Effects of the Invisalign® Palatal Expander (IPE) vs. Rapid Palatal Expander With Facemask in Growing Skeletal Class III Patients: A CBCT Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maxillary skeletal change
研究概览
简要总结
The goal of this clinical trial is to compare two types of palatal expanders used with a facemask in children who have skeletal Class III and a narrow upper jaw. The study will compare the Invisalign Palatal Expander (IPE) and the Rapid Palatal Expander (RPE). Researchers want to learn how these devices affect jaw bones and tooth position. They also want to learn about children's and parents' experiences during treatment.
The main questions this study aims to answer are:
Do IPE and RPE widen the upper jaw differently?
Do they cause different changes in tooth position?
How do children and parents describe their treatment experience?
Participants will be children aged 8 to 12 years who have skeletal Class III and a narrow upper jaw. Children with craniofacial conditions, previous upper jaw expansion, or medical conditions that prevent orthodontic treatment will not take part. Parents and children must give consent before joining the study.
Participants will:
Be assigned to receive either IPE or RPE
Expand the upper jaw to 7 mm (0.25 mm per day)
After expansion, wear a facemask for at least 12 hours per day for 6 to 8 months
Have cone-beam computed tomography (CBCT) scans taken before expansion, after expansion, and after facemask treatment
Take part in an interview with a parent after expansion
Researchers will use CBCT images to measure changes in jaw bones and tooth position. The main outcomes are changes in jaw bones and tooth position. Secondary outcomes include children's and parents' experiences during treatment.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 8 and 12 years
- •Patients in the mixed dentition or early permanent stage have at least three stable teeth per quadrant, good oral hygiene, and healthy periodontal tissues
- •Patients with maxilla-mandibular discrepancies; skeletal class III is indicated by an ANB angle < 0 degrees or a Wits appraisal value that is negative, and Maxillary constriction is characterized by posterior crossbite teeth or having a maxillary width below the norm value.
排除标准
- •Patients with craniofacial anomalies such as cleft lip and palate
- •Patient with a prior history of maxillary expansion.
- •Patients who have systemic conditions that contraindicate orthodontic treatment.
结局指标
主要结局
Maxillary skeletal change
时间窗: T0: Baseline (Day 0) - before initiation of maxillary expansion T1: Post-expansion - after completion of 7 mm expansion with RPE or IPE T2: Post-protraction - after 6 months of active maxillary protraction
* Anterior and posterior midpalatal suture width * Anterior apical base width inferior * Anterior apical base width superior * Posterior apical base width * Anterior width at mid-alveolar level * Posterior width at alveolar crest level
Maxillary dental change
时间窗: T0: Baseline (Day 0) - before initiation of maxillary expansion T1: Post-expansion - after completion of 7 mm expansion with RPE or IPE T2: Post-protraction - after 6 months of active maxillary protraction
* Intermolar width at occlusal surface * Intermolar width at palatal root apices * Right first molar angulation * Left first molar angulation
次要结局
- Functional and perceptual experiences and parental involvement associated with the use of Rapid Palatal Expander (RPE) and Invisalign Palatal Expander (IPE).(Single assessment at 28 days (± 5 days) after appliance insertion)