<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/NCT04485312</url>
  </required_header>
  <id_info>
    <org_study_id>abcxyz</org_study_id>
    <nct_id>NCT04485312</nct_id>
  </id_info>
  <brief_title>Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs</brief_title>
  <official_title>Chance to Avoid New Caries by Adding Chlorhexidine Containing Chemotherapeutic Agent to the Conventional Preventive Protocol for Patients With Special Needs</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>
      Adolescent Special need individuals are most need of easy forms of antibacterial agents, so&#xD;
      in this study, using chemotherapeutic agents like the newly introduced varnish containing&#xD;
      chlorhexidine seems to be a quite promising tool for local delivery to patients with special&#xD;
      needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against&#xD;
      the oral flora while fluorides are well known with their antibacterial ability. This may be&#xD;
      an excellent way to reduce the risk assessment in adolescent special needs patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be divided into two groups according to the tested regimen, where (A1)&#xD;
      represents participants exposed to risk based conventional protocol, (A2) represents&#xD;
      participants exposed to chlorhexidine containing varnish and risk based conventional&#xD;
      preventive protocol. The study will be carried over a period of 10 months (one academic&#xD;
      year), the study will be divided into three phases Phase I: Information of the Cariogram&#xD;
      parameters (caries experience, diet content, diet frequency, plaque amount, mutans&#xD;
      streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be&#xD;
      collected, which will be used to generate the individual caries profile, based on which the&#xD;
      participants will be divided into 2 risks groups. Phase II: Risk based preventive program&#xD;
      will be implemented including the restorative part. Phase III: At the end of 10 months,&#xD;
      caries profile will be generated again&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">July 15, 2021</completion_date>
  <primary_completion_date type="Actual">July 15, 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>chance to avoid new caries</measure>
    <time_frame>10 months</time_frame>
    <description>% of the green sector in the cariogram</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Disabilities Multiple</condition>
  <arm_group>
    <arm_group_label>caries preventive protocol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>chlorhexidine varnish added to the caries preventive protocol</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>chlorhexidine varnish preventive caries protocol for special needs</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>preventive protocol</intervention_name>
    <description>preventive protocol</description>
    <arm_group_label>caries preventive protocol</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>chlorhexidine added to the preventive protocol</intervention_name>
    <description>chlorhexidine varnish added to the preventive protocol</description>
    <arm_group_label>chlorhexidine varnish added to the caries preventive protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of disability like : autism and down syndrome.&#xD;
&#xD;
          -  Must be able to open his/her mouth for varnish application&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  systemically unhealthy patients with fetal diseases&#xD;
&#xD;
          -  Age below 13 and above 18&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>katreen tawfik, master</last_name>
    <role>Principal Investigator</role>
    <affiliation>cairo U</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Katreen Tawfik</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>publications in journal</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>1 year</ipd_time_frame>
    <ipd_access_criteria>online access</ipd_access_criteria>
  </patient_data>
  <!-- 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/NCT04485312
org study id: abcxyz
nct id: NCT04485312
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Adolescent Special need individuals are most need of easy forms of antibacterial agents, so
      in this study, using chemotherapeutic agents like the newly introduced varnish containing
      chlorhexidine seems to be a quite promising tool for local delivery to patients with special
      needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against
      the oral flora while fluorides are well known with their antibacterial ability. This may be
      an excellent way to reduce the risk assessment in adolescent special needs patients.
Participants will be divided into two groups according to the tested regimen, where (A1)
      represents participants exposed to risk based conventional protocol, (A2) represents
      participants exposed to chlorhexidine containing varnish and risk based conventional
      preventive protocol. The study will be carried over a period of 10 months (one academic
      year), the study will be divided into three phases Phase I: Information of the Cariogram
      parameters (caries experience, diet content, diet frequency, plaque amount, mutans
      streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be
      collected, which will be used to generate the individual caries profile, based on which the
      participants will be divided into 2 risks groups. Phase II: Risk based preventive program
      will be implemented including the restorative part. Phase III: At the end of 10 months,
      caries profile will be generated again
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: chance to avoid new caries
time frame: 10 months
description: % of the green sector in the cariogram
arm group label: caries preventive protocol
arm group type: Active Comparator
description: preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)
arm group label: chlorhexidine varnish added to the caries preventive protocol
arm group type: Other
description: chlorhexidine varnish preventive caries protocol for special needs
intervention type: Behavioral
intervention name: preventive protocol
description: preventive protocol
arm group label: caries preventive protocol
intervention type: Behavioral
intervention name: chlorhexidine added to the preventive protocol
description: chlorhexidine varnish added to the preventive protocol
arm group label: chlorhexidine varnish added to the caries preventive protocol
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
last name: katreen tawfik, master
role: Principal Investigator
affiliation: cairo U
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Katreen Tawfik
investigator title: principal investigator
mesh term: Chlorhexidine
sharing ipd: Yes
ipd description: publications in journal
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: 1 year
ipd access criteria: online access