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

NCT ID: NCT07051876

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-21
• Study Completion Date: 2024-07-02

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.

Conditions

Bruxism; Manual Theapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mouthguard Only

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.

Group Type: EXPERIMENTAL

Mouthguard Only

Intervention Type: 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 and Physiotherapy

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.

Group Type: EXPERIMENTAL

Mouthguard and Physiotherapy

Intervention Type: 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.

Interventions

Mouthguard and Physiotherapy

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.

Intervention Type: DEVICE

Mouthguard Only

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.

Intervention Type: DEVICE

Other Intervention Names

MANUAL THERAPY; MOUTHGUARD

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Joseph university

Beirut, Beyrouth, Lebanon

Countries

Lebanon

References

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.

Reference Type: BACKGROUND

PMID: 19264033 (View on PubMed)

Other Identifiers

Usj-2023-200

Identifier Type: -

Identifier Source: org_study_id