- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474389
Can Magnification Loupes Make the Bracket Bonding Procedure Faster and More Comfortable?
A Split-mouth Randomized Controlled Trial Comparing Loupes-assisted Versus Conventional Bonding of Brackets in Terms of Discomfort and Bonding Duration in Crowded Dental Arches.
This study aims to evaluate whether using 3.5x dental magnification loupes improves the speed and patient comfort of the orthodontic bracket placement procedure in patients with crowded dentition, a condition that can make the process more challenging and potentially uncomfortable. We will directly compare the conventional method (unaided vision), which is employed by most orthodontists, with an alternative approach in which the clinician performs bonding while wearing magnification loupes. These loupes provide a clearer and more detailed view of the teeth during the procedure.
Both methods will be applied to the same patient using a split-mouth study design. Our primary goal is to determine which method is faster to perform and which one results in less discomfort for the patient during the appointment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Magnification loupes have become widely used in dental practice, demonstrating superior performance over unaided vision in many specialties such as restorative dentistry, endodontics, and periodontics, primarily by enhancing the operator's precision, ergonomics, and visual acuity. In orthodontics, loupes have also been shown to improve the quality of bracket debonding.
However, the specific role of magnification loupes in potentially modulating the patient's sensory experience immediately after the bonding procedure remains entirely unexplored. It is unknown whether the improved visualization afforded by magnification translates into a more or less comfortable patient experience during bracket placement. The presence of an advanced tool such as loupes may elevate patient expectations, potentially influencing their reported comfort.
Moreover, understanding the patient's immediate comfort is clinically meaningful, as a positive early experience may enhance overall treatment acceptance and cooperation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Rif-dimashq Governorate
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Damascus, Rif-dimashq Governorate, Syria, DM20AM19
- Orthodontics Department, Faculty of Dentistry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- adults aged 18-28 years
- presence of all permanent teeth,
- the presence of dental crowding,
- sound, intact enamel surfaces on teeth to be bonded,
- good oral hygiene, defined as a Plaque Index ≤ 1
Exclusion Criteria:
- the presence of amelogenesis imperfecta, enamel hypoplasia, or white spots affecting the buccal surfaces,
- severe or active periodontal disease,
- congenitally missing teeth,
- prosthetic restorations on the buccal surfaces of teeth to be bonded,
- previous orthodontic re-treatment,
- poor oral hygiene (Plaque Index > 1)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Loupes-assisted bonding
A total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes
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Bonding will be done with improved vision with loupes.
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Active Comparator: Unaided-vision bonding
A total of 600 brackets (120 quadrants from 60 patients) will be bonded with the naked eye, without visual aids
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The orthodontist will bond the brackets using the naked-eye method.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient-reported discomfort
Time Frame: At 5 minutes after bonding the brackets.
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Each quadrant will be assessed using a 100 mm Visual Analog Scale (VAS).
Immediately after the bonding procedure for each quadrant, patients will be asked to mark their perceived discomfort level on a horizontal line ranging from 0 mm ("no discomfort") to 100 mm ("worst imaginable discomfort").
The exact distance from the 0 mm point to the patient's mark will be measured in millimeters, providing an accurate discomfort score for each quadrant.
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At 5 minutes after bonding the brackets.
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Total bonding time
Time Frame: This variable is going to be measured once from the beginning of the bonding procedure till the end.
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Total bonding time per quadrant will be recorded using the stopwatch function of the Clock application on an iPhone, with time measured in minutes, seconds, and sub-seconds.
Recording will start with the initiation of enamel etching and will conclude exactly at the completion of the final light-curing of brackets in each quadrant, representing the total operative time per quadrant.
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This variable is going to be measured once from the beginning of the bonding procedure till the end.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mai M Faour, DDS, Department of Orthodontics, Faculty of Dentistry, University of Damascus
Publications and helpful links
General Publications
- Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. Am J Orthod Dentofacial Orthop. 1989 Jul;96(1):47-53. doi: 10.1016/0889-5406(89)90228-x.
- Litt MD. A model of pain and anxiety associated with acute stressors: distress in dental procedures. Behav Res Ther. 1996 May-Jun;34(5-6):459-76. doi: 10.1016/0005-7967(96)00015-0.
- Kono K, Murakami T, Tanizaki S, Kawanabe N, Fujisawa A, Nakamura M, Hoshijima M, Izawa T, Kamioka H. Comprehensive clinical evaluation of indirect and direct bonding techniques in orthodontic treatment: a single-centre, open-label, quasi-randomized controlled clinical trial. Eur J Orthod. 2024 Dec 1;46(6):cjae036. doi: 10.1093/ejo/cjae036.
- Abdelrahman RSh, Al-Nimri KS, Al Maaitah EF. Pain experience during initial alignment with three types of nickel-titanium archwires: a prospective clinical trial. Angle Orthod. 2015 Nov;85(6):1021-6. doi: 10.2319/071614-498.1.
- Mohanty B, Chekka M, Sowmya C, Khurana R, Manga UM, Varma Datla PK, Somaraj V. Evaluation of Pain and Discomfort Associated with Orthodontic Adjustments. J Pharm Bioallied Sci. 2024 Jul;16(Suppl 3):S2400-S2402. doi: 10.4103/jpbs.jpbs_269_24. Epub 2024 Jul 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDDS-2026-Ortho-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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