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

Study Overview
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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.

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)

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

Conditions
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Augmented Reality

Intervention / Treatment
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* Device: Augmented Reality-Assisted Indirect Bonding
* Device: Digitally-Asssited Indirect Bonding


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of the Method | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Augmented Reality, Indirect Bonding, Digital Orthodontics, Orthodontic bracket