Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries
Randomised clinical trial investigating self-assembling peptide P11-4 in the treatment of early caries
复制标题
DOI：
10.1007/s00784-019-02901-4
复制
发表时间：
2020-01-01
影响因子：
3.4
通讯作者：
Jepsen, S.
中科院分区：
文献类型：
--
作者：
Broseler, F.;Tietmann, C.;Jepsen, S.
目的本前瞻性、随机、分口临床试验比较了自组装肽P-11-4与氟保护漆治疗早期颊部龋损的疗效。材料和方法受试者提出至少两个临床受影响的牙齿在D 0（第0天）和D90与P-11-4（测试）或氟化物清漆（对照）进行治疗。在D180时，在所有研究病灶上应用氟化物保护漆。在D 0、D30、D90、D180和D360拍摄标准化照片，并进行盲态形态测定评估。在允许混杂因素的情况下，使用分层线性模型（HLM）比较试验组和对照组之间的尺寸减小。采用视觉模拟量表（VAS）和总体印象变化问卷（GICQ）作为临床评估。结果共纳入37名受试者（13-36岁），90个早期龋损。HLM分析显示，试验组和对照组之间存在显著差异，表明试验病灶减少，对照病灶大小稳定（p = 0.001）。试验病灶相对于基线的平均大小（SD）降低至D30 = 0.936（0.127），D90 = 0.874（0.173），D180 = 0.844（0.215）且D360 = 0.862（0.352），而对照病变在D30 = 1.018（0.209）、D90 = 1.013（0.207）、D180 = 1.029（0.235）和D360 = 1.068（0.401）时保持稳定。效应量范围为0.47 - 0.82。结论在本研究的范围内，P-11-4治疗的早期龋损的大小显著减小;该结果上级优于氟保护漆治疗（DRKS 00012941）。
Objectives This prospective, randomised, split-mouth, clinical trial compared the efficacy of the self-assembling peptide P-11-4 to fluoride varnish in the treatment of early buccal carious lesions. Materials and methods Subjects presenting at least two clinically affected teeth were treated at D0 (day 0) and D90 with P-11-4 (test) or fluoride varnish (control). At D180, fluoride varnish was applied on all study lesions. Standardised photographs were taken at D0, D30, D90, D180 and D360 and blindly morphometrically assessed. Hierarchical linear models (HLM) under allowance of confounders were used to compare the decrease in size between test and control groups. The visual analog scale (VAS) and Global Impression of Change Questionnaire (GICQ) were used as clinical assessments. Results Overall, 37 subjects (13-36 years) with 90 early carious lesions were included. HLM analysis showed a significant difference between test and control groups, indicating a decrease in test lesions and stabilisation of control lesions size (p = 0.001). The test lesion's mean size (SD) relative to baseline decreased to D30 = 0.936(0.127), D90 = 0.874(0.173), D180 = 0.844(0.215) and D360 = 0.862(0.352), whereas control lesions remained stable at D30 = 1.018(0.209), D90 = 1.013(0.207), D180 = 1.029(0.235) and D360 = 1.068(0.401). The effect sizes ranged from 0.47 to 0.82. Conclusions Within the limits of this study, it was shown that the size of early carious lesions treated with P-11-4 was significantly reduced; this result was superior to that of fluoride varnish treatment (DRKS00012941).