The Application of Radio Frequency Waves

NCT03773640 | Completed

• 1 other identifier: 1072.6120.116.2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

temporomandibular joint dysfunction,; supportive treatment,; occlusal splint,; radiofreqency,; physiotherapy

Outcome Measures

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.

  10 weeks

Study Arms (2)

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.

Device: Radio frequency currents

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.

Drug: Sonophoresis

Interventions

Radio frequency currents DEVICE

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 study group

Sonophoresis DRUG

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.

The control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Department of Prosthetic Dentistry

Krakow, Lesser Poland Voivodeship, 31-155, Poland

Location

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 12, 2018
• Study Start: April 1, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Locations

PL (1)