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Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT04708938
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Halime ARIKAN, Gazi University

Study Description
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Brief Summary:
The aim of the study is to examine the effect of high voltage electrical stimulation on pain, temporomandibular joint mobility, cervical mobility, head position, tender points and joint sounds in individuals with temporomandibular disorders.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Other: High voltage electrical stimulation+exercise therapy Other: Exercise therapy Not Applicable

Detailed Description:

28 individuals who meet the TMER / Research Diagnostic Criteria classification will be randomly divided into 2 groups. Exercise with high voltage electrical stimulation (YVES) will be applied to the 1st group and only exercise will be applied to the 2nd group. The second group will be the control group of the study. Both groups will be informed about the disease before starting the study before the treatment and patient education will be given about the situations that need attention. Again, 2 groups will be given an exercise program from the day they start the treatment, 3 times a week for 4 weeks during the treatment. As sociodemographic information of the individuals, age, gender, height, weight, body mass index, marital and educational status, occupation, smoking and alcohol use, patient history, family history and complaint sides will be recorded. Before starting treatment, individuals will be evaluated for pain, temporomandibular joint mobility, cervical mobility, tender points, and joint sounds:

  1. Pain with Visual Analogue Scale (VAS),
  2. TMJ mobility with a ruler,
  3. Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer,
  4. Head position with universal goniometer and ImageJ software,
  5. Sensitive points with algometer,
  6. Joint sounds will be evaluated as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion).

After 4 weeks of treatment, the measurements will be repeated.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized-controlled, double-blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind trial
Primary Purpose: Treatment
Official Title: Effectiveness of Different Physiotherapy Practices in Temporomandibular Disorders
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment group
High voltage electrical stimulation + exercise therapy
 Other: High voltage electrical stimulation+exercise therapy
The effect of high voltage electrical stimulation on temporomandibular disorders
Active Comparator: Control group
Exercise therapy
 Other: Exercise therapy
The effect of high voltage electrical stimulation on temporomandibular disorders


Outcome Measures
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Primary Outcome Measures :
  1. Change in pain on temporomandibular joint [ Time Frame: Before and after treatment, 4 weeks apart. It takes 10 seconds. ]
    Pain with Visual Analogue Scale (VAS)

  2. Change in temporomandibular joint mobility [ Time Frame: Before and after treatment, 4 weeks apart. It takes 3 minutes. ]
    Temporomandibular joint mobility with a ruler

  3. Change in cervical mobility [ Time Frame: Before and after treatment, 4 weeks apart. It takes 5 minutes. ]
    Cervical mobility with C-ROM (Cervical Range of Motion) inclinometer

  4. Change in head position [ Time Frame: Before and after treatment, 4 weeks apart. It takes 3 minutes. ]
    Head position with universal goniometer and ImageJ software

  5. Change in tender points [ Time Frame: Before and after treatment, 4 weeks apart. It takes 10 minutes. ]
    Tender points with algometer

  6. Change in joint sounds [ Time Frame: Before and after treatment, 4 weeks apart. It takes 2 minutes. ]
    Joint sounds as present / absent as a result of the evaluation of movements in all directions (maximum mouth opening, right / left lateral excursions, protrusion and retrusion)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who have been diagnosed with TMER,
  • Comply with the TMD / RDC classification,
  • Have Class I-II-III occlusion,
  • Volunteer to participate in the study, and fill out the informed consent form will be included.

Exclusion Criteria:

  • Acute trauma,
  • Surgery history,
  • Neurological or psychiatric conditions,
  • Trigeminal or postherpatic neuralgia,
  • Dental or orofacial infection,
  • Intraoral infection or tumor,
  • Oligodontics and anadontics,
  • High voltage electrical stimulation contraindications,
  • Any disease diagnosed in the shoulder and neck areas,
  • Receiving another treatment and,
  • Individuals under the age of 18 will be excluded in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708938


Contacts
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Contact: Halime ARIKAN, MSc 05465765132 halimearikan92@gmail.com

Locations
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Turkey
Gazi University, Faculty of Health Sciences Recruiting
Ankara, None Selected, Turkey, 06490
Contact: Halime ARIKAN, MSc    +90 546 576 51 32    halimearikan92@gmail.com   
Sponsors and Collaborators
Gazi University
Investigators
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Principal Investigator: Halime ARIKAN, MSc. Gazi University, Faculty of Health Sciences
Principal Investigator: Gokhan MARAS, MSc. Gazi University, Faculty of Health Sciences
Principal Investigator: Seyit CITAKER, Dr. Gazi University, Faculty of Health Sciences
Principal Investigator: Cahit UCOK, Dr. Ankara University, Faculty of Dentistry
More Information
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Responsible Party: Halime ARIKAN, Research Assistant, Gazi University
ClinicalTrials.gov Identifier: NCT04708938    
Other Study ID Numbers: 68869993-511.06-E.239934
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: April 6, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Halime ARIKAN, Gazi University:
High voltage stimulation
Temporomandibular disorders
Temporomandibular joint
Cervical spine
Pain
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Disease
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
 Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes