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Augmented Reality-Assisted Miniscrew Placement in Orthodontics: A Clinical Trial

A Clinical Trial Investigating the Accuracy of Augmented Reality-Guided Miniscrew Placement in Orthodontics

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07112417
Acronym
AR-MSP
Enrollment
10
Registered
2025-08-08
Start date
2025-08-31
Completion date
2025-12-01
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic

Keywords

Augmented Reality

Brief 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. 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.

Interventions

DEVICEAugmented Reality

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.

PROCEDUREConventional screw placement

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

No masking will be implemented as both participants and operators will be aware of the intervention type.

Intervention 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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of screw placement1 week post-opAccuracy will be assessed using CBCT imaging compared to planned position

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026