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临床试验/NCT05089396
NCT05089396Unknown不适用

Assessment of Dentoskeletal Effects Concomitant With Skeletally Anchored Maxillary Protraction in Orthodontic Skeletal Class III Patients

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年11月22日最近更新:
适应症

试验速览

阶段
不适用
入组人数
14
试验地点
1
主要终点
midfacial length

研究概览

简要总结

The aim of this study will be directed to the assessment of dentoskeletal effects concomitant with skeletally anchored maxillary protraction in orthodontic skeletal Class III patients.

详细描述

Skeletal Class III is a challenging problem that is confronting orthodontists in their everyday orthodontic practice. The prevalence of this malocclusion varies globally among and within populations with the greatest incidence among Asian countries. It was reported that Class III malocclusion represents 3.98% and 5.93% of malocclusions in mixed and permanent dentitions respectively. Among Egyptians, the prevalence of Class III malocclusion during mixed dentition was found to be 5.9 % according to the sample studied by Fsifis et al.

Different skeletal components contribute to the development of the classic Class III with convex or straight profiles. These components are either maxillary retrognathism, mandibular prognathism relative to other craniofacial structures, or even a combination of them. According to the sample studied by Ellis and Macnamara, they found 65% to 67% of skeletal Class III was due to maxillary skeletal retrusion.

The growth and severity of the sagittal skeletal discrepancy dictate the possible treatment modalities. On one hand, Growth modification is indicated in individuals who have not reached the growth spurt yet. On the other hand, cessation of growth leaves only orthodontic camouflage and orthognathic surgery as treatment options, the severity of the anteroposterior discrepancy and dental compensation determine which of them gives the best clinical results.

The most common approach for the treatment of growing Class III patients with maxillary retrognathism is the facemask (FM) accompanied by rapid maxillary expansion (RME). RME was claimed to open the midpalatal suture and affect the other nine sutures adjacent to the maxilla. Accordingly, it is said to facilitate the orthopedic effect of the facemask. However, a meta-analysis concluded that treatment with facemask with or without RME is clinically effective with a nonsignificant difference.

Forces from protraction facemask are applied to dental structures so, it has side effects as mesial movement and extrusion of maxillary molars, proclination of upper incisors, retroclination of mandibular incisors, backward rotation of the mandible, and increase in the lower facial height. These side effects might be desirable or undesirable according to the clinical situation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
8 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Growing Class III patients with a prepubertal stage of skeletal maturity according to the cervical vertebral maturation method.
  • Skeletal Class III malocclusion with maxillary deficiency (ANB, <0°; N perp-A<1mm) with or without mild mandibular prognathism.
  • Late mixed or early permanent dentition at the start of treatment characterized by a Wits appraisal of -1 mm or less and an Angle Class III molar relationship or anterior crossbite.
  • Vertically normal growth pattern determined by cephalometric radiographs.
  • Patients are free from developmental or congenital conditions such as cleft lip/palate or other craniofacial anomalies.
  • No previous orthodontic treatment.

排除标准

  • Poor oral hygiene or periodontally compromised patient.
  • Patients with craniofacial anomalies or previous history of trauma, bruxism, or parafunctions.
  • Previous orthodontic treatment.

结局指标

主要结局

midfacial length

时间窗: 1 year

linear distance between condylon and A points

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Mohamed Gouda Embaby

Dentist

Al-Azhar University

研究点 (1)

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