AI-Designed Clear Aligners: A Randomized Clinical Trial

NCT06968325 | Active Not Recruiting DMC

• 1 other identifier: 1013425
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Root Resorption; Pain Perception; Treatment Duration

Keywords

Clear aligners Orthodontics Artificial intelligence Root positioning CBCT Intraoral scan TruRoot Segmentation

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  before treatment begin

Study Arms (2)

AI-based TruRoot group

EXPERIMENTAL

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:

Conventional clear aligner group

EXPERIMENTAL

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

Interventions

AI-based TruRoot group: DEVICE

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

AI-based TruRoot group

Conventional clear aligner group DEVICE

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

Conventional clear aligner group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of dentistry

Baghdad, 00964, Iraq

Location

MeSH Terms

Conditions

Root Resorption

Condition Hierarchy (Ancestors)

Tooth Resorption; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dheaa Hussein Al-Groosh, Ph.D. Orthodontics

  College of dentistry - University of baghdad

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)