<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/NCT04446078</url>
  </required_header>
  <id_info>
    <org_study_id>AO4PEEKDevGroup</org_study_id>
    <nct_id>NCT04446078</nct_id>
  </id_info>
  <brief_title>Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full Arch Rehabilitation</brief_title>
  <acronym>AO4PEEKDev</acronym>
  <official_title>Hybrid Polyetheretherketone (PEEK)-Acrylic Resin Prostheses and the All-on-4 Concept for Full Arch Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Malo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Malo Clinic</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>
      It is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations&#xD;
      using peek material. To test this, the study design to be used will be a prospective single&#xD;
      cohort to evaluate the long term outcome of fixed prosthetic implant supported&#xD;
      rehabilitations. The cohort will be evaluated after 5 years of follow-up, regarding&#xD;
      prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical&#xD;
      complications (loosening or fracture of prosthetic components), biological complications&#xD;
      (peri-implant pathology, suppuration, fistulae), incidence of biological complications&#xD;
      (peri-implant pathology, suppuration, excessive marginal bone resorption) in-mouth comfort,&#xD;
      overall chewing feeling, framework integrity, veneer adhesion, veneer chipping, patient&#xD;
      tissue reaction, denture staining, manufacture issues,&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Problem Peek material is already used in the dentistry field, but proof on its long-term&#xD;
      outcome in implant supported fixed rehabilitations is lacking.&#xD;
&#xD;
      Objectives&#xD;
&#xD;
        -  To evaluate the long term outcome of fixed prosthetic implant supported rehabilitations&#xD;
           using peek material.&#xD;
&#xD;
        -  To report the results.&#xD;
&#xD;
      Significance This investigation is of interest, because it will provide an overview of the&#xD;
      long term outcome of implant supported fixed prosthetic rehabilitations using peek material.&#xD;
&#xD;
      Hypothesis The hypothesis that this study will evaluate, will be the distribution of survival&#xD;
      and other variables of interest in implant supported fixed prosthetic rehabilitations using&#xD;
      peek material.&#xD;
&#xD;
      Materials and Methods Methodology This study will be performed at Malo Clinic in Lisbon. It&#xD;
      is estimated to last for approximately 5 years. The study design to be used will be a&#xD;
      prospective single cohort study to evaluate the long-term outcome of implant supported fixed&#xD;
      prosthetic rehabilitations using peek material. The cohort will be evaluated in at least 5&#xD;
      interventions (1 per year), regarding survival and the clinical/technical parameters&#xD;
      established in this study. There will be no risk for the participants, has all procedures for&#xD;
      collecting information will be minimally invasive and non- traumatizing.&#xD;
&#xD;
      Population The population of this study consists in individuals rehabilitated with a fixed&#xD;
      prosthetic rehabilitation supported by immediate function implants, of both genders, without&#xD;
      age restrictions.&#xD;
&#xD;
      Sample size It is expected that the sample will consist of 37 consecutively treated patients&#xD;
      during the year of 2013.&#xD;
&#xD;
      External variables:&#xD;
&#xD;
        -  Withdrawal of the patients;&#xD;
&#xD;
        -  The patient missing the control appointment;&#xD;
&#xD;
        -  Interruption of the treatment by the patient;&#xD;
&#xD;
        -  Patient deceased.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      In this study, the data will be treated by means of descriptive and inferential statistics.&#xD;
      The data will be treated using the Statistical Package for Social Sciences (SPSS) for Windows&#xD;
      version 17.0 ®. Survival will be estimated through life tables. Inferential analysis will be&#xD;
      performed for characterization of the cohort and independent variables.&#xD;
&#xD;
      Adverse events:&#xD;
&#xD;
      An adverse event is defined as any undesirable clinical occurrence in a subject whether it is&#xD;
      considered to be device related or not. If the adverse event is regarded as device related it&#xD;
      is stated as an adverse device effect. An adverse event or adverse device effect may be&#xD;
      serious\severe or non-serious\non-severe. If, as result of an adverse event during a clinical&#xD;
      investigation, a subject has to be hospitalized, or their hospitalization is unduly prolonged&#xD;
      due to potential disability or danger to life because an intervention has been necessitated&#xD;
      or the event is terminal, the adverse event or adverse effect is regarded as serious. All&#xD;
      serious adverse events must be reported to the Ethic Committee and without any delay.&#xD;
&#xD;
      Ethical aspects:&#xD;
&#xD;
      This investigation will be carried out in accordance to the ethical principles and guidelines&#xD;
      stated in the Declaration of Helsinki. The Investigation should be evaluated and approved by&#xD;
      a National Ethic Committee prior to including the first subject in the investigation. The&#xD;
      application to the Ethic committee is to be made by the responsible investigators, and a copy&#xD;
      of the approval should be sent to the monitor before the investigation starts. It is also of&#xD;
      great importance that each subject receives oral and written information about the&#xD;
      investigation, and that she/he must only participate if they truly want to do so. Also, the&#xD;
      subjects must be aware of the fact that they can withdraw from the investigation at any time&#xD;
      and for any reason without jeopardizing their future treatment.&#xD;
&#xD;
      Furthermore, the subjects should be made aware of the fact that the data from his/her&#xD;
      treatment will be registered in a computer database, but that she/he will only be registered&#xD;
      through a code system. This means that the identity of each subject will be unknown to all&#xD;
      others than the doctor performing the treatment. Each subject is entitled to take part of the&#xD;
      information stored about her/his treatment. This information is to be handed out by the&#xD;
      treating doctor.&#xD;
&#xD;
      Database management:&#xD;
&#xD;
      The data collected from the forms will be introduced in a digital database (Microsoft Office&#xD;
      Excel 2003®). The database management will be the responsibility of the Malo Clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2014</start_date>
  <completion_date type="Actual">February 9, 2022</completion_date>
  <primary_completion_date type="Actual">December 29, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>prospective cohort</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>patient coding</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>prosthetic survival</measure>
    <time_frame>5 years</time_frame>
    <description>considering the necessity of replacing the prosthesis; fracture of the infrastructure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>implant survival</measure>
    <time_frame>5 years</time_frame>
    <description>considering the implants' function, censoring as a failure the first implant to fail in a given patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>marginal bone loss</measure>
    <time_frame>5 years</time_frame>
    <description>Marginal bone level was defined as the distance between the implant's platform and the most apical bone-implant contact, while the measurements difference between baseline (connection of the definitive prosthesis) and the subsequent evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque levels</measure>
    <time_frame>5 years</time_frame>
    <description>modified plaque index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding levels</measure>
    <time_frame>5 years</time_frame>
    <description>modified bleeding index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problems during manufacturing</measure>
    <time_frame>5 years</time_frame>
    <description>Evaluation of veneer adhesion by detachment of acrylic resin veneer from PEEK infrastructure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biological complications</measure>
    <time_frame>5 years</time_frame>
    <description>Adverse soft tissue reaction, suppuration, abscess, fistulae and peri-implant pathology (the presence of marginal bone loss and peri-implant pockets of more than 4 mm, with or without the concurrent presence of bleeding on probing or suppuration)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical complications</measure>
    <time_frame>5 years</time_frame>
    <description>Prosthesis, abutments or prosthetic screws fracture or loosening</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient subjective evaluation concerning overall chewing feeling associated with the specific feel during food mastication</measure>
    <time_frame>5 years</time_frame>
    <description>The evaluations performed by the patient were registered on a visual analogue scale ranging between 0-10 (poor to excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient subjective evaluation concerning in mouth comfort specified as the patients' overall evaluation according to the expectations when submitting the prosthesis to function</measure>
    <time_frame>5 years</time_frame>
    <description>The evaluations performed by the patient were registered on a visual analogue scale ranging between 0-10 (poor to excellent)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Dental Implants</condition>
  <condition>Dental Materials</condition>
  <condition>Mandible</condition>
  <condition>Prosthesis Survival</condition>
  <arm_group>
    <arm_group_label>PEEK - All-on-4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients rehabilitated with a PEEK-acrylic resin prosthesis supported by immediate function dental implants inserted through the All-on-4 concept</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PEEK- acrylic resin prosthesis supported by 4 dental implants</intervention_name>
    <description>Patients rehabilitated for edentulism of one or both arches through an implant supported fixed prosthesis</description>
    <arm_group_label>PEEK - All-on-4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  rehabilitated with implant-supported fixed prostheses through the All-on-4 concept&#xD;
             (Nobel Biocare)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in active chemotherapy or radiotherapy,&#xD;
&#xD;
          -  Presenting insufficient bone volume,&#xD;
&#xD;
          -  Unable to provide written informed consent&#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>Miguel A de Araújo Nobre, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Malo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Malo Clinic</name>
      <address>
        <city>Lisbon</city>
        <zip>1600-042</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>February 23, 2023</last_update_submitted>
  <last_update_submitted_qc>February 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>All-on-4; All-on-four</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>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/NCT04446078
org study id: AO4PEEKDevGroup
nct id: NCT04446078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is necessary to evaluate the outcome of implant supported fixed prosthetic rehabilitations
      using peek material. To test this, the study design to be used will be a prospective single
      cohort to evaluate the long term outcome of fixed prosthetic implant supported
      rehabilitations. The cohort will be evaluated after 5 years of follow-up, regarding
      prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical
      complications (loosening or fracture of prosthetic components), biological complications
      (peri-implant pathology, suppuration, fistulae), incidence of biological complications
      (peri-implant pathology, suppuration, excessive marginal bone resorption) in-mouth comfort,
      overall chewing feeling, framework integrity, veneer adhesion, veneer chipping, patient
      tissue reaction, denture staining, manufacture issues,
Problem Peek material is already used in the dentistry field, but proof on its long-term
      outcome in implant supported fixed rehabilitations is lacking.

      Objectives

        -  To evaluate the long term outcome of fixed prosthetic implant supported rehabilitations
           using peek material.

        -  To report the results.

      Significance This investigation is of interest, because it will provide an overview of the
      long term outcome of implant supported fixed prosthetic rehabilitations using peek material.

      Hypothesis The hypothesis that this study will evaluate, will be the distribution of survival
      and other variables of interest in implant supported fixed prosthetic rehabilitations using
      peek material.

      Materials and Methods Methodology This study will be performed at Malo Clinic in Lisbon. It
      is estimated to last for approximately 5 years. The study design to be used will be a
      prospective single cohort study to evaluate the long-term outcome of implant supported fixed
      prosthetic rehabilitations using peek material. The cohort will be evaluated in at least 5
      interventions (1 per year), regarding survival and the clinical/technical parameters
      established in this study. There will be no risk for the participants, has all procedures for
      collecting information will be minimally invasive and non- traumatizing.

      Population The population of this study consists in individuals rehabilitated with a fixed
      prosthetic rehabilitation supported by immediate function implants, of both genders, without
      age restrictions.

      Sample size It is expected that the sample will consist of 37 consecutively treated patients
      during the year of 2013.

      External variables:

        -  Withdrawal of the patients;

        -  The patient missing the control appointment;

        -  Interruption of the treatment by the patient;

        -  Patient deceased.

      Statistical analysis:

      In this study, the data will be treated by means of descriptive and inferential statistics.
      The data will be treated using the Statistical Package for Social Sciences (SPSS) for Windows
      version 17.0 ®. Survival will be estimated through life tables. Inferential analysis will be
      performed for characterization of the cohort and independent variables.

      Adverse events:

      An adverse event is defined as any undesirable clinical occurrence in a subject whether it is
      considered to be device related or not. If the adverse event is regarded as device related it
      is stated as an adverse device effect. An adverse event or adverse device effect may be
      serious\severe or non-serious\non-severe. If, as result of an adverse event during a clinical
      investigation, a subject has to be hospitalized, or their hospitalization is unduly prolonged
      due to potential disability or danger to life because an intervention has been necessitated
      or the event is terminal, the adverse event or adverse effect is regarded as serious. All
      serious adverse events must be reported to the Ethic Committee and without any delay.

      Ethical aspects:

      This investigation will be carried out in accordance to the ethical principles and guidelines
      stated in the Declaration of Helsinki. The Investigation should be evaluated and approved by
      a National Ethic Committee prior to including the first subject in the investigation. The
      application to the Ethic committee is to be made by the responsible investigators, and a copy
      of the approval should be sent to the monitor before the investigation starts. It is also of
      great importance that each subject receives oral and written information about the
      investigation, and that she/he must only participate if they truly want to do so. Also, the
      subjects must be aware of the fact that they can withdraw from the investigation at any time
      and for any reason without jeopardizing their future treatment.

      Furthermore, the subjects should be made aware of the fact that the data from his/her
      treatment will be registered in a computer database, but that she/he will only be registered
      through a code system. This means that the identity of each subject will be unknown to all
      others than the doctor performing the treatment. Each subject is entitled to take part of the
      information stored about her/his treatment. This information is to be handed out by the
      treating doctor.

      Database management:

      The data collected from the forms will be introduced in a digital database (Microsoft Office
      Excel 2003®). The database management will be the responsibility of the Malo Clinic.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective cohort
primary purpose: Treatment
masking: None (Open Label)
masking description: patient coding
measure: prosthetic survival
time frame: 5 years
description: considering the necessity of replacing the prosthesis; fracture of the infrastructure
measure: implant survival
time frame: 5 years
description: considering the implants' function, censoring as a failure the first implant to fail in a given patient
measure: marginal bone loss
time frame: 5 years
description: Marginal bone level was defined as the distance between the implant's platform and the most apical bone-implant contact, while the measurements difference between baseline (connection of the definitive prosthesis) and the subsequent evaluation.
measure: Plaque levels
time frame: 5 years
description: modified plaque index
measure: Bleeding levels
time frame: 5 years
description: modified bleeding index
measure: Problems during manufacturing
time frame: 5 years
description: Evaluation of veneer adhesion by detachment of acrylic resin veneer from PEEK infrastructure.
measure: Biological complications
time frame: 5 years
description: Adverse soft tissue reaction, suppuration, abscess, fistulae and peri-implant pathology (the presence of marginal bone loss and peri-implant pockets of more than 4 mm, with or without the concurrent presence of bleeding on probing or suppuration)
measure: Mechanical complications
time frame: 5 years
description: Prosthesis, abutments or prosthetic screws fracture or loosening
measure: Patient subjective evaluation concerning overall chewing feeling associated with the specific feel during food mastication
time frame: 5 years
description: The evaluations performed by the patient were registered on a visual analogue scale ranging between 0-10 (poor to excellent)
measure: Patient subjective evaluation concerning in mouth comfort specified as the patients' overall evaluation according to the expectations when submitting the prosthesis to function
time frame: 5 years
description: The evaluations performed by the patient were registered on a visual analogue scale ranging between 0-10 (poor to excellent)
arm group label: PEEK - All-on-4
arm group type: Experimental
description: Patients rehabilitated with a PEEK-acrylic resin prosthesis supported by immediate function dental implants inserted through the All-on-4 concept
intervention type: Device
intervention name: PEEK- acrylic resin prosthesis supported by 4 dental implants
description: Patients rehabilitated for edentulism of one or both arches through an implant supported fixed prosthesis
arm group label: PEEK - All-on-4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Miguel A de Araújo Nobre, PhD
role: Principal Investigator
affiliation: Malo Clinic
facility: 
country: Portugal
responsible party type: Sponsor
mesh term: Prosthesis Failure
sharing ipd: No