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

NCT06873503 | Completed DMC

• 1 other identifier: UDDS-Ortho-3-2025
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthodontic Appliance Complication

Outcome Measures

Primary Outcomes (1)

• Perceived Pain Intensity

  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.

  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)

Study Arms (2)

Bracket removal with the mouth open

ACTIVE COMPARATOR

Using a Weingart orthodontic plier, the patient will be asked to keep his mouth open during bracket removal.

Procedure: Bracket removal using a Weingart plier with the mouth open

Bracket removal while biting on a cotton roll

EXPERIMENTAL

During bracket removal with a Weingart orthodontic plier, the patient will be asked to bite on a cotton roll between the upper and lower teeth.

Procedure: Biting on a cotton roll during brakcet removal

Interventions

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.

Bracket removal with the mouth open

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.

Bracket removal while biting on a cotton roll

Eligibility Criteria

• Age: 16 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, DM20AM19, Syria

Location

Related Publications (5)

• Karobari MI, Assiry AA, Mirza MB, Sayed FR, Shaik S, Marya A, Venugopal A, Alam MK, Horn R. Comparative Evaluation of Different Numerical Pain Scales Used for Pain Estimation during Debonding of Orthodontic Brackets. Int J Dent. 2021 Mar 4;2021:6625126. doi: 10.1155/2021/6625126. eCollection 2021.

  PMID: 33747083 BACKGROUND

• Almuzian M, Rizk MZ, Ulhaq A, Alharbi F, Alomari S, Mohammed H. Effectiveness of different debonding techniques and adjunctive methods on pain and discomfort perception during debonding fixed orthodontic appliances: a systematic review. Eur J Orthod. 2019 Sep 21;41(5):486-494. doi: 10.1093/ejo/cjz013.

  PMID: 30934051 BACKGROUND

• Gupta SP, Rauniyar S, Prasad P, Pradhan PMS. A randomized controlled trial to evaluate the effectiveness of different methods on pain management during orthodontic debonding. Prog Orthod. 2022 Mar 1;23(1):7. doi: 10.1186/s40510-022-00401-y.

  PMID: 35229220 BACKGROUND

• Mangnall LA, Dietrich T, Scholey JM. A randomized controlled trial to assess the pain associated with the debond of orthodontic fixed appliances. J Orthod. 2013 Sep;40(3):188-96. doi: 10.1179/1465313313Y.0000000045.

  PMID: 24009318 BACKGROUND

• Williams OL, Bishara SE. Patient discomfort levels at the time of debonding: a pilot study. Am J Orthod Dentofacial Orthop. 1992 Apr;101(4):313-7. doi: 10.1016/S0889-5406(05)80324-5.

  PMID: 1558060 BACKGROUND

Study Officials

• Belal A. Drmch, DDS

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  PRINCIPAL INVESTIGATOR

• Kinda Sultan, DDS MSc PhD

  Department of Orthodontics, Faculty of Dentistry, Damascus University

  STUDY DIRECTOR

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 7, 2025
• First Posted: March 12, 2025
• Study Start: May 19, 2024
• Primary Completion: October 8, 2024
• Study Completion: January 5, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)