Clinical Effectiveness of Damon Ultima Vs Conventional Brackets (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Little Irregularity index:
研究概览
简要总结
Compare the clinical performance, root resorption and pain perception between passive self-ligating Damon Ultema vs conventional brackets.
详细描述
Damon Ultima System was introduced and claimed to be the first true full expression orthodontic system designed for faster and more precise finishing. The brackets were completely reengineered to virtually eliminate play for precise control of rotation, angulation and torque. Moreover, the system used specially designed archwires regarding wire dimensions and shape to fulfill the manufacturers claim.
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
- None
盲法说明
Double (open label)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •15-35 years of age patients who are healthy and without medications such as non-steroidal anti-inflammatory analgesics.
- •Patients with Class I normal occlusion with moderate dental irregularity (with 4-6 irregularity index) requiring non-extraction treatment.
- •Presence of all the permanent teeth apart from the third molars.
- •Patients with good oral hygiene and periodontal health.
- •Without previous orthodontic treatment/ functional appliances
排除标准
- •Patients will be excluded from recruitment if he had sever skeletal discrepancy that requires orthognathic surgery.
- •Patients who have cleft lip or palate, hypodontia, or hyperdontia
结局指标
主要结局
Little Irregularity index:
时间窗: 6 months
This technique involves measuring the linear distance from anatomic contact point to the adjacent anatomic contact point of the mandibular anterior teeth , used to assess the changes in dental alignment throughout the study. initial irregularity index is (3 mm to 7mm) = worse out come and the final irregularity index is zero mm= best out come
Arch parameter measurement:
时间窗: 1 year
Arch length, arch width will be measured in millimeters and shape will be assessed by change from narrow shape arch to wide shape arch
Root alingment
时间窗: 1 year
Root movement in 3 plane of space will be evaluated at the end of the alignment phase after insertion of stainless steel wire which may will Tacke about 6 months and at the end of the treatment after about 6 months using CBCT. The inclination of upper and lower teeth will be assessed
Root resorption
时间窗: 1 year
Orthodontically induced inflammatory root resorption OIIRR will be assessed and the prevalence of root resorption will be calculated using CBCT radiographs.
Occlusal outcomes assessment
时间窗: 1 year
1\. Alignment, 2. Marginal ridge height, 3. Buccolingual inclination, 4. Overjet, 5. Occlusal contacts, 6. Occlusal relationships, 7. Interproximal contacts (1-7) Component: scores \< 0.5 = 0. 0.5 to 1 mm =1. \> 1 mm = 2. 8. Root angulation: Root parallelism = 0. Roots are not parallel = 1. Contacting adjacent tooth = 2. High scores on individual segments, or combinations of individual segments, may cause a case to become Incomplete. SO: the minimum value = 0 the maximum value = 16 the high score means = worse outcome the low score means = better outcome
次要结局
- Patient experience and satisfaction(1 year)
研究者
Nawar Ahmed Abed
Dentist
University of Baghdad