Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration

Официальное название

Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Transcutaneous Electrical Nerve Stimulation (TENS)
  TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
• Устройство High-Frequency Vibration
  High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.

Первичные конечные точки

• Pain During Orthodontic Debonding Measured by VAS [Срок оценки: During and immediately after debonding procedure]

Вторичные конечные точки (4)

• Baseline Anxiety [Срок оценки: Prior to the debonding procedure]
• Patient Satisfaction [Срок оценки: immediately post-procedure]
• Device Application Time [Срок оценки: Periprocedural (during the debonding session)]
• Cost-Effectiveness Analysis [Срок оценки: Periprocedural (during the debonding session) and at immediate post-procedure assessment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Ирак · 1 центр

• College of Dentistry, University of Baghdad — Baghdad

Идентификаторы

NCT: NCT07293975 · TENS-VIB-PAIN-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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