Ireland
--:--IST
Recruiting Not applicable

Bruxism and Diadinamic Current

NCT07241728 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-09-22
Last updated
2025-11-21

Condition(s) studied

Bruxism

Investigational drug(s) / intervention(s)

Exercise ProgramDiadynamic current therapy applied in conjunction with exercise

Exercise Program: Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks. The traditional program will include soft tissue relaxation exercises applied to the masseter and temporalis muscles following breathing exercises, controlled jaw opening and closing, jaw lateralization exercises, motor control targeting the temporomandibular joint and masticatory muscles, isometric strengthening, and stretching techniques. Additionally, exercises for the gradual stabilization of the cervical region and posture exercises will be added. The exercises will be performed three times a week under the supervision of a physical therapist.

Diadynamic current therapy applied in conjunction with exercise: In addition to the exercise program, the experimental group will complete a total of 12 minutes of treatment per session using three different modes of diadynamic current therapy in sequence. Among the current parameters used, the diphase fixe and long-period modes will be applied at the sensory threshold level for four minutes each, while the courtes-period mode will be applied for four minutes at the motor threshold level, at an intensity that will cause short muscle contractions. The application will be performed on the anterior temporalis and masseter muscles, which are located in areas adjacent to the temporomandibular joint and contain painful or myofascial trigger points identified by palpation. Round adhesive electrodes will be used for the surface electrode application.

Study summary

This study was designed to investigate the effectiveness of diadynamic current, one of the electrotherapy methods added to rehabilitation in the treatment of bruxism. Individuals over the age of 18 diagnosed with bruxism will be randomly assigned to one of the following groups using the sealed envelope method: rehabilitation program (control group) or rehabilitation program combined with diadynamic current (experimental group). The intervention will consist of an exercise program conducted jointly for the experimental and control groups. Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks. In addition to the exercise program, the experimental group will receive diadynamic current treatment at each session. Pain intensity will be assessed using the Visual Analog Scale (VAS), pressure pain threshold with an algometer, muscle strength with a hand-held dynamometer, bite force with a pinch meter, maximal mouth opening with a caliper, and head posture with the craniovertebral angle. Oral habits will be evaluated using the Oral Behavior Checklist, and anxiety levels will be assessed with the State-Trait Anxiety Inventory (STAI).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: The study will include patients of both genders who have been clinically diagnosed with bruxism over the age of 18 and who report pain around the jaw (3 or higher on the VAS), and who have provided informed consent. Exclusion Criteria: Patients who have previously used physical therapy or complementary-alternative medicine methods for similar complaints, those with neurological or psychiatric disorders, those with systemic diseases, those with pacemakers or implantable defibrillators; those with a history of cancer, those with an acute infection in the relevant area, those with a history of trauma to the jaw area, those using muscle relaxants, analgesics, or non-steroidal anti-inflammatory drugs, those who have participated in another study within the last 6 months, and individuals who do not agree to participate in the study will be excluded.

Primary outcome measure(s)

  • Pain Assessment — Baseline
    To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.
  • Pain Assessment — 6 weeks
    To determine patients' pain levels, pain intensity at rest and during activity was measured using a Visual Analog Scale (VAS). A 10-centimeter (cm) horizontal line was used on this scale, grading from "0: no pain" to "10: unbearable pain." Patients were asked to rate their current pain within this range.
  • Pressure Pain Assessment — Baseline
    The pressure pain threshold around the temporomandibular joint in the masseter and temporalis muscles will be assessed bilaterally using an algometer. The patient will be asked to indicate when the applied pressure first causes pain. The average of the 3 measurements will be recorded on the assessment form in kg/cm².
  • Pressure Pain Assessment — 6 weeks
    The pressure pain threshold around the temporomandibular joint in the masseter and temporalis muscles will be assessed bilaterally using an algometer. The patient will be asked to indicate when the applied pressure first causes pain. The average of the 3 measurements will be recorded on the assessment form in kg/cm².
  • Muscle Strength Assessment — Baseline
    Muscle strength during jaw opening, closing, lateral movements to the right and left, and protrusion will be measured using a hand-held dynamometer. While performing these movements, counterforce will be applied in the opposite direction. Muscle strength will be recorded in Newtons (N).
  • Muscle Strength Assessment — 6 weeks
    Muscle strength during jaw opening, closing, lateral movements to the right and left, and protrusion will be measured using a hand-held dynamometer. While performing these movements, counterforce will be applied in the opposite direction. Muscle strength will be recorded in Newtons (N).
  • Bite Force — Baseline
    Individuals' bite forces will be assessed using a pinchmeter. Three bite repetitions will be performed to determine the central bite force between the incisors and the lateral bite force between the right and left lateral posterior arches, and the average will be recorded in kilograms.
  • Bite Force — 6 weeks
    Individuals' bite forces will be assessed using a pinchmeter. Three bite repetitions will be performed to determine the central bite force between the incisors and the lateral bite force between the right and left lateral posterior arches, and the average will be recorded in kilograms.
  • Maximum Mouth Opening — Baseline
    The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
  • Maximum Mouth Opening — 6 weeks
    The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).

Trial sites (1)

FacilityCityRegionStatus
Inonu University Malatya Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07241728 on ClinicalTrials.gov ↗ ← All trials in Turkey