<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03814525</url>
  </required_header>
  <id_info>
    <org_study_id>Eduardo</org_study_id>
    <nct_id>NCT03814525</nct_id>
  </id_info>
  <brief_title>Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction</brief_title>
  <official_title>Evaluation of Photobiomodulation Effects on Pain, Edema, Paresthesia and Bone Regeneration After Maxillar Surgical Disjunction: Double Blind, Randomized and Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the present study will be to evaluate the efficacy of photobiomodulation&#xD;
      (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life&#xD;
      arising after maxillar surgical disjunction (MSD). A randomized, double-blind,&#xD;
      placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search&#xD;
      the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex&#xD;
      to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will&#xD;
      be conducted by three oral maxillofacial surgeons who will perform all surgical procedures,&#xD;
      two examiners (who will perform pre and post-surgical evaluations, blinded to the&#xD;
      experimental group) and another researcher who will perform the LED application. Before the&#xD;
      surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity&#xD;
      and the evaluation of the level of anxiety of all the participants will be carried out.&#xD;
      Immediately after the surgeries, the participant will be inserted into the placebo group or&#xD;
      the LED group, according to block randomization defined previously. In the LED group, the&#xD;
      participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and&#xD;
      an intraoral one (660 nm with 2J per point) and in the control group the participants will be&#xD;
      attended in the same way, but with the LED devices kept off. The applications will be in the&#xD;
      immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the&#xD;
      surgeries, when the evaluations will also be performed. Facial measurements, extra and&#xD;
      intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data&#xD;
      regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis;&#xD;
      dysphagia; systemic and superficial temperature in the operated region; use of analgesics and&#xD;
      anti-inflammatories; anxiety and impact of oral health on the participants' quality of life&#xD;
      will be computed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Anticipated">February 28, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The pre and postoperative evaluations will be done by two examiners who will not be aware of the group in which each patient is allocated. The information that will be obtained in the evaluations will be noted in the clinical evaluation card. Participants will not be aware of whether or not they have received the FBM, since the person responsible for the application will position the equipment in the irradiation locations in all participants and will only trigger the light when and where predicted in the specific experimental group. The characteristic sound of the device will be triggered by recording in the control group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>A Visual Analog Scale (VAS) will be printed on the patient evaluation form and the subjects will be instructed by the evaluator to mark a point in the line of 10 cm, indicating the intensity of their pain after 1,2, 7 and 14 days of the surgeries. For the NRS-101 scale, the evaluators will ask patients to assign a number between 0 (no pain) and 100 (worst possible pain) that best represents the pain they are currently experiencing after 1, 2, 7 and 14 days of surgeries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Edema</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Using a flexible plastic millimeter tape (0.5mm precision), five facial measurements will be taken corresponding to the distances between the points listed below as described by Ristow et al. (2013).&#xD;
Line A - posterior tragus point to the most lateral point of the labial commissure Line B - tragus posterior point to pogonium Line C - posterior tragus point to the lateral corner of the eye Line D - lateral corner of eye to lowest point of jaw angle Line E - lower point of the angle of the mandible (gonio) to the middle of the nasal bone</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in intra and extraoral sensitivity</measure>
    <time_frame>After 7, 30, 60, 90 and 120 days of surgeries.</time_frame>
    <description>The evaluation of extra and intraoral sensitivity will be performed in 6 regions: below the lower eyelid, cheek, nose wing, upper lip, oral buccal mucosa and oral palatal mucosa on both sides. The tests will be performed sequentially, with a 2 to 3 minute interval between each. The participant will receive instructions on the tests that will be initially performed on the back of his hand so he can become familiar.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in postoperative bone repair</measure>
    <time_frame>After 30, 60, 90 and 120 days of surgeries.</time_frame>
    <description>The optical density (OD) of the alveolar bone in the anterior region of the palatine suture, in each experimental period, will be calculated and compared with that obtained in the preoperative radiographic examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in temperature</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>The temperature will be measured locally (on both sides) and systemically. Local measurements will be measured using an infrared digital thermometer in the right and left cheek region and anterior nasal spine. The systemic temperature will be measured in the frontal region of the patient in the median position 3 cm above the glabella.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of headache</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Patients will answer yes or not, to indicate whether they had headaches in the examined periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of bruises</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes on the right and left side. The measure will be performed by the examiners who will classify the occurrence of this result into four categories: 1) none; 2) larger diameter smaller than 4 cm; 3) larger diameter between 4 and 10 cm, and 4) larger diameter greater than 10 cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of otalgia</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Patients will answer yes or not, to indicate whether they had otalgia in the examined periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of nausea</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Patients will answer yes or not, to indicate whether they had nausea in the examined periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of nasolacrimation</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Patients will answer yes or not, to indicate whether they had nasolacrimation in the examined periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of nose bleeding</measure>
    <time_frame>After 1, 2, 7 and 14 days of surgeries.</time_frame>
    <description>Patients will answer yes or not, to indicate whether they had nose bleeding in the examined periods.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of dysphagia</measure>
    <time_frame>After 7 and 30 days of surgeries.</time_frame>
    <description>The evaluation of dysphagia will be performed after 7 and 30 days by questioning and classification on a numerical scale in which:&#xD;
(0) total absence of dysphagia;&#xD;
dysphagia to solid foods&#xD;
dysphagia to any liquid or solid food</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative quality of life</measure>
    <time_frame>After 7 and 30 days of surgeries.</time_frame>
    <description>Patients will answer yes or no to the following questions:&#xD;
Are you maintaining your social activities normally?&#xD;
Are you working / studying normally?&#xD;
Are you maintaining your normal diet?&#xD;
Do you have difficulty swallowing because of the surgery?&#xD;
Do you have difficulty in tasting food?&#xD;
Can you chew on the sides?&#xD;
Do you have trouble sleeping because of the surgery?&#xD;
Did you have trouble speaking because of the surgery?&#xD;
Has your appearance changed because of the surgery?&#xD;
Do you feel sick from the surgery?</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Maxillary Diseases</condition>
  <arm_group>
    <arm_group_label>Photobiomodulation group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Photobiomodulation</intervention_name>
    <description>PBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.</description>
    <arm_group_label>Photobiomodulation group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Placebo Photobiomodulation</intervention_name>
    <description>The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Transverse maxillary deficiency ˃ of 5 mm with bilateral posterior crossbite and&#xD;
             indication for surgical maxillary disjunction.&#xD;
&#xD;
          -  Agree to participate in the study after reading and signing the Term of Consent for&#xD;
             Participation in Clinical Research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Transverse maxilla deficiency, with unilateral posterior crossbite.&#xD;
&#xD;
          -  Local or systemic alterations that contraindicate surgical intervention or hinder the&#xD;
             postoperative period.&#xD;
&#xD;
          -  Smokers.&#xD;
&#xD;
          -  Display photo sensitivity history.&#xD;
&#xD;
          -  Possess systemic diseases, chronic pain or neurological and psychiatric disorders.&#xD;
&#xD;
          -  Have been using anti-inflammatories, analgesics or bisphosphonates in the past 15&#xD;
             days.&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Breastfeeding.&#xD;
&#xD;
          -  Participants who present any type of complication during surgery (hemorrhage,&#xD;
             operative difficulty), as these cases will not be in the expected pattern for these&#xD;
             surgeries. These data will not be part of the statistical analysis but will be&#xD;
             described and discussed, as well as possible adverse effects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Conjunto Hospitalar do Mandaqui</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>02402-500</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandra K Bussadori, PhD</last_name>
      <phone>+55112281-5000</phone>
      <email>sandra.skb@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Maxillary Diseases</mesh_term>
    <mesh_term>Paresthesia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814525
org study id: Eduardo
nct id: NCT03814525
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the present study will be to evaluate the efficacy of photobiomodulation
      (PBM) with LED in pain control, facial edema, paresthesia, bone repair and quality of life
      arising after maxillar surgical disjunction (MSD). A randomized, double-blind,
      placebo-controlled clinical trial involving 72 participants aged 18 to 45 years, who search
      the Service of Oral Maxillofacial Surgery and Traumatology of the Mandaqui Hospital Complex
      to undergo MSD, attend to the eligibility criteria and agree to participate. Surgeries will
      be conducted by three oral maxillofacial surgeons who will perform all surgical procedures,
      two examiners (who will perform pre and post-surgical evaluations, blinded to the
      experimental group) and another researcher who will perform the LED application. Before the
      surgeries, facial measures, radiographic examinations, tests of facial and oral sensitivity
      and the evaluation of the level of anxiety of all the participants will be carried out.
      Immediately after the surgeries, the participant will be inserted into the placebo group or
      the LED group, according to block randomization defined previously. In the LED group, the
      participants will receive PBM with an extraoral device (660 and 850 nm with 6J per point) and
      an intraoral one (660 nm with 2J per point) and in the control group the participants will be
      attended in the same way, but with the LED devices kept off. The applications will be in the
      immediate postoperative period, 1, 2, 7, 14, 30, 60, 90 and 120 days after the end of the
      surgeries, when the evaluations will also be performed. Facial measurements, extra and
      intraoral sensitivity, pain and bone repair will be evaluated. Secondarily, the data
      regarding the occurrence of headache; otalgia; nausea; bruise; nasolacrimation; epistaxis;
      dysphagia; systemic and superficial temperature in the operated region; use of analgesics and
      anti-inflammatories; anxiety and impact of oral health on the participants' quality of life
      will be computed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The pre and postoperative evaluations will be done by two examiners who will not be aware of the group in which each patient is allocated. The information that will be obtained in the evaluations will be noted in the clinical evaluation card. Participants will not be aware of whether or not they have received the FBM, since the person responsible for the application will position the equipment in the irradiation locations in all participants and will only trigger the light when and where predicted in the specific experimental group. The characteristic sound of the device will be triggered by recording in the control group.
measure: Change in Pain
time frame: After 1, 2, 7 and 14 days of surgeries.
description: A Visual Analog Scale (VAS) will be printed on the patient evaluation form and the subjects will be instructed by the evaluator to mark a point in the line of 10 cm, indicating the intensity of their pain after 1,2, 7 and 14 days of the surgeries. For the NRS-101 scale, the evaluators will ask patients to assign a number between 0 (no pain) and 100 (worst possible pain) that best represents the pain they are currently experiencing after 1, 2, 7 and 14 days of surgeries.
measure: Change in Edema
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Using a flexible plastic millimeter tape (0.5mm precision), five facial measurements will be taken corresponding to the distances between the points listed below as described by Ristow et al. (2013).
Line A - posterior tragus point to the most lateral point of the labial commissure Line B - tragus posterior point to pogonium Line C - posterior tragus point to the lateral corner of the eye Line D - lateral corner of eye to lowest point of jaw angle Line E - lower point of the angle of the mandible (gonio) to the middle of the nasal bone
measure: Change in intra and extraoral sensitivity
time frame: After 7, 30, 60, 90 and 120 days of surgeries.
description: The evaluation of extra and intraoral sensitivity will be performed in 6 regions: below the lower eyelid, cheek, nose wing, upper lip, oral buccal mucosa and oral palatal mucosa on both sides. The tests will be performed sequentially, with a 2 to 3 minute interval between each. The participant will receive instructions on the tests that will be initially performed on the back of his hand so he can become familiar.
measure: Change in postoperative bone repair
time frame: After 30, 60, 90 and 120 days of surgeries.
description: The optical density (OD) of the alveolar bone in the anterior region of the palatine suture, in each experimental period, will be calculated and compared with that obtained in the preoperative radiographic examination.
measure: Change in temperature
time frame: After 1, 2, 7 and 14 days of surgeries.
description: The temperature will be measured locally (on both sides) and systemically. Local measurements will be measured using an infrared digital thermometer in the right and left cheek region and anterior nasal spine. The systemic temperature will be measured in the frontal region of the patient in the median position 3 cm above the glabella.
measure: Presence of headache
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Patients will answer yes or not, to indicate whether they had headaches in the examined periods.
measure: Presence of bruises
time frame: After 1, 2, 7 and 14 days of surgeries.
description: The presence of hematoma/ecchymosis will be evaluated by measuring the largest diameter of the colorimetric changes on the right and left side. The measure will be performed by the examiners who will classify the occurrence of this result into four categories: 1) none; 2) larger diameter smaller than 4 cm; 3) larger diameter between 4 and 10 cm, and 4) larger diameter greater than 10 cm.
measure: Presence of otalgia
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Patients will answer yes or not, to indicate whether they had otalgia in the examined periods.
measure: Presence of nausea
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Patients will answer yes or not, to indicate whether they had nausea in the examined periods.
measure: Presence of nasolacrimation
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Patients will answer yes or not, to indicate whether they had nasolacrimation in the examined periods.
measure: Presence of nose bleeding
time frame: After 1, 2, 7 and 14 days of surgeries.
description: Patients will answer yes or not, to indicate whether they had nose bleeding in the examined periods.
measure: Presence of dysphagia
time frame: After 7 and 30 days of surgeries.
description: The evaluation of dysphagia will be performed after 7 and 30 days by questioning and classification on a numerical scale in which:
(0) total absence of dysphagia;
dysphagia to solid foods
dysphagia to any liquid or solid food
measure: Postoperative quality of life
time frame: After 7 and 30 days of surgeries.
description: Patients will answer yes or no to the following questions:
Are you maintaining your social activities normally?
Are you working / studying normally?
Are you maintaining your normal diet?
Do you have difficulty swallowing because of the surgery?
Do you have difficulty in tasting food?
Can you chew on the sides?
Do you have trouble sleeping because of the surgery?
Did you have trouble speaking because of the surgery?
Has your appearance changed because of the surgery?
Do you feel sick from the surgery?
arm group label: Photobiomodulation group
arm group type: Active Comparator
description: PBM will be applied after the surgeries with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.
arm group label: Control group
arm group type: Placebo Comparator
description: Participants will be attended in the same way as the PBM group. The person who is responsible for the application of the PMB will simulate the irradiations by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off.
intervention type: Radiation
intervention name: Photobiomodulation
description: PBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.
arm group label: Photobiomodulation group
intervention type: Radiation
intervention name: Placebo Photobiomodulation
description: The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Principal Investigator
mesh term: Maxillary Diseases
mesh term: Paresthesia