Clinical trial NCT06968325: AI-Designed Clear Aligners: A Randomized Clinical Trial
Official title: Clinical Performance of AI-based TruRoot Designed Clear Aligner (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Root Resorption
Pain Perception
Treatment Duration
Keywords: Clear aligners Orthodontics Artificial intelligence Root positioning CBCT Intraoral scan TruRoot Segmentation
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Root position and movement
timeFrame: at the end of treatment
measure: Assessment of Root Position Relative to Alveolar Bone
timeFrame: before treatment begin
Secondary outcomes:
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry, University of dentistry
Study officials:
affiliation: College of dentistry - University of baghdad
name: Dheaa Hussein Al-Groosh, Ph.D. Orthodontics
role: STUDY_CHAIR
References: