Baysal Asli, Ulusoy Seher Nazlı, Uysal Tancan
Associate professor, Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey.
Research assistant, Department of Orthodontics, Faculty of Dentistry, Izmir Katip Celebi University, Izmir, Turkey.
Am J Orthod Dentofacial Orthop. 2016 Nov;150(5):731-739. doi: 10.1016/j.ajodo.2016.06.014.
The aim of this 2-arm parallel trial was to evaluate enamel demineralization after rapid maxillary expansion (RME) compared with an untreated control group using quantitative light-induced fluorescence.
Thirty-six patients who needed RME as part of their orthodontic treatment were separated randomly into either the control group or the intervention group (RME). Eligibility criteria included crossbite, no previous orthodontic treatment, no systemic disease, and all permanent teeth erupted except second and third molars. The main outcome was quantitative evaluation of demineralization, and assessment of the vulnerability of each tooth to demineralization was the secondary outcome. Randomization was made at the start of the study with preprepared random number tables. Blinding was applicable for outcome assessment only. Patients in the RME group underwent expansion with a bonded acrylic expander; patients in the control group were untreated. Records were taken using quantitative light-induced fluorescence Digital Biluminator (Inspektor Research Systems, Amsterdam, The Netherlands) in pretreatment and posttreatment observation phases. The presence and extent of lesions on the buccal surfaces of all teeth, except the second and third molars, were assessed. The fluorescence loss, lesion area, and percentage of fluorescence loss were determined using the system's software. The numbers of teeth with more than a 5% change in fluorescence loss, were calculated. Data were analyzed with Wilcoxon signed rank, Mann-Whitney U, multivariate analysis of variance, and chi-square tests (P <0.05). Risk and odds ratios were calculated.
A total of 36 patients were randomized to either the RME or the control group in a 1:1 ratio. This study was completed with 18 patients in the RME group (8 girls, 10 boys; mean age, 14.2 ± 1.0 years) and 18 patients in the control group (10 girls, 8 boys; mean age: 14.1 ± 0.8 years). All patients completed the study, and none were lost to follow-up. The area of demineralization decreased in the RME group (-17.50 mm), which was a significantly greater decrease than in the control group (0.00) (effect size, -2.63; mean difference, -87.94; 95% confidence interval, -223.75-47.86; P = 0.008). No statistically significant difference was found for fluorescence loss. The numbers of teeth with demineralization and remineralization were higher in the treatment group. According to the risk ratio, the difference between groups regarding demineralization was not significant. No harm was found except gingivitis associated with the bonded appliance.
RME therapy using a bonded expander does not increase enamel demineralization.
This trial was not registered.
The protocol was not published before trial commencement.
本双臂平行试验的目的是，与未经治疗的对照组相比，使用定量光诱导荧光评估快速上颌扩弓（RME）后的牙釉质脱矿情况。
36名需要进行RME作为正畸治疗一部分的患者被随机分为对照组或干预组（RME）。纳入标准包括反咬合、既往未接受过正畸治疗、无全身疾病，且除第二和第三磨牙外所有恒牙均已萌出。主要结局是脱矿的定量评估，次要结局是评估每颗牙齿脱矿的易感性。研究开始时使用预先准备好的随机数字表进行随机分组。仅对结局评估采用盲法。RME组患者使用粘结式丙烯酸扩弓器进行扩弓；对照组患者未接受治疗。在治疗前和治疗后观察阶段，使用定量光诱导荧光数字双光源仪（Inspektor Research Systems，荷兰阿姆斯特丹）进行记录。评估除第二和第三磨牙外所有牙齿颊面病变的存在情况和范围。使用该系统软件确定荧光损失、病变面积和荧光损失百分比。计算荧光损失变化超过5%的牙齿数量。采用Wilcoxon符号秩检验、Mann-Whitney U检验、多因素方差分析和卡方检验（P<0.05）对数据进行分析。计算风险比和优势比。
总共36名患者以1:1的比例随机分为RME组或对照组。本研究完成时，RME组有18名患者（8名女孩，10名男孩；平均年龄14.2±1.0岁），对照组有18名患者（10名女孩，8名男孩；平均年龄14.1±0.8岁）。所有患者均完成研究，无失访情况。RME组的脱矿面积减少（-17.50mm），显著大于对照组（0.00）（效应量，-2.63；平均差值，-87.94；95%置信区间，-223.75 - 47.86；P = 0.008）。荧光损失方面未发现统计学显著差异。治疗组中脱矿和再矿化的牙齿数量较多。根据风险比，两组在脱矿方面的差异不显著。除与粘结矫治器相关的牙龈炎外，未发现其他不良影响。
使用粘结式扩弓器的RME治疗不会增加牙釉质脱矿。
本试验未注册。
方案在试验开始前未发表。
