Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism (TMBruxism)

July 21, 2025 updated by: Maider Sánchez Padilla, Escoles Universitaries Gimbernat

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08195
        • Universitat International de Catalunya (UIC)
        • Contact:
          • Maider Sánchez-Padilla, MSc
          • Phone Number: 0034652743302
          • Email: aqx203214@uic.es

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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.

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 (autonomic nervous system intervention)
Manual therapy applied to structures adjacent to the vagus nerve along its pathway (head, neck, thorax, diaphragm, abdomen).
Other: Autonomic nervous system intervention
Manual therapy applied to structures adjacent to the vagus nerve along its pathway. Head: CV4 tecnique and Jugular foramen tecnique; Neck: stretching and mobilization of the superficial and deep layers; Thorax: Longitudinal and transverse translations of the mediastinum; Diaphragm tecniques, Abdomen: Stretching of the gastro-phrenic ligament with lowering of the stomach and general treatment of the small intestine and the mesentery. Stretching, compression and traction movements will be carried out on these structures.
Other Names:
  • Intervention
Sham Comparator: Group 2 (control)
The hands will be placed on areas similar to those in the intervention group, with the fingertips in contact with the skin of the area. A slight finger pressure will be applied.
Other: Slight finger pressure
The hands will be placed on areas similar to those in the intervention group, with the fingertips in contact with the skin of the area. A slight finger pressure will be applied, which would not have the same effect as the proposed techniques, since those techniques require a greater intensity of manipulation of the described tissues and structures.
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orofacial Pain
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Assessment tests for TemporoMandibular Disorder (TMD) and bruxism condition "AXIS- I" is the assessment tool with a "Symptom questionnaire" that ank about pain in 4 questions.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Orofacial Pain (Masseter and Temporalis)
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
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 That measures pain intensity by applying one kilogram of pressure to three points on the temporalis, the masseter, and the temporomandibular joint.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Chronic Orofacial Pain
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Assessment tests for TMD and bruxism condition "AXIS -II" throught the "Graded chronic pain scale version 2.0". It's a self-report questionnaire, typically using a 0-10 numerical rating scale, that evaluates pain intensity and its interference with activities. The GCPS 2.0 classifies patients into different grades of chronic pain from 0 to 4. Higher scores mean a worse outcome.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Range of Motion (subjective)
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Assessment tests for TemporoMandibular Disorder (TMD) and bruxism condition "AXIS- I" is the assessment tool with a "Symptom questionnaire" that ask about mandibular lock.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Range of Motion (Objective)
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Assessment tests for TMD and bruxism condition "AXIS- I" is the assessment tool with aa DC/ TMD EXAMINATION FORM that measures mouth opening, protrusion, and lateral movements in millimeters
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Jaw Funcionality
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
"AXIS-II" is the assesment tool that include "Jaw Functional Limitation Scale-20 (JFLS-20)". It consists of 20 items that explore the patient's difficulty in performing various activities related to jaw function. Each item is scored from 0 (no limitation) to 10 (severe limitation). A higher score indicates more functional limitation of the jaw.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Oral behavior
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
"AXIS-II" is the assesment tool that include "The Oral Behavior checklist (OBC)"
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Sleep Quality
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
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. It consists of 19 items answered by the patient and, optionally, 5 additional questions for the bed partner. The 19 items are grouped into 7 components. Each component is scored from 0 (no difficulty) to 3 (severe difficulty). The global score is obtained by summing the 7 components, with a range from 0 to 21 points. A score of 5 or less indicates good sleep quality, while a score above 5 indicates poor sleep quality.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Oral health-related quality of life
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
To assess it, the HIP-14 (Oral Health Impact Profile-14) questionnaire will be administered. It consists of 14 items that explore the frequency of problems related to oral health in daily life. The items are answered on a 5-point Likert scale, ranging from "never" (0 or 1) to "very often" (4 or 5). A higher score indicates worse oral health-related quality of life.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Motor recruitment pattern of the masseter, temporalis, and suprahyoid muscles
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
In resting position and during maximum clenching, as measured by the mean power frequency (MPF) recorded in a surface electromyography.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Stress
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
To assess it, the PSS: Perceived Stress Scale will be administered. It consists of 14 items. It uses a 5-point Likert scale for each item. A higher score indicates more stress.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Anxiety
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
To assess it, the GAD-7 (General Anxiety Disorder-7) will be administered. It consists of 7 items, answered on a 4-point Likert scale. The total score ranges from 0 to 21. A score of 10 or higher is considered the cutoff point for identifying clinically significant anxiety. The higher the score, the greater the anxiety.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Heart Rate Variability (HRV)
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.

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.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
Functional impact of Headaches in daily life
Time Frame: From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.
The assessment will be carried out using HIT-6 (Headeach Impact Test-6). It consists of 6 items that assess key areas affected by headaches. The sum of the responses gives a total score between 36 and 78 points. A higher score indicates more impact and disability due to headache.
From the first assesment (1 week prior to the start of the intervention) to 1 week after the intervention, and data collection on the persistence (1 month, 3 months and 6 months after the end of the intervention). A total of 33 weeks of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escoles Universitaries Gimbernat

Collaborators

Universitat Internacional de Catalunya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2025

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

June 30, 2025

First Submitted That Met QC Criteria

July 10, 2025

First Posted (Actual)

July 20, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 21, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TMBruxism

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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