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临床试验/NCT07744685
NCT07744685已完成不适用

External Apical Root Resorption in Three Miniscrew-Supported Maxillary En-Masse Retraction Mechanics: A Randomized Controlled Trial

Damascus University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
External Apical Root Resorption of the Maxillary Anterior Teeth

研究概览

简要总结

External apical root resorption is a possible side effect of fixed orthodontic treatment, particularly in the upper front teeth. This randomized clinical trial was conducted to compare the amount and timing of root resorption associated with three different methods of retracting the upper anterior teeth using miniscrew anchorage. Sixty adult patients with Class II Division 1 malocclusion who required extraction of the upper first premolars were randomly allocated to one of three groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group. In all groups, the six upper anterior teeth were retracted together with the support of orthodontic miniscrews. Panoramic radiographs were obtained before treatment, after completion of leveling and alignment, and after completion of en-masse retraction. Root and crown lengths were measured on these radiographs to estimate external apical root resorption during the leveling and alignment phase, during the retraction phase, and over the complete observation period. The study also compared the pattern of resorption among the upper canines, lateral incisors, and central incisors.

详细描述

Orthodontic camouflage treatment of adult patients with Class II Division 1 malocclusion frequently involves extraction of the maxillary first premolars followed by retraction of the upper anterior teeth. Temporary orthodontic miniscrews can provide skeletal anchorage during this stage and allow the six maxillary anterior teeth to be retracted together as one unit. Although these mechanics are widely used, the anterior teeth remain exposed to orthodontic forces during both the initial leveling and alignment phase and the subsequent retraction phase. External apical root resorption is therefore an important biological safety outcome that should be evaluated throughout treatment rather than only after space closure has been completed.

This single-center, three-arm, parallel-group randomized clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Sixty adult patients with Class II Division 1 malocclusion who required extraction-based orthodontic camouflage treatment were allocated equally to one of three treatment groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group.

The three approaches differed in the relationship between the anterior brackets and the working archwire. The bidimensional approach used smaller anterior bracket slots with larger posterior slots. The hybrid dual-section approach used a customized archwire with different anterior and posterior cross-sections, while the conventional group used a continuous archwire with a uniform cross-section. These mechanical differences may influence archwire engagement, force expression, and the distribution of forces applied to the roots of the maxillary anterior teeth. Their possible effect on external apical root resorption therefore required direct clinical comparison.

All participants underwent bilateral extraction of the maxillary first premolars, fixed-appliance leveling and alignment, and miniscrew-supported en-masse retraction of the six maxillary anterior teeth. The same general treatment stages and skeletal anchorage concept were used in all groups, while the bracket-slot and archwire configurations varied according to group allocation. Retraction continued until an acceptable overjet and a Class I canine relationship were achieved. Participants were reviewed regularly throughout treatment, and miniscrew-related or other treatment-associated adverse events were recorded.

Digital panoramic radiographs were obtained before orthodontic treatment, at the end of leveling and alignment immediately before retraction, and after completion of en-masse retraction. The maxillary central incisors, lateral incisors, and canines on both sides were assessed individually. Crown length was used as a stable reference to correct for differences in radiographic magnification between time points.

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)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18-30 years.
  • Class II Division 1 dental malocclusion according to Angle classification
  • Mild-to-moderate skeletal Class II discrepancy, with an ANB angle greater than 4° and not exceeding 7°.
  • Overjet ranging from 5 to 9 mm.
  • Presence of all six maxillary anterior teeth.
  • Maxillary anterior teeth fully erupted and with complete root formation.

排除标准

  • Patients with previous orthodontic treatment.
  • Missing permanent maxillary teeth.
  • Active periodontal disease.
  • History of trauma to any maxillary anterior tooth.
  • Previous endodontic treatment of any maxillary anterior tooth.
  • Periapical pathology involving any maxillary anterior tooth.
  • Extensive coronal restorations that could interfere with crown-length measurement.
  • Radiographic evidence of pre-existing root resorption before orthodontic treatment.

结局指标

主要结局

External Apical Root Resorption of the Maxillary Anterior Teeth

时间窗: Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.

External apical root resorption was assessed separately for the six maxillary anterior teeth by measuring changes in corrected root length on digital panoramic radiographs using ImageJ software. Crown length was used as a stable reference to correct for differences in radiographic magnification. Root resorption was expressed in millimeters, and the total amount was calculated directly from the initial and final radiographs rather than by adding the interval measurements.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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