AI-Designed Clear Aligners: A Randomized Clinical Trial
Iraq40 participantsStarted 2025-02-25
Plain-language summary
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
Who can participate
Age range
18 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Patients with diseases or syndromes affecting maxillofacial regions,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Root position and movement
Timeframe: at the end of treatment
2
Assessment of Root Position Relative to Alveolar Bone