<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/NCT04497571</url>
  </required_header>
  <id_info>
    <org_study_id>IGR UGranada</org_study_id>
    <nct_id>NCT04497571</nct_id>
  </id_info>
  <brief_title>Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.</brief_title>
  <official_title>Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Granada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Granada</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>
      Compare the survival rate of the implants placed using the ultrasonic technique and placed&#xD;
      using conventional drilling, with an immediate load on the aesthetic zone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Main goals.&#xD;
&#xD;
      Compare the survival rate of the implants placed using the ultrasonic technique and placed&#xD;
      using conventional drilling, with an immediate load on the aesthetic zone.&#xD;
&#xD;
      Specific goals.&#xD;
&#xD;
        -  Evaluate the marginal peri-implant bone loss after the healing period through&#xD;
           radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year&#xD;
           after the implants insertion.&#xD;
&#xD;
        -  Evaluate the primary stability of each individual implant the day of their insertion to&#xD;
           verify their load on the moment of surgery and also compare the values of each&#xD;
           preparation techniques of implant bone preparation.&#xD;
&#xD;
        -  Evaluate the secondary stability of each individual implant and compare the values of&#xD;
           each preparation techniques.&#xD;
&#xD;
        -  Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the&#xD;
           insertion of the implants through these variables: probing depth and bleeding of&#xD;
           probing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">April 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>Randomized clinical trials.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal Bone Loss</measure>
    <time_frame>1 month</time_frame>
    <description>To compare MBL measured using radiographs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal Bone Loss</measure>
    <time_frame>3 months</time_frame>
    <description>To compare MBL measured using radiographs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal Bone Loss</measure>
    <time_frame>6 months</time_frame>
    <description>To compare MBL measured using radiographs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Marginal Bone Loss</measure>
    <time_frame>12 months</time_frame>
    <description>To compare MBL measured using radiographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Primary stability</measure>
    <time_frame>Baseline</time_frame>
    <description>Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary stability</measure>
    <time_frame>3 months</time_frame>
    <description>Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding of probing</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival rate</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>To measure implant success rate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dental Implants</condition>
  <condition>Tooth Loss</condition>
  <arm_group>
    <arm_group_label>Piezoelectric osteotomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implant placement by piezoelectric osteotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional drilling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Implant placement by conventional drilling</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Piezoelectric osteotomy.</intervention_name>
    <description>Implants placed using the ultrasonic technique.</description>
    <arm_group_label>Piezoelectric osteotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional drilling</intervention_name>
    <description>Implants placed using drilling technique</description>
    <arm_group_label>Conventional drilling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.&#xD;
&#xD;
          -  3 months after the dental extraction without alveolar scar tissue remains.&#xD;
&#xD;
          -  Bone availability of at least 5mm of width and 13mm of length.&#xD;
&#xD;
          -  At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant&#xD;
             biological width.&#xD;
&#xD;
          -  Oclusal pattern that ensures prosthetic success.&#xD;
&#xD;
          -  Implants need to have at least a 35 N and 70 ISQ index to be loaded.&#xD;
&#xD;
          -  Index of plaque &lt; 20% and/or inactive periodontal disease.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction in the last 2 months.&#xD;
&#xD;
          -  Uncontrolled coagulation disorders&#xD;
&#xD;
          -  Uncontrolled diabetes (HbA1c&gt; 7.5%).&#xD;
&#xD;
          -  Radiotherapy on head/neck in the last 24 months.&#xD;
&#xD;
          -  Immunocompromised patient.&#xD;
&#xD;
          -  History of medication related to osteonecrosis of the jaws.&#xD;
&#xD;
          -  Psychiatric disorders, alcohol, drugs and large smokers (&gt;10 cigarrillos).&#xD;
&#xD;
          -  Plaque index &gt; 20%.&#xD;
&#xD;
          -  Need for simultaneous or previous peri-implant guided bone regeneration procedures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Isabel Godoy Reina</name>
      <address>
        <city>Almería</city>
        <zip>04001</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Isabel Godoy Reina</last_name>
      <phone>661070242</phone>
      <email>igodorei@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Isabel Godoy Reina</investigator_full_name>
    <investigator_title>Professor of Master of Periodontology and Implant Dentistry, PhD student.</investigator_title>
  </responsible_party>
  <keyword>Dental implants</keyword>
  <keyword>Piezoelectric osteotomy</keyword>
  <keyword>Piezoelectric surgery</keyword>
  <keyword>Immediate load</keyword>
  <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>Undecided</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/NCT04497571
org study id: IGR UGranada
nct id: NCT04497571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Compare the survival rate of the implants placed using the ultrasonic technique and placed
      using conventional drilling, with an immediate load on the aesthetic zone.
Main goals.

      Compare the survival rate of the implants placed using the ultrasonic technique and placed
      using conventional drilling, with an immediate load on the aesthetic zone.

      Specific goals.

        -  Evaluate the marginal peri-implant bone loss after the healing period through
           radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year
           after the implants insertion.

        -  Evaluate the primary stability of each individual implant the day of their insertion to
           verify their load on the moment of surgery and also compare the values of each
           preparation techniques of implant bone preparation.

        -  Evaluate the secondary stability of each individual implant and compare the values of
           each preparation techniques.

        -  Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the
           insertion of the implants through these variables: probing depth and bleeding of
           probing.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized clinical trials.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Marginal Bone Loss
time frame: 1 month
description: To compare MBL measured using radiographs.
measure: Marginal Bone Loss
time frame: 3 months
description: To compare MBL measured using radiographs.
measure: Marginal Bone Loss
time frame: 6 months
description: To compare MBL measured using radiographs.
measure: Marginal Bone Loss
time frame: 12 months
description: To compare MBL measured using radiographs.
measure: Primary stability
time frame: Baseline
description: Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording immediately.
measure: Secondary stability
time frame: 3 months
description: Implant Stability Quotient Values (Osstell ISQ, Osstell USA) obtained from implants in study site, recording at 3 months.
measure: Probing depth
time frame: 3,6,12 months
description: Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
measure: Bleeding of probing
time frame: 3,6,12 months
description: Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
measure: Survival rate
time frame: 3,6,12 months
description: To measure implant success rate.
arm group label: Piezoelectric osteotomy
arm group type: Experimental
description: Implant placement by piezoelectric osteotomy
arm group label: Conventional drilling
arm group type: Active Comparator
description: Implant placement by conventional drilling
intervention type: Procedure
intervention name: Piezoelectric osteotomy.
description: Implants placed using the ultrasonic technique.
arm group label: Piezoelectric osteotomy
intervention type: Procedure
intervention name: Conventional drilling
description: Implants placed using drilling technique
arm group label: Conventional drilling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Isabel Godoy Reina
investigator title: Professor of Master of Periodontology and Implant Dentistry, PhD student.
mesh term: Tooth Loss
sharing ipd: Undecided