PDF(Pubmed)
Abstract：
BACKGROUND: Orthodontic treatment using face mask protraction combined with an alternate rapid maxillary expansion and constriction/protraction face mask (Alt-RAMEC/PFM) protocol is effective in the early treatment of patients with class III malocclusion, but the stability of treatment outcomes represents a major concern. Previous studies have suggested that tonsillar hypertrophy can be a risk factor for class III malocclusion and tonsillectomy may prompt the normalisation of dentofacial growth. However, these studies had a low-to-moderate level of evidence. This study was designed to identify the impact of tonsillectomy before orthodontic treatment on the efficacy and stability of Alt-RAMEC/PFM protocols and the sleep quality and oral health in children with anterior crossbite and tonsillar hypertrophy.
METHODS: This is a two-arm, parallel-group, superiority cluster randomised controlled trial, with four clinics randomly assigned to the surgery-first arm and the orthodontic-first arm in a 1:1 ratio. The Alt-RAMEC protocol involves alternate activation and deactivation of the expander\'s jet screw over 6 weeks to stimulate maxillary suture distraction. Patients will be instructed to wear the PFM for a minimum of 14 hours per day. The primary outcomes are changes in Wits appraisal and the degree of maxillary advancement from baseline to the end of orthodontic treatment. Lateral cephalometric radiographs, polysomnography, Obstructive Sleep Apnoea-18 questionnaire and Oral Health Impact Profile-14 questionnaire will be traced, collected and measured. We will recruit 96 patients intofor the study. To assess differences, repeated multilevel linear mixed modelling analyses will be used.
BACKGROUND: This study has been granted ethical approval by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University (approval No. 2023-D10). Written informed consent will be obtained from the participants and their guardians. The results of the trial will be disseminated through academic conferences and journal publications.
BACKGROUND: ChiCTR2300078833.
METHODS: This is a two-arm, parallel-group, superiority cluster randomised controlled trial, with four clinics randomly assigned to the surgery-first arm and the orthodontic-first arm in a 1:1 ratio. The Alt-RAMEC protocol involves alternate activation and deactivation of the expander\'s jet screw over 6 weeks to stimulate maxillary suture distraction. Patients will be instructed to wear the PFM for a minimum of 14 hours per day. The primary outcomes are changes in Wits appraisal and the degree of maxillary advancement from baseline to the end of orthodontic treatment. Lateral cephalometric radiographs, polysomnography, Obstructive Sleep Apnoea-18 questionnaire and Oral Health Impact Profile-14 questionnaire will be traced, collected and measured. We will recruit 96 patients intofor the study. To assess differences, repeated multilevel linear mixed modelling analyses will be used.
BACKGROUND: This study has been granted ethical approval by the Ethics Committee of the School & Hospital of Stomatology, Wuhan University (approval No. 2023-D10). Written informed consent will be obtained from the participants and their guardians. The results of the trial will be disseminated through academic conferences and journal publications.
BACKGROUND: ChiCTR2300078833.
摘要：
背景：使用面罩前移结合替代快速上颌扩张和收缩/前移面罩（Alt-RAMEC/PFM）方案的正畸治疗在III类错牙合患者的早期治疗中是有效的，但治疗结果的稳定性是一个主要问题.先前的研究表明，扁桃体肥大可能是III类错牙合畸形的危险因素，扁桃体切除术可能会促使牙面生长正常化。然而,这些研究有低至中等水平的证据.这项研究旨在确定正畸治疗前扁桃体切除术对Alt-RAMEC/PFM方案的疗效和稳定性以及前牙咬合和扁桃体肥大儿童的睡眠质量和口腔健康的影响。
方法：这是一个双臂，平行组，优势集群随机对照试验，四个诊所以1:1的比例随机分配到手术第一臂和正畸第一臂。Alt-RAMEC方案涉及在6周内交替激活和停用扩张器的喷射螺钉，以刺激上颌骨缝合线牵引。将指示患者每天佩戴PFM至少14小时。主要结果是Wits评估的变化以及从基线到正畸治疗结束的上颌前移程度。侧位头颅射线照片，多导睡眠图,将追踪阻塞性睡眠呼吸暂停18问卷和口腔健康影响概况14问卷，收集和测量。我们将招募96名患者参加这项研究。为了评估差异，将使用重复的多级线性混合建模分析。
背景：本研究已获得口腔医学学校和医院伦理委员会的伦理批准，武汉大学（批准号：2023-D10）。将获得参与者及其监护人的书面知情同意书。试验结果将通过学术会议和期刊出版物传播。
背景：ChiCTR2300078833。
方法：这是一个双臂，平行组，优势集群随机对照试验，四个诊所以1:1的比例随机分配到手术第一臂和正畸第一臂。Alt-RAMEC方案涉及在6周内交替激活和停用扩张器的喷射螺钉，以刺激上颌骨缝合线牵引。将指示患者每天佩戴PFM至少14小时。主要结果是Wits评估的变化以及从基线到正畸治疗结束的上颌前移程度。侧位头颅射线照片，多导睡眠图,将追踪阻塞性睡眠呼吸暂停18问卷和口腔健康影响概况14问卷，收集和测量。我们将招募96名患者参加这项研究。为了评估差异，将使用重复的多级线性混合建模分析。
背景：本研究已获得口腔医学学校和医院伦理委员会的伦理批准，武汉大学（批准号：2023-D10）。将获得参与者及其监护人的书面知情同意书。试验结果将通过学术会议和期刊出版物传播。
背景：ChiCTR2300078833。
