Effectiveness of Aligners Versus Rapid Maxillary Expansion on 3D Palatal Volume in Mixed Dentition Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Palate morphology
研究概览
简要总结
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.
详细描述
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology. This two-arm parallel-group randomized prospective clinical trial will include patients with: indications for maxillary expansion treatment, age between 6 and 10 years old, mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed by the practitioner. Patients will be assigned to one of two expansion methods (arm A: Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according to a computer-generated randomization list shortly before the start of expansion Primary outcome measure will be the change in palatal morphology (palatal volume and surface area variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper inter-molar width, anterior segment length, posterior segment length), complications, patients' satisfaction and periodontal health. Due to the nature of the intervention blinding will not be possible. Potential statistical differences between the two intervention groups will be evaluated.
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have been diagnosed with transverse maxillary deficiency;
- •mixed dentition phase with cervical vertebral maturation stage (CVMS) less than 4;
- •fully erupted upper and lower first molars;
- •transversal discrepancy ≤5mm
- •demonstration of a good standard of oral hygiene (determined through questioning and clinical examination);
- •subjects willing to consent to the trial and comply with the trial regime.
排除标准
- •any general medical health problems which may influence gingival health, such as those necessitating antibiotic cover as bacteremia prophylaxis, diabetes mellitus, epilepsy, or physical or mental disability;
- •permanent teeth extraction-based treatment (third molars excluded);
- •morphologic crown anomalies;
- •auxiliary treatment during arch expansion stage (such as crossbite elastics);
- •posterior interproximal reduction;
- •orthognathic surgery treatment planned;
- •cleft palate or severe facial deformities.
结局指标
主要结局
Palate morphology
时间窗: 12 months
The primary outcome will be to evaluate the changes in palatal morphology after the treatment of maxillary deficiencies using two different therapies and to re-evaluate changes over the initial 12-months after the end of the treatment. The changes in palatal morphology are defined as the variation in palatal volume and surface. These will be measured from digitized study models within the boundaries of the palate, the gingival and distal planes, defined as follow. The gingival plane will be created by connecting the midpoints of the dentogingival junction of all upper erupted deciduous and permanent teeth. The distal plane will be created through two points at the distal of the first upper permanent molars perpendicular to the gingival plane.
次要结局
- Upper inter-canine width (ICW)(12 months)
- Upper inter-molar width (IMW)(12 months)
研究者
Tommaso Castroflorio
Aggregate Professor of Orthodontics
University of Turin, Italy