registered a priori with PROSPERO (304794).