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临床试验/NCT06522607
NCT06522607招募中不适用

Three-dimensional Analysis of Palatal Morphology of Hypo-, Hyper-, Normodivergent Growing Subjects With Posterior Cross-bite Treated With Rapid Palatal Expander, a Longitudinal Pilot Study.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Morphological changes of the palate

研究概览

简要总结

The aim of the present study is to assess the changes of palatal morphology among growing patients with different vertical facial growth patterns treated with rapid palatal expander.

Thirty-six patients referred to "Policlinico Agostino Gemelli" university hospital will be selected. The eligible criteria are posterior cross-bite, mixed dentition, skeletal Class I relationship and prepubertal stage of cervical vertebral maturation. The patients will be split into three groups according to facial divergency (hyper-, hypo-, normodivergent subjects). For each subject, digital dental casts will be recorded before and after treatment using an intraoral scanner. To evaluate two-dimensional maxillary arch changes, linear measurements will be done. To study comprehensively the palatal shape, a set of 240 landmark and semi-landmarks will be digitized on the palatal vault. Then, Geometric Morphometric Analysis (GMA) will be performed to compare morphological variations of the palate among different vertical facial growth pattern groups.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
7 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Caucasian origin;
  • Mixed dentition stage;
  • Angle class I or straight step or mesial step molar relationship in primary dentition;
  • Skeletal class I (ANB angle between 0° and 5°);
  • Vertical dimension evaluated on lateral cephalograms: SN^GoGn>37°: hyperdivergent, SN^GoGn<27°: hypodivergent, 27°<SN^GoGn>37°: normodivergent;
  • Cervical vertebral stage 1 or 2 (CVS methods 1-2);
  • Posterior cross-bite including deciduous or permanent teeth;
  • Presence of good quality pre-treatment records (history, intraoral and extraoral photographs, oral scan, panoramic radiographs, and lateral cephalometric radiographs with reference ruler);
  • Oral scan and photographs available for each subject 6 months after the beginning of the therapy;
  • Signing the informed consent form.

排除标准

  • Previous orthodontic treatment;
  • Tooth agenesis or supernumerary teeth;
  • Craniofacial abnormalities;
  • Tooth impaction in the maxilla;
  • Torus palatinus;
  • History of dental trauma (avulsion and alveolar/jaw fracture);
  • Refusal to sign consent form.

结局指标

主要结局

Morphological changes of the palate

时间窗: 6 months

The principal aim of this study is to analyze the morphological changes of the palate in growing subjects with posterior cross-bite after rapid palatal expander therapy. The intraoral scans of the maxillary arch will be recorded at T0 (before treatment) and T1 (after treatment). To study comprehensively the palatal shape, 3D Geometric Morphometric Method will be applied. Pre- and post-treatment intraoral scans will be digitized using Stratovan Checkpoint Software, placing 240 landmarks. The landmark configurations will be superimposed with Procrustes Superimposition.

次要结局

  • Geometric Morphometric Analysis of palatal vault among patients with different facial type(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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