Clinical trial NCT06784102: Clinical Evaluation of Pain and Debonding Forces with Damon Clear Debonding Plier Utilizing a Third Wedging Arm
Official title: Clinical Assessment of Pain Levels and Debonding Forces Using the Damon Clear Debonding Plier: a Split-mouth Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Intensity Assessment
Keywords: debonding pain
debonding forces
Damon clear debonding plier
Bracket remover plier
Force-sensitive plier prototype
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 17
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: pain level estimation
timeFrame: 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:
measure: debonding forces
timeFrame: 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
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: University of Baghdad, College of Dentistry
Study officials:
References: