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

September 4, 2023 updated by: Seif El-Din Amr Hussein Hegab

Comparison Between Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients (Randomized Clinical Trial)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Augmented reality is a relatively new addition to the digital armamentarium. It is becoming increasingly popular especially among surgeons, whether general or dental. In light of the clinicians whom have relied on augmented reality in their fields of work, it was suggested that an augmented reality-assisted orthodontic bonding guide be of use. Such an application would theoretically solve many issues of the indirect bonding techniques at hand.

In this study, we shall investigate whether the theory behind such an augmented reality-assisted bonding guide is on par with the digitally-assisted indirect bonding in terms of patient convenience, accuracy of bracket placement and time consumption of the bonding process, to see whether it qualifies to be a method among all the other methods stated in the literature for indirect bonding.

Digital indirect bonding has many advantages, one of which is achieving greater accuracy in bracket positioning, however it has some down sides such as excess composite flashes around brackets after curing and the cost of 3D printing.

Aim of the Study Is to evaluate the patients' convenience upon using the newly introduced augmented reality-assisted bonding guide in comparison to the digitally-assisted indirect bonding tray. Secondary objectives such as accuracy and procedure time consumption between the two methods are also of importance.

Null Hypothesis There will be no difference in the patients' convenience, accuracy and procedure time consumption between the two methods proposed.

Trial Design Split-mouth, randomized, clinical superiority trial with 1:1 allocation ratio.

Sample Size 96 Teeth with different attachments (Brackets and Tubes)

Study Type

Interventional

Enrollment (Estimated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Augmented Reality-Assisted Bonding
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
Virtual Orthodontic attachments are overlaid on top of the patient's teeth using an augmented-reality headset to guide the bracket positioning procedure.
Active Comparator: Digitally-Asssited Indirect Bonding
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
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.
Other Names:
  • 3D Printed Indirect Bonding Guides

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Convenience
Time Frame: Immediately after the bonding procedure.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the Method
Time Frame: After one week of the Bonding Procedure.
Whether the bracket positions were identical to the virtually-planned positions or not. Measured using specialized software for superimposing two 3D virtual models and measuring the differences.
After one week of the Bonding Procedure.
Time
Time Frame: At the time of the Bonding Procedure.
The actual time consumed to bond all attachments using both techniques. This shall include Lab-time and Chair-side time.
At the time of the Bonding Procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seif El-Din Amr Hussein Hegab

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 25, 2024

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

March 25, 2024

Study Registration Dates

First Submitted

December 1, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (Actual)

December 8, 2020

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ORTH 3-3-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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