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临床试验/NCT03159962
NCT03159962已完成不适用

Mandibular Response After Rapid Maxillary Expansion in Class II Growing Patients: a Pilot Randomized Controlled Trial

University of Rome Tor Vergata2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Mandibular displacement after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group

研究概览

简要总结

the effectiveness of RME (Rapid Maxillary Expander) on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group. The primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group

详细描述

Class II malocclusions are commonly observed in orthodontic patients. During treatment planning among the several dento-skeletal pattern combinations of Class II malocclusion, it is important to consider the maxillary transverse deficiency, which is often overlooked.

it has been showed showed an underlying posterior interarch transverse discrepancy of 3 to 5 mm in subjects in early mixed dentition with Class II malocclusions without posterior crossbites in centric occlusion. When these Class II patients are asked to posture their lower jaw forward in a Class I molar relationship, this transverse discrepancy (ie, maxillary constriction) can be observed clinically. It was postulated that in these subjects the mandible is kept in a distal position relative to centric relation because the constricted maxilla is holding it back. The presence of a primitive transverse discrepancy between the dental arches induces a backward position of the mandible, as the occlusal goal is to obtain the highest number of functional contacts.

As reported by several authors, widening the maxilla with rapid maxillary expansion often leads to spontaneous forward posturing of the mandible during the retention period. The orthopedic expansion removes occlusal interferences, allowing the mandible to posture forward, thus improving the sagittal relationships. The mandibular arch acts as a ''foot'' that moves forward after the ''shoe'' is widened.

However, the effectiveness of RME on the sagittal dental or skeletal parameters is still controversial because very little has been written regarding the behavior of antero-posterior mandibular changes in Class II growing subjects who underwent RME as the phase 1 treatment intervention. The reported significant occlusal improvement could be attributed to other reasons, ie, skeletal growth or the use of additional appliances during transition from mixed to permanent dentition. Moreover, the majority of the studies show some limits: they are not randomized, they are not prospective, and they have no control group or they use patients from growth studies as a source for the control group.

Considering that it was not possible to estimate from previous studies the standard deviation to be used for sample size calculation of the main trial with special regards to type of intervention and observation intervals, the primary objective of the present investigation was to conduct a pilot randomized controlled trial (RCT) evaluating the changes in the antero-posterior mandibular position induced by bonded or banded RMEs compared with an untreated Class II control group.

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
None

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者

入选标准

  • early mixed dentition with first molars fully erupted,
  • Class II malocclusion (full-cusp or end-to-end molar relationships),
  • negative posterior transverse interarch discrepancy ≥ 4 mm,
  • Overjet ≥ 5 mm,
  • and prepubertal stage of development (Cervical Stage 1 - Cervical Stage 2 in cervical vertebral maturation)

排除标准

  • previous orthodontic treatment,
  • extracted or congenitally missing teeth,
  • craniofacial syndromes or clefts,
  • use of additional orthodontic devices during the observation period

结局指标

主要结局

Mandibular displacement after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group

时间窗: 12 months

The primary outcome was the change in the position of point Pogonion to the Nasion perpendicular (Pg to N perp). The objective is to evaluate the changes in the sagittal mandibular position induced by bonded or banded RMEs compared with an untreated control group. For each treated patient, standard lateral cephalograms were obtained before treatment and after 1 year to evaluate the dento-skeletal changes. The Control Group was followed up without treatment for 1 year and had lateral cephalograms before and after a one-year interval. Cephalograms were scanned using a professional table scanner (Epson Perfection V700 Photo, CA, USA), with resolution set to 150 dots per inch (dpi) gray scale and were digitized by 1 investigator., followed by a customized digitization regimen and analysis (Viewbox 3.1; dHAL Software, Kifissia, Greece). All cephalograms were at a magnification of 0%. The examiner was blinded to the origin of the films and the group to which each subject belonged

次要结局

  • Occlusal improvement of Class II molar relationship after RME appliance therapy (linear measurement in millimeters) when compared with a matched untreated control group(12 months)
  • Treatment effects on vertical dimension (SN-Go Me; angular measurement) and on Gonial Angle (Ar-Go-Me, angular measurement) and vertical growth pattern after RME appliance therapy when compared with a matched untreated control group(12 months)

研究者

发起方
University of Rome Tor Vergata
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberta Lione

Principal Investigator, Research Fellow, Department of Clinical Sciences and Translational Medicine, University of Rome "Tor Vergata," Rome, Italy

University of Rome Tor Vergata

研究点 (2)

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