Clinical Performance of AI-based TruRoot Designed Clear Aligner (A Randomized Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Assessment of Root Position Relative to Alveolar Bone
研究概览
简要总结
The goal of this clinical trial is to evaluate the clinical performance and validity of applying AI-based TruRoot-designed clear aligners in adult orthodontic patients. The main questions it aims to answer are:
Do TruRoot-designed aligners achieve more accurate root positioning compared to conventional aligners?
Is there a significant difference in clinical parameters such as root resorption, pain levels, treatment duration, and occlusal outcomes between the two groups?
Is the TruRoot AI-based design a valid and clinically applicable method for planning clear aligner treatment?
Researchers will compare:
An AI-based TruRoot group, where aligners are planned using CBCT and intraoral scan superimposition to estimate true root position
A Conventional group, where aligners are designed using intraoral scans only, with expert evaluation to ensure roots remain within the alveolar bone
Participants will:
Receive clear aligner treatment based on either the TruRoot AI system or conventional planning by experts
Undergo CBCT and intraoral scans at baseline and post-treatment
Be assessed for root position accuracy, validity of AI-generated treatment plans, occlusal outcomes via the ABO Objective Grading System, root resorption, self-reported pain, and treatment duration
Attend regular follow-ups throughout the treatment period
详细描述
This randomized clinical trial investigates the clinical validity and performance of AI-based TruRoot-designed clear aligners compared to conventionally designed clear aligners in adult patients undergoing orthodontic treatment. The TruRoot system integrates CBCT and intraoral scan superimposition to estimate true root positioning, whereas the conventional group relies solely on intraoral scans with manual verification by expert orthodontists to ensure root positioning within the alveolar bone.
The primary aim is to assess whether AI-driven root-based treatment planning offers superior clinical outcomes in terms of root accuracy, treatment efficiency, root resorption, pain perception, and occlusal quality. Post-treatment assessments will include CBCT imaging, root position analysis, and occlusal outcome evaluation using the American Board of Orthodontics (ABO) Objective Grading System.
A comprehensive digital workflow will be applied throughout the study:
CRANEX® software will be used for generating high-resolution CBCT slice data.
BlueSky Plan or AI-based CephX® Web Viewer will be employed for segmentation and 3D modeling of dental and skeletal structures.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants should have good general health with healthy periodontium.
- •Adult patient with an age range 18-30 with fully erupted all permanent dentitions excluding third molars.
- •Skeletal and dental Cl I malocclusion with moderate crowding (little irregularity index 4-6 mm).
- •The treatment plan should be non-extraction treatment.
- •No history of trauma or root resorption
排除标准
- •Patients with diseases or syndromes affecting maxillofacial regions,
- •Subject with poor oral hygiene.
- •Defective and missing teeth.
- •Presence of any deep bite or open bite problems,
- •History of trauma, root resorptions and dilacerated roots.
- •Medical conditions affecting tooth movement or bone metabolism.
- •previous extraction or history of previous orthodontic treatment.
结局指标
主要结局
Assessment of Root Position Relative to Alveolar Bone
时间窗: before treatment begin
Evaluation of whether the initially planned root positions in the conventional clear aligner group are contained within the alveolar bone. The assessment will be performed by importing the final STL model (planned before treatment) and superimposing it with pre-treatment CBCT scans.
Root position and movement
时间窗: at the end of treatment
Assessment of the accuracy of final root positions relative to the planned positions in both groups after applying certain amount of torque. and
次要结局
未报告次要终点
研究者
Ahmed Abdulhussain Abbas
Principal Investigator
University of Baghdad