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

NCT ID: NCT07112417

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Orthodontic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"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."
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Augmented Reality

Intervention Type 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 Mini-Screw Placement

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

Group Type ACTIVE_COMPARATOR

Conventional screw placement

Intervention Type 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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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omar hassan abd el azeem

studient of master

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Asyut, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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omar hassan Abd El Azeem, 1

Role: primary

01157504731

Other Identifiers

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AR-Ortho-MSc01

Identifier Type: -

Identifier Source: org_study_id

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