Effect of Rapid Maxillary Expansion with Low Level Laser Therapy Versus Rapid Maxillary Expansion in Children with Posterior Cross Bite
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Bone density of the mid-palatal suture
研究概览
简要总结
The posterior crossbite is a common type of malocclusion that might affect the normal growth pattern. Early treatment is recommended by rapid maxillary expansion with different appliances. This line of treatment needs a sufficient retention period to decrease the rate of relapse. The low level laser therapy has been used to enhance tissue regeneration. This study aims to compare the effect of rapid maxillary expansion with low level laser versus rapid maxillary expansion in children with posterior cross bite malocclusions.
详细描述
This study aims to evaluate the effect of rapid maxillary expansion using the bonded Hyrax expander combined with low level Laser therapy versus rapid maxillary expansion alone. The investigators intend to recruit sixty subjects of both sexes, between the age of 7 and 14 years. Patients with posterior crossbites and patent Mid-palatal sutures will be randomized into one of the two groups of treatment. Full orthodontic records will be collected and the standard orthodontic radiographs will be replaced by cone beam computer tomographic images. The records will be taken before the maxillary expansion and after 6 months of retention. The skeletal, dentoalveolar, and soft tissue effects of the two interventions will be compared.
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, Outcomes Assessor)
盲法说明
The patients will be masked by receiving sham LASER therapy in the control group. While, the outcome assessors will evaluate unidentified radiographic images and will have no knowledge of the intervention allocated.
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Posterior crossbite
- •Patent mid-palatal suture
- •Mixed dentition or early permanent teeth
- •Subjects who reported no medical conditions or prolonged medications
排除标准
- •Poor oral hygiene
- •Active periodontal disease
- •Craniofacial abnormalities
- •Previous orthodontic treatment
- •Any systemic disease or medication that might affect bone metabolism.
结局指标
主要结局
Bone density of the mid-palatal suture
时间窗: six months of retention
Average density of 200mm3 volume, in hounsfield units.
Buccal maxillary width
时间窗: six months of retention
Horizontal distance between the most lateral point on the right and left buccal alveolar plate at the level of the root trifurcation, in millimeters.
Inter-jugale width
时间窗: six months of retention
Horizontal distance between right and left Jugale points, in millimeters.
次要结局
- Palatal bone thickness(six months of retention)
- alveolar tipping angle(six months of retention)
- Bone density of the nasal side of the Midpalatal suture(six months of retention)
- Intermolar width(six months of retention)
- Inter-second premolar width(six months of retention)
- Nasal width(six months of retention)
- Facial width(six months of retention)
- Inter-lateral pterygoid width(six months of retention)
- Inter-mental width(six months of retention)
- Dental tipping angle(six months of retention)
- Inter-first premolar width(six months of retention)
- Inter-infraorbitale width(six months of retention)
- Bi-gonial width(six months of retention)
- Bone density of the oral side of the Midpalatal suture(six months of retention)
- Upper airway dimension(six months of retention)
- Intercanine width(six months of retention)
- Palatal maxillary width(six months of retention)
- Buccal alveolar bone thickness at the mesiobuccal root of the first maxillary permanent molar(six months of retention)
- Buccal alveolar bone thickness at the distobuccal root of the first maxillary permanent molar(six months of retention)
- Pain score(Day 1 of appliance activation)
- Day on which pain on activation stopped(Two weeks)
研究者
Hend Salah ElSayed
Associate Professor
National Research Centre, Egypt