跳至主要内容
临床试验/NCT07051876
NCT07051876已完成不适用

The Effects of Mouthguard and Physiotherapy on Bruxism: An EMG and Posture Angle Analysis

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Change in Masseter Muscle Activity and Cervical Posture Angle from Baseline to 6 Weeks Measured by Surface EMG and Postural Assessment Tools.

研究概览

简要总结

The purpose of this research is to determine whether a clinical trial assessing the impact of physiotherapy and mouthguards on bruxism is feasible. This includes evaluating the feasibility of participant recruitment, implementing the interventions, and collecting data using appropriate techniques. The study will focus on posture angle analysis to assess changes in posture associated with bruxism, and electromyography (EMG) to measure muscular activity. By examining these elements, the study aims to lay the groundwork for a larger clinical trial that could provide conclusive evidence regarding the efficacy of these therapies in treating bruxism.

Participants will be recruited from the USJ dental clinics following their consultation. They will be screened for bruxism using a questionnaire and a clinical examination based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD).

The mouthguard-only group will receive a custom-fitted mouthguard, fabricated by a qualified dentist. Participants will be instructed to wear the mouthguard during sleep for six weeks, to clean it daily, and to store it in a cool, dry place.

The mouthguard and physiotherapy group will receive both a custom-fitted mouthguard and physiotherapy. The home physiotherapy program will include posture improvement exercises, relaxation techniques, and muscle therapy targeting the head, neck, and shoulders. Participants will perform the exercises daily at home, record themselves, and submit the videos each day via a social platform (e.g., Microsoft Teams or WhatsApp, depending on patient preference) for a period of six weeks.

详细描述

Participant recruitment was conducted at USJ dental clinics with support from the occlusal department and private clinic following patient consultations. Screening for bruxism involved a clinical examination and the DC/TMD questionnaire. Ethical approval was granted by the Saint Joseph University of Beirut (approval number USJ-2023-200), and informed consent was obtained from all participants.

Electromyographic (EMG) assessments were carried out by the principal investigator using a portable EMG machine (KM560). Electrodes were placed bilaterally on the masseter muscles. Participants were instructed to bite in maximum intercuspation six times for five seconds each, with rest intervals in between. The device recorded muscle activity during both contraction and relaxation phases to evaluate bruxism-related muscle function.

Forward head posture was analyzed through photogrammetry. Markers were placed at the tragus of the ear and the C7 vertebra. Lateral photographs were taken, and the craniovertebral angle was measured using image analysis software to assess postural alignment.

The physiotherapy protocol consisted of a six-week home program performed daily. It included awareness of the mandibular rest position, relaxation techniques, diaphragmatic breathing, self-massage of the masseter and temporalis muscles, stretching, coordination, and resistance exercises. Participants recorded and submitted daily videos via Teams or WhatsApp to ensure compliance.

Custom mouthguards were fabricated by the researcher. Dental impressions were taken using alginate (Hydrogum 5®), and casts were made. Mouthguards were then vacuum-formed using thermoplastic material (3A MEDES®), followed by trimming and polishing to ensure a comfortable fit.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Confirmed diagnosis of bruxism by a qualified member of the occlusion unit department
  • No history of temporomandibular disorders or other craniofacial pain conditions
  • No history of neurological or psychiatric disorders
  • No current use of medications that affect muscle tone or sleep

排除标准

  • - The presence of any systemic or neuromuscular disorder affecting the jaw muscles or posture.
  • Use of medications, substances, or drugs that may affect jaw muscle activity, such as muscle relaxants or stimulants.
  • Lifestyle: sleep disorder, anxiety
  • Presence of any oral pathology or dental prostheses that may interfere with the use of a mouthguard.
  • Inability to tolerate the EMG electrodes or posture angle analysis.
  • Patient who has recently undergone physiotherapy

结局指标

主要结局

Change in Masseter Muscle Activity and Cervical Posture Angle from Baseline to 6 Weeks Measured by Surface EMG and Postural Assessment Tools.

时间窗: From enrollment to the end of treatment at 6weeks

Surface electromyography (sEMG) will be used to measure muscle activity of the masseter and temporalis during rest and clenching. A posture assessment tool will evaluate changes in head and cervical posture using digital angle measurements. Measurements will be taken at baseline and after 6 weeks of intervention.

次要结局

未报告次要终点

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验