Low-level laser therapy (LLLT) could be an alternative for the treatment of swelling and pain after orthognathic surgery, but there is a paucity of data in the literature on the effects of its use. This study verified the efficacy of an LLLT protocol to reduce swelling and pain after orthognathic surgery. Ten healthy patients who underwent a bilateral sagittal split with Le Fort I osteotomy were randomly selected for this study. The LLLT protocol consisted of intraoral and extraoral application to one side of the face after surgery (irradiated side); application to the other side was simulated (non-irradiated side). The irradiated and non-irradiated sides were compared regarding the swelling coefficient and were assessed for pain using a visual analogue scale. There were no significant differences between the irradiated and non-irradiated sides regarding swelling and pain in the immediate postoperative assessment. Swelling decreased significantly on the irradiated side in the postoperative assessments on days 3, 7, 15, and 30. Self-reported pain was less intense on the irradiated side at the 24-h (1.2 vs. 3.4) and 3-day (0.6 vs. 2.1) assessments, but at 7 days after surgery neither side showed pain. This LLLT protocol can improve the tissue response and reduce the pain and swelling resulting from orthognathic surgery.
Orthognathic surgery is a procedure used to correct dentofacial deformities. The osteotomies most commonly used are the Le Fort I osteotomy, whose popularity dates from the study by Bell in 1975, and the bilateral sagittal split osteotomy (BSSO), first described by Trauner and Obwegeser in 1957 and modified by Dal Pont (1961), Hunsuck (1968), and Epker (1977). Pain and swelling are consequences of tissue injury, and procedures such as cold therapy and the use of drugs (analgesics and anti-inflammatories) help to control these unwanted effects; however they present additional side-effects including gastric or intestinal irritation, cutaneous rash, neutropenia, and hepatic and renal disorders, which may reduce their benefits.
A possible alternative that avoids the undesirable effects of the aforementioned therapies is low-level laser therapy (LLLT). LLLT is a relatively new topic in the biomedical sciences and in maxillofacial surgery in particular, and many more studies will be required to establish its mechanisms of action. LLLT has been described in the literature as exerting a biomodulatory effect and is indicated in cases of pain and tissue repair.
The advantages of LLLT are no contraindications, no adverse effects, and easy apparatus handling and application. To penetrate tissue, the energy delivered through a low-intensity laser-emitting device undergoes multiple scattering, which affects laser energy distribution. The absorption of this energy stimulates or inhibits enzymatic activities and photochemical reactions that induce reaction cascades and physiological processes with therapeutic consequences. The laser thus mediates inflammation and activates the immune system, with broad therapeutic effects.
The investigators hypothesized that LLLT reduces inflammatory mediators resulting in a better postoperative recovery. Hence the purpose of this study was to evaluate the efficacy of an LLLT protocol in the postoperative swelling and pain associated with orthognathic surgery. This was done by comparing laser-irradiated with non-irradiated facial sides in the same person, who was blinded to the treatment received. The investigators hypothesized that LLLT reduces inflammatory mediators resulting in a better postoperative recovery.
Materials and methods
Study design and participants
This randomized, crossover, double-blind clinical trial was carried out in the oral and maxillofacial department of a clinical university hospital. The sample comprised patients who needed bimaxillary orthognathic surgery including a bilateral sagittal split and Le Fort I osteotomy to correct their dentofacial deformity. All patients underwent preoperative orthodontic treatment to correct tooth position. All patients were operated on by the same surgeon. The inclusion criteria were the following: no facial trauma or inferior alveolar nerve (IAN) injury; no neurosensory disturbance before treatment; third molars removed at least 6 months before the orthognathic surgery; bilateral sagittal split osteotomy on both sides of the jaw taking roughly the same time, with minimal IAN manipulation; and no genioplasty. Exclusion criteria were neurovascular bundle rupture; poor BSSO split; postoperative infection; and missing laser application.
The study was approved by the university research ethics board and has been registered in the clinical trials database ( clinicaltrials.gov , protocol No. NCT01530100 ). All subjects signed an informed consent form prior to undergoing treatment and fulfilled the criteria set out without any exclusion.
A standard bilateral sagittal split osteotomy and Le Fort I osteotomy were performed. Pre-, intra-, and postoperative medications were standardized and dosed according to the patient’s weight in order to keep the drugs in the same proportion. All patients received antimicrobial prophylaxis (cefazolin preoperatively), steroids (hydrocortisone intraoperatively and dexamethasone postoperatively until the third day after surgery), and analgesics (tramadol intraoperatively and every 8 h during the first 24 h after admission, and ketorolac until 48 h after the operation).
A gallium–aluminium–arsenide diode low-level laser device (Thera Lase, DMC Brazil; continuous wave, spot size 0.4 mm) was used. The surface exposed to laser therapy was cleaned and air-dried before application. The applications were performed by a single trained professional who did not take part in the surgical procedure.
One side of the face, the ‘irradiated side’, was chosen randomly by draw to receive laser therapy intraorally and extraorally. The laser was applied to four points over the incision line, 1 cm apart, in the immediate postoperative period and at 24, 48, and 72 h after the surgery (wave length ( λ ) = 660 nm (red), energy density (ED) = 5 J/cm 2 , time ( t ) = 10 s/point, laser power ( P ) = 20 mW, energy ( E ) = 1.2 J/point). The laser was applied to eight points in the mandibular ramus and body in the immediate postoperative period and at 24, 48, and 72 h after the surgery ( λ = 789 nm (infrared), DE = 30 J/cm 2 , t = 20 s/point, P = 60 mW, E = 1.2 J/point). The same exposure was used on two points each of the pre-auricular, jugular-digastric, and submandibular lymph nodes ( Fig. 1 ). The total energy used was 21.6 J per session.
After the fourth day, 10 intraoral applications were performed at 48-h intervals on three points 1 cm apart on the path of the inferior alveolar nerve on the mandibular ridge and three points on the lower labial mucosa. Extraoral applications were performed on two points on the lower lip and nine points 1 cm apart in the chin region ( λ = 780 nm (infrared), DE = 70 J/cm 2 , P = 70 mW, t = 40 s/point, E = 2.8 J/point) ( Fig. 2 ). The total energy used was 50.4 J per session.
The laser unit was positioned on the same points on the other side of the face, the ‘non-irradiated side’, but was not activated. During all applications patients were blinded with the use of black glasses and listened to music via headphones so that they did not know which side of the face had been irradiated.
A single trained individual, blinded to the side of laser application, assessed postoperative swelling and pain.
Swelling size was calculated using the modified formula of Carrillo et al., measuring the distance between the tip of the chin and the lower lobe of the ear immediately postoperatively and then at 72 h, 1 week, 15 days, and 30 days postoperatively. At each time-assessment after the surgery, the mandibular length was subtracted from the baseline length, and the result was divided by the baseline length and multiplied by 100. The baseline length used was the distance measured 2 months postoperatively.
A visual analogue scale (VAS) was used to measure pain intensity in the postoperative period: immediately after the operation and at 24 h, 72 h, and 1 week after the operation. Patients were asked about the degree of pain in each period, with 0 defined as the absence of pain and 10 as the maximum tolerable level of pain.
At each session, patients were observed regarding any possible side effects from LLLT, such as burns or erythema.
Data were entered into a Microsoft Excel spreadsheet by one person who was masked to the procedure, and data were imported into IBM SPSS Statistics Version 19 (IBM Corp., Armonk, NY, USA). The Wilcoxon signed-rank test was used to analyze the associations between the variables, comparing the laser-irradiated and non-irradiated groups. The Mann–Whitney test was used to compare the different patients with regard to the influence of the surgical procedure on swelling and pain. Values of P < 0.05 were considered statistically significant.
Ten healthy women (age range 18–54 years; mean age 30 years) underwent Le Fort I osteotomy and bilateral sagittal split osteotomy to correct dentofacial deformities. Four of the procedures involved superior maxillary repositioning and mandibular advancement, with mean maxillary impaction of 4 mm and mean mandibular advancement of 6 mm. The other six procedures involved maxillary advancement with a mean of 5 mm and mandibular setback with a mean of 3 mm. The mean duration of the surgeries was 1 h 53 min, ranging from 1 h 32 min to 2 h 8 min ( Table 1 ). There was no difference between the two types of surgery with regard to swelling ( P = 0.394) or pain ( P = 0.587) in the immediate postoperative assessment (Mann–Whitney test).
|Participant||Gender||Surgery time||Surgery type *|
|01||Female||1 h 58 min||A|
|02||Female||1 h 56 min||A|
|03||Female||1 h 32 min||A|
|04||Female||2 h 03 min||B|
|05||Female||1 h 48 min||A|
|06||Female||1 h 46 min||A|
|07||Female||1 h 57 min||B|
|08||Female||1 h 56 min||A|
|09||Female||2 h 08 min||B|
|10||Female||2 h 03 min||B|