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Abstract：
BACKGROUND: This single-centered randomized controlled clinical trial aimed to evaluate the effectiveness of micro-osteoperforations (MOPs) in accelerating the orthodontic retraction of maxillary incisors.
METHODS: Forty-two patients aged 16-40 were recruited and randomly assigned into two groups, one which underwent MOPs (MOPG) in the buccal and palatal region of all maxillary incisors immediately before the start of retraction and one which did not (CG). Eligibility criteria included the orthodontic need for maxillary first premolars extraction and space closure in two phases. The primary outcome of the study consisted of measuring the rate of space closure and, consequently, the rate of incisors\' retraction using digital model superimposition 14 days later and monthly thereafter for the next 4 months. The secondary outcomes included measuring anchorage loss, central incisors\' inclination, and root length shortening, analyzed using cone beam computed tomography scans acquired before retraction and 4 months after retraction. Randomization was performed using QuickCalcs software. While clinical blinding was not possible, the image\'s examinator was blinded.
RESULTS: Twenty-one patients were randomly assigned to each group. However, due to various reasons, a total of 37 patients (17 male and 20 female) were analyzed (mean age: 24.3 ± 8.1 years in the MOPG; 22.2 ± 4.2 years in the CG) during the trial. No statistically significant difference was found between the MOPG and the CG regarding the incisors\' retraction measured at different time points at the incisal border (14 days, 0.4 mm vs. 0.5 mm; 1 month, 0.79 mm vs. 0.77 mm; 2 months, 1.47 mm vs. 1.41 mm; 3 months, 2.09 mm vs. 1.88 mm; 4 months, 2.62 mm vs. 2.29 mm) and at the cervical level (14 days, 0.28 mm vs. 0.30 mm; 1 month, 0.41 mm vs. 0.32 mm; 2 months, 0.89 mm vs. 0.61 mm; 3 months, 1.36 mm vs. 1.10 mm; 4 months, 1.73 mm vs. 1.39 mm). Similarly, no statistically significant differences were detected in the space closure, anchorage loss, central incisors\' inclination, and radicular length between groups. No adverse effect was observed during the trial.
CONCLUSIONS: MOPs did not accelerate the retraction of the maxillary incisors, nor were they associated with greater incisor inclination or root resorption. Trial registration ClinicalTrials.gov NCT03089996. Registered 24 March 2017- https://clinicaltrials.gov/ct2/show/NCT03089996 .
METHODS: Forty-two patients aged 16-40 were recruited and randomly assigned into two groups, one which underwent MOPs (MOPG) in the buccal and palatal region of all maxillary incisors immediately before the start of retraction and one which did not (CG). Eligibility criteria included the orthodontic need for maxillary first premolars extraction and space closure in two phases. The primary outcome of the study consisted of measuring the rate of space closure and, consequently, the rate of incisors\' retraction using digital model superimposition 14 days later and monthly thereafter for the next 4 months. The secondary outcomes included measuring anchorage loss, central incisors\' inclination, and root length shortening, analyzed using cone beam computed tomography scans acquired before retraction and 4 months after retraction. Randomization was performed using QuickCalcs software. While clinical blinding was not possible, the image\'s examinator was blinded.
RESULTS: Twenty-one patients were randomly assigned to each group. However, due to various reasons, a total of 37 patients (17 male and 20 female) were analyzed (mean age: 24.3 ± 8.1 years in the MOPG; 22.2 ± 4.2 years in the CG) during the trial. No statistically significant difference was found between the MOPG and the CG regarding the incisors\' retraction measured at different time points at the incisal border (14 days, 0.4 mm vs. 0.5 mm; 1 month, 0.79 mm vs. 0.77 mm; 2 months, 1.47 mm vs. 1.41 mm; 3 months, 2.09 mm vs. 1.88 mm; 4 months, 2.62 mm vs. 2.29 mm) and at the cervical level (14 days, 0.28 mm vs. 0.30 mm; 1 month, 0.41 mm vs. 0.32 mm; 2 months, 0.89 mm vs. 0.61 mm; 3 months, 1.36 mm vs. 1.10 mm; 4 months, 1.73 mm vs. 1.39 mm). Similarly, no statistically significant differences were detected in the space closure, anchorage loss, central incisors\' inclination, and radicular length between groups. No adverse effect was observed during the trial.
CONCLUSIONS: MOPs did not accelerate the retraction of the maxillary incisors, nor were they associated with greater incisor inclination or root resorption. Trial registration ClinicalTrials.gov NCT03089996. Registered 24 March 2017- https://clinicaltrials.gov/ct2/show/NCT03089996 .
摘要：
背景：这项以单中心为中心的随机对照临床试验旨在评估微骨手术（MOP）在加速上颌切牙正畸回缩中的有效性。
方法：将42例年龄在16-40岁的患者随机分为两组，其中一个在所有上颌切牙的颊和腭区域接受了MOP（MOPG），而另一个没有（CG）。合格标准包括两个阶段的上颌第一前磨牙拔除和空间闭合的正畸需求。该研究的主要结果包括测量空间闭合率，因此,使用数字模型叠加14天后和之后4个月的每月门牙回缩率。次要结果包括测量锚固损失，中切牙倾斜，和根长缩短，使用收缩前和收缩后4个月采集的锥形束计算机断层扫描进行分析。使用QuickCalcs软件进行随机化。虽然临床盲法是不可能的，图像的检查者是盲目的。
结果：将21名患者随机分配到每组。然而,由于种种原因,在试验期间共分析了37例患者(男性17例,女性20例)(平均年龄:MOPG为24.3±8.1岁;CG为22.2±4.2岁).MOPG和CG在切缘不同时间点测量的门牙回缩方面无统计学差异(14天，0.4mmvs.0.5mm;1个月,0.79毫米vs.0.77毫米；2个月，1.47mmvs.1.41毫米；3个月，2.09mmvs.1.88毫米；4个月，2.62mmvs.2.29毫米）和宫颈水平（14天，0.28mmvs.0.30mm；1个月，0.41mmvs.0.32mm;2个月,0.89毫米vs.0.61mm;3个月,1.36mmvs.1.10毫米；4个月，1.73mmvs.1.39毫米)。同样，在空间闭合中未检测到有统计学意义的差异，锚固损失,中切牙倾斜，和组间的神经根长度。试验期间未观察到不良反应。
结论：MOP没有加速上颌切牙的回缩，它们也不与更大的切牙倾斜度或牙根吸收有关。试验注册ClinicalTrials.govNCT03089996。2017年3月24日注册-https://clinicaltrials.gov/ct2/show/NCT03089996。
方法：将42例年龄在16-40岁的患者随机分为两组，其中一个在所有上颌切牙的颊和腭区域接受了MOP（MOPG），而另一个没有（CG）。合格标准包括两个阶段的上颌第一前磨牙拔除和空间闭合的正畸需求。该研究的主要结果包括测量空间闭合率，因此,使用数字模型叠加14天后和之后4个月的每月门牙回缩率。次要结果包括测量锚固损失，中切牙倾斜，和根长缩短，使用收缩前和收缩后4个月采集的锥形束计算机断层扫描进行分析。使用QuickCalcs软件进行随机化。虽然临床盲法是不可能的，图像的检查者是盲目的。
结果：将21名患者随机分配到每组。然而,由于种种原因,在试验期间共分析了37例患者(男性17例,女性20例)(平均年龄:MOPG为24.3±8.1岁;CG为22.2±4.2岁).MOPG和CG在切缘不同时间点测量的门牙回缩方面无统计学差异(14天，0.4mmvs.0.5mm;1个月,0.79毫米vs.0.77毫米；2个月，1.47mmvs.1.41毫米；3个月，2.09mmvs.1.88毫米；4个月，2.62mmvs.2.29毫米）和宫颈水平（14天，0.28mmvs.0.30mm；1个月，0.41mmvs.0.32mm;2个月,0.89毫米vs.0.61mm;3个月,1.36mmvs.1.10毫米；4个月，1.73mmvs.1.39毫米)。同样，在空间闭合中未检测到有统计学意义的差异，锚固损失,中切牙倾斜，和组间的神经根长度。试验期间未观察到不良反应。
结论：MOP没有加速上颌切牙的回缩，它们也不与更大的切牙倾斜度或牙根吸收有关。试验注册ClinicalTrials.govNCT03089996。2017年3月24日注册-https://clinicaltrials.gov/ct2/show/NCT03089996。
