Clinical trial NCT06873503: Assessment of Pain When Removing Metallic Brackets for Orthodontic Patients Using Two Removal Methods
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 36
Sex: ALL
Minimum age (years): 16
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damascus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Belal A. Drmch, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Kinda Sultan, DDS MSc PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.