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/NCT06032689</url>
    </required_header>
    <id_info>
      <org_study_id>M 11120520</org_study_id>
      <nct_id>NCT06032689</nct_id>
    </id_info>
    <brief_title>A 2-year Clinical Impact of Bulk-fill Low-viscosity Resin Composite Liners in Class II Restorations.</brief_title>
    <official_title>Two-Years Clinical Performance of Bulk-Fill High Viscosity Ormocer Versus Methacrylate-Based Resin Composite Restorative Systems: The Effect of Bulk-Fill Low-viscosity Resin Composite Liners in Class II Restorations.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This randomized clinical trial evaluated the clinical performance of class II resin composite&#xD;
        restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without&#xD;
        a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2&#xD;
        years. The null hypotheses in the study were as follows: (1) Different types of matrix&#xD;
        structures (ormocer vs. methacrylate) have no effect on the marginal integrity of&#xD;
        restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not&#xD;
        affect the marginal or internal adaptation of restorations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was designed following the Consolidated Standards of Reporting Trials (CONSORT)&#xD;
        statement. approvement by the local ethics committee of Mansoura University code register was&#xD;
        taken code M 11120520. The patients were selected as they searched for treatment in the&#xD;
        Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura&#xD;
        University. A group of 30 patients 21 Females and 9 males was chosen from among 92&#xD;
        participants after careful consideration of the inclusion and exclusion criteria. The sample&#xD;
        size estimate was made based on the clinical success rate of posterior class II composite&#xD;
        restorations observed in a prior study (97.5% at 24 months). The sample size needed per group&#xD;
        was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%.&#xD;
        A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after&#xD;
        taking potential dropouts into account. To ensure adherence of the participants to the study,&#xD;
        all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers&#xD;
        were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four&#xD;
        attempts, including visits to the schools, were made to contact a volunteer before he/she was&#xD;
        considered a &quot;loss.&quot; both participants and examiners were blind to the interventions. An&#xD;
        inter-examiner and intra-examiner agreement of at least 90% was requested before the&#xD;
        beginning of the evaluation. Clinical evaluation was performed one week after finishing and&#xD;
        polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World&#xD;
        Dental Federation (FDI) criteria.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2020</start_date>
    <completion_date type="Actual">June 17, 2023</completion_date>
    <primary_completion_date type="Actual">April 27, 2022</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>participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>clinical performance</measure>
      <time_frame>two years</time_frame>
      <description>FDI criteria</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">30</enrollment>
    <condition>Dental Caries Class II</condition>
    <arm_group>
      <arm_group_label>Xtra-fill</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bulk-fill high-viscosity methacrylate-based resin composites.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>X-base</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bulk-fill low-viscosity methacrylate-based resin composites.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Admira fusion x-tra</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bulk-fill high-viscosity ormocer-based resin composites.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Admira fusion x-base</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Bulk-fill low-viscosity ormocer-based resin composites.</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Xtra-fill</intervention_name>
      <description>the material was placed in bulk.</description>
      <arm_group_label>Xtra-fill</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>x-base</intervention_name>
      <description>The x-base liner was placed and then veneered with Xtra-fill.</description>
      <arm_group_label>X-base</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Admira fusion x-tra</intervention_name>
      <description>bulk placement of the restoration Admira fusion -xtra.</description>
      <arm_group_label>Admira fusion x-tra</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Admira fusion x-base</intervention_name>
      <description>Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.</description>
      <arm_group_label>Admira fusion x-base</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients having at least 4 posterior teeth with moderate occlusal-proximal carious&#xD;
               lesions.&#xD;
  &#xD;
            -  Patients ranging in age from 18 to 30 years.&#xD;
  &#xD;
            -  patients with normal occlusion.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          General exclusion criteria:&#xD;
  &#xD;
            -  Patients having severe chronic periodontitis.&#xD;
  &#xD;
            -  Patients with orthodontic appliances.&#xD;
  &#xD;
            -  Abnormal occlusion, parafunctional habits.&#xD;
  &#xD;
            -  Allergy to any of the materials used in the study. Specific teeth exclusion criteria&#xD;
  &#xD;
            -  Teeth with irreversible pulpitis or non-vital.&#xD;
  &#xD;
            -  Fractured or cracked teeth.&#xD;
  &#xD;
            -  Previously restored teeth.&#xD;
  &#xD;
            -  Cavities with isthmus larger than intercuspal distance.&#xD;
  &#xD;
            -  Teeth with deep sub-gingival cavity margins.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>33 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sa Mahmoud, professor</last_name>
      <role>Principal Investigator</role>
      <affiliation>Operative Dentistry</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Mansoura U</name>
        <address>
          <city>Mansoura.</city>
          <state>Mansoura</state>
          <zip>35511</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>June 17, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT06032689/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06032689
  org study id: M 11120520
  nct id: NCT06032689
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This randomized clinical trial evaluated the clinical performance of class II resin composite
        restorations using bulk-fill high-viscosity ormocer versus methacrylate-based with or without
        a thin layer of bulk-fill low-viscosity (flowable) resin composite liners (BLRC) over 2
        years. The null hypotheses in the study were as follows: (1) Different types of matrix
        structures (ormocer vs. methacrylate) have no effect on the marginal integrity of
        restorations; (2) A layer of bulk-fill resin compo-site liner of the same category would not
        affect the marginal or internal adaptation of restorations.
  The study was designed following the Consolidated Standards of Reporting Trials (CONSORT)
        statement. approvement by the local ethics committee of Mansoura University code register was
        taken code M 11120520. The patients were selected as they searched for treatment in the
        Conservative Dentistry Department outpatient clinic, in the Faculty of Dentistry, Mansoura
        University. A group of 30 patients 21 Females and 9 males was chosen from among 92
        participants after careful consideration of the inclusion and exclusion criteria. The sample
        size estimate was made based on the clinical success rate of posterior class II composite
        restorations observed in a prior study (97.5% at 24 months). The sample size needed per group
        was 23 teeth using a significance level of 0.05, power of 80%, and equivalency limit of 15%.
        A total of 30 patients were chosen, for a total of 120 restorations (30 for each group) after
        taking potential dropouts into account. To ensure adherence of the participants to the study,
        all volunteers underwent complete dental treatment and periodic follow-ups. The volunteers
        were contacted by telephone, WhatsApp message, Facebook, and e-mail for the assessments. Four
        attempts, including visits to the schools, were made to contact a volunteer before he/she was
        considered a "loss." both participants and examiners were blind to the interventions. An
        inter-examiner and intra-examiner agreement of at least 90% was requested before the
        beginning of the evaluation. Clinical evaluation was performed one week after finishing and
        polishing (baseline), after 6 months, 12 months, 18 months, and 24 months using the World
        Dental Federation (FDI) criteria.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: participants had at least four class II cavities in a split-mouth design and randomly each cavity was restored using one of four strategies( groups applied)
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: clinical performance
  time frame: two years
  description: FDI criteria
  arm group label: Xtra-fill
  arm group type: Active Comparator
  description: Bulk-fill high-viscosity methacrylate-based resin composites.
  arm group label: X-base
  arm group type: Active Comparator
  description: Bulk-fill low-viscosity methacrylate-based resin composites.
  arm group label: Admira fusion x-tra
  arm group type: Active Comparator
  description: Bulk-fill high-viscosity ormocer-based resin composites.
  arm group label: Admira fusion x-base
  arm group type: Active Comparator
  description: Bulk-fill low-viscosity ormocer-based resin composites.
  intervention type: Combination Product
  intervention name: Xtra-fill
  description: the material was placed in bulk.
  arm group label: Xtra-fill
  intervention type: Combination Product
  intervention name: x-base
  description: The x-base liner was placed and then veneered with Xtra-fill.
  arm group label: X-base
  intervention type: Combination Product
  intervention name: Admira fusion x-tra
  description: bulk placement of the restoration Admira fusion -xtra.
  arm group label: Admira fusion x-tra
  intervention type: Combination Product
  intervention name: Admira fusion x-base
  description: Admira fusion x-base liner was used and then veneered by Admira fusion x-tra.
  arm group label: Admira fusion x-base
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 33 Years
  healthy volunteers: No
  last name: Sa Mahmoud, professor
  role: Principal Investigator
  affiliation: Operative Dentistry
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Dental Caries
  provided document: 