Can Magnification Loupes Make the Bracket Bonding Procedure Faster and More Comfortable?

NCT07474389 | Completed DMC

• 1 other identifier: UDDS-2026-Ortho-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion; Displaced Teeth

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Loupes-assisted bonding

EXPERIMENTAL

A total of 600 brackets (120 quadrants from 60 patients) will be bonded using 3.5× magnification loupes

Procedure: Loupes-based bonding

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

Procedure: Traditional bonding

Interventions

Loupes-based bonding PROCEDURE

Bonding will be done with improved vision with loupes.

Loupes-assisted bonding

Traditional bonding PROCEDURE

The orthodontist will bond the brackets using the naked-eye method.

Unaided-vision bonding

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

Location

Related Publications (5)

• 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.

  PMID: 8687368 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.

  PMID: 39364772 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.

  PMID: 26516711 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.

  PMID: 2750720 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.

  PMID: 39346332 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mai M Faour, DDS

  Department of Orthodontics, Faculty of Dentistry, University of Damascus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: August 23, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)