"Augmented Reality-Assisted Miniscrew Placement in Orthodontics: A Clinical Trial" ("AR-MSP")

"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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthodontic
• Intervention / Treatment: Device: Augmented Reality; Procedure: Conventional screw placement

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of dentistry
    • Contact: omar hassan Abd El Azeem, 1; Phone Number: 01157504731; Email: omar.oh757833@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Augmented Reality-Guided Mini-Screw Placement; Participants in this group will undergo mini-screw placement using augmented reality (AR) guidance to enhance accuracy and reduce placement errors	Device: Augmented 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.
Active Comparator: conventional Mini-Screw Placement; Participants in this group will undergo mini-screw placement using conventional placement	Procedure: Conventional 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of screw placement	Accuracy will be assessed using CBCT imaging compared to planned position	1 week post-op

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): August 31, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 2, 2025
• First Submitted That Met QC Criteria: August 2, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Augmented Reality
• Other Study ID Numbers: AR-Ortho-MSc01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NO plan to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No