- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04038645
Evaluation of Photobiomodulation on Nasal Fractures
Evaluation of Photobiomodulation on Nasal Fractures: a Randomized, Controlled, Double-blind Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anna Carolina RT Horliana, Phd
- Phone Number: 5513981999848
- Email: annacrth@gmail.com
Study Contact Backup
- Name: Paulo A de Almeida, Ms student
- Phone Number: 5511981873721
- Email: pauloaalmeida@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- healthy participants.
- With a maximum of 48 hours after nasal trauma.
Exclusion Criteria:
- Patients using anticoagulant medication or use of medication that is anti-inflammatory chronically .
- Patients who report a hypersensitivity reaction to any drug used in the research
- Patients with previous nasal fractures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Experimental Group (laser)
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 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. |
Placebo Comparator: Control group (Placebo)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Edema
Time Frame: Throughout study completion on average of one year
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain assessed by Vas
Time Frame: Throughout study completion on average of one year
|
The pain will be assessed by applying a VAS visual analogic scale, consisting of a 100-mm line numbered in centimeters, with two closed ends.
One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively.
Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation.
Instructions on marking will always be given to the patient by the same operator
|
Throughout study completion on average of one year
|
Oral health related quality of life (OHRQoL) assessed by ohip-14
Time Frame: Throughout study completion on average of one year
|
Oral health related quality of life: using Oral Health Impact Profile (OHIP-14)questionnaire we will assess the impact on HRQOL will be measured.
This instrument consists of 14 items arranged in 7 factors: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
The answers are given in a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always).
|
Throughout study completion on average of one year
|
C-reactive protein (CRP)
Time Frame: Throughout study completion on average of one year
|
After approximately 4 to 24 hours of trauma, CRP serum levels reach peaks up to 1000 times its initial concentration, although it is a nonspecific marker and is closely related to tissue necrosis and inflammatory processes.
The collection of 10 ml of peripheral blood will be performed through a specific tube by the nurses of the Mandaqui Hospital Group.
This analysis will be performed at baseline and on the last assessment day.
|
Throughout study completion on average of one year
|
temperature
Time Frame: Throughout study completion on average of one year.
|
Temperature will be measured locally and systemically.
The local measurement was measured using a Safety 1st® digital thermometer (Safety 1st®, "No Touch Forehead", Columbus, USA) in the nasal dorsum, one centimeter below the glabella.
|
Throughout study completion on average of one year.
|
Nasal Obstruction
Time Frame: Throughout study completion on average of one year.
|
Nasal Obstruction - To evaluate nose permeability the following methodology will be used, the patient will be asked to numerically choose their sense of obstruction on a scale from zero to ten, zero represents no obstruction of air passage and ten indicates total obstruction.
During evaluations the patient will not be allowed to see previous ratings.
The patient should point out two numbers indicating that the score will be at an intermediate value.
The result will be the average of both values.
The value obtained will be multiplied by 10, for ease of comparison.
|
Throughout study completion on average of one year.
|
Bruise
Time Frame: Throughout study completion on average of one year.
|
Periorbital bruise will be assessed in each patient by assessing the upper and lower eyelids separately, using a 0 to 4-point scale, Kargi scale, 2003
|
Throughout study completion on average of one year.
|
Salivary cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
Time Frame: Throughout study completion on average of one year.
|
5 ml of saliva sample will be collected in 50 ml tubes.
They will be aliquoted (1.2ml) into 2 sterile microtubes and the samples will be stored at -80 ºC until further analysis of cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10 via ELISA.
|
Throughout study completion on average of one year.
|
nasal exudate cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
Time Frame: Throughout study completion on average of one year.
|
Exudate samples will be collected with a paper cone that will be placed in the nasal cavity until resistance is felt.
The cones will be placed in one sterile microcentrifuge tube and stored at -80 Celsius degree (ºC) until further analysis of cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10 via ELISA.
|
Throughout study completion on average of one year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anna Carolina RT Horliana, Phd, Nove de Julho University (Uninove)
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nasal fracture
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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