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The Application of Radio Frequency Waves

Primary Purpose

Temporomandibular Joint Dysfunction Syndrome

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Radio frequency currents
Sonophoresis
Sponsored by
Jagiellonian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Temporomandibular Joint Dysfunction Syndrome focused on measuring temporomandibular joint dysfunction,, supportive treatment,, occlusal splint,, radiofreqency,, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jagiellonian University Department of Prosthetic Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The study group

The control group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2018
Last Updated
December 11, 2018
Sponsor
Jagiellonian University
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1. Study Identification

Unique Protocol Identification Number
NCT03773640
Brief Title
The Application of Radio Frequency Waves
Official Title
The Application of Radio Frequency Waves in Supportive Treatment of Temporomandibular Joint Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jagiellonian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction Syndrome
Keywords
temporomandibular joint dysfunction,, supportive treatment,, occlusal splint,, radiofreqency,, physiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The study group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Radio frequency currents
Intervention Description
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 Type
Drug
Intervention Name(s)
Sonophoresis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of intensity of pain (VAS - scale)
Description
Assessment of intensity of pain of mastication muscles with the use of combined VAS and WNRS scales in own description.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jagiellonian University Department of Prosthetic Dentistry
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-155
Country
Poland

12. IPD Sharing Statement

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The Application of Radio Frequency Waves

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