<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/NCT03242291</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-7-29</org_study_id>
    <nct_id>NCT03242291</nct_id>
  </id_info>
  <brief_title>Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, Randomized Clinical Trial</brief_title>
  <official_title>Evaluation of Marginal Integrity of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional Resin-Based Flowable Composite in Initially Demineralized Pits and Fissure: A One Year, 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>
    <has_dmc>No</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>
      This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber&#xD;
      reinforced flowable composite compared to a conventional resin-based flowable composite&#xD;
      during management of initial carious lesion in adult population over a one year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned&#xD;
      in this study. Patients will be divided into two groups according to type of flowable&#xD;
      composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite&#xD;
      Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed&#xD;
      with conventional resin-based flowable composite. Each restoration will be assessed after one&#xD;
      week, six and twelve months Both materials will be applied according to manufacturer's&#xD;
      instructions where teeth should be cleaned to remove surface stains, then select appropriate&#xD;
      shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and&#xD;
      rinse adhesive system is applied, where acid etching will be applied for 15 seconds then&#xD;
      rinse and dry followed by application of adhesive then light cure 10 seconds, then place and&#xD;
      cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition&#xD;
      layer after light cure with slurry of pumice or polishing paste All restorations were&#xD;
      reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material&#xD;
      used for the restorations. All restorations were be evaluated by calibrated examiners&#xD;
      following the FDI criteria&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>marginal integrity of both restorations</measure>
    <time_frame>12 months</time_frame>
    <description>restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Marginal Integrity of Hydroxyapatite Nanofiber Reinforced Flowable Composite</condition>
  <arm_group>
    <arm_group_label>conventional resin-based flowable composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Hydroxyapatite Nanofiber reinforced flowable composite</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional resin-based flowable composite</intervention_name>
    <description>assessment of marginal integrity of Conventional resin-based flowable composite</description>
    <arm_group_label>Hydroxyapatite Nanofiber reinforced flowable composite</arm_group_label>
    <arm_group_label>conventional resin-based flowable composite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydroxyapatite Nanofiber reinforced flowable composite</intervention_name>
    <description>assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite</description>
    <arm_group_label>Hydroxyapatite Nanofiber reinforced flowable composite</arm_group_label>
    <arm_group_label>conventional resin-based flowable composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients should be over 18 Years old.&#xD;
&#xD;
          -  Patient should have good oral hygiene and general health&#xD;
&#xD;
          -  With at least 2 non-cavitated initial occlusal carious lesion first and/or Second&#xD;
             molar teeth in each quadrant of maxilla or mandible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any of the resins used,&#xD;
&#xD;
          -  Clinically detectable caries,&#xD;
&#xD;
          -  Previously placed sealants or restorations,&#xD;
&#xD;
          -  Bruxism or malocclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>donia mamdouh elshafey, master</last_name>
    <phone>01008820027</phone>
    <phone_ext>002</phone_ext>
    <email>doniaelshafey90@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohamed mostafa radwan, PHD</last_name>
    <phone>01005148901</phone>
    <phone_ext>002</phone_ext>
    <email>mohamedmostafa23@gmail.com</email>
  </overall_contact_backup>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>donia elshafey</investigator_full_name>
    <investigator_title>internal resident</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Metabolism Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03242291
org study id: CEBC-CU-2017-7-29
nct id: NCT03242291
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to evaluate the Marginal integrity of Hydroxyapatite Nanofiber
      reinforced flowable composite compared to a conventional resin-based flowable composite
      during management of initial carious lesion in adult population over a one year period.
A total of 26 volunteer patients with at least 2 non-cavitated molar teeth will be assigned
      in this study. Patients will be divided into two groups according to type of flowable
      composite (R) where groups R1 the pits and fissure will be sealed with Hydroxyapatite
      Nanofiber reinforced flowable composite while groups R2 the pits and fissure will be sealed
      with conventional resin-based flowable composite. Each restoration will be assessed after one
      week, six and twelve months Both materials will be applied according to manufacturer's
      instructions where teeth should be cleaned to remove surface stains, then select appropriate
      shade of the flowable composite, A rubber dam is the preferred method of isolation, etch and
      rinse adhesive system is applied, where acid etching will be applied for 15 seconds then
      rinse and dry followed by application of adhesive then light cure 10 seconds, then place and
      cure in 2 mm increments of the flowable composite for 20 s., gently remove oxygen inhibition
      layer after light cure with slurry of pumice or polishing paste All restorations were
      reviewed after 1 week, 6, 12 months by two investigators who were blinded to the material
      used for the restorations. All restorations were be evaluated by calibrated examiners
      following the FDI criteria
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: marginal integrity of both restorations
time frame: 12 months
description: restorations will be reviewed after 12 months by two investigators who are blinded to the material used for the restorations. All restorations will be evaluated by calibrated examiners following the FDI criteria Data will be explored for normality using Kolmogrov-Smirnov test and Shapirowilk test. Comparisons between before and after treatment for normally distributed numeric variables will be done by Wilcoxon sign test. Comparisons between categorical variables will be performed using the chi square test Mcnemar test. A p-value less than or equal to 0.05 will be considered statistically significance. All tests will be two tailed.
arm group label: conventional resin-based flowable composite
arm group type: Active Comparator
arm group label: Hydroxyapatite Nanofiber reinforced flowable composite
arm group type: Other
intervention type: Other
intervention name: Conventional resin-based flowable composite
description: assessment of marginal integrity of Conventional resin-based flowable composite
arm group label: Hydroxyapatite Nanofiber reinforced flowable composite
arm group label: conventional resin-based flowable composite
intervention type: Other
intervention name: Hydroxyapatite Nanofiber reinforced flowable composite
description: assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
arm group label: Hydroxyapatite Nanofiber reinforced flowable composite
arm group label: conventional resin-based flowable composite
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: donia mamdouh elshafey, master
phone: 01008820027
phone ext: 002
email: doniaelshafey90@gmail.com
last name: mohamed mostafa radwan, PHD
phone: 01005148901
phone ext: 002
email: mohamedmostafa23@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: donia elshafey
investigator title: internal resident
mesh term: Calcium Metabolism Disorders
sharing ipd: Undecided