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临床试验/NCT06244563
NCT06244563已完成不适用

Evaluation of the Efficacy of Different Anchorage-supported Appliances and Different Expansion Procedures for Face Mask Treatment in Prepubertal Children

University of Gaziantep2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月8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
2
主要终点
Evaluation of Skeletal and Dental Changes in Millimetric Measurements

研究概览

简要总结

The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.

详细描述

Face mask therapy is an effective method in the treatment of class III malocclusions due to maxillary insufficiency. In face mask treatment, various intraoral devices are used to transmit protraction forces to the maxilla. According to the anchorage unit, these appliances are divided into tooth-supported and bone-supported. The traditional bonded rapid maxillary expander (RME) is a tooth-supported appliance that allows expansion and is generally used with face masks. However, it causes many side effects due to the transmission of protraction forces through the teeth. Hybrid appliances supported by skeletal and dental anchorage may be preferred over bonded RME in the maxilla for face mask treatment based on their lower dental side effects and high skeletal contribution.

Before transferring the protraction forces to the maxilla using a face mask, expansion is first performed with intraoral devices according to the patient's needs. For this purpose, two different expansion procedures are currently used: routine rapid maxillary expansion (routine) and alternative rapid maxillary expansion and contraction (alt-RAMEC). In the routine rapid maxillary expansion procedure, the expander screw is turned twice a day until the expansion phase is complete. Unlike the routine procedure, in the alt-RAMEC procedure, each week of expansion is followed by a week of contraction. The duration of the expansion-contraction process varies between 7-9 weeks, depending on the patient's need for expansion. These opening and closing phases are increased maxillary protraction by loosening the intermaxillary sutures.

The main purpose of this study is to compare the effects of different combinations of appliances and procedures on maxillary protraction during face mask treatment and determine the most powerful method. Sixty patients who were planned to apply face mask treatment were included in the study and divided into four groups (n=15) (Group 1: Hybrid-Hyrax expander and alt-RAMEC procedure, Group 2: Bonded RME and alt-RAMEC procedure, group 3: Hybrid Hyrax expander and routine protocol, group 4: Bonded RME and routine protocol). To investigate skeletal changes, lateral cephalometric films were taken before (T0) and after (T1) treatment. Dolphin Imaging software and AutoCad 2023 software were used for cephalometric measurements.

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
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Skeletal class III
  • Prepubertal growth stage
  • Reverse overjet

排除标准

  • Previous orthodontic treatment history
  • Patients with craniofacial abnormalities and syndromes.
  • Systemic diseases

结局指标

主要结局

Evaluation of Skeletal and Dental Changes in Millimetric Measurements

时间窗: 9 month

Skeletal and dental changes in the maxilla and mandible were evaluated in millimetres using lateral radiographs taken before and after treatment. To determine skeletal changes A-VRP (mm), Co-A (mm), A-HRP (mm), Pog-VRP (mm), Co-Gn (mm) and WITS (mm) values were measured. To determine dental changes U1-VRP(mm), U1-HRP(mm), U6-VRP(mm), U6-HRP(mm), and L1-VRP(mm) values were measured.

次要结局

  • Evaluation of Skeletal and Dental Changes in Angular Measurements(9 month)

研究者

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

Tugce Ergul

Principal Investigator

University of Gaziantep

研究点 (2)

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