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comparing the effects of Laser therapy with anterior re-positioning splint and a placebo group on clinical signs and symptoms of temporo-mandibular dis-function and assessing articular disc morphology and configuration with magnetic resonance imaging.
to compare the clinical effects of Laser therapy as assessed with research diagnostic criteria of temporo-mandibular disorders to a group that received anterior re-positioning splint therapy and a control group that received placebo Laser. Diagnosis for disc displacement with reduction was performed with magnetic resonance imaging before treatment. assessment of the clinical and MRI findings was again performed after a 3 months observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser therapy | Experimental | 12 laser sessions over 3 months |
|
| anterior re-positioning splint therapy | Active Comparator | anterior re-positioning splint worn for 8 hours during night time for 3 months |
|
| inactive laser therapy | Placebo Comparator | placebo laser for 12 sessions over 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laser therapy | Device | epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of temporomandibular joint pain: assessed by using subjective visual analogue scale | current level of temporomandibular joint pain assessed by using subjective visual analogue scale from 1 to 10 according to the research diagnostic criteria of temporomandibular disorders diagnostic sheets, zero indicates no pain, while 10 indicates the worst pain | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| click: joint sound | joint sound., it is a binary measurement assessed by hand palpation | 3 months |
| limitation of mandibular movements | mouth opening, measured between the incisal edges of upper and lower incisors using a digital caliper, right and left mandibular movements, measured from upper dental midline to lower dental midline using a digital caliper. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mona S Fayed, PHD | Professor of Orthodontics, Faculty of Dentistry, Cairo Universitye | Study Director |
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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 |
|---|---|
| D053685 | Laser Therapy |
| D028022 | Low-Level Light Therapy |
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D010789 | Phototherapy |
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| anterior re-positioning splint | Device | hard acrylic anterior re-positioning splint |
|
|
| inactive Laser therapy | Device | sham Laser, with inactive beam |
|
| 3 months |
| disc recapture | change in articular disc morphology and configuration using two dimensional measurements on a DICOM viewer software including both linear and angular measurements in relation to cartesian coordinates X and Y | 3 months |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D009989 |
| Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |