ClinicalTrials.gg
RecruitingNCT07241728Updated Nov 21, 2025

Bruxism and Diadinamic Current

An interventional study of Exercise Program and Diadynamic current therapy applied in conjunction with exercise in Bruxism, sponsored by Inonu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Sponsored by Inonu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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).

02

Conditions studied

  • Bruxism

Keywords

  • Bruxism
  • Temporomandibular joint
  • Pain
  • Exercise
  • Electric Stimulation Therapy
  • Diadynamic Current
03

In context

Bruxism

151 studies on the registry are indexed under Bruxism; 39 are open to participants now.

This study's planned enrollment of 24 is below the median of 39 across 94 interventional studies indexed under Bruxism.

Browse Bruxism studies →

Lead sponsor

Inonu University is the lead sponsor of 394 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 .

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Rehabilitation Program

    Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks.

    Other: Exercise Program

  • Experimental
    Rehabilitation Program with Diadynamic Current

    In addition to the rehabilitation program, participants will receive diadynamic current therapy during each session.

    Other: Diadynamic current therapy applied in conjunction with exercise

Interventions

  • OtherExercise 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.

    Also known as: Control Group

  • OtherDiadynamic 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.

    Also known as: Experimental Group

06

What researchers measure

Primary outcomes

  1. Pain Assessment

    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.

    Time frame: Baseline

  2. Pain Assessment

    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.

    Time frame: 6 weeks

  3. Pressure Pain Assessment

    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.

    Time frame: Baseline

  4. Pressure Pain Assessment

    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.

    Time frame: 6 weeks

  5. Muscle Strength Assessment

    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).

    Time frame: Baseline

  6. Muscle Strength Assessment

    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).

    Time frame: 6 weeks

  7. Bite Force

    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.

    Time frame: Baseline

  8. Bite Force

    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.

    Time frame: 6 weeks

  9. Maximum Mouth Opening

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

    Time frame: Baseline

  10. Maximum Mouth Opening

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

    Time frame: 6 weeks

Secondary outcomes

  1. Head Posture

    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.

    Time frame: Baseline

  2. Head Posture

    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.

    Time frame: 6 weeks

  3. Determining the Oral Habits

    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.

    Time frame: Baseline

  4. Determining the Oral Habits

    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.

    Time frame: 6 weeks

  5. Determining the Anxiety Level

    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.

    Time frame: Baseline

  6. Determining the Anxiety Level

    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.

    Time frame: 6 weeks

  7. Determining the Sleep Quality

    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.

    Time frame: Baseline

  8. Determining the Sleep Quality

    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.

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07241728
Lead sponsor
Inonu University
Responsible party
BÜŞRA CANDİRİ (assistant professor, Inonu University) — Principal investigator
First posted
Nov 21, 2025
Start date
Sep 22, 2025
Primary completion
Dec 20, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 21, 2025

Study contacts

Büşra CANDİRİ
Contact
candiri_17@hotmail.com
+905073780717
Simay ÖZDEMİR
Contact
ozdemirsimay5@gmail.com
+905453960486

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion