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Clinical Trials/NCT03773640
NCT03773640CompletedNot Applicable

The Application of Radio Frequency Waves in Supportive Treatment of Temporomandibular Joint Dysfunction

Jagiellonian University1 site in 1 country40 target enrollmentStarted: April 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
Assessment of intensity of pain (VAS - scale)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

The study group

Experimental

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.

Intervention: Radio frequency currents (Device)

The control group

Active Comparator

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.

Intervention: Sonophoresis (Drug)

Outcomes

Primary Outcomes

Assessment of intensity of pain (VAS - scale)

Time Frame: 10 weeks

Assessment of intensity of pain of mastication muscles with the use of combined VAS and WNRS scales in own description.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Jagiellonian University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Malgorzata Pihut

Associate Professor

Jagiellonian University

Study Sites (1)

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