Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance

NCT05904587 | Unknown DMC

• 1 other identifier: 780423
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance. The main question it aims to answer is which method (biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, and the use of low-level vibration in reducing pain during the debonding procedure) is most effective in reducing the patients' pain during debonding of conventional orthodontic fixed appliances. Participants will be asked to give their pain score on a scale of 0 to 100 VAS (visual analogue scale) for every region of the dentition. the researcher then will compare different scores of different methods to find the most effective method in reducing pain.

Conditions

Pain

Keywords

pain and debonding

Outcome Measures

Primary Outcomes (1)

• pain during debonding of conventional fixed orthodontic appliance

  pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure

  Intraprocedural

Secondary Outcomes (1)

• the dentition segment with the highest pain scores

  Intraprocedural

Study Arms (4)

open mouth debonding

NO INTERVENTION

debonding of the bracket is done while the mouth of the patient is open and without any support to the teeth during the debonding procedure

biting on soft elastomeric wafer

EXPERIMENTAL

debonding of the bracket is done while the patient is biting on the preshaped soft elastomeric wafer (cut into a horseshoe shape) during the debonding procedure

Other: ortho technology, sports advantage, thermal forming soft EVA 3mm

biting on cotton roll

EXPERIMENTAL

debonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure

Other: cotton roll

biting on the mouthpiece of vibrational device

EXPERIMENTAL

debonding of the bracket is done while the patient is biting on the mouthpiece of the vibrational device (SureSmile® VPro™) delivering vibrations to the dentition during the debonding procedure

Device: SureSmile® VPro™

Interventions

SureSmile® VPro™ DEVICE

the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure

biting on the mouthpiece of vibrational device

ortho technology, sports advantage, thermal forming soft EVA 3mm OTHER

the pain is recorded when the patient is biting on the EVA sheet during the debonding procedure

biting on soft elastomeric wafer

cotton roll OTHER

the pain is recorded when the patient is biting on the cotton roll during the debonding procedure

biting on cotton roll

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients between 15-30 years of age who could understand, assess, and answer the questionnaires.
• No history of taking medicine periodically or in the last 24 hours (e.g., painkillers, corticosteroids, and anti-flu drugs).
• No debonded brackets prior to debonding procedure.
• No missing teeth except extracted premolar.
• Undergoing upper and lower fixed orthodontic treatment with 0.022-inch metal brackets.
• Finishing arch wires present for at least two months.
• No craniofacial deformities that would affect the dentoalveolar bone quality (e.g., cleft lip and palate) .

You may not qualify if:

• History of taking medicine periodically or in the last 24 h (e.g., analgesic, anti-inflammatory and anxiolytic).
• GAD-7 score of ˃8.
• Debonded brackets at the time of debonding.
• Missing teeth except for extracted premolars.
• Active periodontal problems (recession and mobility greater than Grade I),
• Heavily restored or root canal treated tooth.
• Craniofacial deformities that would affect dentoalveolar bone quality (e.g., cleft lip and palate).
• Surgical treatment (including impacted tooth removal) and presence of mini-screws.
• excessive gingival overgrowth.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

College of Dentistry, University of Baghdad

Baghdad, Bab Al-Muadham, 10047, Iraq

RECRUITING

Related Publications (9)

• 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

• Bavbek NC, Tuncer BB, Tortop T, Celik B. Efficacy of different methods to reduce pain during debonding of orthodontic brackets. Angle Orthod. 2016 Nov;86(6):917-924. doi: 10.2319/020116-88R.1. Epub 2016 May 12.

  PMID: 27172508 BACKGROUND

• Celebi, F. (2021) Evaluation of the effects of cotton roll-biting on debonding pain: a split-mouth study. South European Journal of Orthodontics And Dentofacial Research, 8, 1-7.

  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

• Jaypapal, J., Maheshwari, U. and Vijayalakshmi, V. (2020) Comparison of pain perception during debonding between conventional and vibratory therapy. Annals of the Romanian Society for Cell Biology, 24, 701-715.

  BACKGROUND

• Kilinc DD, Sayar G. Evaluation of pain perception during orthodontic debonding of metallic brackets with four different techniques. J Appl Oral Sci. 2019 Jan 7;27:e20180003. doi: 10.1590/1678-7757-2018-0003.

  PMID: 30624460 BACKGROUND

• Pithon MM, Santos Fonseca Figueiredo D, Oliveira DD, Coqueiro Rda S. What is the best method for debonding metallic brackets from the patient's perspective? Prog Orthod. 2015;16:17. doi: 10.1186/s40510-015-0088-7. Epub 2015 Jun 17.

  PMID: 26081783 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

• Musawi AI, Kadhum AS. Effectiveness of high-frequency vibration, cotton rolls and elastomeric wafers in alleviating debonding pain of orthodontic metal brackets: a randomized clinical trial. Sci Rep. 2024 Oct 24;14(1):25160. doi: 10.1038/s41598-024-75725-2.

  PMID: 39448724 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ammar S Kadhum, Asst. Prof.

  University of Baghdad

  STUDY DIRECTOR

Central Study Contacts

Alhasan I Ali, B.D.S.

CONTACT

7505959112; alhassan.ali22031@codental.uobaghdad.edu.iq

Ammar S Kadhum, Asst. Prof.

CONTACT

7702500415; ammar.ortho@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: B.D.S.

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 15, 2023
• Study Start: March 19, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)

Locations

IR (1)