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临床试验/NCT04884022
NCT04884022Unknown不适用

Effectiveness of Two Skeletally Anchored Force Mechanics for Correction of Skeletal Class II Malocclusion in Growing Patients (A Randomized Controlled Clinical Trial)

Alexandria University1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2021年3月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
39
试验地点
1
主要终点
change in the effective mandibular length (Co-Gn)

研究概览

简要总结

Patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited and randomly allocated to three equal groups. first group will be treated by pushing orthopedic force mechanics, second group will be treated by pulling orthopedic force mechanics, and third group will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated and the treatment changes will be compared with the natural growth changes. The study hypothesis is that use of direct bimaxillary miniplate anchorage in conjunction with fixed functional appliance (pushing orthopedic force) or closed coil spring (pulling orthopedic force) will induce statistically significant skeletal mandibular growth in comparison to natural mandibular growth changes.

详细描述

A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty-nine growing patients with skeletal Class II malocclusion due to mandibular retrognathism will be recruited. The sample will be randomly allocated to three equal groups, each including thirteen subjects. Group A will be treated by pushing orthopedic force mechanics using fixed functional appliance (Sabbagh Advanced Repositioning Appliance) anchored to four miniplates (two miniplates inserted in the mandibular symphysis and two infrazygomatic miniplates), and Group B, will be treated by pulling orthopedic force mechanics using Class II springs (CS Class II correction device) anchored to four miniplates (two inserted in the mandibular posterior buccal segment and two inserted in the maxillary anterior segment). In both groups, the appliances will be removed after reaching an edge-to-edge incisor relationship or after 9 months, whichever happens first. A similar third group (Group C) will be observed for 9 months to detect the natural growth changes. Skeletal changes will be evaluated using pretreatment and posttreatment cone beam computed tomography scans (CBCT). The treatment changes will be compared with the natural growth changes observed in group C. Other variables will be also examined including, the dentoalveolar effects, the soft tissue profile, and the patient's acceptance to this treatment modality.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 13 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Chronological age ranges from 11 years to 13 years.
  • •Skeletal Class II malocclusion with a deficient mandible (SNB ≤ 76°).
  • •Horizontal growth pattern (MP/SN ≤ 39°).
  • •Angle Class II division 1 malocclusion with at least 5 mm overjet.
  • •Mandibular arch crowding less than 5 mm.
  • •The patients have to be in the prepubertal growth stage (cervical maturational stage 3 or 4) when applying orthopedic force.
  • •Patients with good oral hygiene, and a healthy periodontal condition.

排除标准

  • •Patients who underwent previous orthodontic treatment.
  • •Patients with previous craniofacial surgeries, chronic diseases, syndromes, or growth problems that may affect bone.
  • •Any signs or symptoms of para-functional habits or previous history of temporomandibular disorders.
  • •Extracted or missing upper permanent teeth (except for third molars).

研究组 & 干预措施

Miniplates in mandibular symphysis & infrazygomatic

Experimental

干预措施: Miniplates in mandibular symphysis & infrazygomatic (Procedure)

Miniplates in external oblique ridge & anterior maxillary region

Active Comparator

干预措施: Miniplates in external oblique ridge & anterior maxillary region (Procedure)

Growing skeletal Class II subjects

No Intervention

结局指标

主要结局

change in the effective mandibular length (Co-Gn)

时间窗: at baseline and after treatment completion about 9 months

Correction of the skeletal Class II relation. This outcome will be detected by measuring the mean change in the effective mandibular length (Co-Gn) and position on CBCT images from baseline data (T1) and after appliance removal (T2) and will be compared with the growth changes observed in the control group

次要结局

  • change in maxillary length (Co-A)(at baseline and after treatment completion about 9 months)
  • patient acceptance of treatment(After treatment completion about 9 months)
  • Changes in the soft tissue angle of convexity(at baseline and after treatment completion about 9 months)

研究者

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

Yasmine Mohamed Sayed Mahmoud

clinical researcher

Alexandria University

研究点 (1)

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