Effect of Low-Intensity Pulsed Ultrasound Applied on Temporomandibular Joint Region on Functional Treatment 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-intensity pulsed ultrasound (LIPUS) 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: control group and experimental group.
The functional appliance (twin-block) will be applied for all patients, while the low-intensity pulsed ultrasound (LIPUS) 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, and the two groups will be compared.
详细描述
Studies of the etiologic factors of Class II malocclusions recognize that most Class II malocclusions are a result of mandibular deficiency and not of maxillary excess. For many patients, especially adults, optimal overall results are best obtained using a combined orthodontic-surgical approach. However, treating such cases early while the patient is still growing, using mandibular propulsive functional appliances, can produce satisfactory improvement in the facial esthetics, and minimizes the need for surgical intervention in many cases.
Ultrasound (US), a form of mechanical energy that is transmitted through and into biological tissues as an acoustic pressure wave at frequencies above the limit of human hearing, is used widely in medicine as a therapeutic, operative and diagnostic tool. Therapeutic US, and some operative US. Previous studies on animals have found that therapeutic ultrasound (US) can stimulate and enhance mandibular growth when applied during the active growth period.
This study will evaluate the effect of low-intensity pulsed ultrasound (LIPUS) on the growth of mandible and the duration of functional treatment.
Twin-block will be applied to the two groups. While the control group will receive the twin-block only, the experimental group will receive the twin-block combined with low-intensity pulsed ultrasound (LIPUS) on Temporomandibular joint (TMJ) region.
Cephalometric radiographs will be obtained 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
- •Angle class II malocclusion because of mandibular retrognathia
- •O.J > 5 , SNB < 78
- •Patient during growth spurt
排除标准
- •TMJ disorders
- •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
The patients in this control group will be treated using the Twin-block appliance.
干预措施: Twin-block (Device)
Twin-block combined with LIPUS
The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).
干预措施: Twin-block (Device)
Twin-block combined with LIPUS
The patients in this experimental group will be treated using the Twin-block combined with LIPUS (Low-intensity pulsed ultrasound).
干预措施: LIPUS (Low-intensity pulsed ultrasound) (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)