<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/NCT04475679</url>
  </required_header>
  <id_info>
    <org_study_id>LL3615088</org_study_id>
    <nct_id>NCT04475679</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Adhese Universal DC in the Indirect Restorative Therapy</brief_title>
  <official_title>Clinical Evaluation of a New Dual Cure Universal Adhesive (Adhese Universal DC) in the Indirect Restorative Therapy: A Randomised, Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ivoclar Vivadent AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ivoclar Vivadent AG</source>
  <oversight_info>
    <has_dmc>No</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>
      A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure&#xD;
      the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for&#xD;
      molars and premolars will be luted with Adhese Universal DC or Adhese Universal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth&#xD;
      vitality and failure rate of placed restorations. Tooth vitality is an indicator for the&#xD;
      health status of the dental pulp. A vitality test is performed to acquire information about&#xD;
      the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test.&#xD;
      Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible&#xD;
      necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the&#xD;
      vitality test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 4, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2026</completion_date>
  <primary_completion_date type="Actual">July 12, 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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative hypersensitivity</measure>
    <time_frame>Baseline to 60 months</time_frame>
    <description>assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 &quot;very good&quot; to 5 &quot;unacceptable&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>loss of vitality of restored teeth</measure>
    <time_frame>Baseline to 60 months</time_frame>
    <description>assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 &quot;very good&quot; to 5 &quot;unacceptable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fracture rate of restored teeth</measure>
    <time_frame>Baseline to 60 months</time_frame>
    <description>assessed following the FDI criteria on a scale from 1 &quot;very good&quot; to 5 &quot;unacceptable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>retention/fracture rate of restorations</measure>
    <time_frame>Baseline to 60 months</time_frame>
    <description>assessed following the FDI criteria on a scale from 1 &quot;very good&quot; to 5 &quot;unacceptable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>marginal quality</measure>
    <time_frame>Baseline to 60 months</time_frame>
    <description>assessed following the FDI criteria on a scale from 1 &quot;very good&quot; to 5 &quot;unacceptable&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Dental Caries</condition>
  <condition>Defective Tooth Restorations</condition>
  <arm_group>
    <arm_group_label>Adhese Universal DC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Adhese Universal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhese Universal DC</intervention_name>
    <description>Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface</description>
    <arm_group_label>Adhese Universal DC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Adhese Universal</intervention_name>
    <description>Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth</description>
    <arm_group_label>Adhese Universal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-65 years&#xD;
&#xD;
          -  Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement&#xD;
             of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of&#xD;
             the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary&#xD;
             caries&#xD;
&#xD;
          -  The occlusal area of the restoration must cover at least 1/3 of the occlusal area of&#xD;
             the tooth.&#xD;
&#xD;
          -  Participant wishes a restoration within the scope of the study (signed informed&#xD;
             consent after detailed explanation and study of the patient information)&#xD;
&#xD;
          -  2-operative discomfort of the tooth to be restored should not exceed 3 on the visual&#xD;
             analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature&#xD;
             stimulus or bite sensitivity&#xD;
&#xD;
          -  Max. 2 restorations per participant in different quadrants.&#xD;
&#xD;
          -  Vital tooth&#xD;
&#xD;
          -  Healthy periodontium, no active periodontitis&#xD;
&#xD;
          -  Contact with adjacent teeth (at least at one side) and opposing teeth present with at&#xD;
             least one contact point.&#xD;
&#xD;
          -  Sufficient language skills&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Sufficient isolation not possible, dry working field cannot be guaranteed&#xD;
&#xD;
          -  Participants with a proven allergy to one of the ingredients of the materials used&#xD;
&#xD;
          -  Participants with proven allergy to local anaesthetics&#xD;
&#xD;
          -  High caries activity/ poor oral hygiene&#xD;
&#xD;
          -  Participants with severe systemic diseases&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Nonvital tooth or tooth with irreversible pulpitis&#xD;
&#xD;
          -  Indication for direct pulp capping&#xD;
&#xD;
          -  Symptoms of SARS-CoV2 infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ivoclar Vivadent</name>
      <address>
        <city>Schaan</city>
        <zip>9494</zip>
        <country>Liechtenstein</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Liechtenstein</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>April 8, 2022</last_update_submitted>
  <last_update_submitted_qc>April 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caries</keyword>
  <keyword>restoration</keyword>
  <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/NCT04475679
org study id: LL3615088
nct id: NCT04475679
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A post market clinical follow up study (PMCF) with Adhese Universal DC is planned to ensure
      the safety and efficacy of the product. It is a study with two arms. Inlays and onlays for
      molars and premolars will be luted with Adhese Universal DC or Adhese Universal.
This study aims to assess the long-term safety of Adhese Universal DC in terms of tooth
      vitality and failure rate of placed restorations. Tooth vitality is an indicator for the
      health status of the dental pulp. A vitality test is performed to acquire information about
      the vitality of teeth. A healthy dental pulp offers a positive response to the vitality test.
      Once the dental pulp is injured an irreversible inflammatory reaction starts with a possible
      necrosis of the dental pulp. Pulpa necrosis is followed by a negative response to the
      vitality test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: postoperative hypersensitivity
time frame: Baseline to 60 months
description: assessed by tests with thermal stimuli and occlusal forces (during biting) determined by VAS (Visual Analog Scale) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
measure: loss of vitality of restored teeth
time frame: Baseline to 60 months
description: assessed by a cold stimuli test (cotton pellet and refrigerating spray) following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
measure: fracture rate of restored teeth
time frame: Baseline to 60 months
description: assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
measure: retention/fracture rate of restorations
time frame: Baseline to 60 months
description: assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
measure: marginal quality
time frame: Baseline to 60 months
description: assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable"
arm group label: Adhese Universal DC
arm group type: Experimental
arm group label: Adhese Universal
arm group type: Active Comparator
intervention type: Device
intervention name: Adhese Universal DC
description: Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface
arm group label: Adhese Universal DC
intervention type: Device
intervention name: Adhese Universal
description: Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
arm group label: Adhese Universal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Liechtenstein
responsible party type: Sponsor
mesh term: Dental Caries