<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/NCT03770819</url>
  </required_header>
  <id_info>
    <org_study_id>KIDSperio-PDT</org_study_id>
    <nct_id>NCT03770819</nct_id>
  </id_info>
  <brief_title>PDT As An Adjunct To SRP In The Management of Chronic Periodontitis</brief_title>
  <official_title>Photodynamic Therapy Using Zinc Oxide Photosensitizer As An Adjunct To Scaling And Root Planing In The Management Of Chronic Periodontitis - A Split Mouth Double Blind Randomized Controlled Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Mysore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>KLE Society's Institute of Dental Sciences</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 present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a&#xD;
      photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic&#xD;
      periodontitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following full mouth SRP, each quadrant will be randomly assigned by simple randomization&#xD;
      using a computer generated randomization technique into one of the following four treatment&#xD;
      modalities.&#xD;
&#xD;
      Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure&#xD;
      device without turning on the light beam).&#xD;
&#xD;
      Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo&#xD;
      gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure&#xD;
      mentioned for each group will be performed on all periodontal pockets in the assigned&#xD;
      quadrant at baseline, end of 1 week and 1 month from the first session.&#xD;
&#xD;
      Clinical parameters and microbial profile will be recorded at baseline (before commencement&#xD;
      of Periodontal treatment), end of 1 month and end of 3 months following periodontal&#xD;
      treatment.&#xD;
&#xD;
      Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula&#xD;
      ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel&#xD;
      will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand&#xD;
      piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous&#xD;
      mode) and light will be activated for 60 seconds. Following this, the pockets will be&#xD;
      irrigated with normal saline solution (0.9%Sodium chloride).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 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>
    <intervention_model_description>16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.&#xD;
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).&#xD;
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.&#xD;
Study period - 3 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Microbial profile</measure>
    <time_frame>3 months</time_frame>
    <description>Change in levels of P.gingivalis following PDT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Plaque index score</measure>
    <time_frame>3 months</time_frame>
    <description>Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival index score</measure>
    <time_frame>3 months</time_frame>
    <description>Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>3 months</time_frame>
    <description>Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>3 months</time_frame>
    <description>Gain in clinical attachment level following PDT</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Application of placebo gel followed by sham Photodynamic therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zinc oxide gel group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application of Zinc oxide gel followed by sham Photodynamic therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PDT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of placebo gel followed by Photodynamic therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Zinc oxide and PDT group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application of Zinc oxide gel followed by Photodynamic therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Photodynamic therapy</intervention_name>
    <description>Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).&#xD;
For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.</description>
    <arm_group_label>PDT group</arm_group_label>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_label>Zinc oxide and PDT group</arm_group_label>
    <arm_group_label>Zinc oxide gel group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders diagnosed with chronic periodontitis in the age group of 30&#xD;
             to 50 years with good systemic health.&#xD;
&#xD;
          -  Presence of a minimum of 20 teeth and at least one site with probing pocket depth&#xD;
             (PPD) of 4-7 mm and clinical attachment level (CAL) of 2 mm or greater, in each of the&#xD;
             four quadrants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have undergone periodontal therapy during the previous 6 months of&#xD;
             commencement of the study.&#xD;
&#xD;
          -  Subjects on antibiotics or immunosuppressant medication 6 months prior to the study.&#xD;
&#xD;
          -  Chronic Smokers, Alcoholics, Smokeless tobacco users.&#xD;
&#xD;
          -  Subjects with acute illnesses/acute intraoral lesions.&#xD;
&#xD;
          -  Pregnant women and lactating mothers.&#xD;
&#xD;
          -  Medically compromised subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KLE Society's Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Veena H.R</investigator_full_name>
    <investigator_title>Reader, Department of Periodontics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03770819
org study id: KIDSperio-PDT
nct id: NCT03770819
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The present study aims to evaluate photodynamic therapy (PDT) using Zinc oxide as a
      photosensitizer as an adjunct to scaling and root planing (SRP) in the management of chronic
      periodontitis.
Following full mouth SRP, each quadrant will be randomly assigned by simple randomization
      using a computer generated randomization technique into one of the following four treatment
      modalities.

      Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure
      device without turning on the light beam).

      Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo
      gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure
      mentioned for each group will be performed on all periodontal pockets in the assigned
      quadrant at baseline, end of 1 week and 1 month from the first session.

      Clinical parameters and microbial profile will be recorded at baseline (before commencement
      of Periodontal treatment), end of 1 month and end of 3 months following periodontal
      treatment.

      Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula
      ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel
      will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand
      piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous
      mode) and light will be activated for 60 seconds. Following this, the pockets will be
      irrigated with normal saline solution (0.9%Sodium chloride).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 16 patients contributing a total of 64 sites will be selected. Recording of clinical and microbiological parameters will be done at baseline, end of 1 month, and 3 months. Oral hygiene instructions will be given. Following full mouth SRP, each quadrant will be randomly assigned by simple randomization using a computer generated randomization technique into one of the following four treatment modalities.
Group 1 (control) - Application of placebo gel followed by sham PDT (Directing the Light cure device without turning on the light beam).
Group 2 -Application of Zinc oxide gel followed by sham PDT. Group 3 - Application of placebo gel followed by PDT. Group 4 - Application of Zinc oxide gel followed by PDT. The procedure mentioned for each group will be performed on all periodontal pockets in the assigned quadrant at baseline, end of 1 week and 1 month from the first session.
Study period - 3 months
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: This is a Split Mouth Double Blind Randomized Controlled Clinical Trial in which both participants and care provider are blinded.
measure: Change in Microbial profile
time frame: 3 months
description: Change in levels of P.gingivalis following PDT
measure: Change in Plaque index score
time frame: 3 months
description: Change in plaque index score from Range: 2-3 to Range: 0 to1.9 following PDT
measure: Change in Gingival index score
time frame: 3 months
description: Change in Gingival index score from Range: 2-3 to Range: 0 to1.9 following PDT
measure: Probing pocket depth
time frame: 3 months
description: Change in probing pocket depth from 5-7 mm to 2.9- 4.2 mm following PDT
measure: Clinical attachment level
time frame: 3 months
description: Gain in clinical attachment level following PDT
arm group label: Placebo group
arm group type: Placebo Comparator
description: Application of placebo gel followed by sham Photodynamic therapy
arm group label: Zinc oxide gel group
arm group type: Active Comparator
description: Application of Zinc oxide gel followed by sham Photodynamic therapy.
arm group label: PDT group
arm group type: Experimental
description: Application of placebo gel followed by Photodynamic therapy.
arm group label: Zinc oxide and PDT group
arm group type: Experimental
description: Application of Zinc oxide gel followed by Photodynamic therapy.
intervention type: Procedure
intervention name: Photodynamic therapy
description: Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam.
arm group label: PDT group
arm group label: Placebo group
arm group label: Zinc oxide and PDT group
arm group label: Zinc oxide gel group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Veena H.R
investigator title: Reader, Department of Periodontics
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: Undecided