- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06707467
Evaluation of Postural Exercises in the Treatment of Temporomandibular Disorders
Determination of the Effectiveness of Postural Exercises Combined With Occlusal Splint Therapy in Internal Temporomandibular Derangements
Fifty-seven patients diagnosed with internal temporomandibular derangement will be included in the study and divided into three groups. All patients will be treated with a proven-effective occlusal splint. The first group will receive only occlusal splint therapy and will serve as the control group. The second group will receive occlusal splint therapy combined with Rocabado exercises, while the third group will receive occlusal splint therapy combined with postural exercises.
Before the treatment process, all patients will complete the Temporomandibular Disorders Diagnostic Criteria (TMD-DC) form. Pain intensity will be measured using the Visual Analog Scale (VAS), pain thresholds will be assessed using an algometer, and the following evaluations will be performed: Cervical Posture Assessment (Craniovertebral Angle with Goniometer)-Cervical Range of Motion Assessment (C-ROM)-Cervical Deep Flexor Muscle Endurance Test-Neck Disability Assessment (NDI - Neck Disability Index)-Psychiatric Assessment (HADS - Hospital Anxiety and Depression Scale).
After two months, patients will be recalled, and all tests will be repeated. The effectiveness of the three treatment protocols will then be evaluated.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being diagnosed with internal temporomandibular disarrangement
- aged 18 years or older
- Willingness to participate in the study
- Ability to speak and understand Turkish, with no communication difficulties severe enough to impede understanding of the exercises
Exclusion Criteria:
- History of acute trauma in the TMJ or surrounding area
- TMJ dysfunction caused by a neurological condition
- History of surgical/invasive procedures or treatments on the TMJ
- Presence of infection or tumoral structures within intraoral structures
- History of tooth loss or use of dental prostheses
- History of surgical procedures in the cervical region
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nineteen patients with internal temporomandibular disarrangement-group 1
Nineteen randomly selected patients with internal temporomandibular disarrangement
|
Nineteen patients diagnosed with internal temporomandibular derangement will be provided with Rocabado exercises in addition to the proven-effective treatment method of occlusal splint therapy.
This approach aims to evaluate whether Rocabado exercises have a positive effect on the treatment process.
|
|
Active Comparator: nineteen patients with internal temporomandibular disarrangement-group 2
nineteen randomly selected patients with internal temporomanidbular disarrangement
|
nineteen patients diagnosed with internal temporomandibular derangement will receive occlusal splint therapy, a treatment method with proven effectiveness.
|
|
Experimental: nineteen patients with internal temporomandibular disarrangement-group 3
nineteen selected patients with internal temporomandibular disarrangements
|
Nineteen patients diagnosed with internal temporomandibular derangement will be provided with posture exercises in addition to the proven-effective treatment method of occlusal splint therapy.
This approach aims to evaluate whether posture exercises have a positive effect on the treatment process.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Pain Reduction
Time Frame: 2 months
|
Three different treatment protocols will be applied to patients with internal temporomandibular derangement, and the results obtained after a 2-month treatment period will be compared to determine which method is the most effective.
To evaluate treatment outcomes, the patients' pre- and post-treatment Visual Analog Scale (VAS) scores will be assessed, with a decrease in the mean VAS score indicating a reduction in pain.
Additionally, the pain threshold in various facial regions will be measured with an algometer before and after treatment to identify which treatment protocol is more effective in reducing pain.
By combining both outcomes, the most effective method for pain reduction will be determined.
|
2 months
|
|
Investigation of the Effect of Postural Exercises and Rocabado Exercises on Physiological Movements
Time Frame: 2 months
|
Changes in cervical range of motion (C-ROM) and the craniovertebral angle will also be evaluated to determine the impact of the treatment methods on these parameters.
In this way, the method that is more effective in improving physiological movements will be identified.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Investigation of the Secondary Effects of Postural Exercises and Rocabado Exercises on Patient's Psychology
Time Frame: 2 months
|
The effect of the treatment protocols applied to the three different groups on the general psychology of the patients will be measured using the Hospital Anxiety and Depression Scale (HADS).
In this test, a higher score indicates a higher level of depressive symptoms, and a successful treatment is expected to result in a decrease in the test score.
|
2 months
|
|
Investigation of the Effect of Postural Exercises and Rocabado Exercises on the Mobility of the Neck and Jaw
Time Frame: 2 month
|
The patient's neck movements will be assessed, and the range of jaw movements will be evaluated.
The study aims to identify which treatment protocol leads to the most significant improvement in jaw and neck mobility.
|
2 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ebru K Mutlu, Clinical Prof., Bandırma Onyedi Eylül University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-186
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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