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CompletedNCT03773640Updated Dec 12, 2018

The Application of Radio Frequency Waves

An interventional study of Radio frequency currents and Sonophoresis in Temporomandibular Joint Dysfunction Syndrome, sponsored by Jagiellonian University. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Jagiellonian University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Apr 2018, registered Dec 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Temporomandibular Joint Dysfunction Syndrome

Keywords

  • temporomandibular joint dysfunction,
  • supportive treatment,
  • occlusal splint,
  • radiofreqency,
  • physiotherapy
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • the will (consent) of the patient,
  • the presence of a general diseases,
  • the presence of traumas,
  • the presence of local inflammations.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    The study group

    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.

    Device: Radio frequency currents

  • Active comparator
    The control group

    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.

    Drug: Sonophoresis

Interventions

  • DeviceRadio frequency currents

    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.

  • DrugSonophoresis

    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.

06

What researchers measure

Primary outcomes

  1. Assessment of intensity of pain (VAS - scale)

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

    Time frame: 10 weeks

07

Study locations

1 site
  • Jagiellonian University Department of Prosthetic Dentistry
    Kraków, Małopolskie 31-155, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03773640
Lead sponsor
Jagiellonian University
Responsible party
Malgorzata Pihut (Associate Professor, Jagiellonian University) — Principal investigator
First posted
Dec 12, 2018
Start date
Apr 1, 2018
Primary completion
Dec 5, 2018
Completion
Dec 5, 2018
Last update
Dec 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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