Clinical trial NCT04658446: Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients
Official title: Comparison Between Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Augmented Reality
Keywords: Augmented Reality
Indirect Bonding
Digital Orthodontics
Orthodontic bracket
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 8
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.
Primary purpose: DEVICE_FEASIBILITY

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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Convenience
timeFrame: Immediately after the bonding procedure.
Secondary outcomes:
measure: Accuracy of the Method
timeFrame: After one week of the Bonding Procedure.
measure: Time
timeFrame: At the time of the Bonding Procedure.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.