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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04658446
Enrollment
8
Registered
2020-12-08
Start date
2024-02-25
Completion date
2024-03-25
Last updated
2023-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Augmented Reality

Keywords

Augmented Reality, Indirect Bonding, Digital Orthodontics, Orthodontic bracket

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)

Interventions

DEVICEAugmented 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.

DEVICEDigitally-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.

Sponsors

Seif El-Din Amr Hussein Hegab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient ConvenienceImmediately 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.

Secondary

MeasureTime frameDescription
Accuracy of the MethodAfter 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.
TimeAt 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.

Contacts

Primary ContactSeif El-Din A. Hegab
seifeldin.amr@dentistry.cu.edu.eg+201146888843

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026