<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/NCT03792178</url>
  </required_header>
  <id_info>
    <org_study_id>150405</org_study_id>
    <nct_id>NCT03792178</nct_id>
  </id_info>
  <brief_title>Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.</brief_title>
  <acronym>EPSBN</acronym>
  <official_title>Evaluation of Post-operative Sensitivity of Bulk Fill Resin Composite Versus the Nano Resin Composite.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rasmia Mamdouh Ali Salem</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our study evaluated and compared the postoperative sensitivity of the placement technique&#xD;
      (incremental and bulk fill) in class II posterior composite resin restorations bonded with&#xD;
      two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly&#xD;
      selected, their age range from 25 to 40 years old. They were divided into 2 main groups&#xD;
      according to the packing technique of composite material; incremental Tetric Evoceram and&#xD;
      Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric&#xD;
      Evoceram composite restorations and they were equally divided according to the adhesive&#xD;
      systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30)&#xD;
      were selected for Tetric Evoceram bulk fill composite restorations and they were equally&#xD;
      divided according to the adhesive systems used (etch and rinse or self-etch adhesive&#xD;
      strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the&#xD;
      visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the&#xD;
      VAS line at home to indicate the intensity of pain at each assessment period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our results revealed that when the two composite types using self-etch adhesive system &amp;&#xD;
      total-etch adhesive system were evaluated; there was no statistically significant difference&#xD;
      between the two composite types after 1 day, 1 week as well as 1 month.&#xD;
&#xD;
      When the two adhesive systems were compared using Bulk Fill composite &amp; incremental Nano&#xD;
      resin composite there was no statistically significant difference between the two adhesive&#xD;
      systems after 1 day, 1 week as well as 1 month.&#xD;
&#xD;
      Using Bulk Fill composite with self-etch adhesive; there was a statistically significant&#xD;
      decrease in prevalence of hypersensitivity after 1 week. There were no cases with&#xD;
      hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch&#xD;
      adhesive; there was a statistically significant decrease in prevalence of hypersensitivity&#xD;
      after 1 week as well as from 1 week to 1 month.&#xD;
&#xD;
      Using Incremental Nano resin composite with self-etch adhesive; there was a statistically&#xD;
      significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to&#xD;
      1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a&#xD;
      statistically significant decrease in prevalence of hypersensitivity after 1 week as well as&#xD;
      from 1 week to 1 month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">April 25, 2017</completion_date>
  <primary_completion_date type="Actual">September 3, 2016</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>
    <intervention_model_description>bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>sensitivity</measure>
    <time_frame>one month follow up</time_frame>
    <description>post operative sensitivity</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Sensitivity</condition>
  <arm_group>
    <arm_group_label>Nano resin composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>are types of synthetic resins which are used in dentistry as restorative material or adhesives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bulk fill composite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bulk fill composite</intervention_name>
    <description>Composite resin dental material</description>
    <arm_group_label>Bulk fill composite</arm_group_label>
    <arm_group_label>Nano resin composite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nano resin composite</intervention_name>
    <description>Dental composite material</description>
    <arm_group_label>Bulk fill composite</arm_group_label>
    <arm_group_label>Nano resin composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must show no signs of spontaneous dental or orofacial pain.&#xD;
&#xD;
          -  The presence of molar and premolar class II teeth requiring composite restorations for&#xD;
             the treatment of primary carious lesions&#xD;
&#xD;
          -  The selected teeth should have an occlusal contact with natural or crowned antagonist&#xD;
             teeth&#xD;
&#xD;
          -  The selected teeth should have a proximal contact with the adjacent teeth.&#xD;
&#xD;
          -  Shallow and mid-sized cavity depths will be included in the study .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Increasing pre-operative sensitivity of the selected teeth.&#xD;
&#xD;
          -  Teeth with abnormal periapical anatomy or caries that will be likely to result in very&#xD;
             deep restorations.&#xD;
&#xD;
          -  Teeth with old restorations or severely destructed dental crowns.&#xD;
&#xD;
          -  Teeth with spontaneous pain&#xD;
&#xD;
          -  Tempro-mandibular joint problems involving symptomatic pain.&#xD;
&#xD;
          -  Patients taking analgesics that could alter their normal pain perception level.&#xD;
&#xD;
          -  Pregnancy or breast feeding, acute and chronic systemic diseases, immunecompromised&#xD;
             patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Rasmia Mamdouh Ali Salem</investigator_full_name>
    <investigator_title>Assistant lecturer at operative Department</investigator_title>
  </responsible_party>
  <keyword>Post operative sensitivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</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/NCT03792178
org study id: 150405
nct id: NCT03792178
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Our study evaluated and compared the postoperative sensitivity of the placement technique
      (incremental and bulk fill) in class II posterior composite resin restorations bonded with
      two different adhesive strategies (self-etch and etch-and-rinse).Sixty patients were randomly
      selected, their age range from 25 to 40 years old. They were divided into 2 main groups
      according to the packing technique of composite material; incremental Tetric Evoceram and
      Tetric Evoceram bulk fill composite.30 patients (n=30) were selected for incremental Tetric
      Evoceram composite restorations and they were equally divided according to the adhesive
      systems used (etch and rinse or self-etch adhesive strategy) (n=15 teeth).30 patients (n=30)
      were selected for Tetric Evoceram bulk fill composite restorations and they were equally
      divided according to the adhesive systems used (etch and rinse or self-etch adhesive
      strategy) (n=15 teeth).Post-operative pain assessed at 24 hours, 1 week and 1 month using the
      visual Analog Scale Score (VAS).Each patient was instructed to place a vertical mark on the
      VAS line at home to indicate the intensity of pain at each assessment period.
Our results revealed that when the two composite types using self-etch adhesive system &
      total-etch adhesive system were evaluated; there was no statistically significant difference
      between the two composite types after 1 day, 1 week as well as 1 month.

      When the two adhesive systems were compared using Bulk Fill composite & incremental Nano
      resin composite there was no statistically significant difference between the two adhesive
      systems after 1 day, 1 week as well as 1 month.

      Using Bulk Fill composite with self-etch adhesive; there was a statistically significant
      decrease in prevalence of hypersensitivity after 1 week. There were no cases with
      hypersensitivity after 1 week as well as 1 month. Using Bulk Fill composite with Total etch
      adhesive; there was a statistically significant decrease in prevalence of hypersensitivity
      after 1 week as well as from 1 week to 1 month.

      Using Incremental Nano resin composite with self-etch adhesive; there was a statistically
      significant decrease in prevalence of hypersensitivity after 1 week as well as from 1 week to
      1 month. Using Incremental Nano resin composite with Total etch adhesive; there was a
      statistically significant decrease in prevalence of hypersensitivity after 1 week as well as
      from 1 week to 1 month.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: bulk fill resin composite placement techqniues versus nano resin composite at postoperative hypersensitivity
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: sensitivity
time frame: one month follow up
description: post operative sensitivity
arm group label: Nano resin composite
arm group type: Active Comparator
description: are types of synthetic resins which are used in dentistry as restorative material or adhesives.
arm group label: Bulk fill composite
arm group type: Experimental
description: Bulk- ll composites are claimed to be restorative materials used in deep preparations and effectively photoactivated in layers up to 4 mm.
intervention type: Other
intervention name: Bulk fill composite
description: Composite resin dental material
arm group label: Bulk fill composite
arm group label: Nano resin composite
intervention type: Other
intervention name: Nano resin composite
description: Dental composite material
arm group label: Bulk fill composite
arm group label: Nano resin composite
criteria: 
gender: All
minimum age: 25 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Rasmia Mamdouh Ali Salem
investigator title: Assistant lecturer at operative Department
mesh term: Hypersensitivity
sharing ipd: Undecided