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Orthodontic Appliance ComplicationNCT06873503

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

A study testing Bracket removal using a Weingart plier with the mouth open and Biting on a cotton roll during brakcet removal in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 25 years
Conditions the study is for
Orthodontic Appliance Complication
What is being tested?
Bracket removal using a Weingart plier with the mouth open and Biting on a cotton roll during brakcet removal
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSyria
Study dates
19 May 2024to 5 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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,
Show all 9Show fewer
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Syria1 site

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

    Damascus, DM20AM19

Other trials in Syria

About this study

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

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:

Read more

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.

Read the 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.

Being tested
Bracket removal using a Weingart plier with the mouth open, Biting on a cotton roll during brakcet removal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bracket removal using a Weingart plier with the mouth openProcedure or surgery

    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 removalProcedure or surgery

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

Study groups in NCT06873503
Study groupRoleWhat they receive
Bracket removal with the mouth openActive comparatorUsing a Weingart orthodontic plier, the patient will be asked to keep his mouth open during bracket removal.
Receives: Procedure: Bracket removal using a Weingart plier with the mouth open
Bracket removal while biting on a cotton rollExperimentalDuring bracket removal with a Weingart orthodontic plier, the patient will be asked to bite on a cotton roll between the upper and lower teeth.
Receives: Procedure: Biting on a cotton roll during brakcet removal

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start19 May 2024
  3. Primary completion8 Oct 2024
  4. Study completion5 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06873503
Sponsor's protocol ID
UDDS-Ortho-3-2025
Status last verified
Mar 2025
First submitted
7 Mar 2025
Last updated
12 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33747083

  • 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.

    PubMed 30934051

  • 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.

    PubMed 35229220

  • 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.

    PubMed 24009318

  • 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.

    PubMed 1558060

Questions about this trial

What is this clinical trial studying?

A study testing Bracket removal using a Weingart plier with the mouth open and Biting on a cotton roll during brakcet removal in people with Orthodontic Appliance Complication, run by Damascus University at 1 site in Syria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06873503, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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