跳至主要内容
临床试验/NCT03705871
NCT03705871已完成不适用

Maxillary Expander With Differential Opening Versus Fan-type Expander: a Randomized Clinical Trial

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年11月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Maxillary width (mm)

研究概览

简要总结

This study will assess the dentoskeletal effects of two types of maxillary expanders in orthodontic patients in the mixed dentition, from 7 to 11 years old. Half of participants will be treated using the expander with differential opening, while the other half will undergo rapid maxillary expansion using the fan-type expander. The null hypothesis is that there is no difference between dentoskeletal effects of the two protocols.

详细描述

Rapid maxillary expansion (RME) is the orthopedic procedure of choice to treat maxillary constriction and posterior crossbite, and the study of dental, skeletal and periodontal effects of this procedure has been widely discussed in the orthodontic literature. The conventional RME expanders promote a similar expansion in the anterior and posterior regions of the maxillary arch. On the other hand, the fan-type expander allows the expansion concentrated in the intercanine region with little effects the intermolar distance. Finally, the expander with differential opening has two palatal screws and the differential activation protocol promotes a different amount of expansion for the anterior and posterior regions of the maxilla. No clinical study compared dental and skeletal effects of the expander with differential opening with those of the fan-type expander, including a three-dimensional analysis using CBCT exams and digital dental models. So, the aim of the present randomized clinical trial is to compare the skeletal and dentoalveolar effects of the maxillary expander with differential opening and the fan-type expander in the mixed dentition.

For this, patients will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of 48 patients from 7 to 11 years old with transverse maxillary dental arch constriction will be prospectively and randomly allocated into two study groups. The first group will consist of 24 individuals treated with the expander with differential opening (DEG). The second group will consist of 24 individuals treated with the fan-type expander (FEG). In 12 patients from each group (immediate subgroups), a cone-beam computed tomography (CBCT) will be performed in the beginning of treatment (T1) and immediately after the rapid maxillary expansion (T2). In the other 24 patients, 12 from DEG and 12 from FEG (late subgroups), a CBCT will be obtained at T1 and 6 months after maxillary expansion (T3). Dental models will be obtained for all patients at T1 and T3. In digital dental models, maxillary arch width, perimeter, length and shape will be assessed. Standardized CBCT coronal sections will be used for measuring maxillary transverse dimensions, nasal cavity width and posterior tooth inclinations. Segmentation and superimposition of T1 and T3 CBCT images at the cranial base will be also performed. The opening of the midpalatal suture at the anterior and posterior region and the geometry of the suture opening will be evaluated in axial reconstructions of the CBCT.Discomfort, pain and quality of life will be evaluated by questionnaires.

After the normality test, the paired t test will be used in the intragroup comparison, and the independent t test will be used in the intergroup comparison. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests.

Possible harms that could appear are related to temporary discomfort during the first days after the installation of the expander. Patients and legal guardians will be carefully oriented and they will be able to stop the treatment at any moment.

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
7 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Both sexes;
  • •Mixed dentition;
  • •Ages ranging from 7 to 11 years old;
  • •Maxillary constriction associated to posterior crossbites;
  • •Angle Class I or Angle Class II malocclusions.

排除标准

  • •Cleft lip and palate;
  • •Craniofacial syndromes;
  • •Carious lesions;
  • •Angle Class III malocclusion;
  • •History of previous orthodontic treatment.

研究组 & 干预措施

Differential Expansion Group

Experimental

The experimental group will be comprised 24 patients treated with a rapid maxillary expansion using the expander with differential opening. The expander is composed by two screws, one posteriorly and the other anteriorly positioned on the palate.

干预措施: Differential Expansion (Device)

Fan-Fype Expander Group

Active Comparator

The active comparator group will be comprised by 24 patients treated with rapid maxillary expansion using the the fan-type expander. The expander is composed by one screw anteriorly positioned on the palate.

干预措施: Fan-Fype Expander (Device)

结局指标

主要结局

Maxillary width (mm)

时间窗: 6 months

Measurements will be performed in coronal sections of CBCT exams.

Maxillary deciduous canines inclination (°)

时间窗: 6 months

Measurement be performed CBCT scans.

Opening of the midpalatal suture (mm)

时间窗: 10 days

Measurement be assessed in axial and coronal sections of CBCT scans.

Maxillary and mandibular arch perimeter (mm)

时间窗: 6 months

Measurements will be performed in digital dental models

Nasal cavity width (mm)

时间窗: 6 months

Measurements will be performed in coronal sections of CBCT exams.

Maxillary and mandibular arch width (mm)

时间窗: 6 months

Measurements will be performed in digital dental models

Maxillary and mandibular arch length

时间窗: 6 months

Measurements will be performed in digital dental models

Maxillary molars inclination (°)

时间窗: 6 months

Measurement will be performed in CBCT scans.

Amount of interincisor diastema (mm)

时间窗: 10 days

Measurement will be assessed in CBCT scans.

次要结局

  • Quality of life evaluation using questionnaires(6 months)
  • Discomfort evaluation using questionnaires(1 month)
  • Dentoskeletal displacements by three-dimensional superimposition of CBCT scams.(6 months)

研究者

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

Camila Massaro

DDS, MSc and PhD student

University of Sao Paulo

研究点 (1)

Loading locations...

相似试验