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The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusal Splint | Experimental | Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical. After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected. |
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| Laser Therapy | Experimental | All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not. The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks. |
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| Occlusal Splint + Laser Therapy | Experimental | The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols. |
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| Acupuncture Laser Therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusal Splint | Device | Occlusion Splint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain in the Temporomandibular Joint and/or masticatory muscles | The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain. | Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Mouth opening | Pain-free opening is defined as the maximum amount a patient can achieve when opening their mouth without experiencing pain and will be measured as the distance between the incisal edges of the upper and lower central incisors. Maximum unassisted mouth opening will be measured as the distance between the upper and lower central incisors and defined as the greatest amount of opening a patient can achieve regardless of pain and discomfort. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Almeida, PhD | Universidade Federal de Alfenas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de Alfenas | Alfenas | Minas Gerais | 37130001 | Brazil |
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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 |
|---|---|
| D017090 | Occlusal Splints |
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| Experimental |
The laser will be applied to predetermined acupuncture points and specific trigger points identified during the clinical examination. The application will be performed symmetrically and bilaterally, regardless of the presence of trigger points. A standardized protocol will be followed for all participants, irrespective of tissue thickness or gender. The equipment to be used will emit an infrared light beam with a wavelength of 808 nm, output power of 100 mW, energy density of 105 J/cm², and a spot size of 0.028 cm², delivering 3 J per point, which corresponds to a 30-second application per point. The protocol will consist of five applications: one at baseline, followed by four weekly sessions. |
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| Occlusal Splint + Acupuncture Laser Therapy | Experimental | In the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period. |
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| Laser Therapy | Radiation | Laser Therapy |
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| Acupuncture Laser Therapy | Radiation | Acupuncture Laser Therapy |
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| Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks. |
| Oral Health Impact Profile | The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire. | Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks. |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D013812 |
| Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |