Bruxism and Diadinamic Current
The Effect of Diadynamic Current Combined With Rehabilitation in Patients With Bruxism: A Randomized Controlled Trial
1 other identifier
interventional
24
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 22, 2025
CompletedFirst Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
November 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
November 21, 2025
November 1, 2025
1.2 years
September 29, 2025
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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.
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.
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.
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.
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).
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).
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.
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.
6 weeks
Maximum Mouth Opening
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
Baseline
Maximum Mouth Opening
The maximum mouth opening will be measured with a caliper and recorded in centimeters (cm).
6 weeks
Secondary Outcomes (8)
Head Posture
Baseline
Head Posture
6 weeks
Determining the Oral Habits
Baseline
Determining the Oral Habits
6 weeks
Determining the Anxiety Level
Baseline
- +3 more secondary outcomes
Study Arms (2)
Rehabilitation Program
ACTIVE COMPARATORParticipants will be given a structured exercise program to be performed in person 3 days a week for 6 weeks.
Rehabilitation Program with Diadynamic Current
EXPERIMENTALIn addition to the rehabilitation program, participants will receive diadynamic current therapy during each session.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inonu Universitylead
Study Sites (1)
Inonu University
Malatya, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 29, 2025
First Posted
November 21, 2025
Study Start
September 22, 2025
Primary Completion (Estimated)
December 20, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share