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临床试验/NCT05204654
NCT05204654终止不适用

A Comparison of Class II Correction Using the Carriere Motion Appliance Versus an In-Office Sectional Appliance: Treatment Effects and Efficiency

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2022年1月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Total Treatment Time

研究概览

简要总结

The "sagittal first" approach to Class II correction in orthodontic treatment involves correcting the antero-posterior (AP) relationship of the maxillary and mandibular dentition prior to the leveling and aligning phase of orthodontic treatment. The Carriere Motion Appliance (CMA) was made to provide sagittal correction prior to orthodontic treatment with minimal secondary tooth movements that are typically seen with Class II correction. The aim in this study is to explore the efficacy and efficiency of Class II molar correction in adolescent patients using the sagittal first approach with either a sectional, in-office fabricated appliance or the CMA, by measuring total treatment duration (in months) as well as comparing dental and skeletal measurements taken from lateral cephalometric radiographs obtained prior to Class II correction (T0) and immediately after removal of the appliance (T1). The investigators will also be comparing secondary molar and canine rotational movements after Class II correction by comparing digital dental casts obtained at T0 and T1.

详细描述

The investigators will be recruiting 12 to 17-year 11-month old patients with a Class II molar relationship,who are presenting for comprehensive orthodontic treatment at the Postgraduate orthodontic clinic at University at Buffalo School of Dental Medicine. Recruited subjects will be randomized into one of 2 groups. Both groups will be receiving a method of Class II correction using the Sagittal First approach, which means the Class II molar relationship will be corrected prior to the leveling and aligning phase of orthodontic treatment. Subjects will be treated using either the Carriere Motion Appliance (CMA), or a sectional appliance fabricated with materials that are commonly found in orthodontic practice. Both appliances will be used according to the CMA guidelines. After Class II correction and removal of appliance, and prior to the next stage of treatment, an additional digital scan of the mouth and a lateral cephalometric radiograph will be taken. Dental and skeletal measurements from initial cephalometric radiographs and models will be subtracted from the corresponding measurements taken on radiographs and models obtained after Class II correction, and comparisons will be made between the two treatment treatment groups. Efficiency will be determined by number of months until Class II molar and canine correction was obtained, and efficacy will be determined by the skeletal and dental measurements obtained.

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)

盲法说明

Lateral cephalometric radiographs and digital study models will be de-identified prior to landmarking and obtaining measurements. The appliances will not be present on the patient when these records are obtained and therefore, when taking measurements, the outcomes assessor will not know which intervention the subjects received.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Males and Females
  • Presenting for comprehensive orthodontic treatment at the Postgraduate orthodontic clinic at the University at Buffalo School of Dental Medicine
  • Unilateral or bilateral ½-cusp to full-cusp Class II molar and canine relationship
  • Growing Patients (~12-17y 11m)
  • Subjects who do not require extractions as part of treatment mechanics
  • Mild to moderate crowding

排除标准

  • Patients in mixed dentition
  • Any missing teeth up to and including permanent first molars
  • Bilateral molar relationship of less than ½ cusp Class II prior to appliance cementation

结局指标

主要结局

Total Treatment Time

时间窗: From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).

Months

次要结局

  • Skeletal Changes(From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).)
  • Dental Changes(From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).)
  • Maxillary Canine and Maxillary First Molar Rotation(From date of Class II correction appliance delivery to date of removal of Class II correction appliance after Class I molar and canine relationship has been established (approximately 120-180 days).)

研究者

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

Alexandria Mary Newton

Orthodontic Resident

State University of New York at Buffalo

研究点 (2)

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