<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/NCT04491097</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01-E14107</org_study_id>
    <nct_id>NCT04491097</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements</brief_title>
  <official_title>Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kuraray Noritake Dental Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      Congenitally missing tooth is one of the most common anomalies in human dentition. The&#xD;
      treatment options of lateral incisor agenesis are closing the space with orthodontic&#xD;
      treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded&#xD;
      fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior&#xD;
      region due to their minimal invasive properties, high clinical success and patient&#xD;
      satisfaction. With the development of new and stronger materials, RBFDs with metal framework&#xD;
      have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and&#xD;
      zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM&#xD;
      single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin&#xD;
      cements.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer&#xD;
      monolithic zirconia ceramic RBFDs which cemented with two different resin cements.&#xD;
&#xD;
      The project includes 20 patients. Most of the patients have been recruited from the Istanbul&#xD;
      Medipol University Dental Clinics in Istanbul. The patients were selected from individuals&#xD;
      who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to&#xD;
      be treated a restoration or undergoing orthodontic treatment.&#xD;
&#xD;
      After giving their consent to take part in the study no preparations were made on abutment&#xD;
      teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs&#xD;
      were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia&#xD;
      HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth&#xD;
      with one of the two different resin cements (Panavia F2.0 or Panavia V5).&#xD;
&#xD;
      The control procedure is:&#xD;
&#xD;
      The restoration is evaluated according to presence of mobility or debonding and fracture at&#xD;
      the connector area. Gingival harmony and periodontal tissues around the restorations were&#xD;
      also examined. Mobility of the abutment tooth was checked in the clinical examination and&#xD;
      alveolar bone was examined with periapical x-ray. The controls will take place after two&#xD;
      weeks, one year, two years, three years and five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate of zirconia ceramic RBFDs</measure>
    <time_frame>5 years</time_frame>
    <description>The survival was evaluated as described in the studies of Chai et al. (1). They described the survival as &quot;the period of time starting at the cementation of the restoration and ending when the restoration was shown to have irreparably failed&quot;. The fracture was evaluated according to the study of Heintze and Rousson (2). They made a classification for fracture of zirconia restorations. Three grades of fracture treatment were assigned to this classification:&#xD;
(1) Grade 1: Fracture surfaces were polished. (2) Grade 2: Fracture surfaces were repaired with resin-based composite. (3) Grade 3: Severe chipping fractures required replacement of affected prostheses.&#xD;
Chai J, Chu FC, Newsome PR, et al: Retrospective survival analysis of 3-unit fixed-fixed and 2-unit cantilevered fixed partial dentures. J Oral Rehabil 2005;32:759-765&#xD;
Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Denture, Partial, Fixed, Resin-Bonded</condition>
  <condition>Tooth Loss / Rehabilitation</condition>
  <condition>Resin Cements</condition>
  <arm_group>
    <arm_group_label>Experimental: Panavia V5 resin cement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Resin cement with non-MDP monomer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Panavia F2.0 resin cement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resin cement with MDP monomer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Panavia V5 resin cement</intervention_name>
    <description>Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.</description>
    <arm_group_label>Experimental: Panavia V5 resin cement</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Panavia F2.0 resin cement</intervention_name>
    <description>Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.</description>
    <arm_group_label>Experimental: Panavia F2.0 resin cement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participating in the study voluntarily&#xD;
&#xD;
          -  Horizontal mobility of central incisors ≤1 mm&#xD;
&#xD;
          -  Central incisors with healthy alveolar bone&#xD;
&#xD;
          -  1-1,5 mm overjet&#xD;
&#xD;
          -  Having a good anterior guidance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with gingivitis or periodontitis Poor oral hygiene Central incisors with&#xD;
             endodontic treatment or periapical disease Central teeth with large fillings or loss&#xD;
             of dental structure on the cementation surface Bad oral habits Patients with clinical&#xD;
             symptoms of bruxism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University School of Dentistry</name>
      <address>
        <city>Istanbul</city>
        <zip>34083</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</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>Tooth Loss</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/NCT04491097
org study id: 10840098-604.01.01-E14107
nct id: NCT04491097
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Congenitally missing tooth is one of the most common anomalies in human dentition. The
      treatment options of lateral incisor agenesis are closing the space with orthodontic
      treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded
      fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior
      region due to their minimal invasive properties, high clinical success and patient
      satisfaction. With the development of new and stronger materials, RBFDs with metal framework
      have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and
      zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM
      single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin
      cements.
The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer
      monolithic zirconia ceramic RBFDs which cemented with two different resin cements.

      The project includes 20 patients. Most of the patients have been recruited from the Istanbul
      Medipol University Dental Clinics in Istanbul. The patients were selected from individuals
      who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to
      be treated a restoration or undergoing orthodontic treatment.

      After giving their consent to take part in the study no preparations were made on abutment
      teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs
      were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia
      HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth
      with one of the two different resin cements (Panavia F2.0 or Panavia V5).

      The control procedure is:

      The restoration is evaluated according to presence of mobility or debonding and fracture at
      the connector area. Gingival harmony and periodontal tissues around the restorations were
      also examined. Mobility of the abutment tooth was checked in the clinical examination and
      alveolar bone was examined with periapical x-ray. The controls will take place after two
      weeks, one year, two years, three years and five years.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Survival rate of zirconia ceramic RBFDs
time frame: 5 years
description: The survival was evaluated as described in the studies of Chai et al. (1). They described the survival as "the period of time starting at the cementation of the restoration and ending when the restoration was shown to have irreparably failed". The fracture was evaluated according to the study of Heintze and Rousson (2). They made a classification for fracture of zirconia restorations. Three grades of fracture treatment were assigned to this classification:
(1) Grade 1: Fracture surfaces were polished. (2) Grade 2: Fracture surfaces were repaired with resin-based composite. (3) Grade 3: Severe chipping fractures required replacement of affected prostheses.
Chai J, Chu FC, Newsome PR, et al: Retrospective survival analysis of 3-unit fixed-fixed and 2-unit cantilevered fixed partial dentures. J Oral Rehabil 2005;32:759-765
Heintze SD, Rousson V. Survival of zirconia- and metal-supported fixed dental prostheses: a systematic review. Int J Prosthodont 2010;23:493-502
arm group label: Experimental: Panavia V5 resin cement
arm group type: Experimental
description: Resin cement with non-MDP monomer
arm group label: Experimental: Panavia F2.0 resin cement
arm group type: Active Comparator
description: Resin cement with MDP monomer
intervention type: Device
intervention name: Panavia V5 resin cement
description: Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
arm group label: Experimental: Panavia V5 resin cement
intervention type: Device
intervention name: Panavia F2.0 resin cement
description: Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
arm group label: Experimental: Panavia F2.0 resin cement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Tooth Loss
sharing ipd: No