Effect of Phototherapy in Individuals With Temporomandibular Disorder.
|ClinicalTrials.gov Identifier: NCT02018770|
Recruitment Status : Unknown
Verified January 2014 by Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho.
Recruitment status was: Recruiting
First Posted : December 23, 2013
Last Update Posted : March 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Disorder.||Radiation: Phototherapy Radiation: Placebo phototherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||December 2014|
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) .
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.
Placebo Comparator: Placebo 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
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
- Pain intensity. [ Time Frame: 1 year ]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.
- Electromyographic activity [ Time Frame: 1 year ]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.
- Analysis of superficial cutaneous temperature [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018770
|University of Nove de Julho||Recruiting|
|Sao Paulo, São Paulo, Brazil, 01415000|
|Contact: Daniela Ap Biasotto-Gonzalez, Doctor +5511999063166 email@example.com|
|Principal Investigator:||Daniela Ap Biasotto-Gonzalez, Doctor||University of Nove de Julho|