<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/NCT03796494</url>
  </required_header>
  <id_info>
    <org_study_id>CT-2019-01</org_study_id>
    <nct_id>NCT03796494</nct_id>
  </id_info>
  <brief_title>Peri-implant Tissues on Aesthetic Slim Abutment Galimplant (PSG)</brief_title>
  <acronym>(PSG)</acronym>
  <official_title>Behavior of the Peri-implant Tissues on the Multiposition Abutment Straight Aesthetic Slim Anti-rotational Galimplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Santiago de Compostela</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Galimplant Dental Implants</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Santiago de Compostela</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of&#xD;
      peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants,&#xD;
      using a classic multi-position, anti-rotational abutment, comparing it to the new&#xD;
      multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery.&#xD;
      To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be&#xD;
      placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study&#xD;
      groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological&#xD;
      stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12&#xD;
      months post-prosthetic loading.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">January 8, 2020</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary stability of implants and peri-implant tissues</measure>
    <time_frame>10 months</time_frame>
    <description>Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Basal Peri-implant tissue level: implant stability</measure>
    <time_frame>1 day</time_frame>
    <description>Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months and 12 months. The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal Radiological Bone Implant level</measure>
    <time_frame>1 day</time_frame>
    <description>At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal Peri-implant tissue level: probing depth</measure>
    <time_frame>1 day</time_frame>
    <description>At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological bone implant stability</measure>
    <time_frame>8 weeks</time_frame>
    <description>After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant tissue stability: probing depth</measure>
    <time_frame>8 weeks</time_frame>
    <description>After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peri-implant tissue stability: ISQ</measure>
    <time_frame>8 weeks</time_frame>
    <description>After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Long-term evaluation of definitive prostheses</measure>
    <time_frame>6 months</time_frame>
    <description>After 6 months of loading of final ceramic restoration, investigators will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal and final values.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Dental Implant Failed</condition>
  <condition>Dental Prosthesis Failure</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group is considered, using the company's classic multi-position straight anti-rotational abutment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Straight abutment</intervention_name>
    <description>This is the classic abutment, straight and anti-rotational for dental implants which have been tested before</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Slim abutment</intervention_name>
    <description>This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients without systemic pathology that are grounds for absolute contraindication&#xD;
&#xD;
          -  Older adults who agree to be part of the study and sign the informed consent&#xD;
&#xD;
          -  Consumption of tobacco less than 5 cigarettes / day&#xD;
&#xD;
          -  Do not be completely toothless&#xD;
&#xD;
          -  Absences of at least two pieces in posterior area with or without free ends to distal,&#xD;
             maxillary or mandibular that do not require regenerative techniques. In case of odd&#xD;
             absences (3,5,7), a Slim pillar will be placed, being the group to always be the&#xD;
             majority.&#xD;
&#xD;
          -  Area of mature bone healed at least 6 months post-extraction.&#xD;
&#xD;
          -  Patients with a sufficient amount of bone to place implants 4 mm in diameter and 10 mm&#xD;
             long&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immunosuppressed&#xD;
&#xD;
          -  Aesthetic edentulous areas of 13-23 and 33-43&#xD;
&#xD;
          -  Smokers of more than 5 cigarettes&#xD;
&#xD;
          -  Index of bleeding greater than 30%&#xD;
&#xD;
          -  Patients with less than 2 mm of keratinized gingiva&#xD;
&#xD;
          -  Implants with primary stability with ISQ &lt;55&#xD;
&#xD;
          -  Implants with ISQ index &lt;55 at 8 weeks&#xD;
&#xD;
          -  When a margin of safety can not be assumed to the inferior dental nerve of at least 1&#xD;
             mm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mario Pérez Sayáns</name>
      <address>
        <city>Santiago De Compostela</city>
        <state>A Coruña</state>
        <zip>15785</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&amp;i=es&amp;s=-2-26-148</url>
    <description>GI-1319</description>
  </link>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>March 31, 2020</last_update_submitted>
  <last_update_submitted_qc>March 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Santiago de Compostela</investigator_affiliation>
    <investigator_full_name>Mario Pérez Sayáns</investigator_full_name>
    <investigator_title>Professor Mario Perez Sayans MD, PhD (Principal investigator)</investigator_title>
  </responsible_party>
  <keyword>dental implant</keyword>
  <keyword>periimplant tissues</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Time Frame:</ipd_time_frame>
    <ipd_access_criteria>under request</ipd_access_criteria>
  </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/NCT03796494
org study id: CT-2019-01
nct id: NCT03796494
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a randomized, single-blind, split-mouth clinical trial to evaluate the performance of
      peri-implant tissues (bone and soft tissues) in conventionally loaded Galimplant implants,
      using a classic multi-position, anti-rotational abutment, comparing it to the new
      multi-abutment aesthetic slim anti-rotational placed both at the time of the implant surgery.
      To this end, 80 Galimplant implants with a diameter of 4 mm and 10 mm in length will be
      placed in areas of mature scarred post-extraction bone. Patients be divided into 2 study
      groups, group C: straight pillar; Group T: Slim pillar. The bone and clinical radiological
      stability of the peri-implant tissues will be evaluated at 6 weeks post-surgery and at 6-12
      months post-prosthetic loading.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Primary stability of implants and peri-implant tissues
time frame: 10 months
description: Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. Investigators will evaluate the immediate post-surgical stability of implants and peri-implant tissues through the Ostell system, based on the resonance frequency analysis (RFA). The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ
measure: Basal Peri-implant tissue level: implant stability
time frame: 1 day
description: Randomly and following the inclusion and exclusion criteria, the implants will be placed with the normal preparation protocol. We will load the crowns 8 weeks after implant surgery. Investigators will evaluate the stability at different moments, 8 weeks, 6 months and 12 months. The implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100, with higher values indicating greater stability. The acceptable stability range lies between 55-85 ISQ. ISQ values are obtained using resonance frequency analysis (RFA).
measure: Basal Radiological Bone Implant level
time frame: 1 day
description: At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.
measure: Basal Peri-implant tissue level: probing depth
time frame: 1 day
description: At the moment of placing the implant, clinical variables will be evaluated: depth of probing (distance from the peri-implant margin to the most depth of the peri-implant sulcus). This will be the basal measure of the implant stability and peri-implant tissue levels. Investigators will calculate the difference between the basal measure and the future measurements.
measure: Radiological bone implant stability
time frame: 8 weeks
description: After the implantation, we´ll load the temporary 8 weeks after the implantation. Investigators will evaluate the bone level stability at 6 weeks in both groups, through a dental X-ray radiography. The bone stability will be measured as a difference between de basal bone level and the actual one in mm.
measure: Peri-implant tissue stability: probing depth
time frame: 8 weeks
description: After the implantation, we´ll load the definitive prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the probing depth or just in case, the recession of the gingival margin. The stability will be given by the differences between both measures, basal and actual in mm.
measure: Peri-implant tissue stability: ISQ
time frame: 8 weeks
description: After the implantation, we´ll load the temporary prostheses in 8 weeks. Investigators will evaluate the peri-implant tissue stability by measuring the ISQ through RFA. The stability will be given by the differences between both measures, basal and actual.
measure: Long-term evaluation of definitive prostheses
time frame: 6 months
description: After 6 months of loading of final ceramic restoration, investigators will evaluate the differences of clinical (mm of probing depth, ISQ implant stability) and radiological aspects (bone implant level in mm calculated from the neck to the actual bone level, comparing on the basal and final values.
arm group label: Control Group
arm group type: Active Comparator
description: The control group is considered, using the company's classic multi-position straight anti-rotational abutment
arm group label: Test group
arm group type: Experimental
description: The test group is considered, where the new multi-position straight esthetic anti-rotational slim abutment is used
intervention type: Procedure
intervention name: Straight abutment
description: This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
arm group label: Control Group
intervention type: Procedure
intervention name: Slim abutment
description: This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space
arm group label: Test group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
url: http://imaisd.usc.es/grupoficha.asp?idpersoatipogrupo=75189&i=es&s=-2-26-148
description: GI-1319
responsible party type: Principal Investigator
investigator affiliation: University of Santiago de Compostela
investigator full name: Mario Pérez Sayáns
investigator title: Professor Mario Perez Sayans MD, PhD (Principal investigator)
mesh term: Prosthesis Failure
sharing ipd: Yes
ipd description: We will anonymize and categorize the clinical and radiological data of the patients to share the information with the other researchers of the group
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Time Frame:
ipd access criteria: under request