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临床试验/NCT06949527
NCT06949527已完成不适用

Ultrasonographic and Sonoelastographic Evaluation of the Effects of Open Bite Activator and Anterior Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle in Skeletal Open Bite Cases

Murat Kaan Erdem2 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15日最近更新:

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
2
主要终点
Change in masseter muscle thickness measured by ultrasonography

研究概览

简要总结

This clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. A total of 24 growing individuals with increased vertical skeletal pattern were treated with a functional appliance and intermaxillary vertical elastics supported by miniscrews placed in the anterior region. Ultrasonographic and sonoelastographic assessments were performed at baseline, 6 months, and 12 months to measure changes in masseter muscle thickness and stiffness. Cephalometric radiographs were also used to evaluate dentofacial structural changes. This study aims to provide insight into the soft tissue changes associated with functional orthopedic treatment in hyperdivergent patients.

详细描述

This prospective clinical study investigates the dentofacial and muscular effects of a combined orthopedic treatment method in patients with skeletal open bite. The intervention includes the use of an open bite activator appliance along with anterior skeletal anchorage-supported vertical elastics. The study was conducted at Ankara University Faculty of Dentistry, Orthodontics Department, and received ethical approval (Approval No: 36290600/78).

A total of 24 growing individuals (14 females, 10 males) with increased vertical facial pattern (GoGn/SN ≥ 36°) were treated over a 12-month period. Patients received custom-made open bite activators designed to eliminate occlusal contact in the anterior region and redirect functional forces posteriorly. Miniscrews were placed between the lateral and canine teeth in both the maxilla and mandible, and vertical elastics were applied between these skeletal anchorage points with a force of 150 grams on each side, worn for 20-22 hours daily.

Masseter muscle changes were assessed using ultrasonography and sonoelastography at three time points: baseline (T0), interim (6 months, T1), and end of treatment (12 months, T2). Muscle thickness and stiffness (elasticity) were measured bilaterally during rest and maximal clenching. Cephalometric radiographs were obtained at T0 and T2 to evaluate skeletal and dentoalveolar changes, including SNA, SNB, ANB angles, overbite, U1-PP, L1-MP, and other relevant vertical and angular measurements.

Statistical analysis revealed significant increases in masseter muscle thickness during the treatment period, especially between T0 and T1. Stiffness values peaked at T1 and slightly decreased at T2, but remained higher than baseline. Cephalometric findings showed improvements in overbite and reductions in vertical growth tendencies, including significant changes in GoGn/SN and PP-MP angles.

This study demonstrates that combined functional appliance and skeletal anchorage-based vertical control therapy can positively influence muscle structure and dentofacial morphology in hyperdivergent skeletal open bite cases. Ultrasonography and sonoelastography proved to be reliable, non-invasive methods for assessing soft tissue changes in orthodontic treatment.

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
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • GoGn/SN angle ≥ 36°
  • Decreased overbite (dental open bite)
  • In active growth phase (confirmed by hand-wrist radiograph)
  • Good oral hygiene
  • No prior orthodontic or orthognathic treatment

排除标准

  • Presence of systemic disease or craniofacial deformity
  • Poor oral hygiene
  • Non-compliance with appliance wear
  • Previous use of skeletal anchorage devices

结局指标

主要结局

Change in masseter muscle thickness measured by ultrasonography

时间窗: Baseline, 6 months, and 12 months

Masseter muscle thickness (in millimeters) will be measured at rest and during maximal clenching using ultrasonography at three time points: baseline (T0), 6 months (T1), and 12 months (T2).

次要结局

  • Change in masseter muscle stiffness assessed by sonoelastography(Baseline, 6 months, and 12 months)

研究者

发起方
Murat Kaan Erdem
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Murat Kaan Erdem

PhD, DDS

Ankara University

研究点 (2)

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