An interventional study of Visceral manual treatment and Respiratory listening in Bruxism, sponsored by University of Seville. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
Objective: check the effectiveness of visceral manual therapy on bruxist patients Design: Experimental, analytical, longitudinal, prospective, randomized, single-blind study with a blinded evaluator.
Subjects: 68 subjects over 18 years old, with bruxism (diagnoses by a dentist). Methods: Subjects will be randomized into 2 groups: an experimental group (EG) to which a visceral manual technique will be applied and a control group (CG) to which a placebo manual technique will be administered. Both groups will receive 2 interventions one week apart. The measurements will be made before and after the interventions, and a last measurement will be made one month after the last intervention. Therefore, the patient will visit the center 3 times.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's planned enrollment of 68 is above the median of 39 across 94 interventional studies indexed under Bruxism.
Browse Bruxism studies →University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
The objective of this technique is to reduce the tension of the tissues of the epigastric area.
Procedure: Visceral manual treatment
It is a maneuver to evaluate the mobility of the ribs during respiration.
Procedure: Respiratory listening
The patient will be placed in a reclining sitting position and triple flexion of the lower limbs to keep the abdominal region relaxed. The therapist will be placed to the right of the patient at the height of the abdomen, with the hands placed in the epigastric area. He will make a skin fold that reduces tension in the area, so that the contact is focused on the visceral tissue of the area. The patient will be asked to take deep breaths, and during the exhalation, the therapist will perform a zigzag movement with vibration of the hands while pulling the tissue caudally. This procedure will be performed for 5 minutes.
The patient and the therapist will be placed in the same position as in the experimental group. The therapist will place his hands in contact with the lower rib cage, and the patient will be asked to take a deep breath. The therapist will not exert any pressure, nor place restrictions on the tissues or movements of the ribcage.
Pressure pain threshold (PPT) Baseline-1
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention
PPT Change-1
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "PTT Baseline-1" immediately post-intervention
PPT Baseline-2
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention at 7 days
PPT Change-2
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "PTT Baseline-2" immediately post-intervention
PPT Change-3
The pressure pain threshold of the fourth cervical vertebra and masseter and temporal muscles will be evaluated using the Wagner Force TenTM Digital Force Gage model FPX 100 algometer. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "PTT Baseline-2" and "PTT Change-2" at 1 month
Heart Rate Variability (HRV) Baseline-1
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Time frame: Baseline pre-intervention
HRV Change-1
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Time frame: Change from "HRV baseline-1" inmediately post-intervention
HRV Baseline-2
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Time frame: Baseline pre-intervention at 7 days
HRV Change-2
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Time frame: Change from "HRV baseline-2" inmediately post-intervention
HRV Change-3
Heart rate variability (HRV) was measured using a Polar H10 strap and the EliteHRV mobile app to collect the data. These data were exported to Kubios software to obtain HRV results. A 5-minute measurement was performed with the patient in the supine position.
Time frame: Change from "HRV baseline-2" and "HRV change-2" at 1 month
Myotonometry baseline-1
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention
Myotonometry change-1
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "myotonometry baseline-1" inmediately post-intervention
Myotonometry baseline-2
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention at 7 days
Myotonometry change-2
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "myotonometry baseline-2" inmediately post-intervention
Myotonometry change-3
The muscle tone of the masseter muscle was assessed using a myotonometer (Myoton muscle diagnostics). 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "myotonometry baseline-2" and "myotonometry change-2" at 1 month
Cervical Range of Motion (CROM) Baseline-1
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention
Cervical Range of Motion (CROM) Change-1
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "CROM Baseline-1" immediately post-intervention
Cervical Range of Motion (CROM) Baseline-2
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention at 7 days
Cervical Range of Motion (CROM) Change-2
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "CROM Baseline-2" immediately post-intervention
Cervical Range of Motion (CROM) Change-3
The evaluator will place the CROM-device® goniometer on the patient's head. It will ask you for movements of flexion, extension, right and left side flexion, and right and left rotation of the cervical spine. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "CROM Baseline-2" and "CROM Change-2" at 1 month
Perceived Stress Scale (PSS-14) Baseline
Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
Time frame: Baseline
PSS-14 Change
Perceived Stress Scale evaluates the level of perceived stress during the last month and consists of 14 items. The maximum score is 56 points. A higher score corresponds to a higher level of perceived stress.
Time frame: Change from Baseline PSS-14 at 1 month
Mandibular Mobility Baseline-1
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention
Mandibular Mobility Change-1
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "Mandibular Mobility Baseline-1" immediately post-intervention
Mandibular Mobility Baseline-2
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Baseline pre-intervention at 7 days
Mandibular Mobility Change-2
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "Mandibular Mobility Baseline-2" immediately post-intervention
Mandibular Mobility Change-3
For the measurement of vertical opening and lateral deviation of the mandible, the TheraBite® range of motion™ will be used. 3 measurements will be made with a period of 30 seconds between measurements and we will obtain the average of the 3.
Time frame: Change from "Mandibular Mobility Baseline-2" and "Mandibular Mobility Change-2" at 1 month
Pittsburgh Sleep Quality Index (PSQI) Baseline
It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.
Time frame: Baseline
PSQI Change
It is a tool used to assess the quality of sleep in the last month.It consists of 7 items that are rated on a scale of 0 to 3. An overall Pittsburgh Sleep Quality Index score greater than 5 produced diagnostic sensitivity and specificity in distinguishing good and poor sleepers.
Time frame: Change from Baseline PSQI at 1 month
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