<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/NCT03818906</url>
  </required_header>
  <id_info>
    <org_study_id>PDTa and reducing pain</org_study_id>
    <nct_id>NCT03818906</nct_id>
  </id_info>
  <brief_title>Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial</brief_title>
  <official_title>Efficacy of aPDT in Reducing Pain and Swelling Following Molar Extraction Surgery- Blinded Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal Fluminense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal Fluminense</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>
      This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the&#xD;
      reduction of swelling and postoperative pain in lower molar extraction procedures. This is a&#xD;
      clinical study approved by the Research Ethics Committee, which will be performed in 40&#xD;
      patients between 20 and 60 years. Patients included in the study should have at least one&#xD;
      lower molar (first or second molar) with indication of exodontia. Participants will follow&#xD;
      the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass&#xD;
      Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics;&#xD;
      immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making&#xD;
      use of medications that interfere with bone remodeling; with cysts or tumors in place.&#xD;
      Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening&#xD;
      of the flap or osteotomy were excluded from the study. After the sample calculation, forty&#xD;
      patients will be involved in this project, where forty molars (first and second molars) will&#xD;
      be extracted in the mandible, which will be randomly divided into 4 groups. The control group&#xD;
      (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way,&#xD;
      without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients&#xD;
      where 10 molars will be extracted and immediately after extraction, the fresh sockets will&#xD;
      receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will&#xD;
      present 10 patients, where 10 molars will be extracted that immediately after the exodontia,&#xD;
      the fresh socket will receive local application of infrared in the outer vestibular portion.&#xD;
      Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be&#xD;
      extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity&#xD;
      will be assessed through a visual analogue scale and swelling assessed by measuring a&#xD;
      perimeter between the tragus, the base of the jaw and the commissure of the lips. The data&#xD;
      will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days&#xD;
      postoperatively.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction of postoperative pain</measure>
    <time_frame>Pain evaluation will be performed prior to the surgical procedure and 7 days after</time_frame>
    <description>Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of postoperative pain in lower molar extraction procedures. Pain intensity will be assessed through a visual analogue scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>reduction of swelling</measure>
    <time_frame>The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.</time_frame>
    <description>Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of swelling. Swelling evaluated through the measurement of a perimeter between the tragus, the base of the mandible and the commissure of the lips</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Tooth Extraction Status Nos</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with first or second molars where the extractions will be performed in a conventional way without any additional local treatment to be done in the alveolus. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with first or second molars where the extractions will be performed in a conventional way and after extraction will be performed aPDT inside the alveolus.The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia the approaches from the previous groups (Test Group 1 and 2 (aPDT + infrared) will be done. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Molar extraction - Control Group</intervention_name>
    <description>The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>aPDT + Molar Extraction - Test Group 1</intervention_name>
    <description>The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT.</description>
    <arm_group_label>Test Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Infrared + Molar Extraction - Test Group 2</intervention_name>
    <description>The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive local application of infrared in vestibular external portion</description>
    <arm_group_label>Test Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>aPDT + Infrared + Molar Extraction - Test Group 3</intervention_name>
    <description>The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT and after that will receive local application of infrared in vestibular external portion.</description>
    <arm_group_label>Test Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients without systemic limitations that indicate surgical procedures with&#xD;
             cooperative behavior&#xD;
&#xD;
          -  with full awareness and approval of the guidelines listed in the free and clarified&#xD;
             term proposed by the research&#xD;
&#xD;
          -  present compromised posterior and inferior teeth requiring exodontia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients with obesity (Body Mass Index - BMI)&#xD;
&#xD;
          -  Make use of any activity smokers and ex smoker to 6 months&#xD;
&#xD;
          -  Diabetics&#xD;
&#xD;
          -  Immunosuppressed&#xD;
&#xD;
          -  in osteoporosis&#xD;
&#xD;
          -  making use of antimicrobials in the last 3 months&#xD;
&#xD;
          -  making use of medications that interfere with bone remodeling&#xD;
&#xD;
          -  with cysts or tumors in place&#xD;
&#xD;
          -  Surgical procedures that exceeded the clinical time of 30 minutes and / or required&#xD;
             opening of the flap or osteotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Livia Antunes, PhD</name>
      <address>
        <city>Nova Friburgo</city>
        <state>Rio De Janeiro</state>
        <zip>28625650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>November 27, 2022</last_update_submitted>
  <last_update_submitted_qc>November 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal Fluminense</investigator_affiliation>
    <investigator_full_name>Livia Azeredo Alves Antunes</investigator_full_name>
    <investigator_title>Professor Lívia Azeredo Alves Antunes</investigator_title>
  </responsible_party>
  <keyword>Photochemotherapy</keyword>
  <!-- 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/NCT03818906
org study id: PDTa and reducing pain
nct id: NCT03818906
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) on the
      reduction of swelling and postoperative pain in lower molar extraction procedures. This is a
      clinical study approved by the Research Ethics Committee, which will be performed in 40
      patients between 20 and 60 years. Patients included in the study should have at least one
      lower molar (first or second molar) with indication of exodontia. Participants will follow
      the exclusion criteria: pregnant or breastfeeding women; patients with obesity (Body Mass
      Index - BMI); make use of any activity smokers and ex smoker to 6 months; diabetics;
      immunosuppressed; in osteoporosis; making use of antimicrobials in the last 3 months; making
      use of medications that interfere with bone remodeling; with cysts or tumors in place.
      Surgical procedures that exceeded the clinical time of 30 minutes and / or required opening
      of the flap or osteotomy were excluded from the study. After the sample calculation, forty
      patients will be involved in this project, where forty molars (first and second molars) will
      be extracted in the mandible, which will be randomly divided into 4 groups. The control group
      (C.G), will contain 10 patients, where 10 molars will be extracted in a conventional way,
      without any additional treatment to be done. Test group 1 (T.G1) will contain 10 patients
      where 10 molars will be extracted and immediately after extraction, the fresh sockets will
      receive in their inner portion a local application of aPDT. The test group 2 (T.G2) will
      present 10 patients, where 10 molars will be extracted that immediately after the exodontia,
      the fresh socket will receive local application of infrared in the outer vestibular portion.
      Finally, Test Group 3 (T.G3), will be composed of 10 patients, where 10 molars will be
      extracted, joining the approaches of the previous groups (aPDT + infrared). Pain intensity
      will be assessed through a visual analogue scale and swelling assessed by measuring a
      perimeter between the tragus, the base of the jaw and the commissure of the lips. The data
      will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days
      postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: reduction of postoperative pain
time frame: Pain evaluation will be performed prior to the surgical procedure and 7 days after
description: Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of postoperative pain in lower molar extraction procedures. Pain intensity will be assessed through a visual analogue scale
measure: reduction of swelling
time frame: The data will be collected in four moments: before the surgery, 72 hours, 7 days and 30 days postoperatively.
description: Evaluate Antimicrobial photodynamic therapy (aPDT)on the reduction of swelling. Swelling evaluated through the measurement of a perimeter between the tragus, the base of the mandible and the commissure of the lips
arm group label: Control Group
arm group type: Active Comparator
description: Patients with first or second molars where the extractions will be performed in a conventional way without any additional local treatment to be done in the alveolus. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
arm group label: Test Group 1
arm group type: Experimental
description: Patients with first or second molars where the extractions will be performed in a conventional way and after extraction will be performed aPDT inside the alveolus.The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
arm group label: Test Group 2
arm group type: Experimental
description: Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia, the fresh socket will receive local application of infrared in the outer vestibular portion. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
arm group label: Test Group 3
arm group type: Experimental
description: Patients with first or second molars where the extractions will be performed in a conventional way and immediately after the exodontia the approaches from the previous groups (Test Group 1 and 2 (aPDT + infrared) will be done. The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th. Subjective evaluation of swelling in 48 hours and 7th day.
intervention type: Procedure
intervention name: Molar extraction - Control Group
description: The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.
arm group label: Control Group
intervention type: Procedure
intervention name: aPDT + Molar Extraction - Test Group 1
description: The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT.
arm group label: Test Group 1
intervention type: Procedure
intervention name: Infrared + Molar Extraction - Test Group 2
description: The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive local application of infrared in vestibular external portion
arm group label: Test Group 2
intervention type: Procedure
intervention name: aPDT + Infrared + Molar Extraction - Test Group 3
description: The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT and after that will receive local application of infrared in vestibular external portion.
arm group label: Test Group 3
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal Fluminense
investigator full name: Livia Azeredo Alves Antunes
investigator title: Professor Lívia Azeredo Alves Antunes