<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/NCT02975674</url>
  </required_header>
  <id_info>
    <org_study_id>213CEIH2016</org_study_id>
    <nct_id>NCT02975674</nct_id>
  </id_info>
  <brief_title>Evaluation of MT-12 Implant Survival and Marginal Bone Loss</brief_title>
  <acronym>213CEIH2016</acronym>
  <official_title>Evaluation of MT-12 Implant Survival and Marginal Bone Loss</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The trial is designed as a consecutive enrollment prospective one-center study. A minimum of&#xD;
      30 patients will be included in the study. At implant installation, the patient will be&#xD;
      randomized to receive one of the two types of implants (Control: internal hexagon connection&#xD;
      implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant&#xD;
      crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage&#xD;
      surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12&#xD;
      months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks&#xD;
      after the impressions are taken.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">February 2021</completion_date>
  <primary_completion_date type="Actual">February 2021</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Marginal bone level</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Peri-implant inflammation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant microbial contamination</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Jaw, Edentulous, Partially</condition>
  <arm_group>
    <arm_group_label>MT-12 dental implant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MT-12 dental implant with Morse taper implant-abutment connection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CON.INT dental implant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CON.INT dental implant with internal hexagon implant-abutment connection</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MT-12 dental implant</intervention_name>
    <description>Placement of the MT-12 dental implant with Morse taper implant-abutment connection</description>
    <arm_group_label>MT-12 dental implant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CON.INT dental implant</intervention_name>
    <description>Placement of the CON.INT dental implant with internal hexagon implant-abutment connection</description>
    <arm_group_label>CON.INT dental implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient &gt;18 and ≤75 years old&#xD;
&#xD;
          -  One missing tooth in the premolar or molar area with both opposing and adjacent teeth&#xD;
             (mesial and distal)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  One-stage bone augmentation&#xD;
&#xD;
          -  Uncontrolled type 1 or 2 diabetes (HgA1c&gt;8)&#xD;
&#xD;
          -  Known auto-immune or inflammatory disease&#xD;
&#xD;
          -  Severe hematologic disorders, such as hemophilia or leukemia&#xD;
&#xD;
          -  Local or systemic infection that may compromise normal healing (e.g., extensive&#xD;
             periapical pathology)&#xD;
&#xD;
          -  Liver or kidney dysfunction/failure&#xD;
&#xD;
          -  Currently receiving cancer treatment or within 18 months from completion of radio- or&#xD;
             chemotherapy&#xD;
&#xD;
          -  Long-term history of oral bisphosphonates use (i.e., 10 years or more)&#xD;
&#xD;
          -  History of intravenous bisphosphonates&#xD;
&#xD;
          -  Long-term (&gt;3 months) history of antibiotics or drugs known to alter the inflammation&#xD;
             and/or immunological system 3 months before inclusion&#xD;
&#xD;
          -  Severe osseous diseases (e.g., Paget disease of bone)&#xD;
&#xD;
          -  Pregnant women or nursing mothers&#xD;
&#xD;
          -  Not able or not willing to follow instructions related to the study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pablo Galindo-Moreno, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad de Granada</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Facultad de Odontología</name>
      <address>
        <city>Granada</city>
        <zip>18071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804.</citation>
    <PMID>25830399</PMID>
  </reference>
  <results_reference>
    <citation>Galindo-Moreno P, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.</citation>
    <PMID>34830709</PMID>
  </results_reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 20, 2023</last_update_submitted>
  <last_update_submitted_qc>May 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Granada</investigator_affiliation>
    <investigator_full_name>Pablo Galindo-Moreno</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Jaw, Edentulous</mesh_term>
    <mesh_term>Jaw, Edentulous, Partially</mesh_term>
  </condition_browse>
  <!-- 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/NCT02975674
org study id: 213CEIH2016
nct id: NCT02975674
lead sponsor: 
has dmc: No
The trial is designed as a consecutive enrollment prospective one-center study. A minimum of
      30 patients will be included in the study. At implant installation, the patient will be
      randomized to receive one of the two types of implants (Control: internal hexagon connection
      implants (CON.INT); Test: Morse taper connection implants (MT-12)). Samples of peri-implant
      crevicular fluid (PICF) and intrasulcular plaque will be collected at -21 (second-stage
      surgery), -14 (impressions), 0 (Baseline: prosthesis delivery), 7 days and 1, 3, 6, 12
      months. Prosthesis will be fabricated and delivered as usual, i.e., approximately two weeks
      after the impressions are taken.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Marginal bone level
time frame: 1 year
measure: Peri-implant inflammation
time frame: 1 year
measure: Peri-implant microbial contamination
time frame: 1 year
arm group label: MT-12 dental implant
arm group type: Experimental
description: MT-12 dental implant with Morse taper implant-abutment connection
arm group label: CON.INT dental implant
arm group type: Active Comparator
description: CON.INT dental implant with internal hexagon implant-abutment connection
intervention type: Device
intervention name: MT-12 dental implant
description: Placement of the MT-12 dental implant with Morse taper implant-abutment connection
arm group label: MT-12 dental implant
intervention type: Device
intervention name: CON.INT dental implant
description: Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
arm group label: CON.INT dental implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pablo Galindo-Moreno, DDS, PhD
role: Principal Investigator
affiliation: Universidad de Granada
facility: 
country: Spain
citation: Galindo-Moreno P, Fernandez-Jimenez A, O'Valle F, Monje A, Silvestre FJ, Juodzbalys G, Sanchez-Fernandez E, Catena A. Influence of the crown-implant connection on the preservation of peri-implant bone: a retrospective multifactorial analysis. Int J Oral Maxillofac Implants. 2015 Mar-Apr;30(2):384-90. doi: 10.11607/jomi.3804.
PMID: 25830399
citation: Galindo-Moreno P, Concha-Jeronimo A, Lopez-Chaichio L, Rodriguez-Alvarez R, Sanchez-Fernandez E, Padial-Molina M. Marginal Bone Loss around Implants with Internal Hexagonal and Internal Conical Connections: A 12-Month Randomized Pilot Study. J Clin Med. 2021 Nov 20;10(22):5427. doi: 10.3390/jcm10225427.
PMID: 34830709
responsible party type: Principal Investigator
investigator affiliation: Universidad de Granada
investigator full name: Pablo Galindo-Moreno
investigator title: Professor
mesh term: Jaw, Edentulous
mesh term: Jaw, Edentulous, Partially