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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-25

Study Completion Date

2024-03-25

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Augmented Reality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

The assessor shall not know which group is which in the accuracy outcome.

Study Groups

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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.

Group Type EXPERIMENTAL

Augmented Reality-Assisted Indirect Bonding

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Digitally-Asssited Indirect Bonding

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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3D Printed Indirect Bonding Guides

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes