Clinical Evaluation of Pain and Debonding Forces with Damon Clear Debonding Plier Utilizing a Third Wedging Arm

NCT06784102 | Completed

• 1 other identifier: 606422
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study aimed to assess pain levels and debonding forces using two different pliers: the traditional bracket remover plier and the Damon clear debonding plier. A total of 40 orthodontic patients (ages 17-25) participated in a split-mouth controlled trial. The patients were divided into two groups, with Group A (Control) using the traditional bracket remover plier and Group B using the Damon clear plier, which features a third wedging arm. Pain perception was evaluated using the Numerical Rating Scale (NRS), and debonding forces were measured using a force-sensitive prototype.

Conditions

Pain Intensity Assessment

Keywords

debonding pain; debonding forces; Damon clear debonding plier; Bracket remover plier; Force-sensitive plier prototype

Outcome Measures

Primary Outcomes (1)

• pain level estimation

  discomfort or pain experienced by patients during the removal of orthodontic brackets from their teeth, patients were prompted to assign a numerical rating scale (NRS) score, ranging from 0 to 10, to assess the perception of pain associated with each individual bracket and the corresponding tooth

  Time frame was immediate, as pain perception was assessed immediately after debonding. Pain levels were measured using a Numerical Rating Scale (NRS) right after the procedure to capture the immediate discomfort and pain

Secondary Outcomes (1)

• debonding forces

  Time frame was immediate, as the force required to detach the brackets was measured immediately during the debonding procedure using a force-sensitive plier prototype, which recorded the force at the exact moment of bracket detachment

Study Arms (2)

Bracket debonding plier group

NO INTERVENTION

The control group (n=40 subjects) involved brackets debonding on the right side (upper and lower quadrants from central incisor to second premolar) of each patient, utilizing a bracket remover debonding plier

Damon clear debonding plier group

EXPERIMENTAL

The study group B (n=40) encompassed debonding on the left side (upper and lower quadrants from central incisor to second premolar) of each patient, employing the Damon clear debonding plier

Other: Damon Clear Debonding Plier (the primary intervention being tested in this study).

Interventions

Damon Clear Debonding Plier (the primary intervention being tested in this study). OTHER

This clinical trial evaluates two types of orthodontic debonding pliers: the Damon Clear Debonding Plier and the traditional Bracket Remover Debonding Plier. The Damon Clear plier features a third wedging arm, which applies an additional lingual or palatal force in addition to the standard occluso-gingival force. The study is designed to assess and compare pain levels and debonding forces between the two pliers. A total of 40 patients, aged 17-25, were treated with both devices using a split-mouth design. The Damon Clear Plier is tested on one side of the mouth while the Bracket Remover Plier is used on the opposite side. Pain perception was measured immediately after the debonding procedure using the Numerical Rating Scale (NRS), and the forces applied during debonding were measured with a force-sensitive prototype. The study aims to identify the device that provides effective debonding with less pain.

Damon clear debonding plier group

Eligibility Criteria

• Age: 17 Years - 25 Years
• Gender Eligibility Details: males and females
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• individuals aged 17-25 years with the ability to comprehend and respond to questionnaires
• no recent medication intake
• the presence of all permanent teeth except third molars
• sound teeth with minimal prior dental interventions
• brackets bonded with 3M bonding agent and composite (3M, St. Paul, U.S)
• no debonded brackets at the time of assessment
• completion of orthodontic treatment using upper and lower fixed appliances with metallic brackets (Roth/MBT prescription, Dentaurum, Ispringen, Germany,)
• absence of miniscrews at the completion of treatment

You may not qualify if:

• patients who were unable to understand the questionnaires,
• those with missing teeth (excluding third molars)
• teeth with prostheses
• craniofacial deformities affecting dentoalveolar bone
• previous surgeries
• heavily restored teeth
• mobile teeth
• teeth with endodontic fillings
• cases with ceramic or plastic brackets
• patients with psychological problems or under psychological medication

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad, College of Dentistry

Baghdad, Iraq

Location

Related Links

• Patients' report of discomfort and pain during debonding of orthodontic brackets: a comparative study of two methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: This study employs a split-mouth approach, where each patient undergoes two different interventions: one side of the mouth is treated using the traditional bracket remover plier (control), while the other side is treated using the Damon clear debonding plier (intervention). This design minimizes variability by allowing direct comparison of outcomes (pain levels and debonding forces) within the same individual.

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 20, 2025
• Study Start: January 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: January 20, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)