3D-Printed Versus Laboratory-Fabricated Hyrax Expanders: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Dimension of the Anterior Midpalatal Suture Opening
研究概览
简要总结
Maxillary expanders are orthodontic appliances that are commonly used to expand the upper jaw. The purpose of this study will be to compare the effects produced by two different maxillary expanders in children 8-13 years old. The first type of expander is made by hand in an orthodontic laboratory, and the second type of expander is designed on a computer and printed using 3D printers. Both expanders are already used in the MUSC Orthodontics Clinic. The purpose of this study is to see if the 3D printed expander is as effective as the traditional expander made by hand in the laboratory, with more comfort to the patient. Patients participating in the study will be randomly assigned to one of two groups: group A will be treated with a laboratory-made maxillary expander, and group B with a 3D-Printed maxillary expander. Information will be collected on the participants' standard clinical follow-up visits including photos, x-rays, and dental photo scans over the course of 6 months to see how the expander is working. In addition, as part of the research study, the participant will be asked to complete online questionnaires with assistance from parents or guardians about his/her quality of life and perception of possible pain and discomfort at different time points. The potential benefits of this study include the use of 3D technology to improve the quality of the orthodontic treatment, with more comfort to the patient.
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
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Maxillary anterior and/or posterior transverse deficiency with or without crossbite
- •Age of 8-13 years
- •Children whose parents/guardians are willing to consent to the child participating in the study
- •Children ages 12-13 who are willing to assent to participating in the study
- •Children who are orthodontic patients at the Medical University of South Carolina Department of Orthodontics or University of Pittsburgh School of Dental Medicine
- •Subjects and parents/guardians who have access to an electronic device with internet connection
排除标准
- •Patients with previous or ongoing orthodontic treatment
- •Patients whose parents have a strong preference as to which expander is used
- •Patients with a history of temporomandibular disorders
- •Presence of congenitally missing teeth
- •Traumatic loss of maxillary incisors
- •Patients with craniofacial syndromes, or cleft lip and/or palate
研究组 & 干预措施
Group Conventional Expander
Conventional Laboratory Fabricated Hyrax Expander
干预措施: Conventional Laboratory Fabricated Hyrax Expander (Device)
Group 3-D Printed Expander
3D-Printed Hyrax Expander
干预措施: 3D-Printed Hyrax Expander (Device)
结局指标
主要结局
Dimension of the Anterior Midpalatal Suture Opening
时间窗: 2 weeks
The dimension of the anterior midpalatal suture opening between the maxillary halves will be measured digitally in millimeters on the occlusal radiograph using a calibrated ruler.
次要结局
- Pain Perception assessed by Visual Analog Scale(2 weeks)
- Change in Interincisal Diastema Width(2 weeks)
- Change in Maxillary Molar Inclination(2 weeks)
- Change in Maxillary Arch Widths(2 weeks)
- Pain Perception assessed by Wong-Baker FACES Scale(2 weeks)
- Oral Health Related Quality of Life (functional limitation, physical discomfort, psychological discomfort, physical disability, psychological disability, social disability, and handicap) assessed by OHIP-14(2 weeks)
研究者
Ildeu Andrade Jr.
Associate Professor
University of Pittsburgh