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

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ClinicalTrials.gov Identifier: NCT04658446
Recruitment Status : Not yet recruiting
First Posted : December 8, 2020
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Seif El-Din Amr Hussein Hegab, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Augmented Reality Device: Augmented Reality-Assisted Indirect Bonding Device: Digitally-Asssited Indirect Bonding Not Applicable

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)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.
Masking: Single (Outcomes Assessor)
Masking Description: The assessor shall not know which group is which in the accuracy outcome.
Primary Purpose: Device Feasibility
Official Title: Comparison Between Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients (Randomized Clinical Trial)
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Augmented Reality-Assisted Bonding
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
Virtual Orthodontic attachments are overlaid on top of the patient's teeth using an augmented-reality headset to guide the bracket positioning procedure.
Active Comparator: Digitally-Asssited Indirect Bonding
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
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.
Other Name: 3D Printed Indirect Bonding Guides


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Accuracy of the Method [ Time Frame: After 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.

  2. Time [ Time Frame: At 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.


Eligibility Criteria
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Ages Eligible for Study:   15 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658446


Contacts
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Contact: Seif El-Din A. Hegab +201146888843 seifeldin.amr@dentistry.cu.edu.eg

Sponsors and Collaborators
Seif El-Din Amr Hussein Hegab
More Information
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Publications of Results:

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Responsible Party: Seif El-Din Amr Hussein Hegab, PhD Candidate/ Researcher, Cairo University
ClinicalTrials.gov Identifier: NCT04658446    
Other Study ID Numbers: ORTH 3-3-2
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seif El-Din Amr Hussein Hegab, Cairo University:
Augmented Reality
Indirect Bonding
Digital Orthodontics
Orthodontic bracket