Surface Electromyography in the Detection and Assessment of Bruxism

N/ANot Yet RecruitingNCT07070947

Escoles Universitaries Gimbernat54 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bruxism, Sleep

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: For patients with bruxism: 1. 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: 1. Abnormal tooth wear consistent with reports of clenching/grinding the teeth during sleep 2. 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 2. 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 3. A minimum pain intensity score of 3 on the Visual Analogue Scale at the masseter and temporal algometry points. 4. EMGs with elevated mean power frequency for the masseter and temporalis muscles (to be defined in the first clinical phase-observational study). 5. Age between 18 and 40 years. For patiens without bruxism: a)Asymptomatic and without signs of bruxism or other craniofacial pathologies. Exclusion Criteria: 1. Having suffered direct trauma, mandibular fractures, or surgeries in the orofacial region. 2. Loss of more than 2 teeth, except for the third molar. 3. Use of muscle relaxant medication or medications that may influence motor behavior. 4. Having received botulinum toxin treatment in the last 6 months. 5. Periodontal disorders or current orthodontic treatment or prosthesis. 6. Partial or total dentures. 7. History of medical disorders (severe psychiatric, physiological, or neurological conditions).

Outcomes

Primary Outcomes

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

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

Time frame: 1 day, baseline

Secondary Outcomes

Orofacial Pain (1)

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

Time frame: 1 day, baseline

Orofacial Pain (2)

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.

Time frame: 1 day, baseline

Orofacial Pain (3)

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

Time frame: 1 day, baseline

Range of Motion (1)

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

Time frame: 1 day, baseline

Range of Motion (2)

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

Time frame: 1 day, baseline

Jaw Funcionality

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

Time frame: 1 day, baseline

Oral behavior

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

Time frame: 1 day, baseline

Headaches

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

Time frame: 1 day, baseline

Sleep Quality

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.

Time frame: 1 day, baseline

Oral health-related quality of life

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

Time frame: 1 day, baseline

Stress

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

Time frame: 1 day, baseline

Anxiety

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

Time frame: 1 day, baseline

Heart Rate Variability (HRV)

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.

Time frame: 1 day, baseline

Surface Electromyography in the Detection and Assessment of Bruxism

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts