Evaluating the Clinical Performance of a Novel Clear Orthodontic Expander Versus Hyrax: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CBCT evaluation
研究概览
简要总结
This study will be conducted to evaluate the effectiveness of a clear expander fabricated from 2-mm biocompatible polyethylene terephthalate glycol (PETG) thermoforming material integrated with an expansion screw in achieving dental and skeletal expansion in adolescent patients, compared with the conventional Hyrax expander.
详细描述
This will be a multicenter randomize clinical trial with two-arm parallel groups, and will be conducted at the Department of Orthodontics, College of Dentistry, University of Baghdad, as well as different specialized dental centers affiliated with the Iraqi Ministry of Health, and some private clinics.
The sample size will be calculated based on previous studies with similar aim to measure the skeletal expansion. A minimum sample size of 17 patients was required, and in order to account for a 15% dropout, a total of 20 patients will be recruited for each group (new clear expander and hyrax expander). The amount of 2.5 mm or greater of maxillary sutural opening will be considered clinically effective.
Two randomizations will be employed, one for the expander type and the other for the cleaning method of the new expander, a computer random generator will be used to develop a simple randomization with an equal allocation ratio (1:1) and without stratification.
Data Collection and Measurements will be include, CBCT evaluation, Intraoral scan of the maxillary arch evaluation, overjet and overbite, CBCT-derived cephalometric images will be used to measure the maxillary mandibular plane angle, Microbial evaluation after using two different methods for cleaning the new clear expander and at the end of the treatment, the patient will be asked to fill out a questionnaire about the treatment, giving information about their experience and satisfaction during treatment.
Data will be analyzed using the Statistical Package for Social Sciences for Windows, version 26.0, including Descriptive Statistics 9numbers, frequencies, percentages, mean, median, and standard deviations), Reliability Statistics (an intraclass correlation coefficient), and Inferential Statistics (Levene's test, Shapiro Wilk test, Paired samples t-test and Independent samples t-test).
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
As the study will be conducted in different clinics, all data collection and measurement will be completed with the investigator being masked to the allocation groups, though blinding of the operator will not be possible due to the appliance design/shape difference, and for the cleaning methods, blinding will be applied for the bacteriological specialist, and for the outcome assessor.
入排标准
- 年龄范围
- 10 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients' age at the start of treatment will range from 10-14 years.
- •Unstable unilateral or bilateral posterior crossbite due to maxillary constriction.
- •The first molars are fully erupted.
- •Good oral health free from caries and periodontal problems at the start of treatment.
- •Good general health.
排除标准
- •Patients with obvious facial asymmetry.
- •Patients with orofacial cleft.
- •Patients with previous orthodontic treatment.
- •Patients with bad oral habits.
- •Patients with active periodontal disease.
研究组 & 干预措施
New clear expander
After obtaining the 3D-printed maxillary dental cast, a 2 mm PETG (rigid) thermoforming material (Leone® S.p.A., Florence, Italy) will be adapted separately to the maxillary cast using a pressure molding vacuum machine. The clear appliance will then be trimmed and finished. Depending on the degree of maxillary constriction, a Leone® Standard or universal expansion screw (Leone® S.p.A.,Florence, Italy) measuring 6-9 mm will be incorporated into the appliance and positioned in the midline of the maxillary cast after splitting the appliance midpalatally embedded in acrylic composed from Methyl methacrylate monomer and Methyl methacrylate polymer Orthocryl® liquid (monomer), and Orthocryl® EQ-powder (polymer) (Dentaurum GmbH & Co. KG, Ispringen, Germany)
干预措施: New clear expander (Device)
Hyrax expander
After obtaining the 3D-printed maxillary dental cast, patients will be treated with a Hyrax expander using a rapid expander from Leone® S.p.A., Florence, Italy, cemented in the upper first premolars and first molars. If the first premolars had not yet erupted, the Hyrax expander will be cemented in the upper first permanent molars only.
干预措施: Hyrax expander (Device)
结局指标
主要结局
CBCT evaluation
时间窗: pre-treatment (T0) and immediately post-treatment (T1) around one to two months
Skeletal and dentoalveolar measurements will be assessed using cone-beam computed tomography (CBCT). Skeletal measurements will include nasal width, midpalatal suture gap, and palatal height, measured in millimeters (mm). Dentoalveolar measurements will include vertical dental heights and maxillary width measured in millimeters (mm), as well as dental inclination measured in degrees (°). All measurements will be obtained from CBCT images using dedicated three-dimensional imaging analysis software.
次要结局
- Intraoral scan of the maxillary arch evaluation(pre-treatment (T0) and post-treatment (T1) around one to two months)
- Clinical evaluation(pre-treatment (T0) and immediately post-treatment (T1) around one to two months)
- Cephalometric analysis(pre-treatment (T0) and immediately post-treatment (T1) around one to two months)
- Patient satisfaction with the appliance(around one to two months)
- Microbial evaluation(after one month.)
研究者
Noor Falah Kadhim Al-Khawaja
postgraduate/PhD student
University of Baghdad