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Completed

NCT Number: NCT07474389

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

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.

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Key information

Age range

18 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthodontics Department, Faculty of Dentistry

Damascus, Rif-dimashq Governorate, DM20AM19, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Loupes-based bonding

Procedure

Bonding will be done with improved vision with loupes.

Traditional bonding

Procedure

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

Primary outcomes

  1. Patient-reported discomfort

    Time frame: At 5 minutes after bonding the brackets.

    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.

  2. Total bonding time

    Time frame: This variable is going to be measured once from the beginning of the bonding procedure till the end.

    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.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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