CompletedNot Applicable

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

Syria36 participantsStarted 2024-05-19

Plain-language 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.

Who can participate

Age range

16 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perceived Pain Intensity

Timeframe: 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)

Trial details

NCT IDNCT06873503

SponsorDamascus University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-08

View on ClinicalTrials.gov More Orthodontic Appliance Complication trials