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ACTIVE NOT RECRUITING
NCT06968325
NA

AI-Designed Clear Aligners: A Randomized Clinical Trial

Sponsor: University of Baghdad

View on ClinicalTrials.gov

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

Official title: Clinical Performance of AI-based TruRoot Designed Clear Aligner (A Randomized Clinical Trial)

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-25

Completion Date

2026-12-01

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DEVICE

AI-based TruRoot group:

Participants in this group will receive clear aligner treatment designed using an artificial intelligence (AI)-based system called TruRoot

DEVICE

Conventional clear aligner group

Participants in this group will receive clear aligner treatment planned manually by expert orthodontists based only on intraoral scans.

Locations (1)

College of Dentistry, University of dentistry

Baghdad, Iraq