Clinical trial NCT02657174: Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery
Official title: Effectiveness of Low Level Laser at the Auriculotherapy Points, in Reducing Postoperative Pain in Third Molar Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: third molar
auriculotherapy
inflammation
pain
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The association between low level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated or to reduce the quantity of these postoperative medications. 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. Eighty third molars surgeries will be performed in 40 healthy patients by a split-mouth design. Immediately after surgery, each side of the patient's mouth will be randomly treated with different regimens in a double-blind design: low level laser in auricular acupuncture points or simulation of its use. This treatment will be performed at 24 and 48 hours after surgery. The primary variable is the post-operative pain. The secondary variables are trismus, edema and local temperature. They will be assessed at baseline, 24 hours, 48 hours and seven days after surgery.The blood samples for analysis of systemic inflammatory cytokines (TNF-α, interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours after surgery.

Detailed description: Third molar surgery is the most common surgical procedure in dentistry. A comfortable, fast postoperative return to daily activities has increased the need to control inflammation and its signs and symptoms, such as pain and edema. Anti-inflammatories and analgesics have been used for this purpose, but they are not exempt from adverse effects, such as allergies and chronic gastritis, not to mention the medicine costs. The association between low level laser and auricular acupuncture can be an alternative when conventional drugs are contraindicated or to reduce the quantity of these postoperative medications. Among the 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. Eighty bilateral, symmetrical lower third molars surgeries will be performed in 40 healthy patients. Each patient will be his or her own control, through a split-mouth technique. Immediately after surgery, each side of the patient's mouth will be randomly treated with different regimens in a double-blind design: low level laser in auricular acupuncture points or simulation of its use (contralateral side). This regimen will be repeated at 24 and 48 hours after surgery. All patients will receive the same medication (paracetamol) and will be oriented to take it only if they have pain. Neither the surgeon nor the patients know the assigned treatment. The primary variable is the post-operative pain assessed by visual analog scale, and the secondary variables are trismus, edema, local temperature. Dysphagia and presence of infection (systemic temperature, lymphadenopathy) will also be evaluated. These variables will be assessed at baseline, 24 hours, 48 hours and seven days after surgery. All adverse effects will be recorded. The blood samples for analysis of systemic inflammatory cytokines (TNF-α, interleukin 1, interleukin 6 and interleukin 8) will be assessed at baseline and 24 hours after surgery.

Eligibility criteria: Inclusion Criteria:

* healthy patients (negative medical history)
* teeth in position II B according classification of Pell and Gregory
* third molar with extraction indication (recurrent infections, poor position, orthodontic indication) with professional statement in writing.

Exclusion Criteria:

* allergic to any drug used in the research (e.g.paracetamol)
* pregnant or breastfeeding women
* smokers
* patients submitted to radiotherapy in the head and neck, systemic or local infection (e.g., pericoronitis or periodontal abscess)
* patients with injuries or radiolucent images associated with the third molar
* patients who have used anti-inflammatory drugs in the last three months
* drug users
* patients who present any complications during surgery (e.g., bleeding, surgical difficulty, surgery longer than 90 minutes).

Primary outcomes:
measure: Change in of post-operative pain by applying a visual analog scale
timeFrame: baseline
measure: Change in of post-operative pain by applying a visual analog scale
timeFrame: Postoperative period: 24 hours after surgery
measure: Change in of post-operative pain by applying a visual analog scale
timeFrame: Postoperative period: 48 hours after surgery
measure: Change in of post-operative pain by applying a visual analog scale
timeFrame: Postoperative period: 7 days after surgery
Secondary outcomes:
measure: Changes in edema
timeFrame: baseline
measure: Changes in mouth opening assessed by the inter-incisor measurement
timeFrame: baseline
measure: Changes in local temperature
timeFrame: baseline
measure: Changes in edema
timeFrame: Postoperative period: 24 hours after surgery
measure: Changes in mouth opening assessed by the inter-incisor measurement
timeFrame: Postoperative period: 24 hours after surgery
measure: Changes in local temperature
timeFrame: Postoperative period: 24 hours after surgery
measure: Changes in edema
timeFrame: Postoperative period: 48 hours after surgery
measure: Changes in mouth opening assessed by the inter-incisor measurement
timeFrame: Postoperative period: 48 hours after surgery
measure: Changes in local temperature
timeFrame: Postoperative period: 48 hours after surgery
measure: Changes in edema
timeFrame: Postoperative period: 7 days after surgery
measure: Changes in mouth opening assessed by the inter-incisor measurement
timeFrame: Postoperative period: 7 days after surgery
measure: Changes in local temperature
timeFrame: Postoperative period: 7 days after surgery
Other outcomes:
measure: Changes in systemic temperature
timeFrame: baseline
measure: Changes in dysphagia through a numerical scale
timeFrame: baseline
measure: Changes in systemic temperature
timeFrame: Postoperative period: 24 hours after surgery
measure: Changes in dysphagia through a numerical scale
timeFrame: Postoperative period: 24 hours after surgery
measure: Changes in systemic temperature
timeFrame: Postoperative period: 48 hours after surgery
measure: Changes in dysphagia through a numerical scale
timeFrame: Postoperative period: 48 hours after surgery
measure: Changes in systemic temperature
timeFrame: Postoperative period: 7 days after surgery
measure: Changes in dysphagia through a numerical scale
timeFrame: Postoperative period: 7 days after surgery
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University (UNINOVE)
Study officials:
affiliation: Nove de Julho University
name: Anna Carolina RT Horliana, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sampaio-Filho H, Bussadori SK, Goncalves MLL, da Silva DFT, Borsatto MC, Tortamano IP, Longo PL, Pavani C, Fernandes KPS, Mesquita-Ferrari RA, Horliana ACRT. Low-level laser treatment applied at auriculotherapy points to reduce postoperative pain in third molar surgery: A randomized, controlled, single-blinded study. PLoS One. 2018 Jun 19;13(6):e0197989. doi: 10.1371/journal.pone.0197989. eCollection 2018.
citation: Sampaio-Filho H, Sotto-Ramos J, Pinto EH, Cabral MR, Longo PL, Tortamano IP, Marcos RL, Silva DF, Pavani C, Horliana AC. Evaluation of low-level laser at auriculotherapy points to reduce postoperative pain in inferior third molar surgery: study protocol for a randomized controlled trial. Trials. 2016 Sep 2;17(1):432. doi: 10.1186/s13063-016-1540-9.