Bruxism and Diadinamic Current

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).

Study Overview

• Status: Recruiting
• Conditions: Bruxism
• Intervention / Treatment: Other: Exercise Program; Other: Diadynamic current therapy applied in conjunction with exercise

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Büşra CANDİRİ; Phone Number: +905073780717; Email: candiri_17@hotmail.com
• Study Contact Backup: Name: Simay ÖZDEMİR; Phone Number: +905453960486; Email: ozdemirsimay5@gmail.com

Study Locations

• Turkey (Türkiye)
  • Malatya, Turkey (Türkiye)
    • Recruiting
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	6 weeks

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: November 20, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Pain; Electric Stimulation Therapy; Bruxism; Temporomandibular joint; Diadynamic Current
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Habits; Pain; Bruxism; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Control Groups; Resistance Training
• Other Study ID Numbers: 2025/8327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No