<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/NCT04403230</url>
  </required_header>
  <id_info>
    <org_study_id>H1448361523684</org_study_id>
    <nct_id>NCT04403230</nct_id>
  </id_info>
  <brief_title>Outcomes on Teeth Prepared With BOPT</brief_title>
  <official_title>Periodontal and Prosthetic Outcomes on Teeth Prepared With Biologically Oriented Preparation Technique: Prospective Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</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>
      The aim of this study is to evaluate the clinical and biological behavior of full coverage&#xD;
      restorations on teeth prepared without finish line in a prospective clinical study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose is to evaluate the clinical and biological behavior of full coverage restorations&#xD;
      on teeth prepared without finish line.&#xD;
&#xD;
      This prospective study included 149 teeth treated using biologically oriented preparation&#xD;
      technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth&#xD;
      restored with crowns, and 75 teeth supporting fixed partial dentures (FPD). Restorations were&#xD;
      fabricated with zirconium oxide cores and ceramic coverings. Patients attended regular annual&#xD;
      check-ups when probe depth, presence of inflammation with bleeding on probing, presence of&#xD;
      plaque, gingival thickness, marginal stability, biological or mechanical complications, and&#xD;
      the patient's level of satisfaction were registered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Anticipated">January 1, 2030</completion_date>
  <primary_completion_date type="Actual">January 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>A possible periodontal complications</measure>
    <time_frame>Through study completion, an average of 15 years.</time_frame>
    <description>Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique</description>
  </primary_outcome>
  <primary_outcome>
    <measure>biological or mechanical prosthetic complications</measure>
    <time_frame>Through study completion, an average of 15 years.</time_frame>
    <description>Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS).</measure>
    <time_frame>Through study completion, an average of 15 years.</time_frame>
    <description>Patient's satisfaction was assesed using a ''Visual Analogue Scale'' (VAS). In wich 0 is the the minimum and 10 de maximum value, and whether higher scores mean a better outcome.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Soft Tissues</condition>
  <condition>Prosthetic</condition>
  <condition>Outcome</condition>
  <arm_group>
    <arm_group_label>Clinical behaviour on teeth prepared without finish line</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Evaluate the clinical behavior of restorations placed on teeth prepared without finish line, monitoring periodontal status as well as the prostheses to assess stability and treatment predictability.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Retreatment of teeth prepared without finish line</intervention_name>
    <description>Retreatment of teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).</description>
    <arm_group_label>Clinical behaviour on teeth prepared without finish line</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients (aged over 18 years).&#xD;
&#xD;
          -  non-smokers.&#xD;
&#xD;
          -  periodontally healthy or periodontally managed.&#xD;
&#xD;
          -  patients who had undergone restoration with fixed prostheses (one-piece crowns or&#xD;
             fixed partial dentures FPDs) in the aesthetic zone (incisors, canines, premolars,&#xD;
             first molars), which needed to be replaced due to biological, esthetic or some other&#xD;
             type of problem.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who were smokers.&#xD;
&#xD;
          -  patients who presented unmanaged parafunctional habits.&#xD;
&#xD;
          -  patients with severe systemic diseases.&#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>Blanca Serra Pastor, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Valencia</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BOPT</keyword>
  <keyword>dental preparation</keyword>
  <keyword>dental crown</keyword>
  <keyword>zirconia</keyword>
  <keyword>periodontal health</keyword>
  <!-- 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/NCT04403230
org study id: H1448361523684
nct id: NCT04403230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate the clinical and biological behavior of full coverage
      restorations on teeth prepared without finish line in a prospective clinical study.
The purpose is to evaluate the clinical and biological behavior of full coverage restorations
      on teeth prepared without finish line.

      This prospective study included 149 teeth treated using biologically oriented preparation
      technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth
      restored with crowns, and 75 teeth supporting fixed partial dentures (FPD). Restorations were
      fabricated with zirconium oxide cores and ceramic coverings. Patients attended regular annual
      check-ups when probe depth, presence of inflammation with bleeding on probing, presence of
      plaque, gingival thickness, marginal stability, biological or mechanical complications, and
      the patient's level of satisfaction were registered.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This prospective study included 149 teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).
primary purpose: Treatment
masking: None (Open Label)
measure: A possible periodontal complications
time frame: Through study completion, an average of 15 years.
description: Analyze periodontal outcome on teeth prepared with biologically oriented preparation technique
measure: biological or mechanical prosthetic complications
time frame: Through study completion, an average of 15 years.
description: Analyze prosthetic outcome on teeth prepared with biologically oriented preparation technique
measure: Patient's level of satisfaction with treatment assessed by means of a visual analogue scale (VAS).
time frame: Through study completion, an average of 15 years.
description: Patient's satisfaction was assesed using a ''Visual Analogue Scale'' (VAS). In wich 0 is the the minimum and 10 de maximum value, and whether higher scores mean a better outcome.
arm group label: Clinical behaviour on teeth prepared without finish line
arm group type: Experimental
description: Evaluate the clinical behavior of restorations placed on teeth prepared without finish line, monitoring periodontal status as well as the prostheses to assess stability and treatment predictability.
intervention type: Procedure
intervention name: Retreatment of teeth prepared without finish line
description: Retreatment of teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).
arm group label: Clinical behaviour on teeth prepared without finish line
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Blanca Serra Pastor, Professor
role: Principal Investigator
affiliation: University of Valencia
responsible party type: Sponsor