Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).
详细描述
Participants aged 17-32 years with full permanent dentition, Class I canine and molar relationships, and moderate crowding (4-8 mm) will be randomly assigned in a 1:1 ratio to either the Damon Ultima group or the Clear Aligner group.
For the Damon Ultima group, brackets will be bonded according to a standardized protocol, utilizing a precise archwire sequence from 0.014-inch CuNiTi up to 0.019x0.0275-inch stainless steel wires. For the Clear Aligner group, patients will be treated with a series of thermoformed removable aligners designed via digital software, with instructions to wear them for 22 hours per day, changing aligners every 2 weeks.
Outcome measurements will include total treatment duration in months, pain perception via a 10-cm Visual Analog Scale (VAS), dental arch changes on 3D digital models, and root resorption via Cone-Beam Computed Tomography (CBCT) radiographs.
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 (Participant)
入排标准
- 年龄范围
- 16 Years 至 32 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
- •Age range between 16-32 years.
- •Presence of full permanent dentition except the third molars.
- •Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
- •Without previous orthodontic treatment/ functional appliances.
排除标准
- •Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
- •Patient with class Ⅱ , Ⅲ malocclusion.
- •Patient with external or internal root resorption.
- •Patients with poor oral hygiene or active periodontal disease.
- •90o or more degree of tooth rotation.
研究组 & 干预措施
Self ligating bracket (Damon Ultima)
Patient will be treated with self ligating bracket (Damon Ultima) until dental levelling alignment , crowding resolved and case will be finished
干预措施: self ligating bracket (Device)
Clear aligner system
Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished
干预措施: Clear aligner (Device)
研究者
Mohanad Ali Mohammed
Dentist, M.S.C in orthodontics .. PHD student
University of Baghdad