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NCT Number: NCT06968325

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Root Resorption Pain Perception Stomatognathic Diseases Tooth Diseases Tooth Resorption Treatment Duration

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

College of Dentistry, University of dentistry

Baghdad, 00964, Iraq

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,
  • 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.

Treatment and study plan

AI-based TruRoot group:

Device

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

Conventional clear aligner group

Device

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

Primary outcomes

  1. Root position and movement

    Time frame: 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

  2. Assessment of Root Position Relative to Alveolar Bone

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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