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临床试验/NCT07094841
NCT07094841尚未招募不适用

Comparative Study Between The Effect of Three Dimensional Printed Appliances Herbst and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space And Temporomandibular Joint TMJ in Growing Class II Malocclusion Patients (Randomized Clinical Trial)

Moataz Sleem Ahmed Ali0 个研究点目标入组 20 人开始时间: 2025年9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
尚未招募
发起方
入组人数
20
主要终点
improvement in ANB angle measured on lateral cephalometric radiographs (degrees)

研究概览

简要总结

The aim of this study is to evaluate effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ) in growing patients with Class II malocclusion.

Primary outcome:

Effect of three dimensional printed appliances Herbst appliance and Mandibular Anterior Repositioning Appliance (MARA) on Class II malocclusion in growing patients.

Secondary outcome: To evaluate effects of two different three dimensional printed functional appliances on Posterior Airway Space (PAS) and Temporomandibular Joint (TMJ).

详细描述

Class II malocclusion is the most common sagittal skeletal imbalance. It can result from mandibular retrusion, maxillary overgrowth, or a posteriorly positioned glenoid fossa According to McNamara (1981), mandibular skeletal retrusion is the predominant skeletal feature in Class II cases, while maxillary skeletal protrusion is relatively uncommon. Class II malocclusion frequently includes Mandibular retrusion, protruding maxillary incisors, increased overjet, imperfect lip closure, and a higher risk of dental trauma and functional disruptions.

Functional appliances aim to correct functional habits, prevent trauma to protrusive incisors, improve facial esthetics, and stimulate mandibular growth for better occlusal balance and long-term stability during development.

Their primary objective is to stimulate mandibular growth by advancing the mandible into a Class I occlusal relationship, and the expectation is that the condylar processes will remodel superiorly and posteriorly in the condylar fossae. Functional appliances are used during growth.They are classified as removable or fixed, with fixed types including rigid, hybrid, and flexible designs. Studies have indicated that rigid fixed functional appliances yield the most effective results in growing patients.

Patient compliance is a critical factor influencing the effectiveness of functional appliances. so, it is important to evaluate removable and fixed appliances separately to accurately assess their clinical efficacy and identify any differences in treatment outcomes. The mandibular anterior repositioning appliance (MARA) is a functional device used to correct Class II malocclusion by repositioning the mandibular condyles anteriorly and inferiorly, promoting remodeling of the condyles and temporal fossae.

The Herbst appliance is a rigid fixed functional device used for Class II correction and is effective over a short treatment period of six to eight months. It functions as an artificial joint by advancing the mandible forward, inducing a "bite-jumping" effect. it has been shown to produce stable and favorable dentoskeletal effects in the correction of Class II malocclusion Additive manufacturing (AM) is a technique for producing three-dimensional (3D) objects by layering materials. Initially introduced in 1980, the process begins with a 3D design that is sliced into cross sections and transmitted to a 3D printer.. This technology is widely applied in medical fields, such as dental and orthodontic appliances. The posterior airway space (PAS), located between the posterior pharyngeal wall and the base of the tongue or soft palate, is part of the extrathoracic airway. A reduced PAS is linked to conditions such as obstructive sleep apnea (OSA) and snoring, Mandibular hypoplasia can present with a range of clinical symptoms, from minor aesthetic concerns to functional impairments and OSA.

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

入选标准

  • •cvm stage 2-3
  • •mild to moderate class 2 mal occlusion
  • •no prior orthodontic treatment
  • •good oral hygiene
  • •good patient compliance

排除标准

  • •previous orthodontic treatment
  • •craniofacial anomlies
  • •severe crowding
  • •severe skeletal protrusion
  • •tmj disorders
  • •poor compliance
  • •dental anomales

研究组 & 干预措施

herbst group

Experimental

干预措施: 3D PRINTED herbst appliance (Device)

mara group

Experimental

干预措施: 3d printed mara (Device)

结局指标

主要结局

improvement in ANB angle measured on lateral cephalometric radiographs (degrees)

时间窗: 4-5 months

次要结局

  • changes in TMJ measured in mm using cbct(4-5 months)
  • changes in posterior airway space measured in mm using cbct(4 -5 months)

研究者

发起方
Moataz Sleem Ahmed Ali
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Moataz Sleem Ahmed Ali

Master's degree candidate in orthodontics

Al-Azhar University

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