Effects Exercises in Temporomandibular Joint Disorders on Pain, Joint and Tongue Functions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTayfun ISIK
About this trial
The goal of this clinical trial is to learn if orofacial exercises works to treat temporomandibular disorders in adults. It will also learn about the safety of orofacial exercises on temporomandibular disorders. The main questions it aims to answer are:
Does orofacial exercises improve function of temporomandibular disorders ? Does orofacial exercises decrease pain in temporomandibular disorders?
Researchers will compare orofacial exercises and manual therapy to manual therapy.
Participants will:
Take manual therapy and orofacial exercises or manual therapy two days in every week for 6 weeks Assessment once every 2 weeks for tests
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 - 65 aged people
Not having received physical therapy for the neck or jaw within the past three months.
No history of surgical or oncological treatment related to the neck or jaw.
Having a diagnosis of temporomandibular disorder according to the RDC/TMD criteria, specifically Group Ia, Group Ib, or Group IIa under Axis I.
Disqualifiers
Individuals who are pregnant or suspected to be pregnant.
Individuals with rheumatologic diseases affecting the temporomandibular joint.
Individuals with a diagnosed psychiatric disorder.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Other interventionThe orofacial and tongue exercises include four-directional tongue mobilizations and resisted tongue movements in forward and upward directions within the oral cavity to improve tongue mobility. In addition, safe mouth opening exercises, as well as cheek and lip exercises, are also included in the exercise program.
Exercise
Other intervention* Through in education program, participants will be informed about joint characteristics, eating and drinking habits, and behavioral training. * Diaphragmatic breathing will be taught to promote relaxation of the cervical muscles and to establish a proper breathing pattern. * Postural exercises will be instructed to improve neck and back mechanics. * Relaxation training may help reduce joint activity that increases during periods of stress. * When necessary, participants will also receive education on the appropriate use of hot and cold agents.
Manual therapy
Other interventionManual therapy will begin with cervical stretching, relaxation of the cervical paraspinal muscles, and release techniques for the sternocleidomastoid and scalene muscles. The intensity of these exercises will be adjusted according to the patient's and tissue's tolerance. Relaxation of the masticatory muscles will be achieved through massage applied externally to the jaw and the temporal region. Passive range-of-motion exercises will be performed to increase the mobility of the temporomandibular joint.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Orofacial GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
orofacial myofunctional evaluation with scores
The Orofacial Myofunctional Evaluation with Scores (OMES) protocol is designed to assess oral dysfunctions through multiple subdomains. These subdomains include appearance and posture, mobility, function, swallowing, mastication, functional occlusion, and mandibular movement. Higher scores indicate better functional status. The protocol has not yet been validated in Turkish. It was first used in a pediatric population and has also demonstrated validity in individuals with temporomandibular disorders.
Time frame
From enrolment to the end of treatment at 6 weeks, in every two weeksSecondary outcomes
1
Pain threshold level of temporomandibular joint and temporal regions
Pain thresholds will be measured using an algometer. In this study, the measurement sites are the masseter muscle (2.5 cm anterior and 1.5 cm inferior to the tragus) and the temporalis muscle (3 cm above the lateral edge of the eye). During the measurement, the algometer will be held perpendicular to the skin. Measurements will be conducted in a quiet room. Each site will be measured three times with 30-second intervals between measurements, and the average of the three measurements will be used for analysis. The validity of algometric measurements has been previously established.
Time frame
From enrollment to the end of treatment at 6 weeks, once every two weeks.2
Pain Level of Numerical Pain Scale
The Numerical Pain Scale (NPS) is a self-reported or clinician-administered measurement tool that uses a numerical rating scale ranging from "no pain" to "worst possible pain". The scale is typically presented as a horizontal or vertical line and most commonly ranges from 0-10 or 0-100. It can be administered either in written or verbal form. Participants are asked to rate the intensity of their pain along this scale.
Time frame
From enrollment to the end of treatment at 6 weeks, once in every two weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tayfun ISIK
Lead sponsor
Ankara Medipol University
Sponsor institution
The Scientific and Technological Research Council of Turkey
Collaborator
Source ClinicalTrials.gov