<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/NCT04446390</url>
  </required_header>
  <id_info>
    <org_study_id>Himalaya herbal toothpaste</org_study_id>
    <nct_id>NCT04446390</nct_id>
  </id_info>
  <brief_title>Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions</brief_title>
  <official_title>Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to assess the effect of different preventive regimens using&#xD;
      herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries&#xD;
      risk in high caries risk patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental caries is a major universal health problem with multiple etiological factors, so&#xD;
      looking for economical and accurate plans for recognizing high-risk persons, and multiple&#xD;
      risk factors to reduce the risk, in addition to caries management, using a caries risk&#xD;
      assessment to detect the person who will develop caries, and provide them with suitable&#xD;
      preventive and treatment regimens to disruption the disease procedure.&#xD;
&#xD;
      The treatment should evade invasive treatments and a large emphasis on prevention (using&#xD;
      fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new&#xD;
      dentistry (minimal intervention). The application of such a regimen to manage initial caries&#xD;
      lesions allows the dentist to reverse initial lesions with the minimal victim of healthy&#xD;
      dental tissues.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">March 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Remineralization of initial carious lesions</measure>
    <time_frame>Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.</time_frame>
    <description>changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caries risk assessment</measure>
    <time_frame>Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.</time_frame>
    <description>Change in caries risk assessment by &quot;cariogram software&quot; as each patient data is collected in order to be inserted into the &quot;Cariogram software&quot; which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>preventive regimen using Herbal toothpaste(Himalaya)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The regimen includes herbal toothpaste containing &quot;Neem , Miswak , Babool and Pomegranate&quot; (Himalaya Complete Care). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preventive regimen using Fluoride based toothpaste(colgate)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Himalaya complete care toothpaste</intervention_name>
    <description>Herbal toothpaste as a part of a caries preventive regimen</description>
    <arm_group_label>preventive regimen using Herbal toothpaste(Himalaya)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>colgate cavity protection</intervention_name>
    <description>fluoride toothpaste as a part of a caries preventive regimen</description>
    <arm_group_label>preventive regimen using Fluoride based toothpaste(colgate)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion criteria of the participants:&#xD;
&#xD;
               1. Healthy patients with free medical history.&#xD;
&#xD;
               2. Age range 15-50 years.&#xD;
&#xD;
               3. Patients with high caries risk assessment according to Cariogram.&#xD;
&#xD;
               4. Patients with initial carious lesions at the facial surface of any teeth&#xD;
&#xD;
               5. High plaque index&#xD;
&#xD;
               6. Not under antibiotic therapy either at the time of the study or up to the last&#xD;
                  month before the start of the study&#xD;
&#xD;
          -  Exclusion criteria of the participants:&#xD;
&#xD;
               1. Patients with a compromised medical history.&#xD;
&#xD;
               2. Patients with dentin caries&#xD;
&#xD;
               3. Extreme plaque accumulation and periodontal problems&#xD;
&#xD;
               4. Completely edentulous patients&#xD;
&#xD;
               5. Participants with a history of allergy to any of the drugs or chemicals used in&#xD;
                  the study.&#xD;
&#xD;
               6. Patients on any antibiotics during the past month&#xD;
&#xD;
          -  Inclusion criteria of the teeth:&#xD;
&#xD;
               1. The WSLs with LF measurements inside the range 14-20 were involved in this study.&#xD;
&#xD;
               2. The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included&#xD;
                  in the study&#xD;
&#xD;
          -  Exclusion criteria of the teeth:&#xD;
&#xD;
               1. The white spot lesion scoring is (&lt;14) or (&gt;20) according to diagnodent&#xD;
&#xD;
               2. The white spot lesion scoring is other than 2, 3 according to ICDAS&#xD;
&#xD;
               3. White spot lesions due to hypomineralization or fluorosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University, Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>January 20, 2022</last_update_submitted>
  <last_update_submitted_qc>January 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yomna Hussin</investigator_full_name>
    <investigator_title>Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Listerine</mesh_term>
    <mesh_term>Sodium Fluoride</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04446390
org study id: Himalaya herbal toothpaste
nct id: NCT04446390
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to assess the effect of different preventive regimens using
      herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries
      risk in high caries risk patients.
Dental caries is a major universal health problem with multiple etiological factors, so
      looking for economical and accurate plans for recognizing high-risk persons, and multiple
      risk factors to reduce the risk, in addition to caries management, using a caries risk
      assessment to detect the person who will develop caries, and provide them with suitable
      preventive and treatment regimens to disruption the disease procedure.

      The treatment should evade invasive treatments and a large emphasis on prevention (using
      fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new
      dentistry (minimal intervention). The application of such a regimen to manage initial caries
      lesions allows the dentist to reverse initial lesions with the minimal victim of healthy
      dental tissues.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Remineralization of initial carious lesions
time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
description: changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)
measure: Caries risk assessment
time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
description: Change in caries risk assessment by "cariogram software" as each patient data is collected in order to be inserted into the "Cariogram software" which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage.
arm group label: preventive regimen using Herbal toothpaste(Himalaya)
arm group type: Experimental
description: The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals.
arm group label: preventive regimen using Fluoride based toothpaste(colgate)
arm group type: Active Comparator
description: preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals.
intervention type: Other
intervention name: Himalaya complete care toothpaste
description: Herbal toothpaste as a part of a caries preventive regimen
arm group label: preventive regimen using Herbal toothpaste(Himalaya)
intervention type: Other
intervention name: colgate cavity protection
description: fluoride toothpaste as a part of a caries preventive regimen
arm group label: preventive regimen using Fluoride based toothpaste(colgate)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yomna Hussin
investigator title: Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
mesh term: Dental Caries
mesh term: Listerine
mesh term: Sodium Fluoride