NCT04038645|Withdrawn
Study Stopped
Researcher will no longer conduct the study
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Researcher will no longer conduct the study
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
December 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Nasal fractures are one of the most incidental of facial traumas. Regression of nasal edema is necessary so that surgical reduction of the fracture can be performed. It is known that photobiomodulation (PBM) reduces pain, edema and modulates inflammation. Regression of edema in a shorter time may decrease hospitalization time, decreasing hospital costs. However, there are no well-designed clinical studies on this subject. Therefore, the objective of this study will be to evaluate if PBM is able to reduce edema in the region of fractured nasal bones prior to nasal reduction and nasal packing, in order to reduce the patient's ability to go through surgery. Thirty-six patients diagnosed with a (primary) nasal fracture admitted to the Mandaqui Hospital Complex whose trauma occurred in the last 48 hours will be randomly divided into: G1- (control) (n = 18). . G2-Light emitter diode (LED) group (n = 18) - The standard hospital treatment will be performed + LED nasal mask. The main variable will be the edema evaluated by the same researcher and with the same technique. Secondary variables will be pain (visual analogue scale - VAS), temperature, rescue medication count, serum C-reactive protein and systemic inflammatory cytokines. Afterwards, the LED or its placebo will also be applied. The questionnaire to assess the impact of treatment on quality of life will be applied at the baseline and after 8 days. Adverse effects will be recorded and reported. If the data is normal, they will be submitted to Student's t-test. The data will be presented by their means ± standard deviation (SD) and the value of p will be set at 0.05.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 25, 2019
Actual (reported)July 31, 2019
Actual (reported)December 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 15, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Edema
It will be applied a grading system for evaluating eyelid edema: 0 point, none; 1 point, minimal; 2 points, extending on to the iris; 3 points, covering the iris; 4 points, massive edema with the eyelid swollen shut.
Throughout study completion on average of one year
pain assessed by Vas
Throughout study completion on average of one year
Oral health related quality of life (OHRQoL) assessed by ohip-14
Throughout study completion on average of one year
C-reactive protein (CRP)
Throughout study completion on average of one year
temperature
Throughout study completion on average of one year.
Nasal Obstruction
Throughout study completion on average of one year.
The patients (n=18) will receive infrared LEDs in 6 points (3 on the right side and 3 on the left side) using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt (mW) . The LED light outputs will be positioned in direct contact with the skin. During application of the LED both patient and operator will wear goggles. The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol.
The patients (n=18) will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days (by the same evaluator), as well as the evaluation of serum CRP.
The patients will receive infrared LEDs in 6 points using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt. During application of the LED both patient and operator will wear goggles. The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol.
Kargi E, Hosnuter M, Babuccu O, Altunkaya H, Altinyazar C. Effect of steroids on edema, ecchymosis, and intraoperative bleeding in rhinoplasty. Ann Plast Surg. 2003 Dec;51(6):570-4. doi: 10.1097/01.sap.0000095652.35806.c5.
Oliveira Sierra S, Melo Deana A, Mesquita Ferrari RA, Maia Albarello P, Bussadori SK, Santos Fernandes KP. Effect of low-level laser therapy on the post-surgical inflammatory process after third molar removal: study protocol for a double-blind randomized controlled trial. Trials. 2013 Nov 6;14:373. doi: 10.1186/1745-6215-14-373.
Anna Carolina RT Horliana, Phd
Nove de Julho University (Uninove)
0 participants (actual enrollment reported by the registry).
The Effect of Inulin Supplementation in Individuals With IBS-C
Inhaled Methoxyflurane for Pain Management in Nasal Bone Fracture Reduction
Patients will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days as well as the evaluation of serum CRP.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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First Submitted
July 25, 2019
First Posted
July 31, 2019
Study Start
December 1, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 15, 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 29, 2023
Record last verified: 2019-12
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Source: ClinicalTrials.gov.
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