xml: <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/NCT05986669</url>
    </required_header>
    <id_info>
      <org_study_id>DSP_001</org_study_id>
      <nct_id>NCT05986669</nct_id>
    </id_info>
    <brief_title>Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data</brief_title>
    <official_title>Safety and Effectiveness of DSP Dental Implant Systems: Prospective Study Multicenter Involving Real-world Data</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>DSP Industrial Ltda</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>DSP Industrial Ltda</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>
        Studies on facial trauma are essential to establish an appropriate treatment approach, assess&#xD;
        the ability to restore functions and seek ways of prevention. Among craniofacial injuries,&#xD;
        fractures of the zygomatic complex are the most frequent, occurring in 25-30% of cases.&#xD;
        Statistical analysis shows that traffic collisions (41%), domestic accidents (23%) and sports&#xD;
        accidents (18%) are the main causes. Dental implants have emerged as a rehabilitative&#xD;
        alternative for these patients, being considered the first choice for individuals who have&#xD;
        lost all or part of their dental arch. In addition to providing a better quality of life, it&#xD;
        reconstitutes masticatory function, self-esteem and phonetics. Understanding the importance&#xD;
        of evaluating the performance of dental implants and considering the responsibility for the&#xD;
        health of patients, there was a need to evaluate the effectiveness and safety of the Standard&#xD;
        Internal Hexagon Implant System (HIS), Large Internal Hexagon (HIL), Flexcone (FC) , Mini&#xD;
        Flexcone (FCM) and Morse Internal Hexagon, from DSP. In this prospective study, 1053 implants&#xD;
        will be included. To be eligible, patients can be of both sexes, be 18 years of age or older,&#xD;
        any race and gender, have partial or total tooth loss, present good local and general health&#xD;
        conditions and psychological disposition to undergo common oral surgery procedures. under&#xD;
        local anesthesia and healthy edentulous region as they will be subsequently submitted to&#xD;
        surgical procedures using the DSP Implant System. Electronic data collection and management&#xD;
        will be performed using the REDCap software, with categorical variables being described as&#xD;
        absolute and relative frequencies and continuous ones being tested for normality using the&#xD;
        Shapiro-Wilk test. Osseointegration percentages between 30 days and 6 months will also be&#xD;
        calculated. Other efficacy outcomes and incidence of adverse events will be estimated with&#xD;
        95% confidence intervals. As a result, from the strengthening of product evaluation actions,&#xD;
        it is expected to demonstrate that the implant has a good safety and efficacy profile to be&#xD;
        offered to the population.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study was designed as a prospective observational clinical record. This protocol will be&#xD;
        submitted to the Ethics Committee and patients will be included only after ethics committee&#xD;
        approval. All data will be collected from procedures performed in actual clinical practice.&#xD;
        Specific surgical interventions will not be performed for the purposes of this study, since&#xD;
        this is an observational study.&#xD;
  &#xD;
        After the surgeries, the patients will be followed up for one year. The patient's data will&#xD;
        be collected on five visits scheduled for assessment of the outcomes of the study. (Baseline,&#xD;
        T0, T90, T180 and T360).&#xD;
  &#xD;
        The forecast for the study end is 24 months after the first inclusion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">May 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Implant success rate 6 months after the procedure</measure>
      <time_frame>6 months</time_frame>
      <description>Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Adverse events related to medical device or procedure</measure>
      <time_frame>Through study completion, an average of 2 years</time_frame>
      <description>Record of events that may happen</description>
    </secondary_outcome>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Dental Implant</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The patients to study will be recruited from the site UNESP and DSP Training Center&#xD;
          according to the inclusion and exclusion criteria shown in the protocol.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients of both sexes will be included;&#xD;
  &#xD;
            -  Regardless of race/color;&#xD;
  &#xD;
            -  Aged between 18 and 70 years;&#xD;
  &#xD;
            -  Who present partial or total tooth loss in a minimum period of three months;&#xD;
  &#xD;
            -  Healthy edentulous region;&#xD;
  &#xD;
            -  Good local and general health conditions, and psychological disposition;&#xD;
  &#xD;
            -  To undergo common oral surgery procedures, under local anesthesia, in addition to&#xD;
               undergoing surgical procedures using one of the implant systems under evaluation&#xD;
               (Standard Internal Hexagon (HIS); Large Internal Hexagon (HIL); Flexcone (FC);&#xD;
               Flexcone Mini (FCM) and Morse Internal Hexagon (HIM).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who need bone grafting;&#xD;
  &#xD;
            -  Smokers who smoke 10 cigarettes/day or more;&#xD;
  &#xD;
            -  Individuals who make continuous use of bisphosphonates and anticoagulants, alcoholics,&#xD;
               and/or users of illicit drugs&#xD;
  &#xD;
            -  Pregnant women;&#xD;
  &#xD;
            -  Diabetics with uncontrolled glycemia and individuals&#xD;
  &#xD;
            -  Patientes who were treated with radiotherapy.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Marcelo C Goiato, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UPECLIN HC FM Botucatu Unesp</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rafael Correira, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>DSP</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marcelo C Goiato, PhD</last_name>
      <phone>+55 18 99752-4700</phone>
      <email>m.goiato@unesp.br</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ruan Barra, MSc</last_name>
      <phone>+55 34 8843-4741</phone>
      <email>ruan_d.barra@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>DSP Oral Clinica</name>
        <address>
          <city>Campo Largo</city>
          <state>Paraná</state>
          <zip>83601-620</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rafael Correira, PhD</last_name>
        <phone>+1 (734) 276-0984</phone>
        <email>rafaelcorreira14@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Emily Santana, Dra</last_name>
        <phone>+55 41 9516-4553</phone>
        <email>emilyqbsantana@gmail.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dental Implants</keyword>
    <keyword>Dental Prostheses</keyword>
    <keyword>Safety and efficacy</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986669
  org study id: DSP_001
  nct id: NCT05986669
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Studies on facial trauma are essential to establish an appropriate treatment approach, assess
        the ability to restore functions and seek ways of prevention. Among craniofacial injuries,
        fractures of the zygomatic complex are the most frequent, occurring in 25-30% of cases.
        Statistical analysis shows that traffic collisions (41%), domestic accidents (23%) and sports
        accidents (18%) are the main causes. Dental implants have emerged as a rehabilitative
        alternative for these patients, being considered the first choice for individuals who have
        lost all or part of their dental arch. In addition to providing a better quality of life, it
        reconstitutes masticatory function, self-esteem and phonetics. Understanding the importance
        of evaluating the performance of dental implants and considering the responsibility for the
        health of patients, there was a need to evaluate the effectiveness and safety of the Standard
        Internal Hexagon Implant System (HIS), Large Internal Hexagon (HIL), Flexcone (FC) , Mini
        Flexcone (FCM) and Morse Internal Hexagon, from DSP. In this prospective study, 1053 implants
        will be included. To be eligible, patients can be of both sexes, be 18 years of age or older,
        any race and gender, have partial or total tooth loss, present good local and general health
        conditions and psychological disposition to undergo common oral surgery procedures. under
        local anesthesia and healthy edentulous region as they will be subsequently submitted to
        surgical procedures using the DSP Implant System. Electronic data collection and management
        will be performed using the REDCap software, with categorical variables being described as
        absolute and relative frequencies and continuous ones being tested for normality using the
        Shapiro-Wilk test. Osseointegration percentages between 30 days and 6 months will also be
        calculated. Other efficacy outcomes and incidence of adverse events will be estimated with
        95% confidence intervals. As a result, from the strengthening of product evaluation actions,
        it is expected to demonstrate that the implant has a good safety and efficacy profile to be
        offered to the population.
  The study was designed as a prospective observational clinical record. This protocol will be
        submitted to the Ethics Committee and patients will be included only after ethics committee
        approval. All data will be collected from procedures performed in actual clinical practice.
        Specific surgical interventions will not be performed for the purposes of this study, since
        this is an observational study.
  
        After the surgeries, the patients will be followed up for one year. The patient's data will
        be collected on five visits scheduled for assessment of the outcomes of the study. (Baseline,
        T0, T90, T180 and T360).
  
        The forecast for the study end is 24 months after the first inclusion.
  observational model: Other
  time perspective: Prospective
  measure: Implant success rate 6 months after the procedure
  time frame: 6 months
  description: Success = no radiolucency, no mobility, no recurrent peri-implant infection, no persistent pain
  measure: Adverse events related to medical device or procedure
  time frame: Through study completion, an average of 2 years
  description: Record of events that may happen
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  last name: Marcelo C Goiato, PhD
  role: Principal Investigator
  affiliation: UPECLIN HC FM Botucatu Unesp
  last name: Rafael Correira, PhD
  role: Principal Investigator
  affiliation: DSP
  last name: Marcelo C Goiato, PhD
  phone: +55 18 99752-4700
  email: m.goiato@unesp.br
  last name: Ruan Barra, MSc
  phone: +55 34 8843-4741
  email: ruan_d.barra@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Brazil
  responsible party type: Sponsor