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

Not Applicable

Completed

• Conditions: Orthodontic Appliance Complication

• Registration Number: NCT06873503
• Lead Sponsor: Damascus University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-05-19
• Primary Completion: 2024-10-08
• Study Completion: 2025-01-05
• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-11
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived Pain Intensity	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.

Trial Locations

Locations (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus; 🇸🇾 Damascus, Syrian Arab Republic