<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/NCT03264118</url>
  </required_header>
  <id_info>
    <org_study_id>BauruSchoolDentistryfurcation</org_study_id>
    <nct_id>NCT03264118</nct_id>
  </id_info>
  <brief_title>Effects of Antimicrobial Photodynamic Therapy on Regeneration of Class II Furcation Lesions</brief_title>
  <official_title>Effects of Antimicrobial Photodynamic Therapy Associated to Biomaterials on Regeneration of Class II Furcation Lesions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Geistlich Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the additional effect of antimicrobial photodynamic&#xD;
      therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone&#xD;
      and porcine collagen membrane.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2, 2017</start_date>
  <completion_date type="Actual">December 22, 2018</completion_date>
  <primary_completion_date type="Actual">December 22, 2018</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>
    <intervention_model_description>Split-mouth design. One side of mouth is test and the other is control side.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Horizontal probing depth</measure>
    <time_frame>one year</time_frame>
    <description>Measured with a periodontal probe (mm). Ideal if 0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tomographic Bone filling</measure>
    <time_frame>One year</time_frame>
    <description>Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>one year</time_frame>
    <description>Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if &lt; 2 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Attachment Level</measure>
    <time_frame>one year</time_frame>
    <description>Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if &lt; 2 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>One year</time_frame>
    <description>Visual confirmation of bleeding after probing. Ideal if not bleeding.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Periodontitis, Chronic</condition>
  <condition>Periodontal Diseases</condition>
  <condition>Periodontal Bone Loss</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Decontamination of furcation defect with scaling and root planing only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antimicrobial Photodynamic Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>Furcation treatment by scaling and root planing</description>
    <arm_group_label>Antimicrobial Photodynamic Therapy</arm_group_label>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toluidine Blue O</intervention_name>
    <description>Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.</description>
    <arm_group_label>Antimicrobial Photodynamic Therapy</arm_group_label>
    <other_name>Antimicrobial photodynamic therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of class II furcation lesion in mandibular 1st and 2nd molars&#xD;
&#xD;
          -  Mandibular 1st and 2nd molars without caries, erosion or abrasion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking habit&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Use of antibiotics in the last six months&#xD;
&#xD;
          -  Periodontal treatment in the last six months&#xD;
&#xD;
          -  Endodontic lesion&#xD;
&#xD;
          -  Systemic diseases that impair wound healing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bauru School of Dentistry</name>
      <address>
        <city>Bauru</city>
        <state>Sao Paulo</state>
        <zip>17012-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bauru School of Dentistry</name>
      <address>
        <city>Bauru</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Luchesi VH, Pimentel SP, Kolbe MF, Ribeiro FV, Casarin RC, Nociti FH Jr, Sallum EA, Casati MZ. Photodynamic therapy in the treatment of class II furcation: a randomized controlled clinical trial. J Clin Periodontol. 2013 Aug;40(8):781-8. doi: 10.1111/jcpe.12121. Epub 2013 Jun 3.</citation>
    <PMID>23731242</PMID>
  </reference>
  <reference>
    <citation>Avila-Ortiz G, De Buitrago JG, Reddy MS. Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S108-30. doi: 10.1902/jop.2015.130677.</citation>
    <PMID>25644295</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carla Andreotti Damante</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Periodontal Guided Tissue Regeneration</keyword>
  <keyword>Photochemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alveolar Bone Loss</mesh_term>
    <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>Tolonium Chloride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264118
org study id: BauruSchoolDentistryfurcation
nct id: NCT03264118
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the additional effect of antimicrobial photodynamic
      therapy regeneration treatment of mandibular furcation lesions when associated to bovine bone
      and porcine collagen membrane.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Split-mouth design. One side of mouth is test and the other is control side.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Horizontal probing depth
time frame: one year
description: Measured with a periodontal probe (mm). Ideal if 0.
measure: Tomographic Bone filling
time frame: One year
description: Complete filling of furcation defect in tomographic images. Ideal is a radiopaque image similar to neighbor bone.
measure: Probing depth
time frame: one year
description: Distance from gingival margin to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
measure: Clinical Attachment Level
time frame: one year
description: Distance from cemento-enamel junction to bottom of sulcus. Measured with a periodontal probe (mm). Ideal if < 2 mm.
measure: Bleeding on probing
time frame: One year
description: Visual confirmation of bleeding after probing. Ideal if not bleeding.
arm group label: Control
arm group type: Active Comparator
description: Decontamination of furcation defect with scaling and root planing only.
arm group label: Antimicrobial Photodynamic Therapy
arm group type: Experimental
description: Decontamination of furcation defect with scaling and root planing complemented by antimicrobial photodynamic therapy.
intervention type: Procedure
intervention name: Scaling and root planing
description: Furcation treatment by scaling and root planing
arm group label: Antimicrobial Photodynamic Therapy
arm group label: Control
intervention type: Drug
intervention name: Toluidine Blue O
description: Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
arm group label: Antimicrobial Photodynamic Therapy
other name: Antimicrobial photodynamic therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
country: Brazil
citation: Luchesi VH, Pimentel SP, Kolbe MF, Ribeiro FV, Casarin RC, Nociti FH Jr, Sallum EA, Casati MZ. Photodynamic therapy in the treatment of class II furcation: a randomized controlled clinical trial. J Clin Periodontol. 2013 Aug;40(8):781-8. doi: 10.1111/jcpe.12121. Epub 2013 Jun 3.
PMID: 23731242
citation: Avila-Ortiz G, De Buitrago JG, Reddy MS. Periodontal regeneration - furcation defects: a systematic review from the AAP Regeneration Workshop. J Periodontol. 2015 Feb;86(2 Suppl):S108-30. doi: 10.1902/jop.2015.130677.
PMID: 25644295
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carla Andreotti Damante
investigator title: Associate professor
mesh term: Alveolar Bone Loss
mesh term: Periodontitis
mesh term: Periodontal Diseases
mesh term: Chronic Periodontitis
mesh term: Tolonium Chloride
sharing ipd: No