<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/NCT03264105</url>
  </required_header>
  <id_info>
    <org_study_id>CEBC-CU-2017-07-31</org_study_id>
    <nct_id>NCT03264105</nct_id>
  </id_info>
  <brief_title>Retention Rate of Hydroxyapatite Nano-Fiber Reinforced Flowable Composite Versus Conventional</brief_title>
  <official_title>Retention Rate 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>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pits and fissures have been considered as the single most important feature leading to the&#xD;
      development of occlusal caries; About 90 % of carious lesions are found in the pits and&#xD;
      fissures of permanent posterior teeth .Several materials and techniques have been developed&#xD;
      to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite&#xD;
      resins as pit-and-fissure sealants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pits and fissures have been considered as the single most important feature leading to the&#xD;
      development of occlusal caries; About 90 % of carious lesions are found in the pits and&#xD;
      fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures&#xD;
      makes them an ideal site for retention of bacteria and food remnants, rendering the&#xD;
      performance of proper hygiene difficult or even impossible .&#xD;
&#xD;
      Several materials and techniques have been developed to enhance the longevity of&#xD;
      pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure&#xD;
      sealants . However, the clinical longevity of flowable composite as fissure sealants is&#xD;
      directly related to their retention, where the percentage of rate of retention differ on a&#xD;
      12-month follow-up examination were the partial loss rate of flowable composite material&#xD;
      ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month&#xD;
      follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate&#xD;
      ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate&#xD;
      isolation, conditioning of enamel, application techniques, particular material&#xD;
      characteristics like viscosity, surface tension, adequate adhesion and penetration of the&#xD;
      material into the previously etched system of fissures.&#xD;
&#xD;
      In order to overcome the shortcomings of traditional dental composites, nanofibers or&#xD;
      nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and&#xD;
      Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic&#xD;
      nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are&#xD;
      calcium phosphates fillers that allow the release of mineral from dental resin composite.&#xD;
      Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and&#xD;
      thin structure, and create a lot of bonding points in the interface with polymeric matrix.&#xD;
      When the composites suffer from huge pressure this allow tremendous stress transfer from weak&#xD;
      polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties&#xD;
      of resin composite. So this study will examine the effect of adding HAP nanofibers on the&#xD;
      clinical performances and retention rate of flowable resin composite.&#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">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The primary assessors will not be blind to intervention/control material due to different in material shade. However, the other assessors will be blind from the type of material they will evaluate the retention rate of the restoration; it will not be allowed amongst the assessor to exchange any information throughout the entire study period.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>retention rate evaluation of both restoration</measure>
    <time_frame>12 months</time_frame>
    <description>restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed.&#xD;
Totally lost (TL): no trace of materials was detected on the surface.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">19</enrollment>
  <condition>Retention Rate of Flowable Composite in Demenerlized Pits and Fissure</condition>
  <arm_group>
    <arm_group_label>NovaPro™ Flow</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional resin-based flowable composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Hydroxyapatite Nanofiber reinforced flowable composite</intervention_name>
    <description>retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite</description>
    <arm_group_label>Conventional resin-based flowable composite</arm_group_label>
    <arm_group_label>NovaPro™ Flow</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional resin-based flowable composite</intervention_name>
    <description>retention rate evaluation of conventional resin-based flowable composite</description>
    <arm_group_label>Conventional resin-based flowable composite</arm_group_label>
    <arm_group_label>NovaPro™ Flow</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients should be over 18 Years old. Patient should have good oral hygiene and general&#xD;
        health. Patient with at least 2 non-cavitated initial occlusal carious lesion in first&#xD;
        and/or second molar teeth in each quadrant of maxilla or mandible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Known allergy to any of the resins used. Clinically detectable cavitated carious lesion.&#xD;
        Previously placed sealants or restorations. Bruxism or malocclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>safinaz hussien fahmy hassan</investigator_full_name>
    <investigator_title>dental resident</investigator_title>
  </responsible_party>
  <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/NCT03264105
org study id: CEBC-CU-2017-07-31
nct id: NCT03264105
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Pits and fissures have been considered as the single most important feature leading to the
      development of occlusal caries; About 90 % of carious lesions are found in the pits and
      fissures of permanent posterior teeth .Several materials and techniques have been developed
      to enhance the longevity of pit-and-fissure sealants, including the use of flowable composite
      resins as pit-and-fissure sealants
Pits and fissures have been considered as the single most important feature leading to the
      development of occlusal caries; About 90 % of carious lesions are found in the pits and
      fissures of permanent posterior teeth . The complex morphology of occlusal pits and fissures
      makes them an ideal site for retention of bacteria and food remnants, rendering the
      performance of proper hygiene difficult or even impossible .

      Several materials and techniques have been developed to enhance the longevity of
      pit-and-fissure sealants, including the use of flowable composite resins as pit-and-fissure
      sealants . However, the clinical longevity of flowable composite as fissure sealants is
      directly related to their retention, where the percentage of rate of retention differ on a
      12-month follow-up examination were the partial loss rate of flowable composite material
      ranges from 15.5% to 16.5% and total loss were ranged from 12.7% to 13%, while on a 24-month
      follow-up examination the partial loss rate ranged from 18.1% to 20% and total loss rate
      ranged from 15.6% to 17%, and that depends on morphology of pits and fissures, adequate
      isolation, conditioning of enamel, application techniques, particular material
      characteristics like viscosity, surface tension, adequate adhesion and penetration of the
      material into the previously etched system of fissures.

      In order to overcome the shortcomings of traditional dental composites, nanofibers or
      nanotubes fillers are broadly used in the academia and industry. The type of Nanofibers and
      Nanotubes used to reinforce dental resin composites include polymeric nanofibers, metallic
      nanofibers, and inorganic hydroxyapatide (HAP) nanofibers. The Hydroxyapatite Nanofibers are
      calcium phosphates fillers that allow the release of mineral from dental resin composite.
      Also HAP nanofibers possessing sufficiently high slenderness ratios and relatively long and
      thin structure, and create a lot of bonding points in the interface with polymeric matrix.
      When the composites suffer from huge pressure this allow tremendous stress transfer from weak
      polymeric matrix to tough HAP nanofibers; and consequently increase the mechanical properties
      of resin composite. So this study will examine the effect of adding HAP nanofibers on the
      clinical performances and retention rate of flowable resin composite.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: The primary assessors will not be blind to intervention/control material due to different in material shade. However, the other assessors will be blind from the type of material they will evaluate the retention rate of the restoration; it will not be allowed amongst the assessor to exchange any information throughout the entire study period.
measure: retention rate evaluation of both restoration
time frame: 12 months
description: restoration will be evaluated after 12 months by two investegators who ar blinded for the material used for the restoration.Each restoration will be independently evaluated using a mirror, blunt explorer, and air stream as the follows: Full retention (FR): the materials were fully present on the occlusal surfaces. Partially lost (PL): the materials were present, but as a result of either wear or loss of the material, part of a previously sealed pit or fissure, or both, was exposed.
Totally lost (TL): no trace of materials was detected on the surface.
arm group label: NovaPro™ Flow
arm group type: Experimental
description: NovaPro™ Flow Flowable Composite, Nanova Biomaterials company, USA
arm group label: Conventional resin-based flowable composite
arm group type: Active Comparator
description: Filtek™Supreme Ultra Flowable Restorative, 3M ESPE company, USA
intervention type: Other
intervention name: Hydroxyapatite Nanofiber reinforced flowable composite
description: retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite
arm group label: Conventional resin-based flowable composite
arm group label: NovaPro™ Flow
intervention type: Other
intervention name: conventional resin-based flowable composite
description: retention rate evaluation of conventional resin-based flowable composite
arm group label: Conventional resin-based flowable composite
arm group label: NovaPro™ Flow
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: safinaz hussien fahmy hassan
investigator title: dental resident
sharing ipd: Undecided