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This study evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). It aims to address both the physical and psychological aspects of TMD, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. Participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. Outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. This research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of TMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Therapy Group | Experimental | Participants receiving behavioral therapy (Cognitive Behavioral Therapy, relaxation techniques, and biofeedback). |
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| Standard Care Group | Active Comparator | Participants will receive standard care, consisting of pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Therapy Group | Behavioral | Includes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity | Assesses changes in self-reported pain levels with scores ranging from 0 (no pain) to 10 (worst pain)levels (0 = no pain, 10 = worst pain) | Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Psychological Distress (Anxiety) | Measures depression levels with a score based on the frequency and severity of symptoms. | Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Psychological Distress (Depression) | Measures depression levels with a score based on the frequency and severity of symptoms. | Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Mouth Opening | Measures the maximum distance (in millimeters) between the upper and lower front teeth during maximum voluntary opening. | Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Jaw Range of Motion |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Khalid University | Abhā | Saudi Arabia |
Individual Participant Data (IPD) from this study will not be shared with other researchers. This decision is based on the need to protect participant privacy and confidentiality, as well as the sensitive nature of the data collected, including psychological and health-related information. Although the study results will be shared in aggregated and anonymized formats through publications and presentations, no raw or identifiable participant data will be disclosed to external parties. This approach ensures compliance with ethical guidelines and data protection regulations.
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| Standard Care Group | Procedure | Includes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions |
|
Assesses the range of motion of the jaw through physical examination, measuring angular movement in degrees.
| Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Pain-Related Disability | Assessed using the TMD Pain Disability Index (TDI) to evaluate the impact of pain on daily activities and quality of life | Baseline, 8 weeks post-treatment, and 6-month follow-up |
| Long-Term Symptom Relief | Sustained improvement in pain, jaw function, and psychological distress over time, assessed using VAS, GAD-7, PHQ-9, and TDI scores. | 6-month follow-up |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D059350 | Chronic Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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