NCT07241728

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress49%
Sep 2025Dec 2026

Study Start

First participant enrolled

September 22, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 21, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2026

Expected
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

September 29, 2025

Last Update Submit

November 20, 2025

Conditions

Keywords

BruxismTemporomandibular jointPainExerciseElectric Stimulation TherapyDiadynamic Current

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 COMPARATOR

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

Other: Exercise Program

Rehabilitation Program with Diadynamic Current

EXPERIMENTAL

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

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
Rehabilitation Program

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
Rehabilitation Program with Diadynamic Current

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

BruxismPainMotor Activity

Interventions

Resistance TrainingControl GroupsExercise

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

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

Locations