Beerens Moniek W, Ten Cate Jacob M, Buijs Mark J, van der Veen Monique H
Department of Orthodontics, Academic Centre for Dentistry Amsterdam, Amsterdam, The Netherlands.
Department of Preventive Dentistry, Academic Centre for Dentistry Amsterdam, Amsterdam, The Netherlands.
Eur J Orthod. 2018 Sep 28;40(5):457-464. doi: 10.1093/ejo/cjx085.
Casein-phosphopeptide-amorphous-calcium-fluoride-phosphate (CPP-ACFP) can remineralize subsurface lesions. It is the active ingredient of MI-Paste-Plus® (MPP). The long-term remineralization efficacy is unknown.
To evaluate the long-term effect of MPP versus a placebo paste on remineralization of enamel after fixed orthodontic treatment over a 12-month period.
This trial was designed as a prospective, double-blinded, placebo-controlled RCT.
Patients with subsurface lesions scheduled for removal of the appliance were included. They applied either MPP or control paste once a day at bedtime for 12 months, complementary to normal oral hygiene.
Changes in enamel lesions (primary outcome) were fluorescence loss and lesion area determined by quantitative light-induced fluorescence (QLF). Secondary outcomes were Microbial composition, by conventional plating, and acidogenicity of plaque, by capillary ion analysis (CIA), and lesion changes scored visually on clinical photographs.
Participants [age = 15.5 years (SD = 1.6)] were randomly assigned to either the MPP or the control group, as determined by a computer-randomization scheme, created and locked before the start of the study. Participants received neutral-coloured concealed toothpaste tubes marked A or B.
The patients and the observers were blinded with respect to the content of tube A or B.
A total of 51 patients were analysed; MPP (n = 25) versus control group (n = 26); data loss (n = 14). There was no significant difference between the groups over time for all the used outcome measures. There was a significant improvement in enamel lesions (fluorescence loss) over time in both groups (P < 0.001 and P < 0.001), with no differences between groups.
Being an in vivo study, non-compliance of the subjects could have influenced the result.
The additional use of MPP in patients with subsurface enamel lesions after orthodontic fixed appliance treatment did not improve these lesions during the 1 year following debonding.
This trial is registered at the medical ethical committee of the VU Medical Centre in Amsterdam (NL.199226.029.07).
酪蛋白磷酸肽-无定形氟化钙磷酸盐（CPP-ACFP）可使牙釉质表层下病变再矿化。它是MI-Paste-Plus®（MPP）的活性成分。其长期再矿化效果尚不清楚。
评估MPP与安慰剂糊剂对固定正畸治疗后牙釉质再矿化的12个月长期效果。
本试验设计为一项前瞻性、双盲、安慰剂对照随机对照试验。
纳入计划拆除矫治器的表层下病变患者。他们在睡前每天使用一次MPP或对照糊剂，持续12个月，作为正常口腔卫生的补充。
牙釉质病变的变化（主要指标）为通过定量光诱导荧光（QLF）测定的荧光损失和病变面积。次要指标包括通过传统平板计数法测定的微生物组成、通过毛细管离子分析（CIA）测定的菌斑产酸性，以及在临床照片上通过视觉对病变变化进行评分。
参与者[年龄=15.5岁（标准差=1.6）]通过计算机随机分组方案随机分配至MPP组或对照组，该方案在研究开始前创建并锁定。参与者收到标记为A或B的中性颜色的隐蔽牙膏管。
患者和观察者对A管或B管的内容物均不知情。
共分析了51例患者；MPP组（n = 25）与对照组（n = 26）；数据缺失（n = 14）。对于所有使用的观察指标，两组随时间均无显著差异。两组牙釉质病变（荧光损失）随时间均有显著改善（P < 0.001和P < 0.001），组间无差异。
作为一项体内研究，受试者的不依从可能影响结果。
正畸固定矫治器治疗后牙釉质表层下病变患者额外使用MPP在拆除矫治器后的1年内并未改善这些病变。
本试验在阿姆斯特丹VU医学中心医学伦理委员会注册（NL.199226.029.07）。
