AI-Designed Clear Aligners: A Randomized Clinical Trial

NCT ID: NCT06968325

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-12-01

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

Detailed Description

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

Conditions

Root Resorption; Pain Perception; Treatment Duration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

AI-based TruRoot group

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.

Group Type: EXPERIMENTAL

AI-based TruRoot group:

Intervention Type: DEVICE

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

Conventional clear aligner 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.

Group Type: EXPERIMENTAL

Conventional clear aligner group

Intervention Type: DEVICE

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

Interventions

AI-based TruRoot group:

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

Intervention Type: DEVICE

Conventional clear aligner group

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. All participants should have good general health with healthy periodontium.

2. Adult patient with an age range 18-30 with fully erupted all permanent dentitions excluding third molars.

3. Skeletal and dental Cl I malocclusion with moderate crowding (little irregularity index 4-6 mm).

4. The treatment plan should be non-extraction treatment.

5. No history of trauma or root resorption

Exclusion Criteria

1. Patients with diseases or syndromes affecting maxillofacial regions,

2. Subject with poor oral hygiene.

3. Defective and missing teeth.

4. Presence of any deep bite or open bite problems,

5. History of trauma, root resorptions and dilacerated roots.

6. Medical conditions affecting tooth movement or bone metabolism.

7. previous extraction or history of previous orthodontic treatment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdulhussain Abbas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dheaa Hussein Al-Groosh, Ph.D. Orthodontics

Role: STUDY_CHAIR

College of dentistry - University of baghdad

Locations

College of Dentistry, University of dentistry

Baghdad, , Iraq

Countries

Iraq

Other Identifiers

1013425

Identifier Type: -

Identifier Source: org_study_id