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NCT Number: NCT07112417

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Patients indicated for orthodontic mini-screw placement as part of their treatment plan.
  • Age between 15 and 40 years.
  • Good general health (ASA I or II).
  • Adequate oral hygiene and healthy periodontal condition.
  • 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).
  • History of craniofacial trauma, surgery, or congenital anomalies in the maxillofacial region.
  • Ongoing periodontal disease or poor oral hygiene.
  • Pregnancy or lactation.
  • Use of medications influencing bone metabolism (e.g., bisphosphonates, corticosteroids).
  • Allergy to local anesthetics or materials used in the procedure.

Treatment and study plan

Augmented reality

Device

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 placement

Procedure

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

Primary outcomes

  1. Accuracy of screw placement

    Time frame: 1 week post-op

    Accuracy will be assessed using CBCT imaging compared to planned position

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: "AR-MSP"

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 8, 2025
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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