BruxismNCT07241728
Bruxism and Diadinamic Current
A study testing Exercise Program and Diadynamic current therapy applied in conjunction with exercise in people with Bruxism, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bruxism
- What is being tested?
- Exercise Program and Diadynamic current therapy applied in conjunction with exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Inonu University
Malatya
About this study
Official title: The Effect of Diadynamic Current Combined With Rehabilitation in Patients With Bruxism: A Randomized Controlled Trial
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).
- Conditions
- Bruxism
- Being tested
- Exercise Program, Diadynamic current therapy applied in conjunction with exercise
- Keywords
- Bruxism, Temporomandibular joint, Pain, Exercise, Electric Stimulation Therapy, Diadynamic Current
- Medical subject headings
- Bruxism, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramOther
Also called Control Group
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 exerciseOther
Also called Experimental Group
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 group | Role | What they receive |
|---|---|---|
| Rehabilitation Program | Active comparator | Participants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks. Receives: Other: Exercise Program |
| Rehabilitation Program with Diadynamic Current | Experimental | In addition to the rehabilitation program, participants will receive diadynamic current therapy during each session. Receives: Other: Diadynamic current therapy applied in conjunction with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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).
Measured: Baseline
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).
Measured: 6 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
Maximum Mouth Opening
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
Measured: Baseline
Maximum Mouth Opening
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
Measured: 6 weeks
Secondary outcomes (8)
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
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.
Measured: Baseline
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start22 Sep 2025
- Primary completion20 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BÜŞRA CANDİRİ, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241728
- Sponsor's protocol ID
- 2025/8327
- Status last verified
- Nov 2025
- First submitted
- 29 Sep 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diadynamic Current Combined With Rehabilitation in Patients With Bruxism: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07241728
- Acronym / sponsor ID
- 2025/8327
- Conditions
- Bruxism
- Keywords
- Bruxism, Temporomandibular joint, Pain, Exercise, Electric Stimulation Therapy, Diadynamic Current
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 20 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Program | Active comparator | Other: Exercise ProgramParticipants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks. |
| Rehabilitation Program with Diadynamic Current | Experimental | Other: Diadynamic current therapy applied in conjunction with exerciseIn addition to the rehabilitation program, participants will receive diadynamic current therapy during each session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramAlso: Control GroupParticipants 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 | Rehabilitation Program |
| Diadynamic current therapy applied in conjunction with exerciseAlso: Experimental GroupIn 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 | Rehabilitation Program with Diadynamic Current |
Primary outcome
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.
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.
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.
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.
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).
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).
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.
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.
Maximum Mouth Opening
Time frame: Baseline
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
Maximum Mouth Opening
Time frame: 6 weeks
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
8 secondary outcomes
Head Posture
Time frame: Baseline
Head Posture
Time frame: 6 weeks
Determining the Oral Habits
Time frame: Baseline
Determining the Oral Habits
Time frame: 6 weeks
Determining the Anxiety Level
Time frame: Baseline
Determining the Anxiety Level
Time frame: 6 weeks
Determining the Sleep Quality
Time frame: Baseline
Determining the Sleep Quality
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program and Diadynamic current therapy applied in conjunction with exercise in people with Bruxism, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Büşra CANDİRİ (+905073780717, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.