Evaluation of the Efficiency and Efficacy of Flapless Cortico-alveolar Perforations Using Mechanical Drills Versus Traditional Corticotomy in the Retraction of Upper Canines: a Three-arm Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change in Canine Retraction Speed
研究概览
简要总结
Patients at the Orthodontic Department of University of Damascus Dental School will be examined and subjects who meet the inclusion criteria will be included.
Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria are accurately matched.
The aim of this study is to compare flapless bone cutting by mechanical drills to evaluate the acceleration of the retraction of upper canines versus traditional bone cutting by piezo-surgery in comparison with a control group without bone cutting after extraction of upper first premolars in class II type I patients.
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
- 18 Years 至 27 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-27 years
- •Patients who have malocclusion class II type I and who require first-premolar extraction with:
- •Dentoalveolar class II type I with ANB between 5 and 9 degrees.
- •Protrusion between (5-10 mm)
- •Overbite between (0-4)
- •Vertical dimension is normal or over the normal range
- •Mild to moderate crowding
- •All patients should have complete permanent occlusion on the maxilla
- •All patients should have normal periodontal tissue and good oral health, which will be assessed by:
- •Depth of the gingival pocket does not exceed 4 mm
- •Plaque index does not exceed 1
- •Gingival index does not exceed 1
排除标准
- •Patients in which oral surgery under local anesthesia is contraindicated due to medical, psychological, or social reasons.
- •Patients who have a general health problem that affects dental movement
- •Patients who have undergone previous orthodontic treatment
- •Patients with mixed occlusion
- •Patients who have lost one or more of their teeth since birth or who have one of the permanent teeth extracted (except the third molar)
- •Patients who have bad oral health or active periodontal disease
结局指标
主要结局
Change in Canine Retraction Speed
时间窗: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
The rate at which canine is going to be retracted (mm/month) in each group will be calculated. This outcome will be measured by the following steps: 1. Drawing a projection from the upper canine apex to the middle palatal bone line. 2. Drawing a projection from the mesial ending of the third palatal rugae to the middle palatal bone line. 3. Measuring the distance (mm) between the two orthogonal projections. 4. The rate of canine retraction will be measured by dividing the distance between the two orthogonal projections by the time elapsed between assessment times.
Change in Canine Rotation
时间窗: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
The angle between the middle palatal bone and the line through the mesial and distal edges of the canine will be measured on each side. The rotation will be assessed by calculating the difference between the angles on two different times. Then, the speed of rotation will be calculated by dividing the rotation angle (degrees) by time that elapsed between assessment times.
Change in Anchorage Loss
时间窗: T1: At the end of alignment (which is expected within 3 months); T2: 1 month after canine retraction; T3: After two months; T4: After 3 months; T5: at the end of canine retraction which is expected within 5 months
Anchorage loss in related the mesial drift of the first molar. This outcome will be measured by drawing two projections from the central groove of the first maxillary molar and the mesial ending of the third palatal rugae to the middle palatal bone line. The mesial migration of the first maxillary molar (mm) will be measured by dividing the distance between the two projections by the time elapsed between assessment times.
Change in Canine Axis
时间窗: T1: at the end of the alignment stage (which is expected within 3 to 4 months); T2: at the end of the canine retraction stage (which is expected to occur with 4 to five months following the onset of this stage).
The changes in the canine axis during retraction will be studied by calculating canine angulation (arithmetic mean of the angulation of the right and left upper canine axis with the anterior cranial base plane) on lateral cephalometric radiographs. The difference between the canine angulation on T1 and T2 will be calculated after comparing the two cephalometric using Viewbox version 4.0.0.98.
次要结局
未报告次要终点