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

Augmented Reality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658446
• Other study ID #: ORTH 3-3-2
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 25, 2024
• Est. completion date: March 25, 2024

Study information

• Verified date: September 2023
• Source: Cairo University
• Contact: Seif El-Din A. Hegab
• Phone: +201146888843
• Email: seifeldin.amr[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: March 25, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Augmented Reality

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seif El-Din Amr Hussein Hegab

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.