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临床试验/NCT06784102
NCT06784102已完成不适用

Clinical Assessment of Pain Levels and Debonding Forces Using the Damon Clear Debonding Plier: a Split-mouth Controlled Clinical Trial

University of Baghdad1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
pain level estimation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
17 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

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

结局指标

主要结局

pain level estimation

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Layth Nissan

Assistant Proffessor

University of Baghdad

研究点 (1)

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