Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Amount of mid-palatal suture opening.
研究概览
简要总结
This clinical trial aims to compare the skeletal and dental effects of conventional Hyrax expanders and 3D-printed Hyrax expanders in adolescent patients with maxillary transverse deficiency. Using cone-beam computed tomography (CBCT) and digital models, the study evaluates the precision, customization, and treatment outcomes of both appliance types to inform evidence-based orthodontic treatment planning.
详细描述
Maxillary transverse deficiency is a common orthodontic problem that often requires skeletal expansion using appliances such as the Hyrax expander. While conventional Hyrax expanders have been widely used, advancements in digital dentistry have introduced 3D-printed alternatives that offer potential benefits in precision, customization, and patient comfort. However, there is currently no clinical evidence comparing the skeletal and dental effects of these two designs.
This study addresses this gap by evaluating and comparing the outcomes of conventional and 3D-printed Hyrax expanders in adolescent patients, a critical developmental stage where maxillary expansion becomes more challenging due to progressive maturation and increased resistance of the mid-palatal suture. The study uses cone-beam computed tomography (CBCT) and digital models to assess skeletal and dental changes, providing clinically relevant data to guide orthodontic treatment planning and appliance selection.
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, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 12 to 17 years.
- •Skeletal age ranges from CVMS 3 to CVMS
- •Skeletal maxillary transverse deficiency with/without crossbite.
- •Cooperative and able to attend follow-up visits.
排除标准
- •Previous orthodontic treatment.
- •Craniofacial syndromes, or cleft lip and/or palate.
- •Patients with vertical growth pattern.
- •Very bad oral hygiene and active periodontal disease.
- •Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.
研究组 & 干预措施
Group A: 3D-Printed Hyrax Expander
Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using a three-dimensionally printed Hyrax expander.
干预措施: Three dimensionally printed hyrax expander (Device)
Group B: Conventionally Fabricated Hyrax Expander
Adolescent patients diagnosed with transverse maxillary arch constriction will undergo maxillary expansion using using a conventionally fabricated Hyrax expander.
干预措施: Conventionally Fabricated Hyrax Expander (Device)
结局指标
主要结局
Amount of mid-palatal suture opening.
时间窗: Three weeks
The amount of suture separation measured in millimeters in the axial plane through CBCT X-ray
次要结局
- Amount of dental expansion(Three weeks)
- The amount of tipping of maxillary molars and premolars.(Three weeks)
- Change of buccal alveolar bone thickness.(Three weeks)
- Pain assessment(Three weeks)
- Oral health-related quality of life.(Three weeks)
- Stability of transverse skeletal width at 6 months post-expansion(Six months)