<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/NCT03306576</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01-E.21426</org_study_id>
    <nct_id>NCT03306576</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of ELS Versus ELS Extra Resin Composite</brief_title>
  <official_title>Clinical Evaluation of Restorations Made of ELS Versus ELS Extra Resin Composite: A Prospective Randomized Controlled Clinical Trial up to 3 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saremco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      Adhesive restorative materials are routinely used in operative dentistry to improve tooth&#xD;
      tissues with minimal preparation, achieve more esthetic and long term restorations. Despite&#xD;
      these efficacy to dentistry these materials still present some drawbacks like polymerization&#xD;
      shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries&#xD;
      are often associated with loss of marginal integrity in composite restorations occurred as a&#xD;
      result of polymerization shrinkage. To achieve optimal long term performance, the&#xD;
      requirements will be first to manage polymerization stress buildup following&#xD;
      restoration.Low-shrinking composites with new formulas have been successful in brilliantly&#xD;
      further developing the leader product els extra low shrinkage.&#xD;
&#xD;
      The objective of this controlled clinical trial is to evaluate the clinical performance of&#xD;
      restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities&#xD;
      that needs to be restored in permanent teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The detrimental impact of resin composite polymerization shrinkage on restoration interface&#xD;
      quality and stability has been recognized since the early use of this material is still one&#xD;
      of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal&#xD;
      integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative&#xD;
      sensitivity, marginal discoloration and possibly secondary caries are often associated with&#xD;
      loss of marginal integrity in composite restorations occurred as a result of polymerization&#xD;
      shrinkage. Various technological solutions were investigated, including improved filler&#xD;
      technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing&#xD;
      compounds within the resin matrix; changes in light-initiation technology to increase curing&#xD;
      depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled&#xD;
      resin composite. To achieve optimal long term performance, the requirements will be first to&#xD;
      manage polymerization stress buildup following restoration. Low-shrinking composites should&#xD;
      help to avoid clinical problems that are commonly associated with composite restorations,&#xD;
      such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of&#xD;
      restoration margins, early development of caries recurrence, with a new formula and improved&#xD;
      sculptability SAREMCO has been successful in brilliantly further developing the leader&#xD;
      product els extra low shrinkage. When using new simplified restorative systems featuring&#xD;
      distinctive physicochemical characteristics, the potential impact of different parameters&#xD;
      such as fatigue behavior and/or elastic modulus on restoration quality and behavior is&#xD;
      unknown and justifies additional investigations. Instead of in vitro evaluations,&#xD;
      consideration of a rather well-established clinical trials suggesting medium to long term&#xD;
      observation periods to discriminately appraise the clinical performance of various operative&#xD;
      protocols.&#xD;
&#xD;
      The project includes 30 patients. Most of the patients have been recruited from the Istanbul&#xD;
      Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the&#xD;
      study Class I &amp; II restorations of both upper and lower molars and premolars are&#xD;
      performed.The treatment procedure is: The patients are offered local anesthetic before&#xD;
      treatment start. The cavity is excavated and filled according to the guidelines for composite&#xD;
      restorations.&#xD;
&#xD;
      The control procedure is:&#xD;
&#xD;
      The restoration is evaluated according to marginal adaptation, cavo surface marginal&#xD;
      discoloration, approximal contact, fractures, caries associated with restorations and&#xD;
      postoperative hypersensitivity. The controls will take place after two weeks, one year, two&#xD;
      years and three years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2017</start_date>
  <completion_date type="Actual">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 15, 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>
    <intervention_model_description>Each participant will receive 2 matched restorations, one of each material.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified FDI criteria</measure>
    <time_frame>3 years</time_frame>
    <description>Restoration failure is based on clinical performance criteria according to the modified FDI criteria</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Caries, Dental</condition>
  <arm_group>
    <arm_group_label>ELS Extra composite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ELS composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELS Extra composite</intervention_name>
    <description>One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.</description>
    <arm_group_label>ELS Extra composite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ELS composite</intervention_name>
    <description>the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.</description>
    <arm_group_label>ELS composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary caries removal&#xD;
&#xD;
          -  Class I &amp; II restoration replacement&#xD;
&#xD;
          -  No obvious untreated caries, dental health problems (regularly checked by a dentist)&#xD;
&#xD;
          -  Good or moderate oral hygiene (plaque score of less than 30% in anterior region&#xD;
             be-fore treatment)&#xD;
&#xD;
          -  No untreated periodontal disease (only DPSI 1, 2)&#xD;
&#xD;
          -  Subjects had to present no active carious lesions&#xD;
&#xD;
          -  Subjects had to be over the age of 18, be classified according to the American Society&#xD;
             of Anesthesiologists (ASA) as ASA I or ASA II, present with good oral hygiene, and be&#xD;
             free of periodontal disease (probing depth and attachment levels within normal limits,&#xD;
             no furcation involvement, and no mobility)&#xD;
&#xD;
          -  Subjects had to agree to keep the scheduled recall appointments for data collection&#xD;
             and maintenance and plan to stay in the area for at least 3 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Caries extends cemento-enamel junction in Class II.&#xD;
&#xD;
          -  Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score&#xD;
             2 or 3&#xD;
&#xD;
          -  Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)&#xD;
&#xD;
          -  Endodontic treatment with extensive loss of tooth tissue&#xD;
&#xD;
          -  Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago&#xD;
&#xD;
          -  Excluding the teeth, with opposing natural dentition (either intact or restored with&#xD;
             intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth&#xD;
&#xD;
          -  Subjects who presented with severe wear facets and/or reported parafunctional&#xD;
             activities such as clenching or nocturnal bruxism&#xD;
&#xD;
          -  Subjects who were restored with a removable partial dental prosthesis (RPDP), unless&#xD;
             the RPDP replaced the tooth that was planned to be restored in the study&#xD;
&#xD;
          -  Subjects who were pregnant pregnant during the duration of the study&#xD;
&#xD;
          -  Subjects who are known to be allergic to the ingredients of resin materials&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mutlu Ozcan, Prof Dr,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich, Center for Dental Materials Unit, Center for Fixed and Removable Prosthodontics and Dental Materials Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Medipol University, Dental School</name>
      <address>
        <city>Istanbul</city>
        <zip>34083</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>October 5, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>Funda Ozturk Bozkurt</investigator_full_name>
    <investigator_title>DDS, PhD</investigator_title>
  </responsible_party>
  <keyword>composite restoration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <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/NCT03306576
org study id: 10840098-604.01.01-E.21426
nct id: NCT03306576
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Adhesive restorative materials are routinely used in operative dentistry to improve tooth
      tissues with minimal preparation, achieve more esthetic and long term restorations. Despite
      these efficacy to dentistry these materials still present some drawbacks like polymerization
      shrinkage. Postoperative sensitivity, marginal discoloration and possibly secondary caries
      are often associated with loss of marginal integrity in composite restorations occurred as a
      result of polymerization shrinkage. To achieve optimal long term performance, the
      requirements will be first to manage polymerization stress buildup following
      restoration.Low-shrinking composites with new formulas have been successful in brilliantly
      further developing the leader product els extra low shrinkage.

      The objective of this controlled clinical trial is to evaluate the clinical performance of
      restorative material ELS versus ELS Extra resin composite for Class I and Class II cavities
      that needs to be restored in permanent teeth.
The detrimental impact of resin composite polymerization shrinkage on restoration interface
      quality and stability has been recognized since the early use of this material is still one
      of the major drawbacks in adhesive dentistry, as it frequently leads to loss of marginal
      integrity or enamel fracture. According to clinical studies, drawbacks such as postoperative
      sensitivity, marginal discoloration and possibly secondary caries are often associated with
      loss of marginal integrity in composite restorations occurred as a result of polymerization
      shrinkage. Various technological solutions were investigated, including improved filler
      technology; improved, novel matrix structure with reduced shrinkage; use of stress-decreasing
      compounds within the resin matrix; changes in light-initiation technology to increase curing
      depth; and use of sonic vibrations and energy to favor flow and adaptation of highly filled
      resin composite. To achieve optimal long term performance, the requirements will be first to
      manage polymerization stress buildup following restoration. Low-shrinking composites should
      help to avoid clinical problems that are commonly associated with composite restorations,
      such as post-operative sensitivity, enamel cracks, rapid discoloration and deterioration of
      restoration margins, early development of caries recurrence, with a new formula and improved
      sculptability SAREMCO has been successful in brilliantly further developing the leader
      product els extra low shrinkage. When using new simplified restorative systems featuring
      distinctive physicochemical characteristics, the potential impact of different parameters
      such as fatigue behavior and/or elastic modulus on restoration quality and behavior is
      unknown and justifies additional investigations. Instead of in vitro evaluations,
      consideration of a rather well-established clinical trials suggesting medium to long term
      observation periods to discriminately appraise the clinical performance of various operative
      protocols.

      The project includes 30 patients. Most of the patients have been recruited from the Istanbul
      Medipol University Dental Clinics in Istanbul. After giving their consent to take part in the
      study Class I & II restorations of both upper and lower molars and premolars are
      performed.The treatment procedure is: The patients are offered local anesthetic before
      treatment start. The cavity is excavated and filled according to the guidelines for composite
      restorations.

      The control procedure is:

      The restoration is evaluated according to marginal adaptation, cavo surface marginal
      discoloration, approximal contact, fractures, caries associated with restorations and
      postoperative hypersensitivity. The controls will take place after two weeks, one year, two
      years and three years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Each participant will receive 2 matched restorations, one of each material.
primary purpose: Treatment
masking: None (Open Label)
measure: Modified FDI criteria
time frame: 3 years
description: Restoration failure is based on clinical performance criteria according to the modified FDI criteria
arm group label: ELS Extra composite
arm group type: Experimental
description: Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions
arm group label: ELS composite
arm group type: Active Comparator
description: Commercially available composite resin restorative that will be used for direct restoration as per manufacturer's instructions
intervention type: Device
intervention name: ELS Extra composite
description: One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
arm group label: ELS Extra composite
intervention type: Device
intervention name: ELS composite
description: the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.
arm group label: ELS composite
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mutlu Ozcan, Prof Dr,PhD
role: Principal Investigator
affiliation: University of Zurich, Center for Dental Materials Unit, Center for Fixed and Removable Prosthodontics and Dental Materials Science
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: Funda Ozturk Bozkurt
investigator title: DDS, PhD
mesh term: Dental Caries
sharing ipd: No