跳至主要内容
临床试验/NCT07031349
NCT07031349招募中不适用

Evaluation of Changes in Upper Airway Dimensions and Subjective Sleep Quality Following Miniscrew-Assisted Rapid Palatal Expansion: A Questionnaire-Based Study

Konya Necmettin Erbakan Üniversitesi2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月30日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire

研究概览

简要总结

At the beginning of MARPE treatment (T1) and at the end of the 3-month consolidation phase (T2), patients will complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to assess the potential benefit of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS).

Additionally, changes in the upper airway will be evaluated using CBCT images obtained at T1 and T2.

详细描述

In this clinical routine, approximately 30% of patients requiring rapid maxillary expansion (RME) are treated using the MARPE (Miniscrew-Assisted Rapid Palatal Expansion) method. To evaluate the potential benefits of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS), patients are asked to complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) at the beginning of treatment (T1) and at the end of the 3-month consolidation phase (T2).

To determine whether patients should undergo MARPE or conventional RME, midpalatal suture maturation is assessed as part of the routine protocol using cone-beam computed tomography (CBCT) images obtained before treatment initiation (T1). At the end of the MARPE screw activation period, a follow-up CBCT scan is routinely obtained to evaluate potential complications such as fractures in the zygomatic buttress region, alveolar bending, and the presence of dehiscence or fenestration on root surfaces. This scan also facilitates the controlled initiation of prolonged fixed orthodontic treatment.

Additionally, CBCT images obtained at T1 and T2 will be used to measure and compare the dimensions of the upper airway, including both oropharyngeal and nasopharyngeal regions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Class I malocclusion Maxillary transverse deficiency Age between 15 and 18 years No systemic disease, cleft lip and palate, or speech disorders No history of prior orthodontic treatment Voluntary agreement to participate in the study Good oral hygiene ANB angle between 2° and 5°

排除标准

  • Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia

结局指标

主要结局

Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire

时间窗: 3 month

The teen-STOP-BANG questionnaire will be used to assess changes in OSA risk following MARPE treatment. STOP-BANG scores range from 0 to 8; a score of at least 3 indicates that the patient is at risk of OSAHS, and a score of at least 5 indicates that the patient is at high risk of OSA.

次要结局

未报告次要终点

研究者

发起方
Konya Necmettin Erbakan Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Sağoğlu

Research Assistant

Konya Necmettin Erbakan Üniversitesi

研究点 (2)

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