<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/NCT03262077</url>
  </required_header>
  <id_info>
    <org_study_id>University of Nove de Julho</org_study_id>
    <nct_id>NCT03262077</nct_id>
  </id_info>
  <brief_title>Dose Parameters for Photodynamic Therapy on Periodontal Disease</brief_title>
  <official_title>Evaluation of Parameters of Tissue Dosimetry in Photodynamic Therapy for the Treatment of Periodontal Disease - Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sandra Kalil Bussadori</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as&#xD;
      an alternative to the use of antibiotics on the periodontal treatment. However, the studies&#xD;
      show several discrepancies between the parameters adopted for PDT, which makes it difficult&#xD;
      to compare the results and measure their efficacy. The objective of this research was to&#xD;
      investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal&#xD;
      disease. In order to achieve this objective, the scattering pattern of light in periodontal&#xD;
      tissue, the concentration of methylene blue in the periodontal pockets and the number of&#xD;
      viable microorganisms were evaluated. This clinical trial included 30 patients with chronic&#xD;
      periodontitis according to the eligibility criteria. The patients were in periodontal&#xD;
      treatment at the Dental Clinic at the University of Nove de Julho, where the research was&#xD;
      carried out. Three incisors from each patient were selected for the experimental procedures.&#xD;
      The pattern of light scattering was observed through intraoral photographs. A laser with&#xD;
      emission of radiation with wavelength of 660 nm and 100 mW of power was used. The&#xD;
      concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by&#xD;
      spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM&#xD;
      in two different formulation and vehicles to evaluate the drug dimerization. Then, the&#xD;
      procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5&#xD;
      min. The microbiological evaluation was performed from subgengival biofilms of the&#xD;
      periodontal pockets of the experimental sites, before and immediately after the irradiation&#xD;
      procedures.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2016</start_date>
  <completion_date type="Actual">June 26, 2017</completion_date>
  <primary_completion_date type="Actual">June 26, 2017</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial reduction</measure>
    <time_frame>48 hours after the laser irradiation procedure.</time_frame>
    <description>Count of Colony Forming Units</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>MB 1 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MB 3 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MB 5 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBS 1 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBS 3 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MBS 5 min</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylene Blue</intervention_name>
    <description>Irradiation with low-level laser for 1, 3, and 5 min</description>
    <arm_group_label>MB 1 min</arm_group_label>
    <arm_group_label>MB 3 min</arm_group_label>
    <arm_group_label>MB 5 min</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Methylene Blue Oral Product</intervention_name>
    <description>Irradiation with low-level laser for 1, 3, and 5 min</description>
    <arm_group_label>MBS 1 min</arm_group_label>
    <arm_group_label>MBS 3 min</arm_group_label>
    <arm_group_label>MBS 5 min</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with chronic periodontitis;&#xD;
&#xD;
          -  The patient should have at least 15 teeth present, with a minimum of 3 incisors with&#xD;
             depth of probing greater than 4 mm;&#xD;
&#xD;
          -  The patient should be in periodontal treatment at the Dental Clinic of the University&#xD;
             of Nove de Julho, where this research was carried out. All patients were treated&#xD;
             according to the protocol recommended by the American Academy of Periodontology;&#xD;
&#xD;
          -  Minimum age of 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  current smokers or regular smoking 12 months prior to enrollment;&#xD;
&#xD;
          -  patients with anemia,&#xD;
&#xD;
          -  patients with active cancer;&#xD;
&#xD;
          -  pregnant;&#xD;
&#xD;
          -  history of antibiotic therapy in the previous six months;&#xD;
&#xD;
          -  history of anti-inflammatory therapy in the previous three months;&#xD;
&#xD;
          -  patients with clotting disorders;&#xD;
&#xD;
          -  patients currently undergoing orthodontic treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</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>Renato Araujo Prates</investigator_full_name>
    <investigator_title>PhD.</investigator_title>
  </responsible_party>
  <keyword>photodynamic therapy</keyword>
  <keyword>periodontal disease</keyword>
  <keyword>dosimetry</keyword>
  <keyword>methylene blue</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylene Blue</mesh_term>
  </intervention_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/NCT03262077
org study id: University of Nove de Julho
nct id: NCT03262077
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as
      an alternative to the use of antibiotics on the periodontal treatment. However, the studies
      show several discrepancies between the parameters adopted for PDT, which makes it difficult
      to compare the results and measure their efficacy. The objective of this research was to
      investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal
      disease. In order to achieve this objective, the scattering pattern of light in periodontal
      tissue, the concentration of methylene blue in the periodontal pockets and the number of
      viable microorganisms were evaluated. This clinical trial included 30 patients with chronic
      periodontitis according to the eligibility criteria. The patients were in periodontal
      treatment at the Dental Clinic at the University of Nove de Julho, where the research was
      carried out. Three incisors from each patient were selected for the experimental procedures.
      The pattern of light scattering was observed through intraoral photographs. A laser with
      emission of radiation with wavelength of 660 nm and 100 mW of power was used. The
      concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by
      spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM
      in two different formulation and vehicles to evaluate the drug dimerization. Then, the
      procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5
      min. The microbiological evaluation was performed from subgengival biofilms of the
      periodontal pockets of the experimental sites, before and immediately after the irradiation
      procedures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Bacterial reduction
time frame: 48 hours after the laser irradiation procedure.
description: Count of Colony Forming Units
arm group label: MB 1 min
arm group type: Experimental
description: Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.
arm group label: MB 3 min
arm group type: Experimental
description: Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.
arm group label: MB 5 min
arm group type: Experimental
description: Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.
arm group label: MBS 1 min
arm group type: Experimental
description: Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.
arm group label: MBS 3 min
arm group type: Experimental
description: Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.
arm group label: MBS 5 min
arm group type: Experimental
description: Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.
intervention type: Drug
intervention name: Methylene Blue
description: Irradiation with low-level laser for 1, 3, and 5 min
arm group label: MB 1 min
arm group label: MB 3 min
arm group label: MB 5 min
intervention type: Drug
intervention name: Methylene Blue Oral Product
description: Irradiation with low-level laser for 1, 3, and 5 min
arm group label: MBS 1 min
arm group label: MBS 3 min
arm group label: MBS 5 min
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Renato Araujo Prates
investigator title: PhD.
mesh term: Periodontitis
mesh term: Periodontal Diseases
mesh term: Chronic Periodontitis
mesh term: Methylene Blue