Efficacy of Transverse Maxillary Expansion With AMCOP Preformed Appliances: Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in upper intermolar distance on digital casts
研究概览
简要总结
The present study aimed to investigate the cross-sectional effect of Class I AMCOP devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).
The criterion for choosing patients was determined by the protocol of using these devices, which is to always perform an AMCOP First Class phase with the aim of improving transverse coordination of the arches, Spee's Curve and Wilson's Curve.
详细描述
This prospective clinical study will investigate the cross-sectional effect of Class I AMCOP (Cranium Occluded Postural Multifunctional Harmonizers, Micerium spa) devices in patients of all possible skeletal types from both vertical skeletal pattern (normodivergent, hyperdivergent, hypodivergent) and sagittal skeletal pattern (skeletal Class I, skeletal Class II, skeletal Class III).
Patients willing to start AMCOP therapy and recruited for the study will be asked to sign the informed consent. Parents will sign the consent for underage patients.
We will recruit patients by following specific inclusion and exclusion criteria during an orthodontic examination.
Diagnostic records will be recorded before treatment (T0) and after 10-12 months of treatment (T1) and included:
- Intraoral and extraoral photographs
- Impressions of the dental arches with digital scanner
- Orthopantomography
- Lateral teleradiography
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients presenting maxillary transverse deficits (that includes: posterior crossbite monolateral or bilateral; end-to-end occlusal relationships; excessive linguoinclination of lower posterior teeth due to the contraction of maxillary arch; limited permutation space of permanent elements)
- •patients with all sagittal and vertical skeletal patterns
排除标准
- •syndromic patterns, cleft lip or cleft palate, severe malformations of the maxillae, severe skeletal asymmetry
- •physical or psychological limitations
- •presence of metallic restorations
- •previous orthodontic treatments
研究组 & 干预措施
Treatment with AMCOP First Class appliance
干预措施: AMCOP appliance (Device)
结局指标
主要结局
Change in upper intermolar distance on digital casts
时间窗: Before treatment (T0) and after 10-12 months of treatment (T1)
The upper intermolar distance take as reference the top of the mesiovestibular cusp of the upper first molars.
次要结局
- Change in upper intercanine distance on digital casts(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in lower intercanine distance on digital casts(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in ANB angle(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Wits Index(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Skeletal Class(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Cranio-Mandibular Angle(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Intermaxillary Angle(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Skeletal Vertical Pattern:(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Articular Angle(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Upper and Lower Goniac Angles(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Mandibular growth pattern(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Upper incisors Inclination(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Lower incisors Inclination(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in Dento-alveolar discrepancy(Before treatment (T0) and after 10-12 months of treatment (T1))
- Change in lower intermolar distance(Before treatment (T0) and after 10-12 months of treatment (T1))
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia