ElNaghy Rahma, Al-Qawasmi Riyad, Hasanin Majd
Department of Graduate Orthodontics, University of Detroit Mercy, Detroit, MI, USA.
Evid Based Dent. 2023 Mar;24(1):28-29. doi: 10.1038/s41432-023-00858-8. Epub 2023 Mar 8.
Single-center randomized clinical trial with two parallel arms. The protocol of the study was approved by the institutional review board (IRB) of the Faculty of Dentistry, Alexandria University (IRB: 00010556-IORG: 0008839) and registered in Clinicaltrials.gov (identifier number: NCT04225637). Before the trial commencement, parents/legal guardians signed informed consents. The study complied with the CONSORT (Consolidated Standards of Reporting Trials).
30 adolescent patients aged between 12 to 16 years with transversely deficient maxilla requiring skeletal maxillary expansion were recruited to be included in the study. Patients received miniscrew-supported Penn expanders and they were randomly allocated (ratio 1:1) into two groups based on the activation protocol; slow maxillary expansion (SME = turn every other day) or rapid maxillary expansion (RME = 2 turn/day).
The patient-reported outcome measures were the following: pain, headache, pressure, dizziness, speech, chewing and swallowing difficulties, swallowing difficulty. The participants rated the reported outcomes using numeric rating scale (NRS) at 4 time points: t = before appliance insertion, t = after first activation, t = after 1 week of activation, and t = after last activation. Patients were advised not to use analgesics, and to contact their provider in case of severe pain. Descriptive measures and patient-reported outcomes at various time points were calculated. Comparisons between the two groups at each time point were assessed using Mann-Whitney U-test. Comparisons of time points in each group were assessed using the Friedman test and followed by post-hoc tests with Bonferroni correction.
6 patients were not included in the analysis for different reasons, allowing a total of 24 patients (12 patients in each group) to be analyzed. Mean ages of the patients in the SME and RME group were 14.30 ± 1.37 and 15.07 ± 1.59, respectively. Median scores were in the bottom quartiles of NRS for all reported outcomes. RME group reported significantly higher scores for all measured variables, with exception of headache and dizziness, which showed no statistical difference between the two group.
Mild to moderate discomfort and functional limitation is anticipated with the activation of miniscrew-anchored Penn expanders. Slow activation protocol provided a better overall patient experience when compared to a rapid activation protocol.
单中心双臂平行随机临床试验。该研究方案已获得亚历山大大学牙科学院机构审查委员会（IRB：00010556 - IORG：0008839）的批准，并在Clinicaltrials.gov上注册（标识符编号：NCT04225637）。在试验开始前，父母/法定监护人签署了知情同意书。该研究遵循CONSORT（试验报告统一标准）。
招募30名年龄在12至16岁之间、上颌骨横向发育不足需要进行上颌骨骨骼扩展的青少年患者纳入研究。患者接受微型螺钉支撑的Penn扩弓器，并根据激活方案随机分配（比例1:1）为两组；慢速上颌扩展（SME = 每隔一天转动一次）或快速上颌扩展（RME = 每天转动2次）。
患者报告的结局指标如下：疼痛、头痛、压力、头晕、言语、咀嚼和吞咽困难、吞咽障碍。参与者在4个时间点使用数字评分量表（NRS）对报告的结局进行评分：t = 矫治器插入前、t = 首次激活后、t = 激活1周后、t = 最后一次激活后。建议患者不要使用镇痛药，若出现严重疼痛应联系其治疗医生。计算了不同时间点的描述性指标和患者报告的结局。使用Mann - Whitney U检验评估两组在每个时间点的差异。使用Friedman检验评估每组时间点之间的差异，并随后进行Bonferroni校正的事后检验。
6名患者因不同原因未纳入分析，最终共24名患者（每组12名）纳入分析。SME组和RME组患者的平均年龄分别为14.30±1.37岁和15.07±1.59岁。所有报告结局的中位数得分均处于NRS的下四分位数。RME组所有测量变量的得分均显著高于SME组，但头痛和头晕除外，两组在这两项上无统计学差异。
微型螺钉锚定的Penn扩弓器激活后预计会出现轻至中度不适和功能受限。与快速激活方案相比，慢速激活方案为患者提供了更好的总体体验。
