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临床试验/NCT07383259
NCT07383259尚未招募不适用

Skeletal and Dentoalveolar Effects of Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate Maxillary Protraction in Growing Class III Patients.

Universidad Complutense de Madrid0 个研究点目标入组 36 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
Change in sagittal skeletal relationship

研究概览

简要总结

This retrospective non-randomized controlled clinical trial aimed to compare the skeletal and dentoalveolar effects of two orthopedic treatment protocols for skeletal Class III malocclusion in growing patients: a conventional tooth-borne rapid maxillary expansion combined with facemask therapy, and a hybrid skeletal anchorage expander combined with chin-plate traction. Lateral cephalometric changes before and after maxillary protraction were analyzed to assess sagittal skeletal correction and dentoalveolar effects.

详细描述

Skeletal Class III malocclusion is frequently associated with maxillary growth deficiency and presents significant functional and esthetic challenges. Conventional treatment using rapid maxillary expansion combined with facemask therapy is effective but limited by patient compliance and undesirable dentoalveolar effects. The introduction of skeletal anchorage devices allows the application of orthopedic forces with reduced dental compensation and extended effectiveness beyond early growth stages.

This study retrospectively evaluated growing patients (CVS1-CVS3) treated with either a tooth-borne expander and facemask or a hybrid skeletal anchorage expander combined with chin-plate traction. Cephalometric variables were measured before treatment (T0) and after completion of maxillary protraction (T1) to compare skeletal and dentoalveolar changes between protocols.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Growing patients (CVS1-CVS3)
  • Patent midpalatal suture (stages A-C)
  • Skeletal Class III malocclusion (ANB < 0°, Wits < -2 mm)
  • Presence of anterior crossbite or edge-to-edge incisal relationship

排除标准

  • Severe craniofacial asymmetry
  • Evidence of active condylar growth
  • Previous orthodontic treatment
  • Craniofacial malformations or syndromes
  • Systemic diseases or medications affecting growth or bone metabolism

研究组 & 干预措施

Tooth-Borne Expander with Facemask (FM)

Active Comparator

Bonded acrylic splint-type Hyrax expander with hooks in the maxillary canine region. Expansion activated once daily (0.25 mm). Facemask therapy initiated two weeks after expansion onset with 400 g per side of elastic traction, directed approximately 30° downward relative to the occlusal plane, worn 14-16 hours per day.

干预措施: Tooth-Borne Expander with Facemask (FM) (Device)

Hybrid Skeletal Anchorage Expander with Chin-Plate (SA)

Experimental

Modified Hybrid Hyrax expander supported by first molars and anchored with miniscrews placed bilaterally in a paramedian position. Expansion activated once daily (0.25 mm). Mandibular chin-plates (bollard-type or single chin-plate depending on eruption stage) were surgically inserted, and Class III elastics delivering 400 g per side were applied following a progressive loading protocol.

干预措施: Hybrid Skeletal Anchorage Expander with Chin-Plate (SA) (Device)

结局指标

主要结局

Change in sagittal skeletal relationship

时间窗: From baseline (T0) through study completion, an average of 1 year (T1)

Changes in the cephalometric angles SNA, ANB, and Wits appraisal measured on lateral cephalograms between T0 and T1

次要结局

  • Cephalometric vertical skeletal changes(From baseline (T0) through study completion, an average of 1 year (T1))
  • Cephalometric dentoalveolar changes(From baseline (T0) through study completion, an average of 1 year (T1))
  • Treatment duration(From baseline (T0) through study completion, an average of 1 year (T1))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Concepción Martín Alvaro

Full Professor

Universidad Complutense de Madrid

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