Feasibility of a Clinical Trial on Physiotherapy and Mouthguards for Bruxism Using Posture and EMG Analysis

Not Applicable

Completed

• Conditions: Bruxism; Manual Theapy

• Registration Number: NCT07051876
• Lead Sponsor: Saint-Joseph University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-05-21
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Study First Submitted: 2025-04-16
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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

Exclusion Criteria

• • 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Saint Joseph university; 🇱🇧 Beirut, Lebanon