xml: <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/NCT05978440</url>
    </required_header>
    <id_info>
      <org_study_id>0682-05/2023 IRB 00010556</org_study_id>
      <secondary_id>IRB 00010556</secondary_id>
      <nct_id>NCT05978440</nct_id>
    </id_info>
    <brief_title>This Trial Will Evaluate the Clinical Performance of Onlay Restorations Fabricated Using Rubber Dam Scanning Techniques.</brief_title>
    <official_title>Clinical and Laboratory Evaluation of Cad-cam Restorations Fabricated From Digital Impression Under Rubber Dam Isolation (Randomized Clinical Trial &amp; In-vitro Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Alexandria University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay&#xD;
        restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory&#xD;
        investigation of their marginal fit.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will&#xD;
        be divided into three groups according to the technique of scanning. Group I: 18 preparations&#xD;
        will be scanned without rubber dam using standard technique, group II: 18 preparations will&#xD;
        be scanned under rubber dam isolation using cut technique, and group III: 18 preparations&#xD;
        will be scanned under rubber dam isolation using lock technique. Final restorations will be&#xD;
        milled, checked and cemented, then will be evaluated using the modified FDI criteria at&#xD;
        baseline, three months, six months, and one year.&#xD;
  &#xD;
        Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for&#xD;
        onlay. The dies will be scanned after they fit in a typodont and grouped with the same&#xD;
        technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit&#xD;
        alignment method and 3D deviation will be calculated for each group itself and to the other&#xD;
        groups. The marginal fit of the restorations produced will be checked using two methods:&#xD;
        Triple scan and measuring the cement thickness after cementation and sectioning of the&#xD;
        samples.&#xD;
  &#xD;
        All data will be collected, and statistically analyzed using suitable tests.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 25, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">November 25, 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.</measure>
      <time_frame>12 months</time_frame>
      <description>Restorations will be evaluated according to three main domains: (40)&#xD;
  Functional (domain F): fracture of material and retention(F1), marginal adaptation(F2), proximal contact point(F3), Form and contour(F4), and Occlusion and wear(F5).&#xD;
  Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3).&#xD;
  Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Inlays</condition>
    <arm_group>
      <arm_group_label>Scanning without rubber dam</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After the onlay preparation, standard digital impression will be recorded for the working quadrant using the IOS without applying the rubber dam. Then the opposing quadrant will be scanned in addition to interocclusal bite registration.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scanning under rubber dam with cut technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group a pre-operative scan will be already taken before the preparation for the working arch, opposing arch and the interocclusal bite registration. Then using the &quot;Cut&quot; feature in the software of the IOS to cut the area of the working tooth. After the preparation, rubber dam will be applied on the working quadrant and then rescan the prepared tooth.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Scanning under rubber dam with new lock technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After the onlay preparation, the rubber dam will be applied to the working quadrant. Digital impression will be taken using the IOS. After that using the &quot;lock&quot; feature in the software of the scanner, all the preparation area and margins will be locked. Rubber dam will be removed, and scanning will be completed for the whole quadrant and opposing arch in addition to interocclusal bite registration.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>onlay preparation</intervention_name>
      <description>CAD-CAM onlay restorations will be fabricated using rubber dam scanning techniques and evaluated clinically up to 12 months</description>
      <arm_group_label>Scanning under rubber dam with cut technique</arm_group_label>
      <arm_group_label>Scanning under rubber dam with new lock technique</arm_group_label>
      <arm_group_label>Scanning without rubber dam</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy adult patients (18-45 years old).&#xD;
  &#xD;
            2. Patients in need of class II (OM or OD) caries in molar teeth with initial, moderate&#xD;
               or extensive stage according to the staging of caries lesions in The International&#xD;
               Caries Detection and Assessment system (ICDASTM codes 2 to 6) (32,33).&#xD;
  &#xD;
            3. Presence of proximal caries in digital x-ray with score 2 to 4 according to the&#xD;
               ICDAS/ICCMS™ radiographic scoring system(32,33).&#xD;
  &#xD;
            4. Vital teeth with absence of clinical signs and symptoms of periapical pathology.&#xD;
  &#xD;
            5. Patient Ability to tolerate Rubber Dam applications.&#xD;
  &#xD;
            6. Patients who will agree to attend regular check-ups.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Bad oral hygiene (Grade 3)(34).&#xD;
  &#xD;
            2. Non- vital teeth or endodontically treated teeth.&#xD;
  &#xD;
            3. Severe Periodontal problems (pockets ≥6mm).&#xD;
  &#xD;
            4. Patients with para-functional habits (e.g., Bruxism, attrition, wear facets)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>hossam m kamel</last_name>
      <role>Study Chair</role>
      <affiliation>Alexandria University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>hossam M kamel</last_name>
      <phone>012858734310</phone>
      <phone_ext>+2</phone_ext>
      <email>hosam.kamel@alexu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>-1-*Rania R Afifi</last_name>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978440
  org study id: 0682-05/2023 IRB 00010556
  secondary id: IRB 00010556
  nct id: NCT05978440
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study will be to evaluate the clinical performance of CAD-CAM onlay
        restorations fabricated using rubber dam scanning techniques up to 12 months and laboratory
        investigation of their marginal fit.
  A total of 54 molars will be prepared for CAD-CAM onlay restorations. The preparations will
        be divided into three groups according to the technique of scanning. Group I: 18 preparations
        will be scanned without rubber dam using standard technique, group II: 18 preparations will
        be scanned under rubber dam isolation using cut technique, and group III: 18 preparations
        will be scanned under rubber dam isolation using lock technique. Final restorations will be
        milled, checked and cemented, then will be evaluated using the modified FDI criteria at
        baseline, three months, six months, and one year.
  
        Thirty resin dies will be 3D printed after scanning of a first molar tooth prepared for
        onlay. The dies will be scanned after they fit in a typodont and grouped with the same
        technique (n=10 per group). The digital scans will be superimposed using a 3D best-fit
        alignment method and 3D deviation will be calculated for each group itself and to the other
        groups. The marginal fit of the restorations produced will be checked using two methods:
        Triple scan and measuring the cement thickness after cementation and sectioning of the
        samples.
  
        All data will be collected, and statistically analyzed using suitable tests.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Evaluate the clinical performance of CAD-CAM onlay restorations fabricated using rubber dam scanning.
  time frame: 12 months
  description: Restorations will be evaluated according to three main domains: (40)
  Functional (domain F): fracture of material and retention(F1), marginal adaptation(F2), proximal contact point(F3), Form and contour(F4), and Occlusion and wear(F5).
  Biological (domain B): Caries at restoration margins(B1), dental hard tissue defects at restoration margin(B2), postoperative hypersensitivity/pulp status(B3).
  Aesthetics (domain A): Surface luster and surface texture(A1), Marginal staining(A2), Color match(A3).
  arm group label: Scanning without rubber dam
  arm group type: Active Comparator
  description: After the onlay preparation, standard digital impression will be recorded for the working quadrant using the IOS without applying the rubber dam. Then the opposing quadrant will be scanned in addition to interocclusal bite registration.
  arm group label: Scanning under rubber dam with cut technique
  arm group type: Experimental
  description: In this group a pre-operative scan will be already taken before the preparation for the working arch, opposing arch and the interocclusal bite registration. Then using the "Cut" feature in the software of the IOS to cut the area of the working tooth. After the preparation, rubber dam will be applied on the working quadrant and then rescan the prepared tooth.
  arm group label: Scanning under rubber dam with new lock technique
  arm group type: Experimental
  description: After the onlay preparation, the rubber dam will be applied to the working quadrant. Digital impression will be taken using the IOS. After that using the "lock" feature in the software of the scanner, all the preparation area and margins will be locked. Rubber dam will be removed, and scanning will be completed for the whole quadrant and opposing arch in addition to interocclusal bite registration.
  intervention type: Procedure
  intervention name: onlay preparation
  description: CAD-CAM onlay restorations will be fabricated using rubber dam scanning techniques and evaluated clinically up to 12 months
  arm group label: Scanning under rubber dam with cut technique
  arm group label: Scanning under rubber dam with new lock technique
  arm group label: Scanning without rubber dam
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: hossam m kamel
  role: Study Chair
  affiliation: Alexandria University
  last name: hossam M kamel
  phone: 012858734310
  phone ext: +2
  email: hosam.kamel@alexu.edu.eg
  last name: -1-*Rania R Afifi
  responsible party type: Sponsor
  sharing ipd: No