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This study will investigate a novel approach to treat pregnant women with tempromandibular disorder using a combined method of low level laser therapy, myofascial release and standard care versus standard care alone. It's hopeful that the results of this study can fill the gap of knowledge surrounding the conservative treatment options for TMD in order to help patients restore their oral function properly and promote new ways of addressing TMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises. |
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| Intervention group | Experimental | Patients received a 4-week treatment program (12 treatment sessions, three times a week). Patients received LLLT and myofascial release combined with the control intervention. the conservative treatment protocol comprised of ultrasound, hot pack application, and exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Level laser therapy | Other | MLS® device (ASA Srl, Vicenza, Italy) IR laser with two synchronized sources (laser diodes) and a wavelength of 808 nm to deliver the intervention. The laser probe will be held vertically in contact with the skin to deliver the irradiation at three mandibular condyle points (front, behind and over) and one point at the external acoustic meatus. The irradiation will be applied with a laser bean of 3.14 cm² diameter for 14 seconds at each place using a pulse rate of 1500 Hz, pulse duration of 100ns, and energy density: 16 J/cm². |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in visual analogue scale | Visual analog scale (VAS), a grading scale range from 0 to 100 mm. 0 mm represented no pain or discomfort at all and 100 mm represented the greatest amount of pain or discomfort imaginable. Participant drew a line that intersects the grading scale to show the amount of pain or discomfort that he or she experienced at that moment. The assessor then used a ruler to measure the length from 0 mm to the intersecting line and recorded the value. | Baseline and after 4 weeks |
| Changes in pain pressure threshold (PPT) | Comparing pain pressure threshold differences on both sides over TMJ, masseter and anterior temporalis. | Baseline and after 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Limitations of daily function in temporomandibular disorder questionnaire | The limitations in daily functions in the temporomandibular disorder questionnaire (LDF-TMDQ) assess participants' functionality by asking them to report how much the jaw problem prevents or limits their performance in a list of 10 daily activities | Baseline and after 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Radwa M Yehia, Ph.D | Faculty of Physical Therapy, October 6 University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| October 6 University Hospital | Al Ḩayy Ath Thāmin | Giza Governorate | 12511 | Egypt |
all of the individual participant data collected during the trial and after deidentification
6 Months after study publication
Email: mohamed.magdy.pt@o6u.edu.eg
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| D000089803 | Myofascial Release Therapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
| D008405 | Massage |
| D064746 |
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| Myofascial release | Other | Patients will be positioned in supine in a treatment table. The therapist seated beside the patient at the side of affected temporomandibular joint to apply gross release technique for masseter, pterygoid and temporalis muscles. At each point, the therapist applied the technique for 90 seconds and repeated 5 times during the session (5 seconds of rest between each repetition).(15) The therapist worn gloves to deliver the intraoral myofascial release. In case the patient reported any latex allergies, the gloves were replaced by a latex free model. |
|
| Standard care | Other |
Active exercises for mandibular muscles will be used to correct the mouth opening
|
|
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |