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/NCT05988801</url>
    </required_header>
    <id_info>
      <org_study_id>Glass Ionomer VS Resin sealant</org_study_id>
      <nct_id>NCT05988801</nct_id>
    </id_info>
    <brief_title>Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars</brief_title>
    <official_title>Clinical and Radiographic Evaluation of Glass Ionomer Sealant Versus Resin Sealant for Pits and Fissures of the First Permanent Molars: 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>
        evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin&#xD;
        sealant in the pits and fissures sealing of the first permanent molars&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        GIC has a hydrophilic nature which makes it compatible with clinical situations when&#xD;
        isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture.&#xD;
        Glass ionomers release fluoride, which promotes enamel remineralization and has an&#xD;
        antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth&#xD;
        does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which&#xD;
        is critical in the case of young patients and patients with disabilities.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">November 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Marginal discoloration</measure>
      <time_frame>6 months</time_frame>
      <description>Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>sealant retention</measure>
      <time_frame>6 months</time_frame>
      <description>Sealant retention will be measured with a mouth mirror and probe and recorded in total retention or partial loss or complete loss</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dental Caries</measure>
      <time_frame>6 months</time_frame>
      <description>The absence or presence of any signs of dental caries or periapical infection will be measured with a periapical X-ray</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">88</enrollment>
    <condition>Pits and Fissures Sealant</condition>
    <arm_group>
      <arm_group_label>Glass ionomer sealant</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>glass ionomer based sealant material</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Resin sealant</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>resin-based sealant material</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Glass ionomer sealant</intervention_name>
      <description>glass ionomer-based sealant material</description>
      <arm_group_label>Glass ionomer sealant</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Resin based sealant</intervention_name>
      <description>resin-based sealant material</description>
      <arm_group_label>Resin sealant</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Children aged between 6 to 9 years&#xD;
  &#xD;
                 -  Children with deeply stained fissures of the first permanent molars.&#xD;
  &#xD;
                 -  First permanent molars are completely erupted&#xD;
  &#xD;
                 -  The patient's willingness to receive treatment&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Special child, a child with compromised systemic health.&#xD;
  &#xD;
                 -  First permanent molars covered by operculum.&#xD;
  &#xD;
                 -  Children with high salivary flow when isolation will be impossible&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>9 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Abrar Hossam Ahmed, Masters student</last_name>
      <phone>00201012979732</phone>
      <email>abrar.saleh@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yasmin Mohamed Yousry, Lecturer</last_name>
      <email>Yasmin.Yousry@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Abrar Hossam Ahmed Saleh</investigator_full_name>
      <investigator_title>principal investigator</investigator_title>
    </responsible_party>
    <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/NCT05988801
  org study id: Glass Ionomer VS Resin sealant
  nct id: NCT05988801
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  evaluation of the clinical and radiographic success of the glass ionomer sealant versus resin
        sealant in the pits and fissures sealing of the first permanent molars
  GIC has a hydrophilic nature which makes it compatible with clinical situations when
        isolation may be difficult. It also sets rapidly, which can reduce sensitivity to moisture.
        Glass ionomers release fluoride, which promotes enamel remineralization and has an
        antimicrobial effect. Another benefit of using glass ionomers as sealants is that the tooth
        does not need to be etched to achieve chemical bonding to the tooth. Thus saving time which
        is critical in the case of young patients and patients with disabilities.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Marginal discoloration
  time frame: 6 months
  description: Marginal discoloration will be measured with visual examination and recorded in Alfa: Lack of discoloration, Bravo: Margin discoloration, and Charlie: Discoloration under the sealant.
  measure: sealant retention
  time frame: 6 months
  description: Sealant retention will be measured with a mouth mirror and probe and recorded in total retention or partial loss or complete loss
  measure: Dental Caries
  time frame: 6 months
  description: The absence or presence of any signs of dental caries or periapical infection will be measured with a periapical X-ray
  arm group label: Glass ionomer sealant
  arm group type: Experimental
  description: glass ionomer based sealant material
  arm group label: Resin sealant
  arm group type: Active Comparator
  description: resin-based sealant material
  intervention type: Other
  intervention name: Glass ionomer sealant
  description: glass ionomer-based sealant material
  arm group label: Glass ionomer sealant
  intervention type: Other
  intervention name: Resin based sealant
  description: resin-based sealant material
  arm group label: Resin sealant
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 9 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Abrar Hossam Ahmed, Masters student
  phone: 00201012979732
  email: abrar.saleh@dentistry.cu.edu.eg
  last name: Yasmin Mohamed Yousry, Lecturer
  email: Yasmin.Yousry@dentistry.cu.edu.eg
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Abrar Hossam Ahmed Saleh
  investigator title: principal investigator
  sharing ipd: No