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

NCT ID: NCT06784102

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-07-15

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.

Detailed Description

This clinical assessment of pain levels and debonding forces using the Damon clear debonding plier was designed as a split-mouth controlled trial to evaluate the efficacy and comfort of two orthodontic debonding methods. Pain is a significant concern during orthodontic treatment, often influencing patient compliance and overall satisfaction. While research has focused extensively on pain during active treatment, less attention has been directed toward discomfort associated with the removal of orthodontic brackets. Debonding, an integral step in concluding orthodontic treatment, should ideally be painless and harmless to the enamel. However, the discomfort experienced by patients during this process remains a largely underexplored domain. This study sought to fill this gap by comparing pain levels and debonding forces between two types of pliers: the traditional bracket remover plier and the Damon clear debonding plier, the latter featuring a third wedging arm.

The study included 40 orthodontic patients aged 17 to 25 years who had completed comprehensive treatment with metallic brackets. A split-mouth design was utilized, where the right side of each patient's mouth, including the upper and lower quadrants from the central incisor to the second premolar, was treated using the traditional bracket remover plier, categorized as Group A. The left side of the mouth, comprising the same set of teeth, was treated with the Damon clear debonding plier, categorized as Group B. Each plier was modified with a strain gauge load cell and connected to a digital weighting indicator scale, creating a force-sensitive prototype capable of precisely measuring the forces applied during debonding.

Participants were screened for eligibility based on strict inclusion and exclusion criteria to ensure standardization. Inclusion criteria required patients to have a full set of permanent teeth (excluding third molars), no significant dental restorations, no psychological conditions, and an ability to comprehend and respond to anxiety and pain assessment questionnaires. Patients with missing teeth, craniofacial abnormalities, mobile teeth, or a history of recent medications that could influence pain perception were excluded. Prior to the procedure, participants' anxiety levels were assessed using two validated tools: the Generalized Anxiety Disorder Assessment (GAD-7) and the Modified Dental Anxiety Scale (MDAS). Those with high anxiety scores were omitted to avoid potential bias.

Pain perception was measured immediately after the debonding procedure using the Numerical Rating Scale (NRS), chosen for its reliability and preference among patients. The force applied during bracket removal was recorded for each tooth. The debonding process targeted the first five teeth in each quadrant, ensuring uniformity in the procedure. A blinded statistician analyzed the collected data using the T-test, with statistical significance set at p<0.05.

Conditions

Pain Intensity Assessment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Bracket debonding plier group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Damon clear debonding plier group

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Baghdad

OTHER

Sponsor Role: lead

Responsible Party

Layth Nissan

Assistant Proffessor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Baghdad, College of Dentistry

Baghdad, , Iraq

Countries

Iraq

Related Links

https://pubmed.ncbi.nlm.nih.gov/21490985/

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

Other Identifiers

606422

Identifier Type: -

Identifier Source: org_study_id