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

NCT07051876 | Completed

• 1 other identifier: Usj-2023-200
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Bruxism; Manual Theapy

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to the end of treatment at 6weeks

Study Arms (2)

Mouthguard Only

EXPERIMENTAL

participants in this arm receive a custom-fitted thermoplastic mouthguard (3A MEDES®) fabricated by a dentist. The mouthguard is worn nightly during sleep for 6 weeks. Participants are instructed on daily cleaning and proper storage. No additional treatments are provided in this arm.

Device: Mouthguard Only

Mouthguard and Physiotherapy

EXPERIMENTAL

Participants in this arm receive the same custom-fitted mouthguard as in the first arm, worn nightly for 6 weeks, along with a daily home-based physiotherapy protocol that includes: Postural correction exercises Mandibular awareness training Relaxation techniques (e.g., Bae method) Diaphragmatic breathing (5 minutes daily or 15 repetitions) Self-massage of masseter and temporalis muscles Stretching and jaw coordination exercises Jaw muscle strengthening with resistance Participants perform exercises once daily for 6 weeks and submit daily video recordings via a messaging platform (e.g., Teams or WhatsApp) to ensure compliance.

Device: Mouthguard and Physiotherapy

Interventions

Mouthguard and Physiotherapy DEVICE

The mouthguard and physiotherapy group will receive a custom-fitted mouthguard along with a physiotherapy program. The home-based physiotherapy exercises will include posture improvement routines, relaxation techniques, and targeted therapy for the muscles of the head, neck, and shoulders. These sessions will be performed daily at home for a duration of six weeks. Each participant will sign a consent form approved by the Ethics Committee of Saint Joseph University.

Also known as: MANUAL THERAPY, MOUTHGUARD

Mouthguard and Physiotherapy

Mouthguard Only DEVICE

The mouthguard only group will receive a custom-fitted mouthguard, which will be fabricated by a qualified dentist. The mouthguard will be worn during sleep for 6 weeks. Participants will be instructed to clean the mouthguard daily and to store it in a cool, dry place.

Mouthguard Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Saint-Joseph University: lead

Study Sites (1)

Saint Joseph university

Beirut, Beyrouth, Lebanon

Location

Related Publications (1)

• Barros Vde M, Seraidarian PI, Cortes MI, de Paula LV. The impact of orofacial pain on the quality of life of patients with temporomandibular disorder. J Orofac Pain. 2009 Winter;23(1):28-37.

  PMID: 19264033 BACKGROUND

MeSH Terms

Conditions

Bruxism

Interventions

Mouth Protectors; Physical Therapy Modalities; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Habits; Behavior

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Therapeutics; Rehabilitation; Complementary Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: July 4, 2025
• Study Start: May 21, 2023
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)