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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loupes-assisted bonding | Experimental | A total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes |
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| Unaided-vision bonding | Active Comparator | A total of 600 brackets (120 quadrants from 60 patients) will be bonded with the naked eye, without visual aids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loupes-based bonding | Procedure | Bonding will be done with improved vision with loupes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported discomfort | 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. | At 5 minutes after bonding the brackets. |
| Total bonding time | 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. | This variable is going to be measured once from the beginning of the bonding procedure till the end. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mai M Faour, DDS | Department of Orthodontics, Faculty of Dentistry, University of Damascus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthodontics Department, Faculty of Dentistry | Damascus | Rif-dimashq Governorate | DM20AM19 | Syria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8687368 | Background | 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. | |
| 39364772 | Background | 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. |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Traditional bonding | Procedure | The orthodontist will bond the brackets using the naked-eye method. |
|
| 26516711 | Background | 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. |
| 2750720 | Background | 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. |
| 39346332 | Background | 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. |