An interventional study of AI-based TruRoot group: and Conventional clear aligner group in Root Resorption, Pain Perception and Treatment Duration, sponsored by University of Baghdad. Active, not recruiting at 1 site in Iraq. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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
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.
Clear aligner designs will be generated through BlueSky Plan software or 3Shape Clear Aligner Studio, incorporating the AI-based TruRoot protocol in the experimental group.
OnDemand 3D software will be used to evaluate root positioning within the alveolar bone post-treatment.
Geomagic® Control X™ will be utilized to quantify tooth movement and assess root volume changes throughout the treatment course.
This study will generate clinical data to validate the use of AI-powered root-based planning protocols in aligner therapy and compare them to conventional expert-driven methods
43 studies on the registry are indexed under Root Resorption; 9 are open to participants now.
This study's enrollment of 40 is above the median of 29 across 36 interventional studies indexed under Root Resorption.
Browse Root Resorption studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
This intervention is distinguished by its use of an AI-based treatment planning protocol that incorporates both CBCT and intraoral scan data for accurate root position estimation.
Device: AI-based TruRoot group:
This intervention differs from the AI-based approach by using only intraoral scans for treatment planning, without incorporating CBCT data. Clear aligners are designed manually by experienced orthodontists based on clinical judgment and standard digital models.
Device: Conventional clear aligner group
Participants in this group will receive clear aligner treatment designed using an artificial intelligence (AI)-based system called TruRoot
Participants in this group will receive clear aligner treatment planned manually by expert orthodontists based only on intraoral scans.
Root position and movement
Assessment of the accuracy of final root positions relative to the planned positions in both groups after applying certain amount of torque. and
Time frame: at the end of treatment
Assessment of Root Position Relative to Alveolar Bone
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.
Time frame: before treatment begin
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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