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Completed

NCT Number: NCT06873503

Assessment of Pain When Removing Metallic Brackets for Orthodontic Patients Using Two Removal Methods

Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then after finishing the orthodontic treatment, Patients were randomly assigned into two groups:

Open mouth group:

The debonding procedure was conducted using the open-mouth technique. All brackets were removed using a Weingart plier (American Orthodontics, Sheboygan, Wisc) by squeezing them from both sides of the mesial-distal surfaces. Before debonding, the stainless steel finishing archwires (0.017 × 0.025 inches) were removed.

Biting-on a-cotton-roll-group:

All brackets were removed using the same plier. The brackets were debonded using a Weingart plier (American Orthodontics, Sheboygan, Wisc) by squeezing them from both sides of the mesial-distal surfaces. Additionally, cotton rolls were placed between the upper and lower teeth, and patients were instructed to bite on them during the procedure. Before debonding, the stainless steel finishing archwires (0.017 × 0.025 inches) were removed. Patients in the second group were instructed to bite on a cotton roll throughout the debonding process.

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Key information

Conditions

Orthodontic Appliance Complication

Age range

16 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

About this study

Pain is a subjective experience that can vary widely among individuals. It is influenced by several factors, including age, gender, personal pain threshold, psychological and social conditions, past negative experiences, and the degree of force applied.

Although various methods for bracket debonding, such as ultrasonic instrumentation, lasers, and electro-thermal debonding, are documented in the literature, hand tools like Weingart pliers remain among the most practical solutions. This study focused on using Weingart pliers to compare the pain scores in two techniques-open mouth and biting on a cotton roll-during bracket removal. These methods are widely used in orthodontic clinics and are readily available to orthodontists.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 16 to 25 years,
  • Undergoing orthodontic treatment with MBT prescription 0.022-inch metal brackets with a single-mesh base (Pinnacle®, MBT compatible 0.022, OrthoTechnology™, Florida, USA) who were in the final stage of their treatment and planned for debonding,
  • The brackets bonded with the same bonding cement (Ivoclar Heliosit Orthodontic Adhesive Composite) and the same primer (Ivoclar Vivadent Tetric N-Bond),
  • Absence of debonded brackets at the debonding process,
  • The 0.017 × 0.025-inch stainless steel finishing archwires in their places for at least one month,
  • Good occlusal relationships and strong intercuspation,
  • No recent use of medications such as painkillers or corticosteroids in the last day,
  • Absence of acute or chronic dental pain induced by periodontal/periapical lesions or caries,
  • There is an absence of a history of surgical treatment, including impacted tooth eruption, tooth transplantation, or the presence of mini-screws.

Exclusion criteria

  • Presence of any craniofacial syndromes or systemic diseases
  • Previous facial trauma
  • Previous orthodontic treatment

Treatment and study plan

Bracket removal using a Weingart plier with the mouth open

Procedure

The brackets will be removed using a Weingart plier. The patient will be asked to keep his mouth open during this procedure.

Biting on a cotton roll during brakcet removal

Procedure

The brackets will be removed using a Weingart plier. During this procedure, the patient will be asked to bite on a cotton roll.

Primary outcomes

  1. Perceived Pain Intensity

    Time frame: This assessment will be done once at the time of removing brackets (i.e., the patient will record the level of perceived pain within few seconds after removing each bracket for each tooth)

    Pain intensity will be evaluated using a 100-mm Visual Analog Scale (VAS), where a score of 0 indicates "no pain" and 100 indicated "extreme pain".

    Patients will be asked to record the perceived pain immediately after removing each bracket.

    This evaluation will cover all teeth on the upper and lower jaws.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Effectiveness of the Weingart Plier in Combination With the Biting on Cotton Rolls in the Management of Pain During the Removal of Metal Brackets: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

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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