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/NCT05987722</url>
    </required_header>
    <id_info>
      <org_study_id>KMUHIRB-F(II)-20200136</org_study_id>
      <nct_id>NCT05987722</nct_id>
    </id_info>
    <brief_title>Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery</brief_title>
    <acronym>Enoxolone</acronym>
    <official_title>Effectiveness of Enoxolone on Oral Conditions of Patients With Periodontal Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Abstract Aim:The Enoxolone (18β-glycyrrhetinic acid; BGA) is a bioactive compound in licorice&#xD;
        that exhibits potential anti-ulcer, anti-inflammatory, and anti-microbial activities, relieve&#xD;
        oral ulcers, pain, improve gingivitis and dental plaque from past relevant experimental&#xD;
        studies,but few clinical trials have evaluated its clinical effectiveness. Therefore, the&#xD;
        purpose of this study is to evaluate the effectiveness of Enoxolone on oral conditions of&#xD;
        patients with periodontal surgery. Methods:This study is a randomized controlled trial.&#xD;
        Patients with severe chronic periodontitis who needed to accept periodontal surgery were&#xD;
        randomly assigned to two groups, the experimental group was Enoxolone toothpaste, and the&#xD;
        control group for Sensodyne toothpaste. After the operation, toothpaste was used three times&#xD;
        a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported&#xD;
        pain score, painkillers, wound healing index (complete epithelization and color matching&#xD;
        score), periodontal pocket depth, gingiva index, plaque index and were recorded before&#xD;
        operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. Data set performs&#xD;
        repeated-measures for the change in mean differences by using the two-tailed independent t&#xD;
        tests and generalized linear model.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Enoxolone is a toothpaste containing 18β-glycyrrhetinic acid (BGA). In this study, the&#xD;
        experimental group used Enoxolone toothpaste, and the control group did not contain BGA&#xD;
        toothpaste (Sensodyne), which is used for oral cleaning of patients after periodontal disease&#xD;
        surgery. The absorption rate is very low, and it will not cause any interaction with western&#xD;
        medicine.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 30, 2021</start_date>
    <completion_date type="Actual">December 8, 2022</completion_date>
    <primary_completion_date type="Actual">June 1, 2022</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>Each patient underwent routine periodontal surgery procedures: (1) On the first day of surgery, the researchers confirmed the correctness of the patient's oral hygiene instructions before surgery; (2) All periodontal surgery was performed by the same dentist. After periodontal surgery was sutured, antibiotics (Amoxicillin 500 mg, every 8 h, for 7 days) and painkillers (Acetaminophen 250 mg, every 6 h as long as it is painful) were provided. The experimental group (N=15) returned home after the operation and used BGA toothpaste (Enoxolone) three times a day for oral cleaning for 12 weeks. The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as those of the experimental group.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The experimental group and the control group were randomly assigned by lottery drawing.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>wound healing index</measure>
      <time_frame>after operation 1st, 2nd, 3rd, 4th, 8th, 12th week</time_frame>
      <description>epithelization and color matching score: A score of 0-10, higher indicates better wound healing.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>patient-reported pain score, painkillers</measure>
      <time_frame>after operation 1week</time_frame>
      <description>the patient-reported pain score(VAS): 0-10 points, the higher the worse. painkillers: 0-15 pills, the more the remaining number of drugs, the better.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Periodontal pocket depth, Gingiva index, Plaque index</measure>
      <time_frame>after operation 1st, 2nd, 3rd, 4th, 8th, 12th week</time_frame>
      <description>Periodontal pocket depth: 0-15 mm, the higher it means bad. Gingiva index: 0-3 points, higher means bad. Plaque index: 0-3 points, higher means bad.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>adverse event</measure>
      <time_frame>after operation 1st, 2nd, 3rd, 4th, 8th, 12th week</time_frame>
      <description>allergy</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">27</enrollment>
    <condition>Periodontal Surgery</condition>
    <arm_group>
      <arm_group_label>Enoxolone</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group (N=15) returned home after the operation and used BGA toothpaste (Enoxolone) three times a day for oral cleaning for 12 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sensodyne</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning for 12 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Enoxolone</intervention_name>
      <description>The experimental group returned home after the operation and used glycyrrhetinic acid toothpaste three times a day for oral cleaning.After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.</description>
      <arm_group_label>Enoxolone</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Sensodyne</intervention_name>
      <description>The Active Comparator group returned home after the operation and used glycyrrhetinic acid -free toothpaste(Sensodyne) three times a day for oral cleaning. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.</description>
      <arm_group_label>Sensodyne</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Those who are over 20 years old.&#xD;
  &#xD;
            -  Those whose health or systemic diseases are well controlled.&#xD;
  &#xD;
            -  Those with severe chronic periodontitis who need to perform periodontal surgery after&#xD;
               being diagnosed by a doctor.&#xD;
  &#xD;
            -  Subjects who are willing to accept this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Allergy to licorice.&#xD;
  &#xD;
            -  Pregnancy or breastfeeding.&#xD;
  &#xD;
            -  Periodontal surgery completed at the same site within 6 months.&#xD;
  &#xD;
            -  Severe bone loss in the apical tissue of the surgical site (including poor prognosis).&#xD;
  &#xD;
            -  Clinical signs of infection, including fistula, suppuration, fever, severe pain and&#xD;
               site swelling.&#xD;
  &#xD;
            -  Platelets less than 50,000.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hsin-Tien Hsu, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Kaohsiung Medical University Hospital, Kaohsiung Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kaohsiung Medical University Hospital, Kaohsiung Medical University</name>
        <address>
          <city>Kaohsiung</city>
          <zip>807</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>April 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Enoxolone</keyword>
    <keyword>Wound healing</keyword>
    <keyword>Plaque index.</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycyrrhetinic Acid</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/NCT05987722
  org study id: KMUHIRB-F(II)-20200136
  nct id: NCT05987722
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Abstract Aim:The Enoxolone (18β-glycyrrhetinic acid; BGA) is a bioactive compound in licorice
        that exhibits potential anti-ulcer, anti-inflammatory, and anti-microbial activities, relieve
        oral ulcers, pain, improve gingivitis and dental plaque from past relevant experimental
        studies,but few clinical trials have evaluated its clinical effectiveness. Therefore, the
        purpose of this study is to evaluate the effectiveness of Enoxolone on oral conditions of
        patients with periodontal surgery. Methods:This study is a randomized controlled trial.
        Patients with severe chronic periodontitis who needed to accept periodontal surgery were
        randomly assigned to two groups, the experimental group was Enoxolone toothpaste, and the
        control group for Sensodyne toothpaste. After the operation, toothpaste was used three times
        a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported
        pain score, painkillers, wound healing index (complete epithelization and color matching
        score), periodontal pocket depth, gingiva index, plaque index and were recorded before
        operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. Data set performs
        repeated-measures for the change in mean differences by using the two-tailed independent t
        tests and generalized linear model.
  Enoxolone is a toothpaste containing 18β-glycyrrhetinic acid (BGA). In this study, the
        experimental group used Enoxolone toothpaste, and the control group did not contain BGA
        toothpaste (Sensodyne), which is used for oral cleaning of patients after periodontal disease
        surgery. The absorption rate is very low, and it will not cause any interaction with western
        medicine.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Each patient underwent routine periodontal surgery procedures: (1) On the first day of surgery, the researchers confirmed the correctness of the patient's oral hygiene instructions before surgery; (2) All periodontal surgery was performed by the same dentist. After periodontal surgery was sutured, antibiotics (Amoxicillin 500 mg, every 8 h, for 7 days) and painkillers (Acetaminophen 250 mg, every 6 h as long as it is painful) were provided. The experimental group (N=15) returned home after the operation and used BGA toothpaste (Enoxolone) three times a day for oral cleaning for 12 weeks. The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as those of the experimental group.
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: The experimental group and the control group were randomly assigned by lottery drawing.
  measure: wound healing index
  time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
  description: epithelization and color matching score: A score of 0-10, higher indicates better wound healing.
  measure: patient-reported pain score, painkillers
  time frame: after operation 1week
  description: the patient-reported pain score(VAS): 0-10 points, the higher the worse. painkillers: 0-15 pills, the more the remaining number of drugs, the better.
  measure: Periodontal pocket depth, Gingiva index, Plaque index
  time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
  description: Periodontal pocket depth: 0-15 mm, the higher it means bad. Gingiva index: 0-3 points, higher means bad. Plaque index: 0-3 points, higher means bad.
  measure: adverse event
  time frame: after operation 1st, 2nd, 3rd, 4th, 8th, 12th week
  description: allergy
  arm group label: Enoxolone
  arm group type: Experimental
  description: The experimental group (N=15) returned home after the operation and used BGA toothpaste (Enoxolone) three times a day for oral cleaning for 12 weeks.
  arm group label: Sensodyne
  arm group type: Active Comparator
  description: The control group (N=12) used BGA-free toothpaste (Sensodyne) for oral cleaning for 12 weeks.
  intervention type: Other
  intervention name: Enoxolone
  description: The experimental group returned home after the operation and used glycyrrhetinic acid toothpaste three times a day for oral cleaning.After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.
  arm group label: Enoxolone
  intervention type: Other
  intervention name: Sensodyne
  description: The Active Comparator group returned home after the operation and used glycyrrhetinic acid -free toothpaste(Sensodyne) three times a day for oral cleaning. After the operation, toothpaste was used three times a day to clean the mouth for 12 weeks . Clinical evaluation was using the patient-reported pain score, painkillers, wound healing index (complete epithelization and color matching score), periodontal pocket depth, gingiva index, plaque index and were recorded before operation and 1st, 2nd, 3rd, 4th, 8th, 12th week after surgery. The control group used ordinary toothpaste for oral cleaning, and the rest of the research time, measurement time and measurement results were the same as the experimental group. During the study period, we will continue to monitor whether there is any adverse reaction, and if any adverse reaction occurs, the trial will be stopped.
  arm group label: Sensodyne
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hsin-Tien Hsu, Professor
  role: Study Director
  affiliation: Kaohsiung Medical University Hospital, Kaohsiung Medical University
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Glycyrrhetinic Acid
  sharing ipd: No