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

NCT07112417 | Not Yet Recruiting

• 1 other identifier: AR-Ortho-MSc01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic

Keywords

Augmented Reality

Outcome Measures

Primary Outcomes (1)

• Accuracy of screw placement

  Accuracy will be assessed using CBCT imaging compared to planned position

  1 week post-op

Study Arms (2)

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

Device: Augmented Reality

conventional Mini-Screw Placement

ACTIVE COMPARATOR

Participants in this group will undergo mini-screw placement using conventional placement

Procedure: Conventional screw placement

Interventions

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.

Augmented Reality-Guided Mini-Screw Placement

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

conventional Mini-Screw Placement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dentistry

Asyut, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be implemented as both participants and operators will be aware of the intervention type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: studient of master

Model Details: "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."

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: August 8, 2025
• Study Start: August 31, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)