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NCT Number: NCT07241728

Bruxism and Diadinamic Current

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).

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Key information

Conditions

Bruxism Behavior Habits Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exercise program

Other

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.

Other names: Control Group

Diadynamic current therapy applied in conjunction with exercise

Other

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.

Other names: Experimental Group

Primary outcomes

  1. Pain Assessment

    Time frame: 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.

  2. Pain Assessment

    Time frame: 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.

  3. Pressure Pain Assessment

    Time frame: 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.

  4. Pressure Pain Assessment

    Time frame: 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.

  5. Muscle Strength Assessment

    Time frame: 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).

  6. Muscle Strength Assessment

    Time frame: 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).

  7. Bite Force

    Time frame: 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.

  8. Bite Force

    Time frame: 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.

  9. Maximum Mouth Opening

    Time frame: Baseline

    The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).

  10. Maximum Mouth Opening

    Time frame: 6 weeks

    The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).

Secondary outcomes

  1. Head Posture

    Time frame: Baseline

    The craniovertebral angle will be measured to assess the head posture. This angle will be evaluated using a goniometer that measures the angle between the seventh cervical vertebra, the tragus, and the horizontal plane.

  2. Head Posture

    Time frame: 6 weeks

    The craniovertebral angle will be measured to assess the head posture. This angle will be evaluated using a goniometer that measures the angle between the seventh cervical vertebra, the tragus, and the horizontal plane.

  3. Determining the Oral Habits

    Time frame: Baseline

    A 21-item Oral Behavior Checklist survey will be used to assess participants' oral habits. This questionnaire uses a 4-point Likert scale to ask how often parafunctional habits such as teeth clenching, teeth grinding, nail biting, lip biting, cheek biting, pen biting, and chewing gum have been performed in the last month.

  4. Determining the Oral Habits

    Time frame: 6 weeks

    A 21-item Oral Behavior Checklist survey will be used to assess participants' oral habits. This questionnaire uses a 4-point Likert scale to ask how often parafunctional habits such as teeth clenching, teeth grinding, nail biting, lip biting, cheek biting, pen biting, and chewing gum have been performed in the last month.

  5. Determining the Anxiety Level

    Time frame: Baseline

    The State-Trait Anxiety Inventory (STAI) will be used to assess participants' anxiety levels. This scale consists of 20 items. Total scores range from 20 to 80, with higher scores indicating greater anxiety.

  6. Determining the Anxiety Level

    Time frame: 6 weeks

    The State-Trait Anxiety Inventory (STAI) will be used to assess participants' anxiety levels. This scale consists of 20 items. Total scores range from 20 to 80, with higher scores indicating greater anxiety.

  7. Determining the Sleep Quality

    Time frame: Baseline

    The Pittsburgh Sleep Quality Index will be used to assess sleep quality. This scale consists of 19 self-assessment questions divided into seven subscales. The total PSQI score is calculated as the sum of these seven subscales, ranging from 0 to 21, with scores above 5 indicating poor sleep quality.

  8. Determining the Sleep Quality

    Time frame: 6 weeks

    The Pittsburgh Sleep Quality Index will be used to assess sleep quality. This scale consists of 19 self-assessment questions divided into seven subscales. The total PSQI score is calculated as the sum of these seven subscales, ranging from 0 to 21, with scores above 5 indicating poor sleep quality.

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra CANDİRİ

CONTACT

[email protected]

+905073780717

Simay ÖZDEMİR

CONTACT

[email protected]

+905453960486

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effect of Diadynamic Current Combined With Rehabilitation in Patients With Bruxism: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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