Rollings Sam, Greene Louise, Borrie Felicity, Lamont Thomas
Department of Restorative Dentistry, University of Aberdeen Dental School and Hospital, Aberdeen, Scotland, UK.
Evid Based Dent. 2012;13(4):117-8. doi: 10.1038/sj.ebd.6400899.
Double blind randomised controlled trial
Sixty patients undergoing orthodontic treatment were randomised to receive either MI Paste Plus (GC America, Alsip III) or a placebo paste (Tom's of Main, Salisbury, UK). To be included, the patients had to be 12 years of age or over, in the permanent dentition, and be considered to be compliant with using the paste. Patients were excluded if they; had been undergoing extensive fluoride regimes, had an impacting medical or dental condition, had been receiving fluoride treatment for white spots, be planning to move within 6 months, or have an allergy to IgE casein. The pastes were self-administered in a fluoride tray for 3 to 5 minutes each night after brushing, for a period of 3 months.
Outcomes were measured at baseline, then at 4, 8, and 12 weeks into treatment) using 2 measures. Standardised photographic records were used to assess WSLs using Banks and Richmond's decalcification index score, from first premolar to first premolar in the maxilla and mandible. Three operators scored the photographs independently. The International Caries Detection and Assessment System (ICDAS) was used for the labial surfaces of the teeth and the scores (0-6) for surfaces were added together to give an overall score.
Five patients refused to participate before the trial began and out of the 60 patients randomised, 50 completed the study (26 MI Paste Plus group 24 in placebo group). There was a 53.5% in the enamel decalcification index score in the MI Paste Plus group but an increase of 91.1% in the placebo group at the end of the 12 week period; ICDAS scores were added together to give an overall score for all teeth; the MI Paste Plus group score was 145 at baseline and 80 after 12 weeks, a 44.8%reduction; in the placebo group, the scores were 116 and 166 respectively, an increase of 43%.
MI Paste Plus prevented and decreased the number of WSLs during orthodontic treatment with the placebo paste group having an increase in the number of WSLs during the trial. These effects were most noticeable on the gingival surfaces. Incisal enamel decalcification index scores were consistently higher than other tooth surfaces, including gingival.
双盲随机对照试验
60名接受正畸治疗的患者被随机分为两组，分别接受MI Paste Plus（GC America公司，阿尔西普三世）或安慰剂糊剂（英国索尔兹伯里的Tom's of Main）。纳入的患者年龄必须在12岁及以上，处于恒牙列，且被认为能配合使用该糊剂。若患者符合以下情况则被排除：正在接受广泛的氟化物治疗方案；患有严重的内科或牙科疾病；正在接受针对白斑的氟化物治疗；计划在6个月内搬家；或对免疫球蛋白E酪蛋白过敏。每晚刷牙后，将糊剂放入含氟托盘自行使用3至5分钟，持续3个月。
在基线时以及治疗的第4、8和12周使用两种测量方法进行观察。使用标准化的照片记录，采用班克斯和里士满的脱矿指数评分来评估上颌和下颌从第一前磨牙到第一前磨牙的白垩色斑（WSLs）情况。三名操作人员独立对照片进行评分。国际龋病检测与评估系统（ICDAS）用于牙齿的唇面，将各表面的评分（0 - 6）相加得出总分。
5名患者在试验开始前拒绝参与，在随机分组的60名患者中，50名完成了研究（MI Paste Plus组26名，安慰剂组24名）。在12周疗程结束时，MI Paste Plus组的釉质脱矿指数评分下降了53.5%，而安慰剂组则增加了91.1%；将ICDAS评分相加得出所有牙齿的总分；MI Paste Plus组基线评分为145分，12周后为80分，下降了44.8%；安慰剂组的评分分别为116分和166分，增加了43%。
MI Paste Plus在正畸治疗期间预防并减少了白垩色斑的数量，而安慰剂糊剂组在试验期间白垩色斑数量增加。这些效果在牙龈表面最为明显。切牙釉质脱矿指数评分始终高于其他牙面，包括牙龈面。
