A Phase 1/2 interventional study of Phototherapy and Placebo phototherapy in Temporomandibular Disorder., sponsored by University of Nove de Julho. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-03-11.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
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%.
609 studies on the registry are indexed under Temporomandibular Joint Disorders; 160 are open to participants now.
This study's planned enrollment of 48 is close to the median of 46 across 434 interventional studies indexed under Temporomandibular Joint Disorders.
Browse Temporomandibular Joint Disorders studies →University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
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) .
Radiation: Phototherapy
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.
Radiation: Placebo phototherapy
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.
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
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.
Time frame: 1 year
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.
Time frame: 1 year
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.
Time frame: 1 year
This study is status unknown, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Temporomandibular Joint Disorders→
University of Nove de Julho