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

Not Applicable

Not yet recruiting

• Conditions: Orthodontic

• Registration Number: NCT07112417
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-02
• Last Update Submitted: 2025-08-02
• Study First Posted: 2025-08-08
• Last Update Posted: 2025-08-08
• Study Start: 2025-08-31
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy of screw placement	1 week post-op	Accuracy will be assessed using CBCT imaging compared to planned position

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Assiut, Egypt