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Clinical Trials/NCT04658446
NCT04658446Not yet recruitingNot Applicable

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

Seif El-Din Amr Hussein Hegab0 sites8 target enrollmentStarted: February 25, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
8
Primary Endpoint
Patient Convenience

Study Overview

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.

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
15 Years to 30 Years (Child, Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

Patient Convenience

Time Frame: Immediately 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 Outcomes

  • Time(At the time of the Bonding Procedure.)
  • Accuracy of the Method(After one week of the Bonding Procedure.)

Investigators

Sponsor
Seif El-Din Amr Hussein Hegab
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Seif El-Din Amr Hussein Hegab

PhD Candidate/ Researcher

Cairo University

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