Orthodontic"AR-MSP"NCT07112417
"Augmented Reality-Assisted Miniscrew Placement in Orthodontics: A Clinical Trial"
A study testing Augmented Reality and Conventional screw placement in people with Orthodontic, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effectiveness and accuracy of using Augmented Reality (AR) technology in the placement of mini-screws (Temporary Anchorage Devices) during orthodontic treatment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Orthodontic
- What is being tested?
- Augmented Reality and Conventional screw placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Aug 2025to 1 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1. Patients indicated for orthodontic mini-screw placement as part of their treatment plan.
- 2. Age between 15 and 40 years.
- 3. Good general health (ASA I or II).
- 4. Adequate oral hygiene and healthy periodontal condition.
- 5. Ability to understand and provide informed consent (or guardian consent for minors).
Who cannot join
- 1 . Systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- 2. History of craniofacial trauma, surgery, or congenital anomalies in the maxillofacial region.
- 3. Ongoing periodontal disease or poor oral hygiene.
- 4. Pregnancy or lactation.
- 5. Use of medications influencing bone metabolism (e.g., bisphosphonates, corticosteroids).
- 6. Allergy to local anesthetics or materials used in the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Dentistry
Asyut
omar hassan Abd El Azeem, 1, 01157504731, omar.oh757833@gmail.com
About this study
Official title: "A Clinical Trial Investigating the Accuracy of Augmented Reality-Guided Miniscrew Placement in Orthodontics"
This study aims to evaluate the effectiveness and accuracy of using Augmented Reality (AR) technology in the placement of mini-screws (Temporary Anchorage Devices) during orthodontic treatment. By combining CBCT images with digital dental scans and visualizing them using AR, clinicians can place mini-screws more precisely. The study is a pilot clinical trial involving patients at the Faculty of Dentistry, Al-Azhar University - Assiut Branch.
Read the detailed description
This is a pilot clinical trial designed to assess the feasibility and accuracy of augmented reality (AR)-guided mini-screw insertion in orthodontic patients. The study involves the use of CBCT imaging and digital intraoral scanning to create a 3D model of the patient's jaw. This model is then processed and integrated into an AR platform that allows real-time visualization of the ideal screw insertion site.
Participants are selected based on inclusion and exclusion criteria. After obtaining informed consent, CBCT and intraoral scans are performed. The proposed mini-screw location is determined digitally and projected using an AR device (tablet or headset) during the clinical procedure.
After insertion, a follow-up CBCT scan is taken to evaluate the deviation between the planned and actual screw positions (linear and angular deviation). Data on insertion time, patient comfort, and operator satisfaction will also be recorded.
The study is conducted at the Faculty of Dentistry, Al-Azhar University - Assiut Branch, with prior ethical approval obtained from the institutional review board.
- Conditions
- Orthodontic
- Being tested
- Augmented Reality, Conventional screw placement
- Keywords
- Augmented Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented RealityDevice
Participants in this group will undergo mini-screw placement assisted by augmented reality (AR) technology. A customized AR system will guide the clinician in real-time to ensure optimal screw positioning, improve accuracy, and minimize placement errors.
Conventional screw placementProcedure or surgery
Participants in this group will receive mini-screw placement using the conventional freehand method without augmented reality assistance. The screws will be placed according to standard clinical protocols based on anatomical landmarks and clinician experience
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality-Guided Mini-Screw Placement | Active comparator | Participants in this group will undergo mini-screw placement using augmented reality (AR) guidance to enhance accuracy and reduce placement errors Receives: Device: Augmented Reality |
| conventional Mini-Screw Placement | Active comparator | Participants in this group will undergo mini-screw placement using conventional placement Receives: Procedure: Conventional screw placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of screw placement
Accuracy will be assessed using CBCT imaging compared to planned position
Measured: 1 week post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthodonticStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Model description
- "This is a randomized controlled clinical trial to evaluate the effectiveness of augmented reality (AR)-guided placement of orthodontic mini-screws compared to conventional placement methods. Participants will be randomly assigned to either the AR-guided group or the conventional placement group."
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, omar hassan abd el azeem, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112417
- Sponsor's protocol ID
- AR-Ortho-MSc01
- Acronym
- "AR-MSP"
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: NO plan to share
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Clinical Trial Investigating the Accuracy of Augmented Reality-Guided Miniscrew Placement in Orthodontics"
- ClinicalTrials.gov ID
- NCT07112417
- Acronym / sponsor ID
- "AR-MSP" / AR-Ortho-MSc01
- Conditions
- Orthodontic
- Keywords
- Augmented Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 8 Aug 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.
This study aims to evaluate the effectiveness and accuracy of using Augmented Reality (AR) technology in the placement of mini-screws (Temporary Anchorage Devices) during orthodontic treatment. By combining CBCT images with digital dental scans and visualizing them using AR, clinicians can place mini-screws more precisely. The study is a pilot clinical trial involving patients at the Faculty of Dentistry, Al-Azhar University - Assiut Branch.
Detailed description
This is a pilot clinical trial designed to assess the feasibility and accuracy of augmented reality (AR)-guided mini-screw insertion in orthodontic patients. The study involves the use of CBCT imaging and digital intraoral scanning to create a 3D model of the patient's jaw. This model is then processed and integrated into an AR platform that allows real-time visualization of the ideal screw insertion site.
Participants are selected based on inclusion and exclusion criteria. After obtaining informed consent, CBCT and intraoral scans are performed. The proposed mini-screw location is determined digitally and projected using an AR device (tablet or headset) during the clinical procedure.
After insertion, a follow-up CBCT scan is taken to evaluate the deviation between the planned and actual screw positions (linear and angular deviation). Data on insertion time, patient comfort, and operator satisfaction will also be recorded.
The study is conducted at the Faculty of Dentistry, Al-Azhar University - Assiut Branch, with prior ethical approval obtained from the institutional review board.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "This is a randomized controlled clinical trial to evaluate the effectiveness of augmented reality (AR)-guided placement of orthodontic mini-screws compared to conventional placement methods. Participants will be randomly assigned to either the AR-guided group or the conventional placement group."
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality-Guided Mini-Screw Placement | Active comparator | Device: Augmented RealityParticipants in this group will undergo mini-screw placement using augmented reality (AR) guidance to enhance accuracy and reduce placement errors |
| conventional Mini-Screw Placement | Active comparator | Procedure: Conventional screw placementParticipants in this group will undergo mini-screw placement using conventional placement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Patients indicated for orthodontic mini-screw placement as part of their treatment plan.
- 2. Age between 15 and 40 years.
- 3. Good general health (ASA I or II).
- 4. Adequate oral hygiene and healthy periodontal condition.
- 5. Ability to understand and provide informed consent (or guardian consent for minors).
Key exclusion criteria (6 listed)
- 1 . Systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- 2. History of craniofacial trauma, surgery, or congenital anomalies in the maxillofacial region.
- 3. Ongoing periodontal disease or poor oral hygiene.
- 4. Pregnancy or lactation.
- 5. Use of medications influencing bone metabolism (e.g., bisphosphonates, corticosteroids).
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 |
|---|---|---|
| Augmented RealityParticipants in this group will undergo mini-screw placement assisted by augmented reality (AR) technology. A customized AR system will guide the clinician in real-time to ensure optimal screw positioning, improve accuracy, and minimize placement errors. | Device | Augmented Reality-Guided Mini-Screw Placement |
| Conventional screw placementParticipants in this group will receive mini-screw placement using the conventional freehand method without augmented reality assistance. The screws will be placed according to standard clinical protocols based on anatomical landmarks and clinician experience | Procedure or surgery | conventional Mini-Screw Placement |
Primary outcome
Accuracy of screw placement
Time frame: 1 week post-op
Accuracy will be assessed using CBCT imaging compared to planned position
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 8 Aug 2025.
- Individual participant dataSharing planned: No. NO plan to share
Related trials for Orthodontic
Active, not recruitingObservational study
Accuracy and Time Efficiency of AI Versus Manual Segmentation in Adult Crowding Using Aligner Software
Dental Crowding
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
RecruitingObservational study
Microplastic Exposure From Clear Aligner Wear (MPE)
Microplastic Exposure
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Active, not recruiting
A Split-Mouth Clinical Trial Evaluating the Bond Failure Rate of a New Etch-Free Orthodontic Adhesive
Bracket Bonding, Orthodontic Treatment
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality and Conventional screw placement in people with Orthodontic, run by Al-Azhar University at 1 site in Egypt.
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 6 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: opening soon, as of the sponsor's last update on 8 Aug 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of screw placement (time frame: 1 week post-op). 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 8 Aug 2025.