Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain During Orthodontic Debonding Measured by VAS
研究概览
简要总结
This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention.
People who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure.
Before the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10.
The purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.
详细描述
This clinical study aims to evaluate and compare the effectiveness and cost-effectiveness of TENS (Dental Pain Eraser) and high-frequency vibration (SureSmile® VPro™) in reducing discomfort during orthodontic bracket removal, improving patient satisfaction, and optimizing efficiency. The study includes a control group, and results are intended to provide evidence-based guidance for orthodontists to enhance the patient experience during debonding procedures.
Participants will be individuals who have completed fixed orthodontic treatment and are scheduled for bracket removal. Before the procedure, their baseline dental anxiety will be assessed. The assigned intervention will be applied either immediately before (TENS) or during (vibration) the bracket removal session. Participants' experiences of pain and satisfaction will be monitored throughout the procedure. Sex and baseline anxiety will be considered in the analysis to evaluate their influence on outcomes. A cost-effectiveness analysis will be performed to determine the most efficient method among the interventions.
The research will be conducted in a standardized clinical setting, adhering to established bracket removal protocols to ensure participant safety and minimize variability. The procedures will be performed by the same operator following consistent techniques.
This study is designed to generate practical insights into pain management during orthodontic debonding, focusing on participant comfort, satisfaction, and procedural efficiency, without compromising the quality of care. The findings may guide future clinical recommendations and improve patient-centered orthodontic practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for fixed orthodontic appliance removal.
- •Permanent dentition present, including both anterior and posterior teeth.
- •Age between 15-35 years.
- •Ability to provide informed consent and comply with study procedures.
- •General health adequate for routine orthodontic care.
- •No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs.
排除标准
- •Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.
- •Teeth with extensive restorations or prostheses that prevent standard bracket debonding.
- •Patients with known allergy or contraindication to TENS or vibration devices.
- •Pregnant women.
- •Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.
- •Excessive gingival overgrowth that may impede debonding or influence study outcomes.
研究组 & 干预措施
Transcutaneous Electrical Nerve Stimulation (TENS)
Participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) applied immediately before orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
High-Frequency Vibration (SureSmile® VPro™)
Participants in this arm will receive high-frequency vibration applied during orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session.
干预措施: High-Frequency Vibration (Device)
No Intervention
Participants in this arm will undergo standard orthodontic bracket removal without any additional device. Pain, satisfaction, and procedural efficiency will be assessed during a single session.
结局指标
主要结局
Pain During Orthodontic Debonding Measured by VAS
时间窗: During and immediately after debonding procedure
Pain during debonding will be measured immediately after the procedure using VAS 0-100 mm, where 0 = no pain and 100 = worst imaginable pain.
次要结局
- Baseline Anxiety(Prior to the debonding procedure)
- Patient Satisfaction(immediately post-procedure)
- Device Application Time(Periprocedural (during the debonding session))
- Cost-Effectiveness Analysis(Periprocedural (during the debonding session) and at immediate post-procedure assessment.)
研究者
Malak Ramzi Abdulmoula Alsaqqaf
Student Researcher
University of Baghdad