Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients

NCT04658446 | Unknown

• 1 other identifier: ORTH 3-3-2
• Study Type: interventional
• Target: 8
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparing two indirect bonding techniques. Augmented Reality-assisted bonding and Digital 3D printed indirect bonding trays in regards to patient convenience, accuracy of bracket placement and time consumption of each technique used.

Conditions

Augmented Reality

Keywords

Augmented Reality; Indirect Bonding; Digital Orthodontics; Orthodontic bracket

Outcome Measures

Primary Outcomes (1)

• Patient Convenience

  Whether the patient was at ease during the bonding procedure or not and the overall convenience of the procedure from the patient's point of view.

  Immediately after the bonding procedure.

Secondary Outcomes (2)

• Accuracy of the Method

  After one week of the Bonding Procedure.

• Time

  At the time of the Bonding Procedure.

Study Arms (2)

Augmented Reality-Assisted Bonding

EXPERIMENTAL

The quadrant of the upper arch that shall use the AR-assisted bonding method. From the maxillary central incisor to the maxillary first permanent molar of the same quadrant.

Device: Augmented Reality-Assisted Indirect Bonding

Digitally-Asssited Indirect Bonding

ACTIVE COMPARATOR

The quadrant of the upper arch that shall use the digitally-assisted bonding method utilizing a 3D printed tray. From the maxillary central incisor to the maxillary first permanent molar of the same quadrant.

Device: Digitally-Asssited Indirect Bonding

Interventions

Augmented Reality-Assisted Indirect Bonding DEVICE

Virtual Orthodontic attachments are overlaid on top of the patient's teeth using an augmented-reality headset to guide the bracket positioning procedure.

Augmented Reality-Assisted Bonding

Digitally-Asssited Indirect Bonding DEVICE

3D printed models with precise brackets positioned as virtually pre-planned. To aid in the transfer of the planned bracket positions to the patient's physical teeth.

Also known as: 3D Printed Indirect Bonding Guides

Digitally-Asssited Indirect Bonding

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Arch length deficiency ≤ 5 mm.
• Good oral hygiene.
• Fully erupted permanent dentition, not necessarily including third molars.

You may not qualify if:

• Patient with active periodontal diseases.
• Anterior cross-bite.
• Enamel hypoplasia.
• Previous orthodontic treatment.
• Teeth with caries or restorations on labial surfaces.

Sponsors & Collaborators

• Seif El-Din Amr Hussein Hegab: lead

Related Publications (3)

• Castilla AE, Crowe JJ, Moses JR, Wang M, Ferracane JL, Covell DA Jr. Measurement and comparison of bracket transfer accuracy of five indirect bonding techniques. Angle Orthod. 2014 Jul;84(4):607-14. doi: 10.2319/070113-484.1. Epub 2014 Feb 20.

  PMID: 24555689 RESULT

• El-Timamy AM, El-Sharaby FA, Eid FH, Mostafa YA. Three-dimensional imaging for indirect-direct bonding. Am J Orthod Dentofacial Orthop. 2016 Jun;149(6):928-31. doi: 10.1016/j.ajodo.2015.12.009.

  PMID: 27242004 RESULT

• Kwon HB, Park YS, Han JS. Augmented reality in dentistry: a current perspective. Acta Odontol Scand. 2018 Oct;76(7):497-503. doi: 10.1080/00016357.2018.1441437. Epub 2018 Feb 21.

  PMID: 29465283 RESULT

Central Study Contacts

Seif El-Din A. Hegab

CONTACT

+201146888843; seifeldin.amr@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor shall not know which group is which in the accuracy outcome.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate/ Researcher

Model Details: 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: February 25, 2024
• Primary Completion: February 28, 2024
• Study Completion: March 25, 2024
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share