Pain Intensity AssessmentNCT06784102
Clinical Evaluation of Pain and Debonding Forces with Damon Clear Debonding Plier Utilizing a Third Wedging Arm
A study testing Damon Clear Debonding Plier (the primary intervention being tested in this study). in people with Pain Intensity Assessment, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Intensity Assessment
- What is being tested?
- Damon Clear Debonding Plier (the primary intervention being tested in this study).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 15 Jan 2022to 15 Jul 2023
- 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 17 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- mobile teeth
- teeth with endodontic fillings
- cases with ceramic or plastic brackets
- patients with psychological problems or under psychological medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Assessment of Pain Levels and Debonding Forces Using the Damon Clear Debonding Plier: a Split-mouth Controlled Clinical Trial
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.
Read the 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
- Being tested
- Damon Clear Debonding Plier (the primary intervention being tested in this study).
- Keywords
- debonding pain, debonding forces, Damon clear debonding plier, Bracket remover plier, Force-sensitive plier prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Damon Clear Debonding Plier (the primary intervention being tested in this study). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
the amount of force required to detach an orthodontic bracket from a tooth during the debonding process. It is an important factor in determining the effectiveness and safety of the procedure. Excessive debonding force can cause damage to the enamel or surrounding tissues, while insufficient force may lead to a delay or incomplete removal of the brackets. The force is typically applied through specific tools (debonding pliers), and the direction and distribution of the force can influence both the ease of brackets removal and the potential for patient discomfort
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start15 Jan 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Intensity AssessmentStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Layth Nissan, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784102
- Sponsor's protocol ID
- 606422
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiality of research and participants information
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Pain Levels and Debonding Forces Using the Damon Clear Debonding Plier: a Split-mouth Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06784102
- Acronym / sponsor ID
- 606422
- Conditions
- Pain Intensity Assessment
- Keywords
- debonding pain, debonding forces, Damon clear debonding plier, Bracket remover plier, Force-sensitive plier prototype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Damon Clear Debonding Plier (the primary intervention being tested in this study).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 |
Who may qualify
- Ages
- 17 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Damon clear debonding plier group |
Primary outcome
pain level estimation
Time frame: 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
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
1 secondary outcome
debonding forces
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Patients' report of discomfort and pain during debonding of orthodontic brackets: a comparative study of two methodsLink provided by the sponsor.
- Individual participant dataSharing planned: No. confidentiality of research and participants information
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Damon Clear Debonding Plier (the primary intervention being tested in this study). in people with Pain Intensity Assessment, run by University of Baghdad at 1 site in Iraq.
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 8 inclusion and 10 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 20 Jan 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 Iraq. 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?
pain level estimation (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.