<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/NCT03812276</url>
  </required_header>
  <id_info>
    <org_study_id>CS.O.002</org_study_id>
    <nct_id>NCT03812276</nct_id>
  </id_info>
  <brief_title>Neodent Implantable Devices of GM Line</brief_title>
  <official_title>Prospective Observational Study of Neodent Implantable Devices of GM Line</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neodent</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Neodent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted&#xD;
      treatment protocol, allowing for treatment of patients with different bone qualities.&#xD;
&#xD;
      The objective of the study is to prospectively collect clinical data to confirm the long-term&#xD;
      safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in&#xD;
      daily dental practice setting, by means of success and survival rates of these devices.&#xD;
&#xD;
      Devices will be used according to standard routine in daily practice, according to all&#xD;
      indications as specified by the manufacturer in the IFU (instructions for use). patients will&#xD;
      be followed for 36 months after implant placement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.&#xD;
&#xD;
      The sample will be prospectively and consecutively selected and will consist of patients who&#xD;
      are 18 years of age or older, who are in need of one or more dental implants and who qualify&#xD;
      for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from&#xD;
      each patient participating in the study prior to any study related procedure.&#xD;
&#xD;
      Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone&#xD;
      bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a&#xD;
      single subject. Implants will be placed 2mm below the alveolar ridge.&#xD;
&#xD;
      The selection of the prosthetic component and loading protocol (late or immediate) will be&#xD;
      conducted according to the need of each subject and to the manufacturer's instructions (IFU).&#xD;
      Thus, implant immediate loading may be performed (at the discretion of the surgeon) when&#xD;
      primary stability reach at least 32 N.cm and the patient present physiological occlusion.&#xD;
&#xD;
      Data concerning the studied variables will be collected by fulfilling the Case Report Form&#xD;
      (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL -&#xD;
      Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant&#xD;
      placement. A visit window of more or less one month is eligible for each of the planned&#xD;
      intervals.&#xD;
&#xD;
      Standardized digital periapical radiographs, computed tomography scans and photographs will&#xD;
      be obtained in an usual daily practice frequency, as determined by the investigator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 14, 2019</start_date>
  <completion_date type="Actual">January 28, 2023</completion_date>
  <primary_completion_date type="Actual">January 10, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>36 Months</target_duration>
  <primary_outcome>
    <measure>Implant survival and success rates</measure>
    <time_frame>36 months after implant placement</time_frame>
    <description>Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implant survival and success rates</measure>
    <time_frame>6, 12 and 24 months after implant placement</time_frame>
    <description>Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prosthetic survival and success rates</measure>
    <time_frame>12, 24 and 36 months after implant placement</time_frame>
    <description>Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire</measure>
    <time_frame>6, 12, 24 and 36 months after implant placement</time_frame>
    <description>The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire</measure>
    <time_frame>Implant placement, 12, 24 and 36 months after implant placement</time_frame>
    <description>The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse events related to the implant, prosthesis, surgery and oral health</measure>
    <time_frame>Implant placement, 6, 12, 24 and 36 months after implant placement</time_frame>
    <description>Determined by inquiring with the patient and clinical evaluation.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Jaw, Edentulous</condition>
  <condition>Jaw, Edentulous, Partially</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <description>Neodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dental Implants</intervention_name>
    <description>Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use).</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years of age or older who are in need of and who qualify for dental implant&#xD;
        placement with GM Helix implants at the involved study centers. Patients that give written&#xD;
        informed consent to participate in this clinical study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older;&#xD;
&#xD;
          -  Need of one or more dental implants;&#xD;
&#xD;
          -  Qualify for placement of Neodent GM Helix implants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        As exclusion criteria, solely the device contraindications according to the IFU&#xD;
        (instructions for use) will be applied:&#xD;
&#xD;
          -  Signs of allergy or hypersensitivity to the chemical ingredients of the material:&#xD;
             titanium alloy;&#xD;
&#xD;
          -  Presence of acute inflammatory or infectious processes in live tissue;&#xD;
&#xD;
          -  Unsuitable bone volume or quality;&#xD;
&#xD;
          -  Serious medical problems (e.g. bone metabolism disorders, blood clotting disorders,&#xD;
             unsuitable healing capacity);&#xD;
&#xD;
          -  Insufficient oral hygiene;&#xD;
&#xD;
          -  Incomplete jawbone growth;&#xD;
&#xD;
          -  Patient uncooperative and not motivated;&#xD;
&#xD;
          -  Abuse of drugs or alcohol;&#xD;
&#xD;
          -  Psychosis;&#xD;
&#xD;
          -  Prolonged functional disorders which resist any treatment with medications;&#xD;
&#xD;
          -  Xerostomia;&#xD;
&#xD;
          -  Weakened immunological system;&#xD;
&#xD;
          -  Diseases which require the use of steroids;&#xD;
&#xD;
          -  Uncontrolled endocrinological diseases;&#xD;
&#xD;
          -  Pregnancy.&#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>
  <overall_official>
    <last_name>Larissa Trojan, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Neodent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Instituto Latino Americano de Pesquisa e Ensino Odontológico (ILAPEO)</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>80710-150</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Positivo</name>
      <address>
        <city>Curitiba</city>
        <state>Paraná</state>
        <zip>81280-330</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>February 8, 2023</last_update_submitted>
  <last_update_submitted_qc>February 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Dental Implants</keyword>
  <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>
    <mesh_term>Mouth, Edentulous</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/NCT03812276
org study id: CS.O.002
nct id: NCT03812276
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Acqua GM (Grand Morse) Helix implants present an optimized implant design with adapted
      treatment protocol, allowing for treatment of patients with different bone qualities.

      The objective of the study is to prospectively collect clinical data to confirm the long-term
      safety and clinical performance of Acqua GM Helix implants and GM prosthetic abutments in
      daily dental practice setting, by means of success and survival rates of these devices.

      Devices will be used according to standard routine in daily practice, according to all
      indications as specified by the manufacturer in the IFU (instructions for use). patients will
      be followed for 36 months after implant placement.
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.

      The sample will be prospectively and consecutively selected and will consist of patients who
      are 18 years of age or older, who are in need of one or more dental implants and who qualify
      for placement of Neodent GM Helix implants. Informed consent in writing will be obtained from
      each patient participating in the study prior to any study related procedure.

      Neodent Acqua GM Helix implants will be placed under local anesthesia and with adequate bone
      bed preparation, as recommended by the manufacturer. Multiple implants may be placed in a
      single subject. Implants will be placed 2mm below the alveolar ridge.

      The selection of the prosthetic component and loading protocol (late or immediate) will be
      conducted according to the need of each subject and to the manufacturer's instructions (IFU).
      Thus, implant immediate loading may be performed (at the discretion of the surgeon) when
      primary stability reach at least 32 N.cm and the patient present physiological occlusion.

      Data concerning the studied variables will be collected by fulfilling the Case Report Form
      (CRF), in the following stages: First visit (Screening); T0 - Implant(s) placement; TL -
      Implant loading; T6, T12, T24 and T36 - 6, 12, 24 and 36 months, respectively, after implant
      placement. A visit window of more or less one month is eligible for each of the planned
      intervals.

      Standardized digital periapical radiographs, computed tomography scans and photographs will
      be obtained in an usual daily practice frequency, as determined by the investigator.
observational model: Cohort
time perspective: Prospective
measure: Implant survival and success rates
time frame: 36 months after implant placement
description: Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
measure: Implant survival and success rates
time frame: 6, 12 and 24 months after implant placement
description: Implant survival will be defined as no loss of the implant at each follow-up. Evaluation of implant success will be assessed based on the criteria proposed by Buser et al. (1990).
measure: Prosthetic survival and success rates
time frame: 12, 24 and 36 months after implant placement
description: Prosthetic survival will be assessed as the prosthesis remaining in situ at each follow-up, irrespective of its condition. Success will be defined as the prosthesis that remained unchanged and did not require any intervention during the entire observational period.
measure: Patient Satisfaction: OHIP-14 (Oral Health Impact Profile) questionnaire
time frame: 6, 12, 24 and 36 months after implant placement
description: The Portuguese translation of OHIP-14 [18,19] questionnaire will be used to assess Oral Health Related Quality of Life (OHRQoL), as a measure of patient satisfaction with treatment. Scores will range from 0 (absence of negative impacts on oral health) to 28 (high frequency of negative impacts on oral health).
measure: Clinician Satisfaction: VAS (Visual Analogue Scale) questionnaire
time frame: Implant placement, 12, 24 and 36 months after implant placement
description: The assessment will be performed by means of a questionnaire using a visual analog scale (VAS) in the form of a 10 cm horizontal line, where 0 (left end) indicates minimum satisfaction and 10 (right end) indicates maximum satisfaction. The clinician will be instructed to mark the position considered to best represent their degree of general satisfaction with patient treatment. The score will be measured in centimeters from the left end of the line to the marked point.
measure: Rate of adverse events related to the implant, prosthesis, surgery and oral health
time frame: Implant placement, 6, 12, 24 and 36 months after implant placement
description: Determined by inquiring with the patient and clinical evaluation.
arm group label: Study Group
description: Neodent Acqua GM Helix dental implants will be placed. Multiple implants may be placed in a single subject.
intervention type: Device
intervention name: Dental Implants
description: Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use).
arm group label: Study Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Larissa Trojan, PhD
role: Study Chair
affiliation: Neodent
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Jaw, Edentulous
mesh term: Jaw, Edentulous, Partially
mesh term: Mouth, Edentulous
sharing ipd: No