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临床试验/NCT07326345
NCT07326345招募中不适用

Evaluation of the Effects of Different Rapid Maxillary Expansion Methods on the Nasomaxillary Complex Structures

Merve Kulaksız1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月29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
30
试验地点
1
主要终点
Changes in Craniofacial Volumes

研究概览

简要总结

Maxillary transverse deficiency is an orthodontic anomaly characterized by the upper and lower dental arches being incompatible due to insufficient width of the maxilla. This condition typically manifests with clinical symptoms such as crossbite, crowding of teeth, and impaired respiratory function. Genetic factors, early primary tooth loss, mouth breathing, thumb sucking, and abnormal swallowing are among the causes of maxillary narrowing. Treatment options vary depending on the patient's age and the degree of suture closure. In pediatric and adolescent patients, rapid (RPE) or slow (SPE) orthodontic expansion can be achieved with palatal expansion appliances. However, in adult patients, due to the less flexible bone structure of the maxilla, methods such as surgically assisted expansion (SARME) or mini-screw-assisted expansion (MARPE) are preferred. Recent studies have shown that MARPE can be effective as a non-surgical alternative in young adults and can provide direct skeletal expansion without damaging the teeth.

详细描述

Thirty patients with maxillary transverse narrowing will be divided into two groups, MARPE and SARME, based on the amount of expansion required and suture ossification. Hybrid appliances will be custom-made for 15 patients undergoing mini-screw-supported rapid maxillary expansion. The position and number of screws will be determined individually for each patient. The screws to be used will have a diameter of 2 mm and a length of 14 mm. The screws will be placed under local anesthesia. A minimum of 2 and a maximum of 4 screws will be applied to patients. In the group undergoing surgical-assisted rapid maxillary expansion, expansion will be applied using an acrylic cap splint. In the SARME group, patients will undergo a standard Le Fort 1 osteotomy under general anesthesia. The appliances in both groups will be removed after a 6-month retention period. Cone beam computed tomography (90 kVp; 10 mA; 200 mm Voxel Size) will be taken from patients in both groups before starting the expansion treatment (T0) and after the 6-month retention period. Measurements will be performed on these radiological images using the Planmeca Romexis program. The volume, anteroposterior diameter, transverse diameter, length, and angle of the nasolacrimal canal and nasopalatine canal will be measured before and after treatment. The volume of the maxillary sinus and the diameter of the ostium openings will be measured. The nasal breathing volume and septal deviation will be measured on CBCT before treatment (T0) and at the end of the retention period (T1), and the results will be compared.

研究设计

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

入排标准

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

入选标准

  • Diagnosis of maxillary transverse deficiency.
  • Patients aged 15 years and older.
  • Presence of unilateral or bilateral crossbite.

排除标准

  • Severe facial deformities or craniofacial syndromes.
  • History of previous orthodontic treatment.
  • Existing pathology or history of surgery related to the paranasal sinuses, nasolacrimal system, or orbital cavity.
  • Inadequate patient cooperation.
  • History of trauma, or previous maxillofacial/plastic surgery procedures.
  • Clinical signs or symptoms of maxillary sinus pathology (e.g., maxillary sinus cysts, sinusitis).

结局指标

主要结局

Changes in Craniofacial Volumes

时间窗: Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).

Evaluation of volumetric changes using CBCT analysis. Specific measurements include the total volume of the nasolacrimal and nasopalatine canals, maxillary sinus volume, and nasal airway volume.

Changes in Linear Dimensions of Canals and Ostium

时间窗: Before expansion (T0) and after 6-month retention (T1).

Assessment of linear changes including the anteroposterior and transverse diameters and lengths of the nasolacrimal and nasopalatine canals. Additionally, the diameter of the maxillary sinus ostium openings will be measured in millimeters.

Changes in Angulation and Septal Deviation

时间窗: Cone-beam computed tomography (CBCT) scans will be obtained from patients in both groups at two specific time points: before the initiation of expansion treatment (T0) and following the 6-month retention period (T1).

Assessment of angular changes in craniofacial structures. This includes the angulation of the nasolacrimal and nasopalatine canals and the degree of nasal septal deviation.

次要结局

未报告次要终点

研究者

发起方
Merve Kulaksız
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merve Kulaksız

PhD student, Department of Orthodontics

Bezmialem Vakif University

研究点 (1)

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