<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/NCT03836781</url>
  </required_header>
  <id_info>
    <org_study_id>2037</org_study_id>
    <nct_id>NCT03836781</nct_id>
  </id_info>
  <brief_title>Teh Effect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist</brief_title>
  <official_title>Comparison of Teh TEMPEffect of Subgingival Irrigation Wif Ketorolac and Chlorhexidine in Patients Wif Chronic Periodontist.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amirhossein Farahmand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Islamic Azad University, Tehran</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>
      In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with&#xD;
      clinical and radiographic findings showed that all of the periodontal parameters before the&#xD;
      treatment, during the treatment period Then, scaling &amp; Root planing and oral hygiene&#xD;
      instructions were given to the patients, and after 2 weeks, the patients who received the&#xD;
      study were randomly divided into two groups (Balanced Block Randomization) with four blocks&#xD;
      according to the visit time. To group A, oral chlorohexidine and to B group, the drug&#xD;
      Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival&#xD;
      wash with an insulin syringe, which lasted for 3 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with&#xD;
      clinical and radiographic findings showed that all of the periodontal parameters before the&#xD;
      treatment, during the treatment period Then, scaling &amp; Root planing and oral hygiene&#xD;
      instructions were given to the patients, and after 2 weeks, the patients who received the&#xD;
      study were randomly divided into two groups (Balanced Block Randomization) with four blocks&#xD;
      according to the visit time. To group A, oral chlorohexidine (Ghol Darou-Tehran) and to B&#xD;
      group, the drug Ketorolac (Exir-Boroujerd) was given. 5 mm of the drugs required every 15&#xD;
      days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.&#xD;
      Pl, BI, PD were evaluated in the study sessions. At the end of the clinical change, a&#xD;
      multiple measure ANOVA test was used to compare the preceding and follow-up sessions in both&#xD;
      groups, considering the intervention method as Between subject comparison And measured at the&#xD;
      time of measurement as a Repeated Factor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2018</start_date>
  <completion_date type="Actual">June 15, 2019</completion_date>
  <primary_completion_date type="Actual">June 8, 2019</primary_completion_date>
  <phase>Phase 2/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>split mouth</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pocket depth</measure>
    <time_frame>3 month</time_frame>
    <description>Clinical periodontal measurements to Williams periodontal probe</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>ketorolac 3%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chlorhexidine 2%</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe</description>
    <arm_group_label>ketorolac 3%</arm_group_label>
    <other_name>Group A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chlorhexidine 2%</intervention_name>
    <description>Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe</description>
    <arm_group_label>chlorhexidine 2%</arm_group_label>
    <other_name>Group B</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        40 patients with periodontitis chronic and has a 2 molar symmetrically in the lower jaw&#xD;
        pockets of the periodontal depth of at least 5 mm and CAL 1-2 mm in at least one of the&#xD;
        surfaces of the teeth, were selected&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. systemic disease&#xD;
&#xD;
          2. pregnancy or breastfeeding&#xD;
&#xD;
          3. allergy drug used&#xD;
&#xD;
          4. smoking&#xD;
&#xD;
          5. medication 6. not willing to consent to participate in the study&#xD;
&#xD;
        7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal&#xD;
        treatment in the previous 6 months 10-orthodontic treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amirhossein Farahmand</name>
      <address>
        <city>Tehran</city>
        <zip>19</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Islamic Azad University, Tehran</investigator_affiliation>
    <investigator_full_name>Amirhossein Farahmand</investigator_full_name>
    <investigator_title>assistant prof</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Ketorolac</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/NCT03836781
org study id: 2037
nct id: NCT03836781
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with
      clinical and radiographic findings showed that all of the periodontal parameters before the
      treatment, during the treatment period Then, scaling & Root planing and oral hygiene
      instructions were given to the patients, and after 2 weeks, the patients who received the
      study were randomly divided into two groups (Balanced Block Randomization) with four blocks
      according to the visit time. To group A, oral chlorohexidine and to B group, the drug
      Ketorolac was given. 5 mm of the drugs required every 15 days the areas underwent a gingival
      wash with an insulin syringe, which lasted for 3 months.
In this study, 40 patients with a history of Mild- Periodontitis who were diagnosed with
      clinical and radiographic findings showed that all of the periodontal parameters before the
      treatment, during the treatment period Then, scaling & Root planing and oral hygiene
      instructions were given to the patients, and after 2 weeks, the patients who received the
      study were randomly divided into two groups (Balanced Block Randomization) with four blocks
      according to the visit time. To group A, oral chlorohexidine (Ghol Darou-Tehran) and to B
      group, the drug Ketorolac (Exir-Boroujerd) was given. 5 mm of the drugs required every 15
      days the areas underwent a gingival wash with an insulin syringe, which lasted for 3 months.
      Pl, BI, PD were evaluated in the study sessions. At the end of the clinical change, a
      multiple measure ANOVA test was used to compare the preceding and follow-up sessions in both
      groups, considering the intervention method as Between subject comparison And measured at the
      time of measurement as a Repeated Factor.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: split mouth
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pocket depth
time frame: 3 month
description: Clinical periodontal measurements to Williams periodontal probe
arm group label: ketorolac 3%
arm group type: Active Comparator
description: ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
arm group label: chlorhexidine 2%
arm group type: Other
description: chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
intervention type: Drug
intervention name: Ketorolac
description: Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
arm group label: ketorolac 3%
other name: Group A
intervention type: Drug
intervention name: Chlorhexidine 2%
description: Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
arm group label: chlorhexidine 2%
other name: Group B
criteria: 
gender: All
minimum age: 30 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Islamic Azad University, Tehran
investigator full name: Amirhossein Farahmand
investigator title: assistant prof
mesh term: Periodontitis
mesh term: Chronic Periodontitis
mesh term: Chlorhexidine
mesh term: Ketorolac
sharing ipd: No