Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial

Abstract

Background: A comfortable postoperative return to daily activities has increased the need to control inflammation after third molar surgery. Anti-inflammatory drugs and analgesics are not exempt from adverse effects such as allergies and chronic gastritis, and they are not without cost. The association between low-level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated. Among its advantages, we can mention the low risk of side effects, low cost and simplicity of application. The objective of this study is to evaluate the efficiency of low-level laser at auriculotherapy points in reducing postoperative pain in lower third molar surgery.

Methods/design: Ninety bilateral, symmetrical lower third molar surgeries will be performed in 45 healthy patients. Each patient will be their own control, through a split-mouth crossover study. One side of the mouth will be randomly chosen and, immediately after surgery, will be treated with low-level laser. After 21 days, the contralateral side will be operated on with low-level laser simulation used postoperatively. This regimen (laser application or not) will be repeated at 24 and 48 h after surgery. All patients will be requested to take analgesics (acetaminophen) if they have pain, i.e. in case of pain. Neither the surgeon nor the patients will know the assigned treatment. The primary variable will be postoperative pain assessed using a Visual Analog Scale, and the secondary variables will be trismus, edema, local temperature, dysphagia, presence of infection and painkiller ingestion. These variables will be assessed at baseline, 24 h, 48 h and 7 days after surgery. Blood samples for systemic inflammatory cytokine (TNF-α, IL-1, IL-6 and IL-8) analysis will be assessed at baseline and 24 h after surgery.

Discussion: Some authors believe that using a wavelength of 633 to 670 nm is a good option for laser therapy in the field of acupuncture. This wavelength can penetrate biological tissue to a depth of about 3 mm. However, for auriculotherapy points, the stimulus (mustard seeds, needles 1 to 2.5 mm) does not penetrate so deeply. For this reason, we chose a laser wavelength of 660 nm (red wavelength).

Trial registration: ClinicalTrials.gov Identifier: NCT02657174 , registered on 11 January 2016.

Keywords: Auriculotherapy; Laser; Pain; Postoperative; Third molar surgery.

Fig. 1

Auricular acupuncture points. Legend: (1) Shen Men, (2) Sympathetic (SNV), (3) Stomach, (4) Toothache 3, (5) Jaw, (6) Adrenal

Fig. 2

The criteria for the determination of edema. Legend: (I) The corner of the eye to the angle of the jaw, (II) The tragus to the labial commissure, and (III) The tragus to pogonion

Fig. 3

Flowchart presenting an overview of the study

Fig. 4

Template of recommended content for the schedule of enrollment, interventions and assessments.* Legend: *Recommended content can be displayed using various schematic formats. See SPIRIT 2013 Explanation and Elaboration for examples from protocols (Additional file 1)