<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/NCT03283280</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-10-9-2017</org_study_id>
    <nct_id>NCT03283280</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Short Fiber Reinforced Resin Composite Versus Indirect Nanohybrid Resin Composite Onlay Restorations.</brief_title>
  <official_title>Clinical Performance of Short Fiber Reinforced Resin Composite Restorations Versus Indirect Nanohybrid Resin Composite Onlay Restorations in Complex Proximal Cavities of Molars</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      clinical performance of short fiber reinforced resin composite versus indirect nanohybrid&#xD;
      resin composite onlay restorations in complex proximal cavities of molar teeth will be&#xD;
      evaluated over one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resin composite materials have been rapidly developed in the latest few years. Direct resin&#xD;
      composite restorations become the golden standard for restoring intracoronal cavities. While&#xD;
      for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic&#xD;
      restorations in most situations being more esthetic and conservative with lower cost (Rocca &amp;&#xD;
      Krejci, 2007).&#xD;
&#xD;
      Indirect resin composite onlays usually are lab processed in two appointments but it can be&#xD;
      made in one appointment through CAD/CAM technology or by flexible model technique (semidirect&#xD;
      technique).&#xD;
&#xD;
      These restorations offer more control on the proximal contacts and the anatomic form over the&#xD;
      direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses&#xD;
      are decreased and become limited to the width of the luting space. Annual failure rate (AFR)&#xD;
      of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).&#xD;
&#xD;
      One of the advancement in resin composite technology is the evolution of short fiber&#xD;
      reinforced resin composite (SFRC) material that allows making a direct onlay restoration&#xD;
      possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).&#xD;
&#xD;
      This material is made to be used as a dentine substitute in the high stress-bearing areas. It&#xD;
      is covered by a conventional resin composite filling to act as the enamel replacement this&#xD;
      combination gives us a kind of biomimetic restoration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">June 1, 2019</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>Single (Outcomes Assessor)</masking>
    <masking_description>The outcome assessors will be blinded to the material type</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Clinical performance</measure>
    <time_frame>Change from the Baseline at six months and 12 months.</time_frame>
    <description>Measured using modified USPHS criteria for clinical evaluation of restoration failure</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Dental Restoration Failure of Marginal Integrity</condition>
  <arm_group>
    <arm_group_label>Short fiber RC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Short fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nanohybrid RC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ever X Posterior</intervention_name>
    <description>Resin composite restoration can be made as a direct onlay</description>
    <arm_group_label>Nanohybrid RC</arm_group_label>
    <arm_group_label>Short fiber RC</arm_group_label>
    <other_name>Short fiber reinforced resin composite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Pulp asymptomatic vital carious upper or lower molars.&#xD;
&#xD;
          2. Proximal complex carious cavities involving one or two weak cusps.&#xD;
&#xD;
          3. Replacement of old amalgam or resin composite restoration due to recurrent caries or&#xD;
             either tooth or restoration fracture.&#xD;
&#xD;
          4. Presence of favorable occlusion.&#xD;
&#xD;
          5. Healthy volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.&#xD;
&#xD;
          2. Deep subgingival cavity margins.&#xD;
&#xD;
          3. Possible future prosthodontic restoration of teeth.&#xD;
&#xD;
          4. Severe periodontal problems.&#xD;
&#xD;
          5. Medically compromised patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rawda Hesham Abd ElAziz, Msc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant lecturer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <zip>11331</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.gceurope.com/products/everxposterior/</url>
    <description>Short fiber reinforced resin composite</description>
  </link>
  <link>
    <url>http://www.voco.com/us/product/GrandioSO/index.html</url>
    <description>Indirect nanohybrid resin composite</description>
  </link>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>July 24, 2019</last_update_submitted>
  <last_update_submitted_qc>July 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Rawda Hesham Abd ElAziz</investigator_full_name>
    <investigator_title>Assistant lecturer</investigator_title>
  </responsible_party>
  <keyword>Short fiber reinforced resin composite</keyword>
  <keyword>Nanohybrid resin composite</keyword>
  <keyword>Indirect resin composite restoration</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03283280
org study id: CEBD-CU-10-9-2017
nct id: NCT03283280
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
clinical performance of short fiber reinforced resin composite versus indirect nanohybrid
      resin composite onlay restorations in complex proximal cavities of molar teeth will be
      evaluated over one year.
Resin composite materials have been rapidly developed in the latest few years. Direct resin
      composite restorations become the golden standard for restoring intracoronal cavities. While
      for the extracoronal cavities, the indirect resin composite onlays tend to replace metallic
      restorations in most situations being more esthetic and conservative with lower cost (Rocca &
      Krejci, 2007).

      Indirect resin composite onlays usually are lab processed in two appointments but it can be
      made in one appointment through CAD/CAM technology or by flexible model technique (semidirect
      technique).

      These restorations offer more control on the proximal contacts and the anatomic form over the
      direct approach. Polymerization shrinkage occurs outside the patient mouth so the stresses
      are decreased and become limited to the width of the luting space. Annual failure rate (AFR)
      of indirect posterior resin composite restorations is up to 10% (Manhart et al, 2004).

      One of the advancement in resin composite technology is the evolution of short fiber
      reinforced resin composite (SFRC) material that allows making a direct onlay restoration
      possible thus offers less procedural steps and saves more time (Garoushi et al, 2013).

      This material is made to be used as a dentine substitute in the high stress-bearing areas. It
      is covered by a conventional resin composite filling to act as the enamel replacement this
      combination gives us a kind of biomimetic restoration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The outcome assessors will be blinded to the material type
measure: Change in the Clinical performance
time frame: Change from the Baseline at six months and 12 months.
description: Measured using modified USPHS criteria for clinical evaluation of restoration failure
arm group label: Short fiber RC
arm group type: Experimental
description: Short fiber reinforced resin composite restoration (Ever X Posterior, Gc Europe) that is used in high stress bearing areas as direct onlay restoration.
arm group label: Nanohybrid RC
arm group type: Active Comparator
description: Nanohybrid resin composite (GrandioSO, VOCO GmbH Germany ) that can be used to make indirect restorations in posterior teeth.
intervention type: Other
intervention name: Ever X Posterior
description: Resin composite restoration can be made as a direct onlay
arm group label: Nanohybrid RC
arm group label: Short fiber RC
other name: Short fiber reinforced resin composite
criteria: 
gender: All
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rawda Hesham Abd ElAziz, Msc
role: Principal Investigator
affiliation: Assistant lecturer
facility: 
country: Egypt
url: http://www.gceurope.com/products/everxposterior/
description: Short fiber reinforced resin composite
url: http://www.voco.com/us/product/GrandioSO/index.html
description: Indirect nanohybrid resin composite
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Rawda Hesham Abd ElAziz
investigator title: Assistant lecturer
sharing ipd: No