Clinical trial NCT03773640: The Application of Radio Frequency Waves
Official title: The Application of Radio Frequency Waves in Supportive Treatment of Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: temporomandibular joint dysfunction,
supportive treatment,
occlusal splint,
radiofreqency,
physiotherapy
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study group I (20 patients) and control group II (20 patients) consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting Room of Temporomandibular Joint Dysfunction at The Institute of Dentistry in Krakow to undertake prosthetic treatment of pain form of temporomandibular disorders, with the dominant muscle component.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of the study was to evaluate the influence of radio waves on the functioning of masseter muscles in the course of painful functional disorders of the organ, and thus the usefulness of these procedures in the treatment supporting temporomandibular joint dysfunction.

Material and method The study group I (20 patients) and control group II (20 patients) consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle component.

Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.

The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.

Detailed description: In recent years, the number of patients applying for prosthetic treatment due to painful forms of temporomandibular joint dysfunction has been increasing. Temporomandibular joints disorders (TMJD )include dysfunction of the masticatory muscles of the stomatognathic system, temporomandibular joints and the surrounding structures. There are often associated with abnormal conditions of occlusion.

The aim of the study was to evaluate the influence of radio waves on the functioning of masseter muscles in the course of painful functional disorders of the organ, and thus the usefulness of these procedures in the treatment supporting temporomandibular joint dysfunction.

Material and method The study group I (20 patients) and control group II (20 patients) consisted of patients, aged 19 to 45 years, of both sexes, who reported to the Consulting Room of Temporomandibular Joint Dysfunction in Institute of Dentistry in Krakow to undertake prosthetic treatment of pain form of temporomandibular disorders with the dominant muscle component.

Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.

The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.

Eligibility criteria: Inclusion Criteria:

* pain form of temporomandibular joints dysfunction,
* the required age range,
* good general state of health,

Exclusion Criteria:

* the will (consent) of the patient,
* the presence of a general diseases,
* the presence of traumas,
* the presence of local inflammations.

Primary outcomes:
measure: Assessment of intensity of pain (VAS - scale)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Jagiellonian University Department of Prosthetic Dentistry
state: Małopolskie
Study officials:
References: