3D Changes Comparing the Crossbow Appliance and Later Full Fixed Brackets Against Simultaneous Use of Full Fixed Brackets Plus Forsus Springs Among Mild to Moderate Class II Malocclusion Cases: A Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Facial soft tissue, dental and skeletal changes
研究概览
简要总结
Class II malocclusion (mismatch between the upper and lower jaw in which the lower jaw appears to be smaller from a profile point of view) are common in the general population. Around 1/3 of the population have some degree of this skeletal/dental problem and it is one frequent reason why patients decide to undergo orthodontic treatment. Treatment alternatives will basically depend on the facial skeletal development of the patient and also on the magnitude of the skeletal/dental discrepancy.
For patients that are not yet fully skeletal mature, the treatment of mild to moderate Class II malocclusion involves a combination of a small skeletal growth modification effect and more significant dental movements. For skeletal mature individuals with a severe mismatch, the treatment usually involves jaw surgery to fully correct the malocclusion. For less severe cases orthodontic camouflage exclusively done by orthodontic movements is an option.
If the case is not severe enough to warrant a surgical approach there are several treatment alternatives. One of the most commonly used options is the use of orthodontic loaded springs that apply forces through brackets and arch wires bonded into the teeth so that the teeth will interrelate better.
A different alternative was proposed some years ago. The Xbow (spelled Crossbow) appliance differs from the above-proposed option in that no brackets are bonded or arch wires used. The orthodontic springs are applied to a metal framework cemented on some upper and lower teeth. Once the skeletal/dental problem is believed to have been significantly improved, fine tuning of the remaining dental problems is managed with brackets and arch wires. The theoretical advantage of such a design is that adverse effects, such as root resorption and decalcification from the long-term use of brackets and arch wires, are theoretically minimized as the brackets and arch wires have to be used for a shorter period of time.
Although there are some retrospective reports about the skeletal and dental effects of the Xbow appliance and only one prospective trial comparing the skeletal and dental changes to a non-treated growing sample; no randomized clinical trial has yet evaluated the changes compared to a current standard of care alternative which is the simultaneous use of loaded springs concurrent with brackets and arch wires.
详细描述
Background
Class II malocclusion is a common orthodontic problem that requires comprehensive treatment planning. Treatment of Class II malocclusion is frequently initiated in mid to late mixed dentition whereby crowding and/or an increased over jet becomes alarming to patients and parents. Earlier correction of Class II abnormalities could be suggested in patients with significant occlusion discrepancies, increased risk of trauma to protruding upper incisors and impairment of mastication functions.
Among the available Class II correctors, cemented/fixed options are gaining popularity. Systematic reviews have shed some light on what fixed Class II correction devices appear to produce during treatment of mild to moderate Class II malocclusion. Short-term changes were a combination of skeletal and dental modifications. Skeletal modifications include both maxillary restriction and mandibular repositioning, and dental effects usually consist of inclination of mandibular incisors and maxillary molar distal movement.
Cephalometric analysis is a valuable tool used for diagnosis and treatment planning for dental malocclusion and underlying skeletal discrepancies. In view of the fact that a malocclusion is a product of an interaction between the alignment of the erupting teeth in their basal bone and the skeletal position of the basal bone itself, cephalometric analysis are used to evaluate dentoalveolar proportions and elucidate the anatomic basis for both jaw and tooth related abnormalities in the sagittal plane.
The Xbow appliance is a recently introduced orthodontic device that is used in late mixed or early permanent dentition before full fixed orthodontic treatment is initiated. Its main goal is to rapidly correct/improve the occlusion in a Class II malocclusion in mild to moderate cases. Full brackets thereafter will fine-tune the final occlusion.
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
- 11 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be of either gender between 11 and 15 years-of-age.
- •They will have mild to moderate Class II division 1 malocclusions.
- •Late mixed dentition or early permanent dentition.
排除标准
- •Severe vertical growth tendency or syndromic cases.
- •Craniofacial growth completed.
结局指标
主要结局
Facial soft tissue, dental and skeletal changes
时间窗: 24 months
Outcomes to be measured from Computer Beam Computer Tomography data and dental casts.
次要结局
- Root resorption(24 months)
- Enamel decalcification(24 months)
