<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/NCT03790605</url>
  </required_header>
  <id_info>
    <org_study_id>riya1curcumin</org_study_id>
    <nct_id>NCT03790605</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis</brief_title>
  <official_title>Evaluation of the Host Modulating Effects of 1% Curcumin Chips as an Adjunct to Non Surgical Mechanical Debridement in the Treatment of Periodontitis: A Randomised Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KLE Society's Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will follow a parallel arm, randomised, double blinded, placebo controlled design.&#xD;
&#xD;
      There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root&#xD;
      planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing&#xD;
      (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical&#xD;
      attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks)&#xD;
      Interleukin 1 beta in GCF&#xD;
&#xD;
      Statistical analysis Repeated measures of ANOVA Paired t-tests&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 4, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2020</primary_completion_date>
  <phase>Phase 3</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>Total subjects = 40 INCLUSION CRITERION&#xD;
Systemically healthy individuals both males and females of 20-60 years&#xD;
Presence of a minimum of 20 teeth in the oral cavity&#xD;
Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP) EXCLUSION CRITERION&#xD;
1 Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose 2 Systemic diseases and/or Inflammatory conditions, Obesity 3 Former or current tobacco users 4 Chronic consumption of alcohol 5 Use of anti-inflammatory drugs and antibiotics over the past 3 months 6 Periodontal therapy in any form, surgical or non surgical in the past 6 months 7 Pregnant and lactating mothers</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cytokine parameter</measure>
    <time_frame>Change from Baseline to 4 weeks</time_frame>
    <description>Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>Changes from Baseline to 4 weeks and 12 weeks</time_frame>
    <description>Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level</measure>
    <time_frame>Changes from Baseline to 4 weeks and 12 weeks</time_frame>
    <description>Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Bleeding Index by Loe and Silness in 1963</measure>
    <time_frame>Changes from Baseline to 4 weeks and 12 weeks</time_frame>
    <description>Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index by Silness and Loe in 1964</measure>
    <time_frame>Baseline from. 4 weeks, 12 weeks</time_frame>
    <description>Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>1% curcumin chip</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo chip</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1 % curcumin chip</intervention_name>
    <description>CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle</description>
    <arm_group_label>1% curcumin chip</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo chip</intervention_name>
    <description>PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle</description>
    <arm_group_label>Placebo chip</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Scaling and root planing</intervention_name>
    <description>Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips</description>
    <arm_group_label>1% curcumin chip</arm_group_label>
    <arm_group_label>Placebo chip</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Systemically healthy individuals&#xD;
&#xD;
          2. Presence of a minimum of 20 teeth in the oral cavity&#xD;
&#xD;
          3. Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis&#xD;
             in its stages 2 and 3, as described by the 2017 World Workshop on the Classification&#xD;
             of Periodontal and Peri-Implant Diseases and Conditions, and published by the American&#xD;
             Academy of Periodontology (AAP)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose&#xD;
&#xD;
          2. Systemic diseases and/or Inflammatory conditions, Obesity&#xD;
&#xD;
          3. Former or current tobacco users&#xD;
&#xD;
          4. Chronic consumption of alcohol&#xD;
&#xD;
          5. Use of anti-inflammatory drugs and antibiotics over the past 3 months&#xD;
&#xD;
          6. Periodontal therapy in any form, surgical or non surgical in the past 6 months&#xD;
&#xD;
          7. Pregnant and lactating mothers&#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>
  <overall_contact>
    <last_name>Riya A Daniel, BDS, PG student</last_name>
    <phone>9444140560</phone>
    <phone_ext>+91</phone_ext>
    <email>riyaad.rd@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>K L E society's Dental College</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560022</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Riya Daniel, BDS</last_name>
      <phone>9444140560</phone>
      <phone_ext>+91</phone_ext>
      <email>riyaad.rd@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 12, 2019</last_update_submitted>
  <last_update_submitted_qc>December 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 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>Dr. Riya Achamma Daniel</investigator_full_name>
    <investigator_title>Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore</investigator_title>
  </responsible_party>
  <keyword>periodontitis, 1% curcumin chips, host modulation therapy, anti inflammatory effect, interleukin 1 beta</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Curcumin</mesh_term>
    <mesh_term>Iproplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers</ipd_description>
  </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/NCT03790605
org study id: riya1curcumin
nct id: NCT03790605
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The study will follow a parallel arm, randomised, double blinded, placebo controlled design.

      There will be two groups Group 1 = receiving 1% curcumin chips after routine scaling and root
      planing (n=20) Group 2 = receiving placebo chips after routine scaling and root planing
      (n=20) Clinical parameters: ( Baseline, 4 weeks, 12 weeks) Probing pocket depth, clinical
      attachment level, gingival index, plaque index Cytokine parameter ( Baseline, 4 weeks)
      Interleukin 1 beta in GCF

      Statistical analysis Repeated measures of ANOVA Paired t-tests
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Total subjects = 40 INCLUSION CRITERION
Systemically healthy individuals both males and females of 20-60 years
Presence of a minimum of 20 teeth in the oral cavity
Localised periodontal pockets with probing depths greater than 4mm i.e., Periodontitis in its stages 2 and 3, as described by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions, and published by the American Academy of Periodontology (AAP) EXCLUSION CRITERION
1 Known allergy to curcumin and/ or hydroxyl propyl methyl cellulose 2 Systemic diseases and/or Inflammatory conditions, Obesity 3 Former or current tobacco users 4 Chronic consumption of alcohol 5 Use of anti-inflammatory drugs and antibiotics over the past 3 months 6 Periodontal therapy in any form, surgical or non surgical in the past 6 months 7 Pregnant and lactating mothers
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The study design follows a double blinded design where the participant and the outcome assessor are unaware of the intervention to the subject
measure: Cytokine parameter
time frame: Change from Baseline to 4 weeks
description: Intragroup comparison within each group (1-curcumin group and 2- placebo group) and intergroup comparison between the two groups of levels of interleukin 1 beta in the gingival crevicular fluid quantified by ELISA in picogram per milliliter
measure: Probing pocket depth
time frame: Changes from Baseline to 4 weeks and 12 weeks
description: Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
measure: Clinical attachment level
time frame: Changes from Baseline to 4 weeks and 12 weeks
description: Intragroup within each group (1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
measure: Gingival Bleeding Index by Loe and Silness in 1963
time frame: Changes from Baseline to 4 weeks and 12 weeks
description: Intragroup within each group ( 1-curcumin group and 2- placebo group) and intergroup comparison between the two group
measure: Plaque index by Silness and Loe in 1964
time frame: Baseline from. 4 weeks, 12 weeks
description: Intragroup within each group ( 1- curcumin group and 2- placebo group) and intergroup comparison between the two groups
arm group label: 1% curcumin chip
arm group type: Experimental
description: Following routine full mouth scaling and root planing within 48 hours, a single chip of 1% curcumin will be placed locally within a single isolated periodontal pocket(the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip(second placement)
arm group label: Placebo chip
arm group type: Placebo Comparator
description: Following routine full mouth scaling and root planing within 48 hours, a single placebo chip will be placed locally within a single isolated periodontal pocket (the deepest pocket in a patient will be chosen) using a forceps. The patient will be recalled after two weeks for the placement of another chip (second placement)
intervention type: Drug
intervention name: 1 % curcumin chip
description: CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
arm group label: 1% curcumin chip
intervention type: Other
intervention name: Placebo chip
description: PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
arm group label: Placebo chip
intervention type: Procedure
intervention name: Scaling and root planing
description: Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips
arm group label: 1% curcumin chip
arm group label: Placebo chip
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Riya A Daniel, BDS, PG student
phone: 9444140560
phone ext: +91
email: riyaad.rd@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Principal Investigator
investigator affiliation: KLE Society's Institute of Dental Sciences
investigator full name: Dr. Riya Achamma Daniel
investigator title: Post graduate student, Principal Investigator, Department of Periodontics, KLE Society's Institute of Dental Sciences, Bangalore
mesh term: Periodontitis
mesh term: Curcumin
mesh term: Iproplatin
sharing ipd: No
ipd description: For the purpose of confidentiality, as will be promised to the participants while signing the informed consent, all individual records except that of the parameters assessed during the study and the photographs taken will remain unshared to the public or fellow researchers