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NCT Number: NCT07070947

Surface Electromyography in the Detection and Assessment of Bruxism

Introduction:

Sleep bruxism is defined as the repetitive activity of the masticatory muscles, characterized by clenching or grinding of the teeth. Studies confirm the association between sleep bruxism and episodes of masticatory muscle activity, with an increase in autonomic sympathetic activity observed during transient periods of sleep. This is associated with nocturnal awakenings, related to increased cardiac, cerebral (cortical arousal), respiratory, and muscular activity.

Objectives: The main objectives are "To study the mean power frequency (MPF) of the masticatory muscles measured by surface electromyography (sEMG) in the general population (with and without bruxism according to ICSD-3 and DC/TMD criteria)"; and "to assess the effectiveness of manual therapy applied to structures adjacent to the vagus nerve based on its impact on orofacial pain and symptomatology in patients with bruxism".

Material and Methods:

A cross-sectional observational study and a randomized controlled experimental study were designed. The first will analyze data collected by sEMG in the masticatory muscles, at rest and during maximum clenching, comparing results between bruxists and non-bruxists. The second will analyze, compared to the control group, data collected on signs (range of motion alteration, presence of sounds), symptomatology (pain, headaches, sensation of blockage, functional limitation) caused by bruxism, sleep quality (Pittsburgh Sleep Quality Index (PSQI)), oral health-related quality of life (OHIP-14), stress and anxiety status (Perceived Stress Scale and GAD-7 (Generalized Anxiety Disorder-7), respectively), and sympathetic-vagal balance (Heart Rate Variability in its frequency and time domains) before and after a manual therapy intervention on structures adjacent to the vagus nerve pathway (head, neck, thorax, diaphragm, abdomen). The collected data will be analyzed using IBM SPSS® version 25.0.0.

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Key information

Conditions

Bruxism, Sleep Bruxism Mental Disorders Nervous System Diseases Parasomnias Sleep Bruxism Sleep Wake Disorders Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitat International de Catalunya (UIC)

Sant Cugat del Vallès, Barcelona, 08195, Spain

Location contact

Maider Sánchez-Padilla, MSc

CONTACT

[email protected]

0034 93 589 37 27

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

For patients with bruxism:

  • Sleep bruxism diagnosed according to the ICSD-III (International Classification of Sleep Disorders, 3rd edition):
  • Regular or frequent tooth grinding sounds occurring during sleep and the presence of one or more of the following clinical signs and symptoms:
  • Abnormal tooth wear consistent with reports of clenching/grinding the teeth during sleep
  • Transient morning pain or fatigue in the jaw muscles; and/or temporal headaches; and/or jaw locking upon awakening, consistent with reports of clenching/grinding the teeth during sleep
  • Sleep bruxism diagnosed according to the RDC/TMD:
  • Interview: During the interview, subjects are asked about the following symptoms: reports of regular or frequent tooth grinding during sleep, muscle fatigue, temporal headache, transient morning muscle pain in the jaw, and jaw locking upon awakening.
  • Physical examination: Presence or signs suggesting abnormal dental wear, such as teeth with flattened cusps and/or loss of contour with dentin exposure.
  • Hypertrophy of the masticatory muscles
  • Dental impressions on the tongue
  • Linea alba on the cheeks along the bite line
  • Damage to dental tissue
  • Excessive dental wear
  • A minimum pain intensity score of 3 on the Visual Analogue Scale at the masseter and temporal algometry points.
  • EMGs with elevated mean power frequency for the masseter and temporalis muscles (to be defined in the first clinical phase-observational study).
  • Age between 18 and 40 years.

For patiens without bruxism:

a)Asymptomatic and without signs of bruxism or other craniofacial pathologies.

Exclusion criteria

  • Having suffered direct trauma, mandibular fractures, or surgeries in the orofacial region.
  • Loss of more than 2 teeth, except for the third molar.
  • Use of muscle relaxant medication or medications that may influence motor behavior.
  • Having received botulinum toxin treatment in the last 6 months.
  • Periodontal disorders or current orthodontic treatment or prosthesis.
  • Partial or total dentures.
  • History of medical disorders (severe psychiatric, physiological, or neurological conditions).

Treatment and study plan

sEMG

Diagnostic Test

The spectral characteristics in the amplitude domain will be recorded through the root mean square (RMS, unit: μV) or the mean power frequency (MPF, unit: Hz) of the musculature to be evaluated by means of EMGs, with the electrodes placed parallel to the muscle fibers of the temporal, masseter, and suprahyoid muscles. Standardized EMGs will be recorded and compared in resting position and during maximum voluntary clenching

Primary outcomes

  1. Motor recruitment pattern of the masseter, temporalis, and suprahyoid muscles

    Time frame: 1 day, baseline

    In resting position and during maximum clenching, as measured by the mean power frequency (MPF) recorded in a surface electromyography.

Secondary outcomes

  1. Orofacial Pain (1)

    Time frame: 1 day, baseline

    Assessment tests for TMD and bruxism condition "AXIS- I" is the assessment tool with a "Symptom questionnaire"

  2. Orofacial Pain (2)

    Time frame: 1 day, baseline

    Assessment tests for TMD and bruxism condition "AXIS- I" is the assessment tool with a Pressure Pain Threshold of masseter and temporalis muscles with a DC/ TMD EXAMINATION FORM.

  3. Orofacial Pain (3)

    Time frame: 1 day, baseline

    Assessment tests for TMD and bruxism condition "AXIS -II" throught the "Graded chronic pain scale version 2.0"

  4. Range of Motion (1)

    Time frame: 1 day, baseline

    Assessment tests for TMD and bruxism condition "AXIS- I" is the assessment tool with a "Symptom questionnaire".

  5. Range of Motion (2)

    Time frame: 1 day, baseline

    Assessment tests for TMD and bruxism condition "AXIS- I" is the assessment tool with a range of motion with a DC/ TMD EXAMINATION FORM.

  6. Jaw Funcionality

    Time frame: 1 day, baseline

    AXIS-II" is the assesment tool that include "Jaw Functional Limitation Scale-20

  7. Oral behavior

    Time frame: 1 day, baseline

    AXIS-II" is the assesment tool that include "The Oral Behavior checklist

  8. Headaches

    Time frame: 1 day, baseline

    The assessment will be carried out using HIT-6 (Headeach Impact Test-6)

  9. Sleep Quality

    Time frame: 1 day, baseline

    Sleep quality is considered one of the most important measures related to bruxism. To assess it, the Pittsburgh Sleep Quality Index (PSQI) questionnaire will be administered.

  10. Oral health-related quality of life

    Time frame: 1 day, baseline

    To assess it, the HIP-14 (Oral Health Impact Profile-14) questionnaire will be administered.

  11. Stress

    Time frame: 1 day, baseline

    To assess it, the PPS: Perceived Stress Scale will be administered.

  12. Anxiety

    Time frame: 1 day, baseline

    To assess it, the GAD-7 (General Anxiety Disorder-7) will be administered.

  13. Heart Rate Variability (HRV)

    Time frame: 1 day, baseline

    Spectral analysis of the time variation between consecutive heartbeats, referred to as the RR interval, which records the activity of the autonomic nervous system. This is collected using the chest strap "Polar H10 Band," which connects to the mobile app "Elite HRV" or "Kubios Software." It collects the frequency measures: LF (low frequency), HF (high frequency), and the ratio between them (LF/HF) as an indicator of sympathetic-vagal balance. It collects the time-domain measures: Mean RR interval; SDNN: standard deviation of all RR intervals; pNN50; RMSSD.

Study contacts

Contact information is provided by the study sponsor or research team.

Maider Sánchez-Padilla, MSc

CONTACT

[email protected]

0034 93 589 37 27

Sponsors and collaborators

Lead sponsor

Escoles Universitaries Gimbernat

Other

Collaborators

  • Universitat Internacional de Catalunya

Registry information

Official study title

Efficacy of Manual Therapy in Indirect Non-Invasive Neuromodulation of the Vagus Nerve in the Treatment of Bruxism in Young Adult Population up to 40 Years Old

Acronym: EMGBruxism

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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