<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/NCT01670305</url>
  </required_header>
  <id_info>
    <org_study_id>0272.0.251.000-10</org_study_id>
    <nct_id>NCT01670305</nct_id>
  </id_info>
  <brief_title>Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis</brief_title>
  <official_title>Photodynamic Therapy and Periodontal Therapy. A Clinical, Microbiological and Immunoenzymatic Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Paulista University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Paulista University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Residual pockets and furcation defects are challenging sites that require additional&#xD;
      periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic&#xD;
      therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT&#xD;
      in association with scaling and root planing (SRP) in class II furcation lesions with probing&#xD;
      pocket depth (PPD) &gt;5mm and bleeding on probing (BoP). A blind randomized controlled clinical&#xD;
      trial was conducted in subjects presenting at least three residual pockets in single root&#xD;
      teeth and subjects with at least one molar presenting class II furcation defect. To evaluate&#xD;
      the effect of a single PDT as monotherapy in residual pockets, the selected sites were&#xD;
      assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of&#xD;
      PDT in association with SRP in class II furcation lesions, the selected sites were assigned&#xD;
      to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed&#xD;
      at baseline, 3 and 6 months post-therapies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Residual pockets and class II furcation lesions are challenging sites that require additional&#xD;
      periodontal therapy. The aims of this study were to evaluate:&#xD;
&#xD;
      1) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2)&#xD;
      the effect of PDT in association with SRP in class II furcation lesions.&#xD;
&#xD;
      A blind randomized controlled clinical trial was conducted in subjects presenting at least&#xD;
      three residual pockets in single root teeth and subjects with at least one molar presenting&#xD;
      class II furcation involvement.&#xD;
&#xD;
      To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites&#xD;
      were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP&#xD;
      alone.&#xD;
&#xD;
      To evaluate the effect of PDT in association with SRP in class II furcation lesions, the&#xD;
      selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological,&#xD;
      immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the&#xD;
      gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS)&#xD;
      and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">May 2011</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Clinical attachment level at 3 and 6 months.</measure>
    <time_frame>baseline, 3 and 6 months post-therapies</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing Pocket depth</measure>
    <time_frame>baseline, 3 and 6 months post-therapies.</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Periodontal Disease</condition>
  <arm_group>
    <arm_group_label>Residual pocket - PDT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photosensitizer plus diiodo laser</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Residual pocket - Photosensitizer</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Photosensitizer alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Residual pocket - SRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>scaling and root planing alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Furcation - PDT+SRP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Photosensitizer plus diiodo laser associated with scaling and root planing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Furcation - SRP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Photosensitizer associated with scaling and root planing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Residual pockets will be treated by laser + photosensitizer</intervention_name>
    <description>Experimental group: Residual pockets will be treated by laser + photosensitizer</description>
    <arm_group_label>Residual pocket - PDT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Residual pockets will be treated only photosensitizer</intervention_name>
    <description>Placebo Comparator: Residual pockets will be treated only photosensitizer</description>
    <arm_group_label>Residual pocket - Photosensitizer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Residual pockets will be treated scaling and root planing</intervention_name>
    <description>Active Comparator: Residual pockets will be treated scaling and root planing</description>
    <arm_group_label>Residual pocket - SRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laser + photosensitizer associated with scaling and root planing</intervention_name>
    <description>Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing</description>
    <arm_group_label>Furcation - PDT+SRP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>furcation defects will be treated by scaling and root planing</intervention_name>
    <description>Active Comparator: furcation defects will be treated by scaling and root planing</description>
    <arm_group_label>Furcation - SRP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of chronic periodontitis (according to the criteria of the 1999&#xD;
             international classification)&#xD;
&#xD;
          -  at least three contralateral single rooted teeth with residual PPD &gt; 5mm with bleeding&#xD;
             on probing (BoP) in supportive periodontal therapy or with at least one molar&#xD;
             presenting class II furcation defect.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactation&#xD;
&#xD;
          -  current smoking and smoking within the past 10 years&#xD;
&#xD;
          -  antibiotic therapies in the previous 6 months&#xD;
&#xD;
          -  use of mouth rinses containing antimicrobials in the preceding 2 months&#xD;
&#xD;
          -  systemic conditions that could affect the progression of periodontitis&#xD;
&#xD;
          -  orthodontic appliances&#xD;
&#xD;
          -  use of long-term administration of anti-inflammatory and immunosuppressive medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>School of dentistry - Paulista University UNIP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www3.unip.br/default.asp</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>June 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>September 10, 2013</last_update_submitted>
  <last_update_submitted_qc>September 10, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Paulista University</investigator_affiliation>
    <investigator_full_name>Marcio Zaffalon Casati</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Photosensitizing Agents</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/NCT01670305
org study id: 0272.0.251.000-10
nct id: NCT01670305
lead sponsor: 
has dmc: Yes
Residual pockets and furcation defects are challenging sites that require additional
      periodontal therapy. The aim of this study is evaluate 1)the effect of a single photodynamic
      therapy (PDT) as monotherapy residual pockets in single rooted teeth and 2) the effect of PDT
      in association with scaling and root planing (SRP) in class II furcation lesions with probing
      pocket depth (PPD) >5mm and bleeding on probing (BoP). A blind randomized controlled clinical
      trial was conducted in subjects presenting at least three residual pockets in single root
      teeth and subjects with at least one molar presenting class II furcation defect. To evaluate
      the effect of a single PDT as monotherapy in residual pockets, the selected sites were
      assigned to receive: PDT alone, photosensitizer alone or SRP alone. To evaluate the effect of
      PDT in association with SRP in class II furcation lesions, the selected sites were assigned
      to PDT+SRP or SRP alone. Clinical, microbiological and immunoenzymatic analyses were assessed
      at baseline, 3 and 6 months post-therapies.
Residual pockets and class II furcation lesions are challenging sites that require additional
      periodontal therapy. The aims of this study were to evaluate:

      1) the effect of a single PDT as monotherapy residual pockets in single rooted teeth and 2)
      the effect of PDT in association with SRP in class II furcation lesions.

      A blind randomized controlled clinical trial was conducted in subjects presenting at least
      three residual pockets in single root teeth and subjects with at least one molar presenting
      class II furcation involvement.

      To evaluate the effect of a single PDT as monotherapy in residual pockets, the selected sites
      were assigned to receive one of following therapies: PDT alone, photosensitizer alone or SRP
      alone.

      To evaluate the effect of PDT in association with SRP in class II furcation lesions, the
      selected sites were assigned to receive PDT+SRP or SRP alone. Microbiological,
      immunoenzymatic analyses and clinical parameters: probing pocket depth (PPD), position of the
      gingival margin (PGM), relative clinical attachment level (RCAL), full mouth plaque (FMPS)
      and bleeding score (FMBS), will be assessed at baseline,3 and 6 months post-therapies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in Clinical attachment level at 3 and 6 months.
time frame: baseline, 3 and 6 months post-therapies
measure: Probing Pocket depth
time frame: baseline, 3 and 6 months post-therapies.
arm group label: Residual pocket - PDT
arm group type: Experimental
description: Photosensitizer plus diiodo laser
arm group label: Residual pocket - Photosensitizer
arm group type: Placebo Comparator
description: Photosensitizer alone
arm group label: Residual pocket - SRP
arm group type: Active Comparator
description: scaling and root planing alone
arm group label: Furcation - PDT+SRP
arm group type: Experimental
description: Photosensitizer plus diiodo laser associated with scaling and root planing
arm group label: Furcation - SRP
arm group type: Active Comparator
description: Photosensitizer associated with scaling and root planing
intervention type: Procedure
intervention name: Residual pockets will be treated by laser + photosensitizer
description: Experimental group: Residual pockets will be treated by laser + photosensitizer
arm group label: Residual pocket - PDT
intervention type: Procedure
intervention name: Residual pockets will be treated only photosensitizer
description: Placebo Comparator: Residual pockets will be treated only photosensitizer
arm group label: Residual pocket - Photosensitizer
intervention type: Procedure
intervention name: Residual pockets will be treated scaling and root planing
description: Active Comparator: Residual pockets will be treated scaling and root planing
arm group label: Residual pocket - SRP
intervention type: Procedure
intervention name: laser + photosensitizer associated with scaling and root planing
description: Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing
arm group label: Furcation - PDT+SRP
intervention type: Procedure
intervention name: furcation defects will be treated by scaling and root planing
description: Active Comparator: furcation defects will be treated by scaling and root planing
arm group label: Furcation - SRP
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
url: http://www3.unip.br/default.asp
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Paulista University
investigator full name: Marcio Zaffalon Casati
investigator title: Professor
mesh term: Periodontal Diseases
mesh term: Photosensitizing Agents