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AI-Designed Clear Aligners: A Randomized Clinical Trial

NCT06968325 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-21

No results posted yet for this study

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

Interventions

DEVICE

AI-based TruRoot group:

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

DEVICE

Conventional clear aligner group

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

Sponsors & Collaborators

  • University of Baghdad

    lead OTHER

Principal Investigators

  • Dheaa Hussein Al-Groosh, Ph.D. Orthodontics · College of dentistry - University of baghdad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06968325 on ClinicalTrials.gov