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临床试验/NCT04828213
NCT04828213已完成不适用

Tooth-Borne Versus Tooth-Bone-Borne Rapid Maxillary Expanders: A Stereophotogrammetric Evaluation of Soft Tissues

Gökçenur Gökçe0 个研究点目标入组 32 人开始时间: 2016年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
主要终点
Increasing soft tissue facial measurement-1

研究概览

简要总结

The force exerted by the rapid maxillary expansion (RME) appliances provides expansion of the transverse dimension by splitting of the midpalatal suture. This expansion results in three-dimensional (3D) changes in maxillary position which also effects circummaxillary surrounding structures. The aim of this randomized clinical trial (RCT) was to evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry.

详细描述

Introduction

To evaluate the effects of tooth-borne and tooth-bone-borne rapid maxillary expansion (RME) on soft tissue with stereophotogrammetry. Methods: 32 patients (15 males, 17 females) who met inclusion criteria were divided into two groups. In the first group, tooth-borne RME appliance (Hyrax) was applied to 16 patients (9 males, 7 females mean age 13.4 ± 1.3 years) and in the second group, tooth-bone-borne RME appliance (Hybrid Hyrax) was applied to 16 patients (6 males, 10 females mean age 13.05 ±1.24 years). A simple electronically generated randomization was performed before trial commencement using the Random Allocation Software program. Allocation concealment involved numbered, sealed, and opaque envelopes prepared before trial commencement. One envelope was sequentially opened for each participant during recruitment. Each envelope contained a card with the name of 1 expander. The initials of the name of the participant, the type of expander, and the date of allocation were identified in the external surface of the envelope. One operator was responsible for the randomization process, allocation concealment, and implementation. The primary outcomes of this study was assessment of changes in soft tissues before RME (T0) and post-retention (T1) period by stereophotogrammetry. Independent and dependent sample t tests were used to compare intra- and inter-group differences at P<0.05 significance level.

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, Outcomes Assessor)

盲法说明

Double (Participant, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • No previous tonsillar, nasal or adenoid surgery and orthodontic treatment,
  • Bilateral crossbite and need for RME,
  • Maxillary and mandibular permanent teeth fully erupted,
  • Willingness to participate in the study

排除标准

  • the presence of adenotonsillectomy due to tonsillar hypertrophy or adenoidal hypertrophy
  • Having nasal/nasopharyngeal /oropharyngeal pathologies, craniofacial syndromes, systemic disease, poor oral hygiene,
  • History of previous orthodontic treatment.

结局指标

主要结局

Increasing soft tissue facial measurement-1

时间窗: At baseline and after 3 months retention period

Increasing anterior face height

Increasing soft tissue facial measurement-2

时间窗: At baseline and after 3 months retention period

Increasing upper lip length

Increasing soft tissue facial measurement-3

时间窗: At baseline and after 3 months retention period

Increasing lower face height

次要结局

未报告次要终点

研究者

发起方
Gökçenur Gökçe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gökçenur Gökçe

Assistant professor

Izmir Katip Celebi University

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