Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02657174
Recruitment Status : Unknown
Verified January 2016 by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : January 15, 2016
Last Update Posted : January 15, 2016
Sponsor:
Information provided by (Responsible Party):
Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho

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.

Condition or disease Intervention/treatment Phase
Pain Device: low level laser in auricular acupuncture points Device: low level laser device off in auricular acupuncture points Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Low Level Laser at the Auriculotherapy Points, in Reducing Postoperative Pain in Third Molar Surgery
Study Start Date : August 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: G1- experimental active comparator group
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
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.

Placebo Comparator: G2- control group
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
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.




Primary Outcome Measures :
  1. Change in of post-operative pain by applying a visual analog scale [ Time Frame: baseline ]
    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.

  2. Change in of post-operative pain by applying a visual analog scale [ Time Frame: Postoperative period: 24 hours after surgery ]
    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.

  3. Change in of post-operative pain by applying a visual analog scale [ Time Frame: Postoperative period: 48 hours after surgery ]
    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.

  4. Change in of post-operative pain by applying a visual analog scale [ Time Frame: Postoperative period: 7 days after surgery ]
    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.


Secondary Outcome Measures :
  1. Changes in edema [ Time Frame: baseline ]
    The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.

  2. Changes in mouth opening assessed by the inter-incisor measurement [ Time Frame: baseline ]
    For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper. During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.

  3. Changes in local temperature [ Time Frame: baseline ]
    The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).

  4. Changes in edema [ Time Frame: Postoperative period: 24 hours after surgery ]
    The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.

  5. Changes in mouth opening assessed by the inter-incisor measurement [ Time Frame: Postoperative period: 24 hours after surgery ]
    For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper. During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.

  6. Changes in local temperature [ Time Frame: Postoperative period: 24 hours after surgery ]
    The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).

  7. Changes in edema [ Time Frame: Postoperative period: 48 hours after surgery ]
    The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.

  8. Changes in mouth opening assessed by the inter-incisor measurement [ Time Frame: Postoperative period: 48 hours after surgery ]
    For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper. During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.

  9. Changes in local temperature [ Time Frame: Postoperative period: 48 hours after surgery ]
    The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).

  10. Changes in edema [ Time Frame: Postoperative period: 7 days after surgery ]
    The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion.

  11. Changes in mouth opening assessed by the inter-incisor measurement [ Time Frame: Postoperative period: 7 days after surgery ]
    For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper. During clinical examination (one week before the surgery), the patient will be asked to perform his/her maximum mouth opening, which will be measured in millimeters.

  12. Changes in local temperature [ Time Frame: Postoperative period: 7 days after surgery ]
    The local temperature will be measured in the mandibular angle region 2 cm above the lower jaw board (Safety 1st® model "No Touch Forehead", Columbus, USA).


Other Outcome Measures:
  1. Changes in systemic temperature [ Time Frame: baseline ]
    Fever (systemic) is an indicator of infection. Because in case of infection pain is usually worse, it may become a bias. The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).

  2. Changes in dysphagia through a numerical scale [ Time Frame: baseline ]
    The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.

  3. Changes in systemic temperature [ Time Frame: Postoperative period: 24 hours after surgery ]
    Fever (systemic) is an indicator of infection. Because in case of infection pain is usually worse, it may become a bias. The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).

  4. Changes in dysphagia through a numerical scale [ Time Frame: Postoperative period: 24 hours after surgery ]
    The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.

  5. Changes in systemic temperature [ Time Frame: Postoperative period: 48 hours after surgery ]
    Fever (systemic) is an indicator of infection. Because in case of infection pain is usually worse, it may become a bias. The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).

  6. Changes in dysphagia through a numerical scale [ Time Frame: Postoperative period: 48 hours after surgery ]
    The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.

  7. Changes in systemic temperature [ Time Frame: Postoperative period: 7 days after surgery ]
    Fever (systemic) is an indicator of infection. Because in case of infection pain is usually worse, it may become a bias. The temperature will be measured using a digital thermometer (Safety 1st® model "No Touch Forehead", Columbus, USA).

  8. Changes in dysphagia through a numerical scale [ Time Frame: Postoperative period: 7 days after surgery ]
    The assessment of dysphagia will be conducted through a numerical scale: 0 - indicates total absence of dysphagia; 1 - dysphagia for solid food; 2 - dysphagia for any food, liquid or solid.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657174


Contacts
Layout table for location contacts
Contact: Anna Carolina RT Horliana, PhD annacrth@gmail.com
Contact: Helio S Filho, Ms heliosampaiofilho@gmail.com

Locations
Layout table for location information
Brazil
Nove de Julho University (UNINOVE) Recruiting
São Paulo, Brazil, 01504-001
Contact: Anna Carolina RT Horliana, PhD    +5511 3385-9197    annacrth@gmail.com   
Sponsors and Collaborators
University of Nove de Julho
Investigators
Layout table for investigator information
Principal Investigator: Anna Carolina RT Horliana, PhD Nove de Julho University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Anna Carolina Ratto Tempestini Horliana, PhD, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02657174     History of Changes
Other Study ID Numbers: 1.100.869
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho:
third molar
auriculotherapy
inflammation
pain

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms