xml: <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/NCT06021847</url>
    </required_header>
    <id_info>
      <org_study_id>4447082022</org_study_id>
      <nct_id>NCT06021847</nct_id>
    </id_info>
    <brief_title>Ozonated Water in Treatment of Denture Stomatitis</brief_title>
    <official_title>Effect of Ozone Water in Treatment of Denture Inflammation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Research Centre, Egypt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Research Centre, Egypt</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 effect of Ozonated water on the treatment of oral stomatitis associated with complete&#xD;
        denture wearer in comparison to Chlorhexidine mouthwash&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Compete denture wearers having oral denture stomatitis were divided into two groups. group I&#xD;
        used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida&#xD;
        albicans, the degree inflammation and pain grade were evaluated before starting the treatment&#xD;
        then every week till one month. Also&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patients didn't know which treatment they received.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Candida albicans colonies</measure>
      <time_frame>day one, 7th day, 14th day and 30th day</time_frame>
      <description>The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>-Evaluation of inflammation and pain grade</measure>
      <time_frame>day 1, and 30th day</time_frame>
      <description>- Evaluation of inflammation and pain grade by questionnaire</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Denture Stomatitis</condition>
    <arm_group>
      <arm_group_label>Group I patients treated with ozonated water</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group II patients treated with chlorhexidine mouthwash</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ozonated water</intervention_name>
      <description>ozonated water was prepared with a concentration of (2-4 mg/l) ozone for 1 min. in a 25 mg of double distilled water 37o C employing an Ozone generator (Ozone generator type N 1888A, China.)</description>
      <arm_group_label>Group I patients treated with ozonated water</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Chlorhexidine mouthwash</intervention_name>
      <description>Commercial available chlorhexidine mouthwash in the market was used.</description>
      <arm_group_label>Group II patients treated with chlorhexidine mouthwash</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Completely edentulous male patients wearing heat cured acrylic resin removable&#xD;
               prosthesis.&#xD;
  &#xD;
            -  Patients having denture associated oral stomatitis.&#xD;
  &#xD;
            -  Healthy patients free of any systemic diseases.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smoker patients.&#xD;
  &#xD;
            -  Patients suffering from any auto immune or systemic diseases, Temporo-mandibular joint&#xD;
               disorder ( TMJ disorders and parafunctional oral habits.&#xD;
  &#xD;
            -  Patients with a history of radiotherapy or chemotherapy.&#xD;
  &#xD;
            -  Patients having oral lesions.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Asmaa N, Elboraey, Ass,Pro</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Research Centre, Egypt</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>National Research Centre</name>
        <address>
          <city>Cairo</city>
          <zip>12622</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2022</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
      <investigator_full_name>Asmaa Nabil Elboraey</investigator_full_name>
      <investigator_title>Associate Professor of Removable Prosthodontics</investigator_title>
    </responsible_party>
    <keyword>Ozonated water</keyword>
    <keyword>denture stomatitis</keyword>
    <keyword>Chlorhexidine mouthwash</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomatitis</mesh_term>
      <mesh_term>Stomatitis, Denture</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chlorhexidine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021847
  org study id: 4447082022
  nct id: NCT06021847
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The effect of Ozonated water on the treatment of oral stomatitis associated with complete
        denture wearer in comparison to Chlorhexidine mouthwash
  Compete denture wearers having oral denture stomatitis were divided into two groups. group I
        used Ozonated water while group II used Chlorhexidine mouthwash. The growth of Candida
        albicans, the degree inflammation and pain grade were evaluated before starting the treatment
        then every week till one month. Also
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Two groups ( complete denture wearers with oral stomatitis). Group I treated with ozonated water while group II treated with chlorhexidine mouthwash.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The patients didn't know which treatment they received.
  measure: Candida albicans colonies
  time frame: day one, 7th day, 14th day and 30th day
  description: The number of Candida albicans forming units (CFU) was used to assess the effect of two types of treatments.
  measure: -Evaluation of inflammation and pain grade
  time frame: day 1, and 30th day
  description: - Evaluation of inflammation and pain grade by questionnaire
  arm group label: Group I patients treated with ozonated water
  arm group type: Active Comparator
  description: The patients were used ozonated water as mouth wash for treatment of denture associated oral stomatitis.
  arm group label: Group II patients treated with chlorhexidine mouthwash
  arm group type: Active Comparator
  description: The patients were used chlorhexidine mouth wash for treatment of denture associated oral stomatitis
  intervention type: Other
  intervention name: Ozonated water
  description: ozonated water was prepared with a concentration of (2-4 mg/l) ozone for 1 min. in a 25 mg of double distilled water 37o C employing an Ozone generator (Ozone generator type N 1888A, China.)
  arm group label: Group I patients treated with ozonated water
  intervention type: Other
  intervention name: Chlorhexidine mouthwash
  description: Commercial available chlorhexidine mouthwash in the market was used.
  arm group label: Group II patients treated with chlorhexidine mouthwash
  criteria: 
  gender: Male
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Asmaa N, Elboraey, Ass,Pro
  role: Principal Investigator
  affiliation: National Research Centre, Egypt
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: National Research Centre, Egypt
  investigator full name: Asmaa Nabil Elboraey
  investigator title: Associate Professor of Removable Prosthodontics
  mesh term: Stomatitis
  mesh term: Stomatitis, Denture
  mesh term: Chlorhexidine
  sharing ipd: No