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临床试验/NCT02475785
NCT02475785已完成不适用

Evaluation of Mini Plates Anchorage in Conjunction With Forsus Fatigue Resistant Device for Correction of Skeletal Class II Malocclusion in Growing Subjects: A Randomized Controlled Trial

Sherif A. Elkordy2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
correction of the skeletal Class II profile

研究概览

简要总结

The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular effects while preventing the excessive proclination of the lower incisors at the end of the treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied to the upper and lower dental arches in female patients with skeletal Class II malocclusion

详细描述

  1. Background:

Class II malocclusions are characterized by an incorrect relationship between the maxillary and mandibular arches due to skeletal or dental problems or a combination of both. The prevalence of this malocclusion was recently found to be 20.6% in the Egyptian population in the age between 11 and 14 years with mandibular retrusion as its most common characteristic. It was also mentioned that other populations showed the predominance of the mandibular retrusion (80%) as opposed to only 20% expressing excessive maxillary development.

Class II profiles attractiveness was previously investigated in the literature. It was found that patients, their peers, orthodontists and oral surgeons, rated subjects with Class I profiles as more attractive than others with Class II profiles. It was also reported that the profile of normal adolescent patients were more favorably perceived by laypersons than untreated Class II division 1 malocclusion subjects.

In growing patients having Class II mandibular retrusion, functional orthopedic appliances are commonly used for mandibular advancement based on the concept of growth modification. However, two main problems appeared to compromise the desired treatment outcomes of these appliances; the need for patient cooperation and the lack of the possibility of combining their use with fixed appliance therapy in order to shorten treatment duration.

Many systematic reviews and meta-analyses were recently performed in the literature answering the question of whether removable functional appliances (RFAs) produced skeletal effects for correction the skeletal discrepancy through inducing actual increase in mandibular dimensions. Most recently two systematic reviews concluded that the skeletal effects of RFAs were minimal and could be considered of negligible clinical importance. They mentioned that treatment of Class II malocclusion with RFAs was associated with a minimal stimulation of mandibular growth, a minimal restriction of maxillary growth and more significant dento-alveolar and soft tissue changes.

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
10 Years 至 13 Years(Child)
性别
Female
接受健康志愿者

入选标准

  • Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
  • Horizontal or neutral growth pattern. (MMP ≤ 30°)
  • Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
  • Mandibular arch crowding less than 3 mm.
  • At the time of insertion of the FFRD, the patients had to be in the "Middle Phalanx of the Middle finger" stage G or H (MP3 G or MP3 H stage) according to Rajagopal.

排除标准

  • Systemic Disease.
  • Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
  • Extracted or missing upper permanent tooth/teeth (except for third molars).
  • Facial Asymmetry.
  • Para-functional habits.
  • Severe proclination or crowding that requires extractions in the lower arch.

研究组 & 干预措施

FFRD and mini plates group

Experimental

Upper will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires.

2 Y shaped mini plates will be inserted in the mandibular symphysis Insertion of the FFRD with Direct application over the mandibular mini plates

干预措施: FFRD and mini plates group (Device)

conventional FFRD

Active Comparator

Upper and lower arches will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires.

Insertion of FFRD with application over the lower archwire

干预措施: Conventional FFRD (Device)

untreated control group

No Intervention

Patients will be observed for an average duration of 6-8 months

结局指标

主要结局

correction of the skeletal Class II profile

时间窗: expected average of 10 months

This outcome will be detected through measurement of the mean change in the effective mandibular length and position from baseline data that when increased will result in a decrease in profile convexity. This measurement will be done after FFRD removal and correction of the sagittal relationship. Cone-beam computed tomography (CBCT) images will be used for analysis of this outcome where changes in effective mandibular length (Co-Gn) will be measured in mm

次要结局

  • Dento-alveolar side effects(expected average of 10 months)
  • Angle of soft tissue convexity(expected average of 10 months)
  • Position of lips and Chin(expected average of 10 months)

研究者

发起方
Sherif A. Elkordy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sherif A. Elkordy

Dr

Cairo University

研究点 (2)

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