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临床试验/NCT06859606
NCT06859606已完成不适用

Mandibular Sequential Distalization Versus Class III Elastics With Clear Aligners in Class III Patients: a Randomized Controlled Trial

Saint Camillus International University of Health Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年12月1日最近更新:

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
Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm)

研究概览

简要总结

Distalizing mandibular molars may be indicated for patients with minor skeletal Class III discrepancies or in Class III subjects with mild crowding. Traditionally, mandibular molar distalization was accomplished using elastics, open coils, and the multiloop edgewise archwire technique. In recent years, several techniques have been developed to reduce the dependence on patient compliance, such as skeletal anchorage. Recently, several reports have been published on mandibular distal movement using miniscrews and some case reports have shown the possibility of obtaining Class III correction with sequential mandibular distalization in non-growing subjects by means of clear aligners. However, a sound clinical judgment should always be made on the basis of a higher level of evidence. Therefore, the purpose of the present prospective study is to provide a detailed analysis of the underlying skeletal and dental changes determined by mandibular distalization therapy with the sequential Invisalign protocol in permanent dentition. This will be accomplished by testing the following null hypothesis: mandibular molar distalization is not achievable with aligners without the application of TADs.

详细描述

Class III malocclusion is considered one of the most challenging maxillofacial disorders in clinical practice characterized by an antero-posterior discrepancy with mandibular protrusion, maxillary retrusion, or a combination of both. In adult patients, managing this condition is further complicated by the absence of residual skeletal growth, limiting therapeutic options to orthodontic interventions and, in some cases, surgical procedures. Diagnosis in Class III adult patients requires distinguishing between skeletal malocclusion and dento-alveolar discrepancy. The combination of orthognathic surgery and orthodontic therapy represents the gold standard for more severe skeletal Class III disharmonies, leading to an improvement of both function and aesthetics. On the other hand, in Class III cases characterized by a prevalent dental component or mild skeletal discrepancy, the malocclusion can be addressed with a dento-alveolar compensation. In these cases, the clinical objectives are to achieve a correct sagittal, canine and molar Class I relationship, as well as ideal values of overjet and overbite. The non-surgical orthopedic approach involves the application of Class III elastics or the distalization of the lower molars, which can improve the sagittal occlusal relationship. As a matter of fact, mandibular distalization allows the increase of lower arch length along with the achievement of the necessary space to correct a Class III relationship. However, bone density and root anatomy make lower molar distalization difficult to achieve. In addition, one of the most frequent adverse effects is represented by the anterior anchorage loss with a worsening of lower incisor proclination and overjet values. Traditional appliances feature the use of open coil springs, inter arch elastics, and lip bumper device combined with fixed appliances. Nowadays, the development of clear aligner technology provides new opportunities even in the management of complex malocclusion cases, including Class III discrepancies. In particular, molar distalization movements and intermaxillary elastics have been proposed as a valid clinical strategy to improve the occlusal relationship without requiring skeletal anchorage devices. During the sagittal mechanics, over-corrected movements should be planned in order to obtain more bodily movements of the lower molars. Moreover, the best accuracy and predictability of distalization movements are supported by the sequential staging and the presence of attachments on the tooth surfaces. Nowadays, scientific evidence on this topic is limited and it is influenced by restrictions in terms of sample size, retrospective design, and lack of long-term observation. Hence, the aim of the present study was to evaluate the efficacy and efficiency of intermaxillary elastics combined with lower molar distalization by means of clear aligners in the treatment of Class III malocclusion in adult patients. More specifically, a randomized controlled trial (RCT) was conducted to evaluate the antero-posterior correction induced by Class III elastics combined with lower distalization movements and the application of Class III elastics alone. The possibility of achieving satisfying clinical outcomes without the use of skeletal anchorage was considered to avoid an invasive orthodontic approach

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 (Participant, Investigator)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult age (≥19 years)
  • permanent dentition including second permanent molars
  • skeletal Class I or slight Class III (-2° < ANB < +2°)
  • normal skeletal divergency pattern (SN^GoGn, 27°-37°)
  • Class III canine and molar relationship at baseline (T0), moderate lower arch crowding (≤ +4 mm)
  • good compliance with aligners and elastics (≥ 20 hours/day)

排除标准

  • severe skeletal Class III malocclusion (ANB < -2°)
  • transversal maxillary deficiency
  • use of Temporary Anchorage Devices (TADs)
  • extraction treatments other than third molars
  • periodontal disease or temporomandibular disorders (TMDs).

结局指标

主要结局

Lower molar positional changes expressed by means of linear and angular measurements (L6-MP mm; L6-MP angle; L6 - CoGo mm; L6 apex - CoGo mm)

时间窗: from the start of treatment to the end at 24 months

L6-MP mm: linear distance between the mesial cusp of lower first molar and Mandibular plane L6-MP angle: angle between long axis of lower first molar and Mandibular plane L6 - CoGo mm: linear distance between the mesial cusp of lower first molar and CoGo line L6 apex - CoGo mm: linear distance between the apex of lower first molar and CoGo line

次要结局

  • Changes in inclination of the lower incisors (IMPA angle)(from the start of treatment to the and at 24 months)
  • Changes in position of the lower incisors (L1-CoGo mm; L1apex - CoGo)(from the start of treatment to the and at 24 months)
  • Sagittal skeletal changes (SNA angle, SNB angle, ANB angle)(from start of treatment to to the end at 24 months)
  • Sagittal skeletal changes (Wits appraisal)(from start of treatment to to the end at 24 months)
  • Vertical skeletal changes (SN^MP angle, Gonial Angle)(from the start of treatment to the end at 24 months)
  • Changes of upper incisors inclination(from the start of treatment to the and at 24 months)
  • Overbite and Overjet values(from the start of treatment to the and at 24 months)

研究者

发起方
Saint Camillus International University of Health Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesca Gazzani

Research Assistant

Saint Camillus International University of Health Sciences

研究点 (2)

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