Evaluation of the Efficacy of Periodontally Accelerated Osteogenic Orthodontics in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Two-Arm Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Duration of Alignment
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 two groups of patients with moderate crowding of the lower anterior teeth First group (Experimental): the patients in this group will be treated with orthodontic fixed appliances + surgery to the alveolus of the lower anterior teeth in order to induce remodeling of the bony structures and enhance orthodontic movement.
Second group (Control): the patients in this group will be treated using fixed appliances with any acceleration method.
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 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Class I malocclusion with moderate crowding (4-6 mm of tooth-size-arch-length-discrepancy).
- •Good oral hygiene and periodontal health.
- •No severe skeletal discrepancy.
- •Normal inclination for the upper and lower incisors.
- •No congenitally missing or extracted teeth (except for the third molars).
排除标准
- •Bi-maxillary severe dental protrusion.
- •Previous orthodontic treatment.
- •Subject with psychological abnormalities.
- •Subject with systemic diseases.
结局指标
主要结局
Duration of Alignment
时间窗: The assessment is based on calculating days from the beginning of treatment till the end of the alignment stage which is expected to happen within 5 to 6 months
The time required in days will be calculated from the beginning of treatment till the end of the alignment stage
Change in Little's Index of Irregularity
时间窗: T0: one day before the beginning of treatment; T1: after 1 month; T2: after 2 months; T3: after 4 months; T4: after 5 months; T5: at the end of the alignment stage which is expected within 5 - 6 months
The irregularity of the lower incisors is calculated by measuring the amount of deviations of the anatomic contact points between the six anterior teeth in the horizontal direction in mm, since the sum of these measurements represents the value of the index (Little, 1975). When the sum of these deviations is less than 3 mm, this indicates that the teeth are slightly crowded. When the sum is greater than 10 mm, this indicated very severe crowding. The ordinary orthodontic treatment aims to keep this Index less than 1 mm at the end of treatment.
Change in Alveolar Defect
时间窗: T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months
Using cone-beam computed tomography (CBCT), each tooth root will be evaluated in axial and cross-sectional slices at the buccal and lingual surfaces. When no cortical bone is observed around the root in at least three sequential views, this will be considered an alveolar defect. If the alveolar bone height is more than 2 mm from the cemento-enamel junction, it will be classified as dehiscence ,When the defect does not involve the alveolar crest, this case will be classified as fenestration. The status of the alveolar bone will be assessed twice.
次要结局
- Change in inter-canine width(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)
- Change in Alveolar Bone Thickness(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)
- Change in Lower Incisors' Inclination(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)
- Change in the positioning of the upper lip(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)
- Change in the positioning of the lower lip(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)
- Change in the naso-labial angle(T1: One day before the beginning of treatment; T2: at the end of the alignment stage which is expected within 5-6 months)