<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/NCT04436913</url>
  </required_header>
  <id_info>
    <org_study_id>Himalaya complete care</org_study_id>
    <nct_id>NCT04436913</nct_id>
  </id_info>
  <brief_title>Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish &amp; Toothpaste in High Caries Patients</brief_title>
  <official_title>Evaluation of Prevention Potential of Preventive Regimens Containing Herbal-based and Fluoride-based Toothpastes Versus Fluoride Varnish and Fluoride Toothpaste Only in High Caries Risk Patients: A 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 in order to determine the prevention effect of caries preventive&#xD;
      regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride&#xD;
      toothpaste and fluoride varnish on the caries risk of patients with high caries risk.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental caries is highly predominant worldwide. So, in addition to treating this caries,&#xD;
      patients should be managed to avoid new caries. Preventive measures could be applied to the&#xD;
      patients who are most expected to develop dental caries who are identified by caries risk&#xD;
      assessment. Thus, effective caries risk assessment is essential to control new caries&#xD;
      development.&#xD;
&#xD;
      Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial&#xD;
      to identify those who are most likely to have dental caries by caries risk assessment and&#xD;
      giving them the essential preventive measures. Though some caries preventive measures have&#xD;
      showed success in descriptive clinical trials, there is little information on their&#xD;
      practicality with high caries risk groups in everyday usage.&#xD;
&#xD;
      Oral health is an essential part of general well being, people have used herbs in order to&#xD;
      prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the&#xD;
      use of medicinal plants for oral healthcare.&#xD;
&#xD;
      Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are&#xD;
      becoming more popular than chemicals due to the side effects of synthetic antibiotics and the&#xD;
      antibiotic resistance in microorganisms.&#xD;
&#xD;
      Studies propose that herbal extracts are highly effective against significant microorganism&#xD;
      which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental&#xD;
      caries through combined effects of antibacterial agents, oral acid neutralisers and decreased&#xD;
      plaque bacterial enzyme inhibitors present in the herbal toothpaste.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 16, 2021</start_date>
  <completion_date type="Actual">January 31, 2022</completion_date>
  <primary_completion_date type="Actual">September 20, 2021</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>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.&#xD;
This data includes caries experience, related diseases, diet content, fluoride program, salivary buffer capacity, saliva secretion rate, diet frequency, &quot;Mutans streptococci&quot; count, amount of plaque, and clinical examination.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preventive regimen using Fluoride based toothpaste (Signal).</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluoride toothpaste and fluoride varnish</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish</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>Signal toothpaste</intervention_name>
    <description>fluoride based toothpaste as a part of a caries preventive regimen</description>
    <arm_group_label>preventive regimen using Fluoride based toothpaste (Signal).</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Signal toothpaste and fluoride varnish</intervention_name>
    <description>application of fluoride varnish and using fluoride based toothpaste</description>
    <arm_group_label>Fluoride toothpaste and fluoride varnish</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy patients with free medical history.&#xD;
&#xD;
          -  Age range 15-50 years.&#xD;
&#xD;
          -  Patients with high caries risk assessment due to increased cariogenic bacteria&#xD;
             according to Cariogram.&#xD;
&#xD;
          -  low fermentable carbohydrates diet patient&#xD;
&#xD;
          -  Not under antibiotic therapy either at the time of the study or up to the last month&#xD;
             before the start of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a compromised medical history.&#xD;
&#xD;
          -  Cariogenic diet patient.&#xD;
&#xD;
          -  Extreme plaque accumulation and periodontal problems&#xD;
&#xD;
          -  Participants with a history of allergy to any of the drugs or chemicals used in the&#xD;
             study.&#xD;
&#xD;
          -  Patients on any antibiotics during the past month&#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_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>July 29, 2022</last_update_submitted>
  <last_update_submitted_qc>July 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hoda Abdelmeguid Mohamed Fathy Ismail Sabry</investigator_full_name>
    <investigator_title>Principal Investigator , Master degree student, 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>Fluorides</mesh_term>
    <mesh_term>Fluorides, Topical</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/NCT04436913
org study id: Himalaya complete care
nct id: NCT04436913
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be conducted in order to determine the prevention effect of caries preventive
      regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride
      toothpaste and fluoride varnish on the caries risk of patients with high caries risk.
Dental caries is highly predominant worldwide. So, in addition to treating this caries,
      patients should be managed to avoid new caries. Preventive measures could be applied to the
      patients who are most expected to develop dental caries who are identified by caries risk
      assessment. Thus, effective caries risk assessment is essential to control new caries
      development.

      Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial
      to identify those who are most likely to have dental caries by caries risk assessment and
      giving them the essential preventive measures. Though some caries preventive measures have
      showed success in descriptive clinical trials, there is little information on their
      practicality with high caries risk groups in everyday usage.

      Oral health is an essential part of general well being, people have used herbs in order to
      prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the
      use of medicinal plants for oral healthcare.

      Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are
      becoming more popular than chemicals due to the side effects of synthetic antibiotics and the
      antibiotic resistance in microorganisms.

      Studies propose that herbal extracts are highly effective against significant microorganism
      which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental
      caries through combined effects of antibacterial agents, oral acid neutralisers and decreased
      plaque bacterial enzyme inhibitors present in the herbal toothpaste.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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.
This data includes caries experience, related diseases, diet content, fluoride program, salivary buffer capacity, saliva secretion rate, diet frequency, "Mutans streptococci" count, amount of plaque, and clinical examination.
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).
arm group label: preventive regimen using Fluoride based toothpaste (Signal).
arm group type: Experimental
description: Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride)
arm group label: Fluoride toothpaste and fluoride varnish
arm group type: Active Comparator
description: Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish
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: Signal toothpaste
description: fluoride based toothpaste as a part of a caries preventive regimen
arm group label: preventive regimen using Fluoride based toothpaste (Signal).
intervention type: Other
intervention name: Signal toothpaste and fluoride varnish
description: application of fluoride varnish and using fluoride based toothpaste
arm group label: Fluoride toothpaste and fluoride varnish
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hoda Abdelmeguid Mohamed Fathy Ismail Sabry
investigator title: Principal Investigator , Master degree student, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
mesh term: Dental Caries
mesh term: Fluorides
mesh term: Fluorides, Topical