Evaluation of Low-level Laser at Auriculotherapy Points to Reduce Postoperative Pain in Inferior Third Molar Surgery

NCT02657174 | Unknown Phase 4 DMC

• 1 other identifier: 1.100.869
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

third molar; auriculotherapy; inflammation; pain

Outcome Measures

Primary Outcomes (4)

• Change in of post-operative pain by applying a visual analog scale

  The pain will be assessed by applying a visual analog 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.

  baseline

• Change in of post-operative pain by applying a visual analog scale

  The pain will be assessed by applying a visual analog 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.

  Postoperative period: 24 hours after surgery

• Change in of post-operative pain by applying a visual analog scale

  The pain will be assessed by applying a visual analog 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.

  Postoperative period: 48 hours after surgery

• Change in of post-operative pain by applying a visual analog scale

  The pain will be assessed by applying a visual analog 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.

  Postoperative period: 7 days after surgery

Secondary Outcomes (12)

• Changes in edema

  baseline

• Changes in mouth opening assessed by the inter-incisor measurement

  baseline

• Changes in local temperature

  baseline

• Changes in edema

  Postoperative period: 24 hours after surgery

• Changes in mouth opening assessed by the inter-incisor measurement

  Postoperative period: 24 hours after surgery

Other Outcomes (8)

• Changes in systemic temperature

  baseline

• Changes in dysphagia through a numerical scale

  baseline

• Changes in systemic temperature

  Postoperative period: 24 hours after surgery

Study Arms (2)

G1- experimental active comparator group

EXPERIMENTAL

G1 - (Experimental) 40 third molars surgeries will be performed in a conventional manner. At the end of surgery low level laser in auricular acupuncture points will be applied for prevention of inflammation and pain in a split-mouth design.

Device: low level laser in auricular acupuncture points

G2- control group

PLACEBO COMPARATOR

G2 - (Control) 40 third molars surgeries will be performed in the conventional manner, identically to the G1. At the end of surgery low level laser device off in auricular acupuncture points will be applied. The patient will receive low level laser with a protection of lead in the laser nozzle, in order to block the passage of light, in the same auricular points used in G1, with split-mouth design.

Device: low level laser device off in auricular acupuncture points

Interventions

low level laser in auricular acupuncture points DEVICE

40 third molars surgeries will be performed in a conventional manner. At the end of surgery, low level laser will be applied at auricular points for prevention of inflammation and pain in the immediate post-operative period (baseline).The operator will mark the points that will be irradiated on the outer atrium of the patient with red gel pen to avoid interference with red laser (λ = 660 nm). The low level laser points will be irradiated in the same operated side.

G1- experimental active comparator group

low level laser device off in auricular acupuncture points DEVICE

40 surgeries will be performed in the conventional manner, identically to the G1. The patient will receive low level laser with a protection of lead in the laser nozzle, in order to block the passage of light, in the same auricular points used in G1.

G2- control group

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University (UNINOVE)

São Paulo, 01504-001, Brazil

RECRUITING

Related Publications (2)

• 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.

  PMID: 29920521 DERIVED

• 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.

  PMID: 27590454 DERIVED

MeSH Terms

Conditions

Pain; Inflammation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Anna Carolina RT Horliana, PhD

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Carolina RT Horliana, PhD

CONTACT

annacrth@gmail.com

Helio S Filho, Ms

CONTACT

heliosampaiofilho@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 15, 2016
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: August 1, 2017
• Last Updated: January 15, 2016

Record last verified: 2016-01

Locations

BR (1)