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/NCT05962632</url>
    </required_header>
    <id_info>
      <org_study_id>E&amp;C</org_study_id>
      <nct_id>NCT05962632</nct_id>
    </id_info>
    <brief_title>Efficacy and Cost-effectiveness of Different Caries Preventive Protocols</brief_title>
    <official_title>Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Roya mohamed Hamad Elmaghrbi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shofu Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Cairo University</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>
        To compare the caries preventive efficacy of clinical-based, home based or E-based oral&#xD;
        health interventions and their cost effectiveness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Caries risk assessment and preventive measures have been performed over years with different&#xD;
        perspectives without attention to budgeting and economic value and the preventive protocols&#xD;
        remain uncertain for adults.&#xD;
  &#xD;
        caries prevention, for example using fluoride varnish, has been found only limitedly&#xD;
        cost-effective in clinic settings, which is why alternative strategies involving home-based&#xD;
        interventions are sought .Electronic health (E-health) interventions for patient motivation&#xD;
        and enhancing of patient adherence, for example via reminders about the reinforcement of&#xD;
        hygiene measures and dietary counseling as well as recall visits were found to be of value&#xD;
        This randomized controlled clinical study aims to compare the caries preventive efficacy of&#xD;
        clinical-based, home based or E-based oral health interventions and their cost effectiveness&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>Early Phase 1</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>Single (Outcomes Assessor)</masking>
      <masking_description>assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Caries increment</measure>
      <time_frame>12 moths</time_frame>
      <description>number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cost-Effectiveness</measure>
      <time_frame>12 months</time_frame>
      <description>the cost effective will be calculated by the statistician (Net costs/Change in health outcome).</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Caries Prevention</condition>
    <arm_group>
      <arm_group_label>Clinical-based preventive platform</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>applying of Fluoride varnish every 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Home-based preventive platform</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>topical remineralizing agent</description>
    </arm_group>
    <arm_group>
      <arm_group_label>E health platform</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mobile application</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Basic preventive measures</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fluoride based varnish (Dentkist Charm Fill Varnish )</intervention_name>
      <description>topical Fluoride varnish administrated professionally every 3 months in the clinic</description>
      <arm_group_label>Clinical-based preventive platform</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pro care gel remineralizing agent</intervention_name>
      <description>topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company</description>
      <arm_group_label>Home-based preventive platform</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Mobile application</intervention_name>
      <description>examine the impact of Mobile application on caries prevention</description>
      <arm_group_label>E health platform</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC</intervention_name>
      <description>interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )</description>
      <arm_group_label>Basic preventive measures</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  High caries risk patients.&#xD;
  &#xD;
            -  18-25years.&#xD;
  &#xD;
            -  Males or females.&#xD;
  &#xD;
            -  Participants approving to enrol in this study.&#xD;
  &#xD;
            -  Participants not enrolled in any other study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          low or moderate caries risk&#xD;
  &#xD;
            -  Participants with systematic conditions.&#xD;
  &#xD;
            -  Patients younger than 18 years.&#xD;
  &#xD;
            -  Evidence of parafunctional habits.&#xD;
  &#xD;
            -  with developmental dental anomalies.&#xD;
  &#xD;
            -  undergoing or will start orthodontic treatment.&#xD;
  &#xD;
            -  with removable prosthesis&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>roya mohamed hamad, master</last_name>
      <phone>01030435140</phone>
      <email>roya.hamad@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>roya mohamed hamad, master</last_name>
      <phone>01030435140</phone>
      <email>rowamohamed2014@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>Schwendicke F, Splieth CH, Thomson WM, Reda S, Stolpe M, Foster Page L. Cost-effectiveness of caries-preventive fluoride varnish applications in clinic settings among patients of low, moderate and high risk. Community Dent Oral Epidemiol. 2018 Feb;46(1):8-16. doi: 10.1111/cdoe.12320. Epub 2017 Jul 6.</citation>
      <PMID>28682498</PMID>
    </reference>
    <reference>
      <citation>El Tantawi M, Bakhurji E, Al-Ansari A, AlSubaie A, Al Subaie HA, AlAli A. Indicators of adolescents' preference to receive oral health information using social media. Acta Odontol Scand. 2019 Apr;77(3):213-218. doi: 10.1080/00016357.2018.1536803. Epub 2019 Jan 11.</citation>
      <PMID>30632864</PMID>
    </reference>
    <reference>
      <citation>Achilleos E, Rahiotis C, Kavvadia K, Vougiouklakis G. Clinical Evaluation of Two Different Prevention Programs in Adults Depending on Their Caries Risk Profile: One-year Results. Oper Dent. 2019 Mar/Apr;44(2):127-137. doi: 10.2341/17-164-C. Epub 2018 Dec 5.</citation>
      <PMID>30517071</PMID>
    </reference>
    <reference>
      <citation>Shinkai K, Yoshii D. Effect of the S-PRG filler content in the multi-ion releasing paste on the acid resistance of the enamel surface after polishing with the paste. Dent Mater J. 2021 Sep 30;40(5):1136-1141. doi: 10.4012/dmj.2020-303. Epub 2021 May 21.</citation>
      <PMID>34024883</PMID>
    </reference>
    <reference>
      <citation>Imazato S, Nakatsuka T, Kitagawa H, Sasaki JI, Yamaguchi S, Ito S, Takeuchi H, Nomura R, Nakano K. Multiple-Ion Releasing Bioactive Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler: Innovative Technology for Dental Treatment and Care. J Funct Biomater. 2023 Apr 21;14(4):236. doi: 10.3390/jfb14040236.</citation>
      <PMID>37103326</PMID>
    </reference>
    <reference>
      <citation>Fraihat N, Madae'en S, Bencze Z, Herczeg A, Varga O. Clinical Effectiveness and Cost-Effectiveness of Oral-Health Promotion in Dental Caries Prevention among Children: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 25;16(15):2668. doi: 10.3390/ijerph16152668.</citation>
      <PMID>31349691</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Roya mohamed Hamad Elmaghrbi</investigator_full_name>
      <investigator_title>doctor</investigator_title>
    </responsible_party>
    <keyword>prevention</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fluorides</mesh_term>
    </intervention_browse>
    <!-- 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/NCT05962632
  org study id: E&C
  nct id: NCT05962632
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To compare the caries preventive efficacy of clinical-based, home based or E-based oral
        health interventions and their cost effectiveness.
  Caries risk assessment and preventive measures have been performed over years with different
        perspectives without attention to budgeting and economic value and the preventive protocols
        remain uncertain for adults.
  
        caries prevention, for example using fluoride varnish, has been found only limitedly
        cost-effective in clinic settings, which is why alternative strategies involving home-based
        interventions are sought .Electronic health (E-health) interventions for patient motivation
        and enhancing of patient adherence, for example via reminders about the reinforcement of
        hygiene measures and dietary counseling as well as recall visits were found to be of value
        This randomized controlled clinical study aims to compare the caries preventive efficacy of
        clinical-based, home based or E-based oral health interventions and their cost effectiveness
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.
  measure: Caries increment
  time frame: 12 moths
  description: number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.
  measure: Cost-Effectiveness
  time frame: 12 months
  description: the cost effective will be calculated by the statistician (Net costs/Change in health outcome).
  arm group label: Clinical-based preventive platform
  arm group type: Experimental
  description: applying of Fluoride varnish every 3 months
  arm group label: Home-based preventive platform
  arm group type: Experimental
  description: topical remineralizing agent
  arm group label: E health platform
  arm group type: Experimental
  description: Mobile application
  arm group label: Basic preventive measures
  arm group type: Active Comparator
  description: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC
  intervention type: Drug
  intervention name: Fluoride based varnish (Dentkist Charm Fill Varnish )
  description: topical Fluoride varnish administrated professionally every 3 months in the clinic
  arm group label: Clinical-based preventive platform
  intervention type: Drug
  intervention name: pro care gel remineralizing agent
  description: topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company
  arm group label: Home-based preventive platform
  intervention type: Device
  intervention name: Mobile application
  description: examine the impact of Mobile application on caries prevention
  arm group label: E health platform
  intervention type: Combination Product
  intervention name: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC
  description: interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )
  arm group label: Basic preventive measures
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: roya mohamed hamad, master
  phone: 01030435140
  email: roya.hamad@dentistry.cu.edu.eg
  last name: roya mohamed hamad, master
  phone: 01030435140
  email: rowamohamed2014@gmail.com
  citation: Schwendicke F, Splieth CH, Thomson WM, Reda S, Stolpe M, Foster Page L. Cost-effectiveness of caries-preventive fluoride varnish applications in clinic settings among patients of low, moderate and high risk. Community Dent Oral Epidemiol. 2018 Feb;46(1):8-16. doi: 10.1111/cdoe.12320. Epub 2017 Jul 6.
  PMID: 28682498
  citation: El Tantawi M, Bakhurji E, Al-Ansari A, AlSubaie A, Al Subaie HA, AlAli A. Indicators of adolescents' preference to receive oral health information using social media. Acta Odontol Scand. 2019 Apr;77(3):213-218. doi: 10.1080/00016357.2018.1536803. Epub 2019 Jan 11.
  PMID: 30632864
  citation: Achilleos E, Rahiotis C, Kavvadia K, Vougiouklakis G. Clinical Evaluation of Two Different Prevention Programs in Adults Depending on Their Caries Risk Profile: One-year Results. Oper Dent. 2019 Mar/Apr;44(2):127-137. doi: 10.2341/17-164-C. Epub 2018 Dec 5.
  PMID: 30517071
  citation: Shinkai K, Yoshii D. Effect of the S-PRG filler content in the multi-ion releasing paste on the acid resistance of the enamel surface after polishing with the paste. Dent Mater J. 2021 Sep 30;40(5):1136-1141. doi: 10.4012/dmj.2020-303. Epub 2021 May 21.
  PMID: 34024883
  citation: Imazato S, Nakatsuka T, Kitagawa H, Sasaki JI, Yamaguchi S, Ito S, Takeuchi H, Nomura R, Nakano K. Multiple-Ion Releasing Bioactive Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler: Innovative Technology for Dental Treatment and Care. J Funct Biomater. 2023 Apr 21;14(4):236. doi: 10.3390/jfb14040236.
  PMID: 37103326
  citation: Fraihat N, Madae'en S, Bencze Z, Herczeg A, Varga O. Clinical Effectiveness and Cost-Effectiveness of Oral-Health Promotion in Dental Caries Prevention among Children: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 25;16(15):2668. doi: 10.3390/ijerph16152668.
  PMID: 31349691
  responsible party type: Sponsor-Investigator
  investigator affiliation: Cairo University
  investigator full name: Roya mohamed Hamad Elmaghrbi
  investigator title: doctor
  mesh term: Fluorides