The Effects of Combined Treatment With Low-level Laser and Functional Appliances on the Correction of Class II Malocclusion: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The duration of functional treatment
研究概览
简要总结
This experimental study will evaluate the effect of combined treatment with low-level laser and functional appliances (twin-block) on the correction of Class II malocclusion, compared with the control group treated with functional appliances (twin-block) only.
The study sample will consist of 40 patients with Class II malocclusion. The sample will be allocated randomly into two groups: a control group and an experimental group.
Functional appliance (twin-block) will be applied for all patients. Low-level laser will be applied for the experimental group only. The skeleto-dental changes occurring after functional treatment will be assessed using cephalometric radiographs; pre- and post- treatment changes for each group will be evaluated individually.
详细描述
Class II malocclusion is considered as the most common malocclusion between patients.
Recently low-level laser enters the world of dentistry, some studies assessed the effect of low-level laser on the growth of mandibles and condyles in animals and showed that there is a good effect of laser on the mandible growth.
This study will evaluate the effect of low-level laser on the growth of the mandible and the duration of functional treatment.
Twin-block will be applied in two groups: The control group will receive the twin-block only, and the experimental group will receive the twin-block combined with low-level laser therapy on the TMG region.
Cephalometric radiographs will be gotten before and after functional treatment to evaluate the dento-skeletal changes.
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)
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletal Class II malocclusion because of mandibular retrognathia
- •Overjet > 5
- •SNB < 78
排除标准
- •Poor oral hygiene
- •Previous orthodontic treatment.
- •Patients with syndromes, clefts, or craniofacial abnormalities.
- •Reason of contraindication of functional treatment
研究组 & 干预措施
Twin-block group
Functional treatment will be applied using the Twin-block appliance.
干预措施: Twin-block appliance (Device)
Twin-block combined with low level laser
Functional treatment will be applied using the Twin-block appliance combined with low level laser.
干预措施: Twin-block appliance (Device)
Twin-block combined with low level laser
Functional treatment will be applied using the Twin-block appliance combined with low level laser.
干预措施: Low level laser (Other)
结局指标
主要结局
The duration of functional treatment
时间窗: After functional treatment which will take approximately 8 months
The duration of the functional treatment will be measured and compared between groups.
次要结局
- Dentoskeletal effects of the functional treatment(Changes will be evaluated before and after functional treatment which will take approximately 8 months)