Augmented RealityNCT04658446
Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients
A study testing Augmented Reality-Assisted Indirect Bonding and Digitally-Asssited Indirect Bonding in people with Augmented Reality, run by Seif El-Din Amr Hussein Hegab.
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. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Augmented Reality
- What is being tested?
- Augmented Reality-Assisted Indirect Bonding and Digitally-Asssited Indirect Bonding
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2024to 25 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Arch length deficiency ≤ 5 mm.
- Good oral hygiene.
- Fully erupted permanent dentition, not necessarily including third molars.
Who cannot join
- Patient with active periodontal diseases.
- Anterior cross-bite.
- Enamel hypoplasia.
- Previous orthodontic treatment.
- Teeth with caries or restorations on labial surfaces.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison Between Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients (Randomized Clinical Trial)
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.
Read the 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)
- Conditions
- Augmented Reality
- Being tested
- Augmented Reality-Assisted Indirect Bonding, Digitally-Asssited Indirect Bonding
- Keywords
- Augmented Reality, Indirect Bonding, Digital Orthodontics, Orthodontic bracket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality-Assisted Indirect BondingDevice
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 BondingDevice
Also called 3D Printed Indirect Bonding Guides
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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality-Assisted Bonding | Experimental | 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. Receives: Device: Augmented Reality-Assisted Indirect Bonding |
| Digitally-Asssited Indirect Bonding | Active comparator | 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. Receives: Device: Digitally-Asssited Indirect Bonding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the bonding procedure.
Secondary outcomes (2)
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.
Measured: After one week of the Bonding Procedure.
Time
The actual time consumed to bond all attachments using both techniques. This shall include Lab-time and Chair-side time.
Measured: At the time of the Bonding Procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start25 Feb 2024 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion25 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Augmented RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seif El-Din Amr Hussein Hegab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seif El-Din Amr Hussein Hegab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658446
- Sponsor's protocol ID
- ORTH 3-3-2
- Status last verified
- Sep 2023
- First submitted
- 1 Dec 2020
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24555689El-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.
PubMed 27242004Kwon 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.
PubMed 29465283
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Augmented Reality-Assisted Bonding Versus Digitally-Assisted Indirect Bonding in Orthodontic Patients (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT04658446
- Acronym / sponsor ID
- ORTH 3-3-2
- Conditions
- Augmented Reality
- Keywords
- Augmented Reality, Indirect Bonding, Digital Orthodontics, Orthodontic bracket
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Seif El-Din Amr Hussein HegabUniversity, hospital or other
- Study start
- 25 Feb 2024 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 25 Mar 2024 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 8 Patients with Split-mouth trial design. Full permanent dentition. In need of Orthodontic treatment with fixed appliance therapy.
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality-Assisted Bonding | Experimental | Device: Augmented Reality-Assisted Indirect BondingThe 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. |
| Digitally-Asssited Indirect Bonding | Active comparator | Device: Digitally-Asssited Indirect BondingThe 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. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Arch length deficiency ≤ 5 mm.
- Good oral hygiene.
- Fully erupted permanent dentition, not necessarily including third molars.
Key exclusion criteria (5 listed)
- Patient with active periodontal diseases.
- Anterior cross-bite.
- Enamel hypoplasia.
- Previous orthodontic treatment.
- Teeth with caries or restorations on labial surfaces.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Reality-Assisted Indirect BondingVirtual Orthodontic attachments are overlaid on top of the patient's teeth using an augmented-reality headset to guide the bracket positioning procedure. | Device | Augmented Reality-Assisted Bonding |
| Digitally-Asssited Indirect BondingAlso: 3D Printed Indirect Bonding Guides3D 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. | Device | Digitally-Asssited Indirect Bonding |
Primary outcome
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.
2 secondary outcomes
Accuracy of the Method
Time frame: After one week of the Bonding Procedure.
Time
Time frame: At the time of the Bonding Procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Results publication: PubMed 24555689Castilla 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.
- Results publication: PubMed 27242004El-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.
- Results publication: PubMed 29465283Kwon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality-Assisted Indirect Bonding and Digitally-Asssited Indirect Bonding in people with Augmented Reality, run by Seif El-Din Amr Hussein Hegab.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seif El-Din A. Hegab (+201146888843, seifeldin.amr@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Convenience (time frame: Immediately after the bonding procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04658446, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.