Manual Therapy in Vagus Nerve Neuromodulation for the Treatment of Bruxism
ConditionBruxism, Sleep
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorEscoles Universitaries Gimbernat
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Autonomic nervous system intervention
Other interventionManual 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.
Slight finger pressure
Other interventionThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1 (autonomic nervous system intervention)Experimental treatment 1 intervention
Group B: Group 2 (control)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Orofacial Pain
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.
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.Secondary outcomes
1
Orofacial Pain (Masseter and Temporalis)
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.
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.2
Chronic Orofacial Pain
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.
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.3
Range of Motion (subjective)
Assessment tests for TemporoMandibular Disorder (TMD) and bruxism condition "AXIS- I" is the assessment tool with a "Symptom questionnaire" that ask about mandibular lock.
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.4
Range of Motion (Objective)
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
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.Sponsors and contacts
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Escoles Universitaries Gimbernat
Lead sponsor
Universitat Internacional de Catalunya
Collaborator
Source ClinicalTrials.gov
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