<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/NCT04475172</url>
  </required_header>
  <id_info>
    <org_study_id>ECPSAFCsCFC</org_study_id>
    <nct_id>NCT04475172</nct_id>
  </id_info>
  <brief_title>Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions</brief_title>
  <official_title>Evaluation Of Clinical Performance of Self-adhering Flowable Composite vs Conventional Flowable Composite in Cervical Carious Lesions: 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>
      This clinical trial will be conducted to compare the clinical performance of a new&#xD;
      self-adhering flowable composite in restoring CLs compared to conventional flowable composite&#xD;
      in geriatric patients over 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of&#xD;
      restorative material in adhesive dentistry. Today, there are only two available products in&#xD;
      the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable&#xD;
      composite was introduced to address the time-consuming procedure used with traditional&#xD;
      materials Their resin matrix contains acidic functional adhesive monomers mediating bonding&#xD;
      with dental hard tissues and, therefore, separate etching and additional bonding are not&#xD;
      required. SAFCs have been mainly advertised for the restoration of small Class I, Class III&#xD;
      and V cavities, for cavity lining, and for use as a pit and fissure sealant.&#xD;
&#xD;
      Self-adhering flowable composite combines the merits of both adhesive and restorative&#xD;
      material technologies in one product, bringing novel horizons to restorative techniques, as&#xD;
      it is a direct composite resin restorative material that has an adhesive resin together with&#xD;
      a flowable composite resin. It is based on the bonding technology that uses glycerophosphate&#xD;
      dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to&#xD;
      enhance wetting and penetration by resin into dentin. This resin bonds chemically between the&#xD;
      phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also,&#xD;
      micromechanically between the polymerized monomers of the self-adhering flowable composite&#xD;
      resin and the collagen fibers and smear layer of dentin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">October 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Quadruple</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal integrity of Class V restorations</measure>
    <time_frame>Clinical Evaluation of Marginal integrity after 6 months after starting treatment.</time_frame>
    <description>clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative sensitivity</measure>
    <time_frame>at baseline and 3 months after starting treatment .</time_frame>
    <description>clinical evaluation according to Modified United States Public Health Service Criteria (Bayne and Schmalz, 2005)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Fusio™ Flowable Self-Adhesive Flowable Composite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2-Cavity preparation steps:&#xD;
patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting.&#xD;
Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration.&#xD;
2% chlorhexidine gluconate disinfecting solution .&#xD;
wash the dentin surface with water spray and air dry with maximum air pressure for 5 s.&#xD;
A) Intervention: Fusio™ Flowable (Self adhesive flowable composite):&#xD;
Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional flowable composite [Tetric Evo Flow (FF)].</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Tetric Evo Flow (Conventional flowable composite):&#xD;
After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product.&#xD;
Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material.&#xD;
All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Self-Adhesive Flowable Composite</intervention_name>
    <description>Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive.&#xD;
It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin.</description>
    <arm_group_label>Conventional flowable composite [Tetric Evo Flow (FF)].</arm_group_label>
    <arm_group_label>Fusio™ Flowable Self-Adhesive Flowable Composite</arm_group_label>
    <other_name>Fusio™ Flowable Self-Adhesive Flowable Composite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cervical Class V carious lesions in anterior and premolars teeth.&#xD;
&#xD;
          -  Age above 60 years.&#xD;
&#xD;
          -  Males and females.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • patient less than 60 years with disabilities, systemic disease, severe medical&#xD;
             conditions, rampant caries, and xerostomia.&#xD;
&#xD;
               -  In addition, teeth with potential prosthodontics restoration and nonvital or&#xD;
                  endodontically treated teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 16, 2020</last_update_submitted>
  <last_update_submitted_qc>July 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Fatheya Mansour Atifa Elshnawy</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <!-- 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/NCT04475172
org study id: ECPSAFCsCFC
nct id: NCT04475172
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This clinical trial will be conducted to compare the clinical performance of a new
      self-adhering flowable composite in restoring CLs compared to conventional flowable composite
      in geriatric patients over 12 months.
Recently, self-adhesive flowable composites (SAFCs) have been introduced as a new class of
      restorative material in adhesive dentistry. Today, there are only two available products in
      the market for clinical use: Vertise Flow and Fusio Liquid Dentin. Self-adhering flowable
      composite was introduced to address the time-consuming procedure used with traditional
      materials Their resin matrix contains acidic functional adhesive monomers mediating bonding
      with dental hard tissues and, therefore, separate etching and additional bonding are not
      required. SAFCs have been mainly advertised for the restoration of small Class I, Class III
      and V cavities, for cavity lining, and for use as a pit and fissure sealant.

      Self-adhering flowable composite combines the merits of both adhesive and restorative
      material technologies in one product, bringing novel horizons to restorative techniques, as
      it is a direct composite resin restorative material that has an adhesive resin together with
      a flowable composite resin. It is based on the bonding technology that uses glycerophosphate
      dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to
      enhance wetting and penetration by resin into dentin. This resin bonds chemically between the
      phosphate groups of a GPDM monomer and the hydroxyapatite of tooth structure and, also,
      micromechanically between the polymerized monomers of the self-adhering flowable composite
      resin and the collagen fibers and smear layer of dentin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Quadruple
measure: Marginal integrity of Class V restorations
time frame: Clinical Evaluation of Marginal integrity after 6 months after starting treatment.
description: clinical evaluation according to Modified USPHS Criteria (Bayne and Schmalz, 2005) unit of measurement :Alfa, Bravo,charlie and Delta
measure: Postoperative sensitivity
time frame: at baseline and 3 months after starting treatment .
description: clinical evaluation according to Modified United States Public Health Service Criteria (Bayne and Schmalz, 2005)
arm group label: Fusio™ Flowable Self-Adhesive Flowable Composite
arm group type: Experimental
description: 2-Cavity preparation steps:
patients will be given local anesthesia as required,the operative field will be isolated with rubber dam before starting.
Conventional design Class V cavity will be prepared on the buccal surface of tooth by No. #330 bur (0.8 mm in diameter and 1.6 mm in length) , tooth surfaces will be kept moist to protect them against dehydration.
2% chlorhexidine gluconate disinfecting solution .
wash the dentin surface with water spray and air dry with maximum air pressure for 5 s.
A) Intervention: Fusio™ Flowable (Self adhesive flowable composite):
Simply syringe into the preparation 1 mm increments, agitate with tip or brush for 20 s, and light-cure.No need for an etchant or an adhesive.
arm group label: Conventional flowable composite [Tetric Evo Flow (FF)].
arm group type: Active Comparator
description: Tetric Evo Flow (Conventional flowable composite):
After cleaning cavities, apply conditioning material (phosphoric acid etching 37% ) and apply bonding agent (ExciTE® F) according to the instructions for use of the product.
Apply Tetric EvoFlow in layers of 1mm. Polymerize each layer separately following the instructions for use of this product. . Hold the light emission window as closely as possible to the surface of the restorative material.
All 20 Class V restorations will be prepared, restored, finished, and polished by one operator. Each of the 10 patients had one (FL) restoration and the other restoration will be filled with (FF).
intervention type: Combination Product
intervention name: Self-Adhesive Flowable Composite
description: Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive.
It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin.
arm group label: Conventional flowable composite [Tetric Evo Flow (FF)].
arm group label: Fusio™ Flowable Self-Adhesive Flowable Composite
other name: Fusio™ Flowable Self-Adhesive Flowable Composite
criteria: 
gender: All
minimum age: 60 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Fatheya Mansour Atifa Elshnawy
investigator title: principal investigator
mesh term: Dental Caries