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临床试验/NCT06939179
NCT06939179已完成不适用

Evaluation of the Effect of Face Mask Therapy and RPE Application on Blood Oxygen Levels

Biruni University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
examination of oxygen level of Class III malocclusion

研究概览

简要总结

Skeletal Class III malocclusions are characterized by maxillary retrusion, mandibular protrusion, or a combination of both. In growing individuals presenting with maxillary deficiency, the face mask appliance is widely recognized as one of the most effective and frequently utilized orthopedic interventions. The primary objective of face mask therapy is to stimulate forward and downward growth of the maxilla by disarticulating and activating the circummaxillary sutural system. The application of protraction forces via a face mask results in anterior displacement of the maxillary dentition, accompanied by lingual inclination of the mandibular incisors. Orthopedic effects of the appliance typically include forward and downward movement of the maxilla with a slight degree of upward rotation, posterior dental extrusion, and backward rotation of the mandible. Numerous studies have demonstrated that combining rapid maxillary expansion (RME) with face mask therapy enhances skeletal outcomes, especially when initiated during the early stages of growth. Delayed intervention is often associated with reduced orthopedic responsiveness.

Foersch et al. evaluated the effects of pre-treatment rapid maxillary expansion on face mask therapy outcomes and concluded that expansion positively influences sagittal skeletal changes. In the absence of expansion, greater dental compensation was observed, particularly in the transverse dimension. From a clinical standpoint, anterior crossbite correction can typically be achieved within approximately 3 to 4 months, depending on the severity of the malocclusion. However, establishing a stable overbite and molar relationship usually requires an additional 4 to 6 months of treatment. A prospective clinical study analyzing treatment outcomes in Class III patients reported that overjet correction occurred through 31% maxillary advancement, 21% mandibular retraction, 28% labial proclination of the maxillary incisors, and 20% lingual retroclination of the mandibular incisors. To compensate for potential adverse effects of late mandibular growth, overcorrection of the overjet and molar relationship has been recommended. RME has also been associated with significant anatomical and functional changes in the upper airway. Specifically, an increase in the width of the nasal cavity base leads to a reduction in nasal airway resistance and improvement in nasal respiration. Recent investigations have documented post-treatment increases in pharyngeal airway dimensions and corresponding enhancements in nasal breathing. In a clinical study involving 25 patients with Class III malocclusion due to maxillary deficiency, face mask therapy resulted in a significant increase in nasopharyngeal airway space, which remained stable after a four-year follow-up period. Another study comparing 18 patients treated with RME and face mask therapy against an untreated control group of 163 individuals demonstrated a statistically significant enlargement of the nasopharyngeal space in the treated group. Pulse oximetry operates based on two fundamental physical principles. First, arterial blood generates a pulsatile signal, while non-pulsatile signals originate from venous and capillary beds. Second, modern oximeters utilize light-emitting diodes (LEDs) emitting at wavelengths of 660 nm (red) and 940 nm (infrared), as oxyhemoglobin and deoxygenated hemoglobin display distinct absorption spectra at these wavelengths. In a study conducted by Niaki et al., among patients exhibiting mouth breathing patterns, 65.4% were classified as hypoxemic, while 34.6% had normal oxygen saturation levels. Gender analysis revealed that 31.4% of males and 40% of females demonstrated normal oxygen saturation.Mouth breathing has been shown to influence craniofacial growth and may contribute to the development of various malocclusion patterns. Conversely, specific malocclusion types can exacerbate oral breathing tendencies. It is important to acknowledge that oral respiration has a measurable impact on blood oxygen levels and overall respiratory function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •6-10 years of age Class III Malocclusion

排除标准

  • •+10 years of age

研究组 & 干预措施

non treated control group

Active Comparator

The control group was asked about their respiratory tract and quality on the day they were first admitted to our clinic, pulse oximetry measurements will be made and they were called back at the end of 6 months, which is the average face mask treatment period, and this process was repeated.

干预措施: Class III Malocclusion (Other)

face mask with rapid maxillary expansion treated group

Experimental

group will be administered a rapid upper jaw expansion protocol with a face mask device and will be asked questions about the airway and its quality. The rapid maxillary expansion appliance applied to this group is bonded hyrax type.

干预措施: Class III Malocclusion (Other)

face mask without rapid maxillary expansion group

Experimental

Thisgroup, a bonded appliance without an expansion effect on the upper jaw was designed and applied. A petit-type facemask appliance will be applied with the appliance and respiratory quality will be questioned.

干预措施: Class III Malocclusion (Other)

结局指标

主要结局

examination of oxygen level of Class III malocclusion

时间窗: up to 6 months

examination of oxygen levels with or without Class III Malocclusion treatment

次要结局

未报告次要终点

研究者

发起方
Biruni University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Burak Aydin

investigator

Biruni University

研究点 (1)

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