Clinical trial NCT04038645: Evaluation of Photobiomodulation on Nasal Fractures
Official title: Evaluation of Photobiomodulation on Nasal Fractures: a Randomized, Controlled, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nasal Fracture
Keywords: Nasal Fracture
Photobiomodulation
Laser
Edema
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 36 patients will be allocated in the experimental and control groups: G1 - Experimental Group (n = 18 Photobiomodulation PBM) - the treatment will be performed in a conventional manner and the patient will receive laser at low intensity.

G2 - Control group (n = 18 -placebo of PBM) - treatment will be performed in a conventional manner and simulation of PBM treatment.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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). The control group will be submitted to the standard hospital treatment: standard drug therapy (50mg diclofenac sodium - 5 days, 8 / 8h orally and 500mg dipyrone - 5 days, 6 / 6h , orally). Tylex 30mg orally will be given as rescue medication. In this group there will be simulation of the use of the mask. G2- LED group (n = 18) - The standard hospital treatment will be performed + LED nasal mask (3 points on each side of the nose), λ = 830nm, radiant exposure of 9.7 Joules J / cm2 for 10 minutes. Treatment will be performed at patient admission (up to 24 hours after nasal trauma), and at intervals explained below, for approximately 08 days after hospital admission. 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 (TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL- nasal fossa and saliva. All evaluations will be performed at baseline (T0) up to 48 hours after trauma, aiming at equivalence in the inflammatory process, (T1) 96h after trauma and (T2) 192h after trauma. 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 ± SD and the value of p will be set at 0.05.

Eligibility criteria: 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.

Primary outcomes:
measure: Edema
timeFrame: Throughout study completion on average of one year
Secondary outcomes:
measure: pain assessed by Vas
timeFrame: Throughout study completion on average of one year
measure: Oral health related quality of life (OHRQoL) assessed by ohip-14
timeFrame: Throughout study completion on average of one year
measure: C-reactive protein (CRP)
timeFrame: Throughout study completion on average of one year
measure: temperature
timeFrame: Throughout study completion on average of one year.
measure: Nasal Obstruction
timeFrame: Throughout study completion on average of one year.
measure: Bruise
timeFrame: Throughout study completion on average of one year.
measure: Salivary cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
timeFrame: Throughout study completion on average of one year.
measure: nasal exudate cytokines TNF-α, interleukin-1 (IL-1), IL-6, IL-8 and IL-10
timeFrame: Throughout study completion on average of one year.
Other outcomes:
Locations:
Study officials:
affiliation: Nove de Julho University (Uninove)
name: Anna Carolina RT Horliana, Phd
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.