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临床试验/NCT05298280
NCT05298280已完成不适用

Vertical Effects in Class II Patients Treated With Distalization: Comparison Between Multibracket Conventional Therapy and Clear Aligners

University of Rome Tor Vergata2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019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
40
试验地点
2
主要终点
SN^GoGn

研究概览

简要总结

Class II malocclusion presents a major and common challenge to orthodontists. Treatment of Class II malocclusion is one of the most investigated and controversial issues in contemporary orthodontics because of the extensive variability of treatment strategies addressing the morphological characteristics of this malocclusion. The therapeutic approaches include tooth extractions, orthopedic appliances and extraoral or intraoral distalizing appliances. Maxillary molar distalization is one of the most common strategies to correct Class II molar relationship and it is commonly indicated for patients with maxillary dentoalveolar protrusion or minor skeletal discrepancies. One of the most used devices is Pendulum appliance, introducted by Hilgers in 1992.

In the last decades, the orthodontic treatment with removable clear aligners has become an increasing common choice because of the growing number of adult patients who ask for aesthetic and comfortable alternatives to conventional fixed appliances.

In 1997, Align Technology (Santa Clara, Calif) adapted and incorporated modern technologies to introduce the clear aligner treatment (CAT). Only few investigations have focused on the predictability of orthodontic tooth movement with CAT. A systematic review by Rossini et al. pointed out that among the dental movements analyzed in 11 studies, the bodily distalization was the most predictable.

Clinicians can consider the use of aligners in treatment planning for adult patients requiring 2 to 3 mm of maxillary molar distalization.

However, a detailed analysis of the skeletal and dental changes that compared pendulum appliance and clear aligners in class II treatment is still lacking.

On the basis of these considerations, the aim of the present prospective study was to analyze the effects on vertical dentoskeletal changes following maxillary molar distalization with pendulum and full fixed appliances and clear aligners.

详细描述

Class II malocclusion presents a major and common challenge to orthodontists. Treatment of Class II malocclusion is one of the most investigated and controversial issues in contemporary orthodontics because of the extensive variability of treatment strategies addressing the morphological characteristics of this malocclusion. The therapeutic approaches include tooth extractions, orthopedic appliances and extraoral or intraoral distalizing appliances. Maxillary molar distalization is one of the most common strategies to correct Class II molar relationship and it is commonly indicated for patients with maxillary dentoalveolar protrusion or minor skeletal discrepancies. One of the most used devices is Pendulum appliance, introducted by Hilgers in 1992. It is a tooth-tissue-borne appliance that includes a Nance button on the palate for intraoral anchorage and titanium-molybdenum coils that deliver a mild and continuous force to the maxillary molars. Despite its efficacy for maxillary molar distalization, there are side-effects, including labial/mesial tipping and protrusion of the maxillary incisors and premolars, distal tipping of the maxillary molars, increase in lower anterior face height, clockwise mandibular rotation, and extrusion of the first premolars. Consequently, these side-effects have to be corrected during the following fixed appliance treatment phase.

In the last decades, the orthodontic treatment with removable clear aligners has become an increasing common choice because of the growing number of adult patients who ask for aesthetic and comfortable alternatives to conventional fixed appliances.

In 1997, Align Technology (Santa Clara, Calif) adapted and incorporated modern technologies to introduce the clear aligner treatment (CAT). Only few investigations have focused on the predictability of orthodontic tooth movement with CAT. A systematic review by Rossini et al. pointed out that among the dental movements analyzed in 11 studies, the bodily distalization was the most predictable.

Simon et al. reported a high accuracy (88%) of the bodily movement of upper molars with aligners when a mean distalization movement of 2.7 mm was prescribed. The authors reported the best accuracy when the movement was supported by the presence of an attachment on the tooth surface. Furthermore, they underlined the importance of staging in the treatment predictability.

Ravera et al. showed that clear aligners are effective in distalizing maxillary molars in non-growing subjects without significant vertical and mesiodistal tipping movements. The authors reported that the lower facial height did not change at the end of the treatment. Therefore, clinicians can consider the use of aligners in treatment planning for adult patients requiring 2 to 3 mm of maxillary molar distalization.

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
Double (Investigator, Outcomes Assessor)

盲法说明

The observer (BA) who performed all the measurements was blinded to the group assignment. The study was blinded in regard to the statistical analysis: blinding was obtained by eliminating from the elaboration file every reference to patient group assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • bilateral Class II or end to end Class II molar relationship
  • skeletal Class I or II malocclusion (ANB angle between 2° and 7°)
  • normodivergence on the vertical plane (SN^GoGn angle less than 37°)
  • crowding in the lower arch (≤6 mm)
  • good quality of pre and post treatment radiographs
  • good general health with healthy periodontium

排除标准

  • patients who required functional appliance therapy
  • those who had previous orthodontic treatment or extraction
  • hypodontia
  • craniofacial syndromes or cleft
  • previous prosthodontic treatments of the upper molars

结局指标

主要结局

SN^GoGn

时间窗: At the beginning and at the end of the teraphy

The SN-GoGn angle is an angular measurement included in the study to quantify the inclination of the mandibular base relative to the cranial base. Its average value is 32°

次要结局

  • Overjet(At the beginning and at the end of the teraphy)

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

Associate Researcher

University of Rome Tor Vergata

研究点 (2)

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