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The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phototherapy | Experimental | Three groups will receive different fototerapia of light sources, and group 1 will not receive dose: Group A (0, 65Joules), Group B (1.30 Joules) and Group C (1.95 Joules) . |
|
| Placebo phototherapy | Placebo Comparator | The volunteers will be subjected to the same Groups intervention Phototherapy . The but researcher will receive placebo pen. It is the caveat that, after completed the voluntary participation, will be held with the active pen treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phototherapy | Radiation | Portable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity. | Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Electromyographic activity | The electrical powers of masticatory muscles will be verified in this study through surface electromyography, specifically the masseter and temporal muscles, serving as a useful tool to quantify muscle activity during Mastication and thus identify its functional changes. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of superficial cutaneous temperature | A thermal camera model FLIR T450 ® SC Systems (Stockholm, Sweden) is used to measure the surface skin temperature of the masseter and temporal muscles to verify the effect of phototherapy in them. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela Ap Biasotto-Gonzalez, Doctor | University of Nove de Julho | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nove de Julho | Recruiting | São Paulo | São Paulo | 01415000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28602137 | Derived | Herpich CM, Leal-Junior ECP, Gomes CAFP, Gloria IPDS, Amaral AP, Amaral MFRS, Politti F, Biasotto-Gonzalez DA. Immediate and short-term effects of phototherapy on pain, muscle activity, and joint mobility in women with temporomandibular disorder: a randomized, double-blind, placebo-controlled, clinical trial. Disabil Rehabil. 2018 Sep;40(19):2318-2324. doi: 10.1080/09638288.2017.1336648. Epub 2017 Jun 11. | |
| 25514875 |
| Label | URL |
|---|---|
| URL of the University of Nove de Julho | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 5, 2015 | |
| Reset | Feb 23, 2015 | |
| Release | Mar 6, 2015 | |
| Reset | Mar 17, 2015 | |
| Release | May 12, 2015 | |
| Reset | May 29, 2015 | |
| Release | Feb 18, 2022 | |
| Reset | Apr 19, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2015 | Feb 23, 2015 | |||
| Mar 6, 2015 |
| 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 |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Placebo phototherapy | Radiation | The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy. |
|
| Derived |
| Herpich CM, Leal-Junior EC, Amaral AP, Tosato Jde P, Gloria IP, Garcia MB, Barbosa BR, El Hage Y, Arruda EE, Gomes CA, Rodrigues MS, de Sousa DF, de Carvalho Pde T, Bussadori SK, Gonzalez Tde O, Politti F, Biasotto-Gonzalez DA. Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial. Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491. |
| Mar 17, 2015 |
| May 12, 2015 | May 29, 2015 |
| Feb 18, 2022 | Apr 19, 2022 |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |