AI-Designed Clear Aligners: A Randomized Clinical Trial

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

NCT Number	NCT06968325
Lead Sponsor	University of Baghdad
Conditions	Root Resorption, Pain Perception, Treatment Duration
Enrollment	40 participants
Start Date	2025-02-25
Primary Completion	2026-06-01 (estimated)
Study Completion	2026-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-21