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Effectiveness of Visceral Manual Therapy in Bruxist Patients

U

University of Seville

Status

Enrolling

Conditions

Bruxism

Treatments

Procedure: Respiratory listening
Procedure: Visceral manual treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05751694
070223TDCNR

Details and patient eligibility

About

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.

Enrollment

68 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subjects with bruxism diagnosed and referred by a dentist
  • Age: older than 18 years-old.

Exclusion criteria

  • Recent craniofacial, mandibular or cervical trauma or fracture.
  • Temporomandibular joint surgery.
  • Acute pain due to other components of the masticatory system (caries, inflammation of the dental root).
  • Abdominal surgery.
  • Gastric ulcers.
  • Gastritis.
  • Previous or current gastric neoplasm.
  • Neurological or systemic diseases.
  • Pregnant, including the period of breastfeeding.
  • Patients receiving chemotherapy or radiotherapy.
  • Cognitive, psychosomatic or psychiatric illnesses that may affect the data obtained.
  • Basic systemic disease of rheumatic origin (for example, arthritis, osteoarthritis, gout and psoriasis).
  • Cerebrovascular and brain diseases.
  • Arrhythmia and other cardiac problems.
  • Implanted electronic devices.
  • Drug or alcohol abuse, analgesic or sedative therapy, and use of medications that affect the central nervous system (for example, antidepressants, anxiolytics, and anticonvulsants).
  • Patients who have previous experience with manual treatment of the diaphragm

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups

Visceral manual treatment
Experimental group
Description:
The objective of this technique is to reduce the tension of the tissues of the epigastric area.
Treatment:
Procedure: Visceral manual treatment
Respiratory listening
Active Comparator group
Description:
It is a maneuver to evaluate the mobility of the ribs during respiration.
Treatment:
Procedure: Respiratory listening

Trial contacts and locations

1

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Central trial contact

Cayetano Navarro Rico, Phd Student; Lourdes M Fernández Seguín, PhD

Data sourced from clinicaltrials.gov

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