Root ResorptionNCT06968325
AI-Designed Clear Aligners: A Randomized Clinical Trial
A study testing AI-based TruRoot group: and Conventional clear aligner group in people with Root Resorption and Pain Perception, run by University of Baghdad at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Root Resorption, Pain Perception, Treatment Duration
- What is being tested?
- AI-based TruRoot group: and Conventional clear aligner group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 25 Feb 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Performance of AI-based TruRoot Designed Clear Aligner (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?
Read more
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
Read the 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
- Being tested
- AI-based TruRoot group:, Conventional clear aligner group
- Keywords
- Clear aligners Orthodontics Artificial intelligence Root positioning CBCT Intraoral scan TruRoot Segmentation
- Medical subject headings
- Root Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 groupDevice
Participants in this group will receive clear aligner treatment planned manually by expert orthodontists based only on intraoral scans.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional clear aligner group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: before treatment begin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start25 Feb 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root ResorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdulhussain Abbas, University of Baghdad
- Investigators
- Dheaa Hussein Al-Groosh, Ph.D. Orthodontics, Study chair, College of dentistry - University of baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968325
- Sponsor's protocol ID
- 1013425
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of AI-based TruRoot Designed Clear Aligner (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06968325
- Acronym / sponsor ID
- 1013425
- Conditions
- Root Resorption, Pain Perception, Treatment Duration
- Keywords
- Clear aligners Orthodontics Artificial intelligence Root positioning CBCT Intraoral scan TruRoot Segmentation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-based TruRoot group | Experimental | Device: 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. |
| Conventional clear aligner group | Experimental | Device: Conventional clear aligner groupThis 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based TruRoot group:Participants in this group will receive clear aligner treatment designed using an artificial intelligence (AI)-based system called TruRoot | Device | AI-based TruRoot group |
| Conventional clear aligner groupParticipants in this group will receive clear aligner treatment planned manually by expert orthodontists based only on intraoral scans. | Device | Conventional clear aligner group |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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3-D Evaluation of Alveolar Bone Changes and Root Resorption After Traction of Buccally Displaced Maxillary Canines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dheaa Hussein Al-Groosh, Ph.D. Orthodontics study chair
College of dentistry - University of baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based TruRoot group: and Conventional clear aligner group in people with Root Resorption and Pain Perception, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Root position and movement (time frame: at the end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.