<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/NCT02991573</url>
  </required_header>
  <id_info>
    <org_study_id>CIP 14.1515 (STH 18842)</org_study_id>
    <nct_id>NCT02991573</nct_id>
  </id_info>
  <brief_title>Clinical Study Class II on Ceram.x Universal and Prime&amp;Bond</brief_title>
  <official_title>Clinical Post-Market Surveillance Study of Ceram.x Universal and Prime&amp;Bond Universal When Used for Class II Restorations at the University of Sheffield</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dentsply International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Damage to teeth from decay or previous old silver fillings can be repaired with&#xD;
      tooth-coloured filling materials that stick to the tooth. These materials have been around&#xD;
      for some years and have become more sophisticated; with greater ease of placement by the&#xD;
      dentist and better durability for the patient. The fillings are designed to be used in&#xD;
      combination with a specific glue (adhesive) that is designed to stick to the different parts&#xD;
      of the tooth to provide a good seal, the outer enamel and the inner dentine.&#xD;
&#xD;
      This study will examine the performance of a state-of-the-art modern tooth coloured filling&#xD;
      material (Ceram X) in combination with an existing adhesive (control adhesive) and a new&#xD;
      adhesive (Prime &amp; Bond Universal) used in two different techniques; both of which are known&#xD;
      to work but one is easier to apply. This results in three treatment groups.&#xD;
&#xD;
      At the start of the study, the test material Prime&amp;Bond Universal is CE-marked, as are all&#xD;
      other medical devices used. Thus, this study is not conducted to meet any regulatory&#xD;
      requirements. The rationale of this study is the extension of knowledge primarily concerning&#xD;
      the clinical performance of Prime&amp;Bond Universal in molars.&#xD;
&#xD;
      Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75&#xD;
      restorations in total) to assess the performance of the materials in a comparative design.&#xD;
      The study restorations will be monitored for a period of 18 months (with the option to extend&#xD;
      the evaluation period to 48 months).&#xD;
&#xD;
      After placement of restorations under controlled clinical conditions, the primary objective&#xD;
      of the study is the determination of post-operative sensitivity and pulp vitality, marginal&#xD;
      adaptation and staining of margins of the restorations. In addition, fracture of material and&#xD;
      retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be&#xD;
      determined as well as the failure rate as defined by the ADA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2015</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale.</measure>
    <time_frame>14 days, 6 months, 12 months and 48 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>existing adhesive (control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>control adhesive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>new adhesive: technique 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prime &amp; Bond Universal: technique 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>new adhesive: technique 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prime &amp; Bond Universal: technique 2</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prime &amp; Bond Universal</intervention_name>
    <description>Prime &amp; Bond Universal</description>
    <arm_group_label>new adhesive: technique 1</arm_group_label>
    <arm_group_label>new adhesive: technique 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ceram X</intervention_name>
    <arm_group_label>existing adhesive (control)</arm_group_label>
    <arm_group_label>new adhesive: technique 1</arm_group_label>
    <arm_group_label>new adhesive: technique 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prime &amp; Bond XP</intervention_name>
    <description>Control</description>
    <arm_group_label>existing adhesive (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>technique 1</intervention_name>
    <arm_group_label>new adhesive: technique 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>technique 2</intervention_name>
    <arm_group_label>new adhesive: technique 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria for patient selection:&#xD;
&#xD;
          -  Patients of either gender and at least 18 years old at the start of the study&#xD;
             (enrollment), who are seeking treatment at the dental clinic involved, will be invited&#xD;
             to participate in the study if they are in need of at least one eligible Class II&#xD;
             posterior restoration in a permanent molar.&#xD;
&#xD;
        Tooth inclusion criteria:&#xD;
&#xD;
          -  Per patient, a maximum of three Class II restorations will be included. If three&#xD;
             restorations are indicated and eligible, one of each material will be included.&#xD;
&#xD;
          -  Vital, non-symptomatic permanent teeth with Class II lesions are suitable for&#xD;
             inclusion into the study if the following criteria are met:&#xD;
&#xD;
               -  - location: first or second molars (ADA guidelines[1]);&#xD;
&#xD;
               -  - restoration size: moderate: no cusp replacements;&#xD;
&#xD;
               -  - cavity size: occlusal width ≥ 1/3 of intercuspal distance (ADA guidelines[1]);&#xD;
&#xD;
               -  - cavity outline: preparation to include a proximal box with or without an&#xD;
                  occlusal step;&#xD;
&#xD;
               -  - box: cervical outline in enamel;&#xD;
&#xD;
               -  - occlusion: at least one opposing contact point in enamel.&#xD;
&#xD;
          -  Enrollment of patients will continue until the specified minimum number of&#xD;
             restorations per group (N=25) and/or the minimum number of patients (N=50) have been&#xD;
             reached.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion criteria for patient selection:&#xD;
&#xD;
          -  The exclusion criteria (i.e. contraindications) as described in the Instructions for&#xD;
             Use of the test, control and restorative materials apply:&#xD;
&#xD;
          -  Use with patients who have a history of severe allergic reaction methacrylate resins&#xD;
             or any of the components; direct application to dental pulp (direct pulp capping).&#xD;
&#xD;
          -  Patients who are unable to give informed consent or vulnerable population as defined&#xD;
             in ISO 14155[4] will not be enrolled.&#xD;
&#xD;
        Tooth exclusion criteria:&#xD;
&#xD;
        As a rule, the materials are not to be used in situations as specified in the Instructions&#xD;
        for Use - Section Contraindications.&#xD;
&#xD;
          -  direct or indirect pulp-capping Furthermore, teeth with class II lesions are excluded&#xD;
             when involved with&#xD;
&#xD;
          -  inflammation or pulpitis (pain),&#xD;
&#xD;
          -  periodontitis with probing depth &gt; 6 mm,&#xD;
&#xD;
          -  extraction of tooth to be expected within the next 12 months,&#xD;
&#xD;
          -  signs of strong parafunctions or erosion (exposed dentin on occlusal surface and/or&#xD;
             wear facets &gt; 6 mm2)&#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>Nicolas Martin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS FT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Professor Nicolas Martin</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S10 2TA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 4, 2015</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02991573
org study id: CIP 14.1515 (STH 18842)
nct id: NCT02991573
lead sponsor: 
collaborator: 
has dmc: No
Damage to teeth from decay or previous old silver fillings can be repaired with
      tooth-coloured filling materials that stick to the tooth. These materials have been around
      for some years and have become more sophisticated; with greater ease of placement by the
      dentist and better durability for the patient. The fillings are designed to be used in
      combination with a specific glue (adhesive) that is designed to stick to the different parts
      of the tooth to provide a good seal, the outer enamel and the inner dentine.

      This study will examine the performance of a state-of-the-art modern tooth coloured filling
      material (Ceram X) in combination with an existing adhesive (control adhesive) and a new
      adhesive (Prime & Bond Universal) used in two different techniques; both of which are known
      to work but one is easier to apply. This results in three treatment groups.

      At the start of the study, the test material Prime&Bond Universal is CE-marked, as are all
      other medical devices used. Thus, this study is not conducted to meet any regulatory
      requirements. The rationale of this study is the extension of knowledge primarily concerning
      the clinical performance of Prime&Bond Universal in molars.

      Two investigators (to be confirmed) will place a minimum of 25 restorations per group (75
      restorations in total) to assess the performance of the materials in a comparative design.
      The study restorations will be monitored for a period of 18 months (with the option to extend
      the evaluation period to 48 months).

      After placement of restorations under controlled clinical conditions, the primary objective
      of the study is the determination of post-operative sensitivity and pulp vitality, marginal
      adaptation and staining of margins of the restorations. In addition, fracture of material and
      retention, recurrent caries, occlusal contour and wear, approximal anatomical form will be
      determined as well as the failure rate as defined by the ADA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Number of participants with treatment-related postoperative sensitivity recorded as a change from baseline to that reported at 14 days, 6 months, 12 months and 48 months, assessed using a visual analog scale.
time frame: 14 days, 6 months, 12 months and 48 months
arm group label: existing adhesive (control)
arm group type: Active Comparator
description: control adhesive
arm group label: new adhesive: technique 1
arm group type: Experimental
description: Prime & Bond Universal: technique 1
arm group label: new adhesive: technique 2
arm group type: Experimental
description: Prime & Bond Universal: technique 2
intervention type: Device
intervention name: Prime & Bond Universal
description: Prime & Bond Universal
arm group label: new adhesive: technique 1
arm group label: new adhesive: technique 2
intervention type: Device
intervention name: Ceram X
arm group label: existing adhesive (control)
arm group label: new adhesive: technique 1
arm group label: new adhesive: technique 2
intervention type: Device
intervention name: Prime & Bond XP
description: Control
arm group label: existing adhesive (control)
intervention type: Procedure
intervention name: technique 1
arm group label: new adhesive: technique 1
intervention type: Procedure
intervention name: technique 2
arm group label: new adhesive: technique 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas Martin, Professor
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS FT
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dental Caries
sharing ipd: No