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临床试验/NCT05114642
NCT05114642已完成不适用

Evaluation of the Effect of Face Mask Treatment on Head Posture, Pharyngeal Airway, Skeletal and Dental Structures in Patients With Maxillary Retrognathia

Taner OZTURK, DDS, MS1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月30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
60
试验地点
1
主要终点
Hyoid bone position change

研究概览

简要总结

The aim of this study was to evaluate the changes in head posture, position of the hyoid bone, pharyngeal airway and cervical posture after the use of Petit type face mask in patients with skeletal class III malocclusion (ANB angle < 0) with ongoing growth.

No other study was found in the literature in which head posture, cervical posture, and hyoid bone position were evaluated after the use of a face mask and compared with a control group consisting of patients of the same age group and the same malocclusion.

详细描述

All radiographic assessments, including cephalometric, pharyngeal airway and craniocervical measurements were performed by the same researcher and she was blind to all the treatment details, orthodontic records, and information of the subjects to prevent bias. Lateral cephalometric radiographs were taken digitally with an X-ray unit (OP300; Instrumentarium Dental, Tuusula, Finland) according to the manufacturer and same technician. Subjects were positioned at the natural head position, teeth in centric occlusion, and lightly closed lips for lateral cephalometric radiographs. Skeletal development of individuals was evaluated using cervical vertebra maturation method (Ref: Bacetti T., An Improved Version of the Cervical Vertebral Maturation (CVM) Method for the Assessment of Mandibular Growth. Angle Orthod.). The skeletal development of individuals was evaluated using the cervical vertebra maturation method and it was determined that all patients were in the prepubertal stage (CS1-CS3). (Ref: Cevidanes L., Comparison of two protocols for maxillary protraction: bone anchors versus face mask with rapid maxillary expansion. Angle Orthod.)

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •For the study group it is as follows:
  • •Patients with skeletal Class III association (ANB < 0°)
  • •Maxillary insufficiency patients
  • •Patients with ongoing growth development
  • •Patients who have used a 'Petit type face mask' for anterior positioning of the maxilla
  • •For the control group it is as follows:
  • •Patients with skeletal Class III association (ANB < 0°)
  • •Maxillary insufficiency patients
  • •Patients with ongoing growth development
  • •Patients who have not had any orthodontic treatment

排除标准

  • •Patients with a congenital anomaly or a craniofacial deformity
  • •Patients who have undergone orthodontic treatment
  • •Patients with tooth extraction or tooth loss
  • •Patients with a history of trauma
  • •Patients who have completed growth development (patients with Ru on wrist film)

研究组 & 干预措施

Skeletal Class III Malocclusion Treatment with Face Mask Group

Experimental

In patients with skeletal class III malocclusion (ANB angle < 0,0) due to maxillary deficiency, rapid maxillary expansion appliances prepared on dental plaster models made of acrylic material covering all the upper dental posterior tooth surfaces were applied before the upper jaw was orthopedically brought forward with a face mask. This process was stopped when the expansion was made so that the palatal tubercles of the maxillary permanent first molars align with the buccal tubercles of the mandibular permanent first molars. Immediately afterwards, the petit-type face mask was applied to the hooks of the maxillary expansion device with the help of elastic bands and used continuously for at least 18 hours a day. After obtaining a positive overjet, the face mask appliance was used at night to ensure retention, and then the treatment was terminated.

干预措施: Skeletal Class III Malocclusion Treatment with Face Mask Group (Device)

Control Group

No Intervention

A control group was formed from patients in the same age group who had skeletal class III malocclusion due to maxillary growth deficiency but were not treated. In this way, the changes that occurred in the normal process in the head, craniocervical postures, pharyngeal airway and hyoid bones of the patients whose growth and development continued could be distinguished.

结局指标

主要结局

Hyoid bone position change

时间窗: Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.

Investigation of the change in hyoid bone position after treatment of class III malocclusion due to maxillary deficiency with a face mask using hyoid bone location measurements (H-Cv2, H-Cv3, H-Mandibular line, H-Me).

Pharyngeal airway change

时间窗: Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.

Investigation of the change in pharyngeal airway dimensions after treatment of class III malocclusion due to maxillary deficiency with a face mask using pharyngeal airway sagittal dimension measurements (PNS-UPW, Cv2-MPW, Cv3-LPW, HRL/U-PNS, U-PNS, PASmin).

Craniocervical posture change

时间窗: Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.

Investigation of the change in head posture after treatment of class III malocclusion due to maxillary deficiency with a face mask using craniocervical angles (NSL/CVT, NSL/OPT, CVT/HOR, OPT/HOR, NL/VER, NSL/VER).

次要结局

  • Correlation of craniocervical posture, pharyngeal airway and hyoid bone change(Before treatment (T0) and after treatment (up to about 10-12 month; T1) for the study group. First measurement (T0) for the control group and after similar follow-up time (up to about 10-12 month; T1) as for the treatment group.)

研究者

发起方
Taner OZTURK, DDS, MS
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Taner OZTURK, DDS, MS

Lecturer

TC Erciyes University

研究点 (1)

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