Evaluation of the Effects of the Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain perception
研究概览
简要总结
Design: Two-arm parallel randomized clinical trial in mixed dentition (6-12 years).
Arms: (1) 9 mm, 900 g leaf expander; (2) 9 mm Hyrax expander. Follow-up: From appliance insertion → completion of intended expansion → 6-month retention.
Primary outcome: Pain perception during the first 7 days post-insertion (daily patient-reported scale).
Secondary outcomes: Skeletal and dental changes on CBCT.
详细描述
Participants receive a banded maxillary expansion appliance cemented to maxillary first permanent molars, assigned to:
Leaf expander arm: Nickel-titanium leaf-spring expander, 9 mm screw, delivering force of ~900 g.
Hyrax expander arm: Conventional tooth-borne jackscrew expander, 9 mm screw. Standard activation: two turns per week.
Retention: Both appliances kept passively in situ for 6 months of retention following achievement of planned expansion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
statistician
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Mixed dentition stage
- •Unilateral or bilateral posterior crossbite.
- •Patients in prepubertal stage with cervical vertebral maturation stage 1-
- •Fully erupted maxillary and mandibular permanent first molars.
- •Skeletal class I or II.
排除标准
- •Previous orthodontic treatment.
- •Missing teeth.
- •Inadequate oral hygiene.
- •Patients with bad oral habits.
- •Patients with medical conditions.
- •Patients with cleft lip and palate.
研究组 & 干预措施
Banded Leaf expander supported on the maxillary first permanent molars
9mm leaf expander delievering 900 gm force will be supported on the upper first permanent molars with the appliance arm extending to the canines
干预措施: The Leaf expander (Device)
Banded Hyrax expander supported on the maxillary first permanent molars
9mm Hyrax expander will be supported on the upper first permanent molars with the appliance arm extending to the canines
干预措施: Hyrax expander (Device)
结局指标
主要结局
Pain perception
时间窗: first week after appliance insertion
Pain perception during the first week after insertion using Wong-Becker faces scale with minimum value of zero and maximum value of ten, ten score represents the worst pain percieved.
次要结局
- skeletal expansion(6 months post expansion)
- dental tipping(6 months post-expansion)
研究者
Noura Mohamed Hamza Hassan Saleh
Principal investigator
Cairo University