<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/NCT03834636</url>
  </required_header>
  <id_info>
    <org_study_id>PPGO 029</org_study_id>
    <nct_id>NCT03834636</nct_id>
  </id_info>
  <brief_title>Impact of Patients Risk Factors on the Longevity of Aesthetic Restorations</brief_title>
  <official_title>Impact of Patients Risk Factors, Type of Dental Material and Dental Technique on the Longevity of Aesthetic Dental Restorations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Pelotas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federal University of Pelotas</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>
      The objective of this double-blind randomized clinical trial is to evaluate the influence of&#xD;
      caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years&#xD;
      follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond&#xD;
      2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™&#xD;
      Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization&#xD;
      will be stratified according to the risk of caries and cavity type. The primary outcomes will&#xD;
      be longevity, annual failure rate (AFR) and the success of the restorations, and the&#xD;
      secondary outcome will be causes for restorations' failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 10, 2012</start_date>
  <completion_date type="Anticipated">January 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2022</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>This study is a prospective randomized clinical trial, triple-blind, (patients, investigator and clinical evaluator) with parallel groups. After completing the ICDAS (International Caries Detection and Assessment), clinical occlusal stress examination and questionnaire application on occlusal stress, patients will be randomly divided into two types of dental adhesives and two types of composite resin. Randomization will be stratified according to the risk of caries determined by the ICDAS and the type of cavity to be filled. Operators (Master students and undergraduate students from the last year of the School of Dentistry, Federal University of Pelotas) will place the restorations supervised by highly trained clinicians.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival of the restorations</measure>
    <time_frame>Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.</time_frame>
    <description>Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.&#xD;
Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Success of the restorations</measure>
    <time_frame>Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.</time_frame>
    <description>Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction with the treatment</measure>
    <time_frame>Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.</time_frame>
    <description>Patient satisfaction will be recorded with FDI criteria</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Dental Restorations Longevity</condition>
  <condition>Dental Restoration Failure</condition>
  <condition>Esthetics, Dental</condition>
  <arm_group>
    <arm_group_label>Nanoparticulated composite - self-etch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nanoparticulated composite - total-etch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nanohybrid composite - self-etch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nanohybrid composite - total-etch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restorations with nanoparticulated composites and self etch adhesives</intervention_name>
    <description>The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)</description>
    <arm_group_label>Nanoparticulated composite - self-etch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restorations with nanoparticulated composites and total-etch adhesives</intervention_name>
    <description>The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)</description>
    <arm_group_label>Nanoparticulated composite - total-etch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restorations with nanohybrid composites and self etch adhesives</intervention_name>
    <description>The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).</description>
    <arm_group_label>Nanohybrid composite - self-etch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Restorations with nanohybrid composites and total-etch adhesives</intervention_name>
    <description>The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).</description>
    <arm_group_label>Nanohybrid composite - total-etch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with restorative needs in anterior teeth;&#xD;
&#xD;
          -  Patients able to understand and sign the informed consent form;&#xD;
&#xD;
          -  Patients willing to return to follow up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who had a need for Class III and Class IV restorations that did not involve&#xD;
             at least 1/3 of the tooth;&#xD;
&#xD;
          -  Patients under orthodontic treatment;&#xD;
&#xD;
          -  Patients with a compromised general health condition, presenting a greater risk than&#xD;
             ASA II, according to the ASA-PS (American Society of Anesthesiologists - Physical&#xD;
             Status);&#xD;
&#xD;
          -  Patients who had no occlusal contact with an opposing tooth and/or crown;&#xD;
&#xD;
          -  Patient with absence of bilateral balanced occlusion;&#xD;
&#xD;
          -  Patient with deep caries lesions in close contact with the dental pulp and in need of&#xD;
             expectant treatment or direct pulp capping;&#xD;
&#xD;
          -  Patients with post-retained need in anterior teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maximiliano S Cenci</last_name>
    <role>Principal Investigator</role>
    <affiliation>Graduate Program in Dentistry - Federal University of Pelotas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal Univeristy of Pelotas</name>
      <address>
        <city>Pelotas</city>
        <state>RS</state>
        <zip>96015080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Pelotas</investigator_affiliation>
    <investigator_full_name>Maximiliano Sergio Cenci</investigator_full_name>
    <investigator_title>Associate Professor, Principal Investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03834636
org study id: PPGO 029
nct id: NCT03834636
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this double-blind randomized clinical trial is to evaluate the influence of
      caries risk, occlusal stress and missing teeth on anterior restorations over a 10 years
      follow up period. 300 teeth will be randomized according to two adhesive systems: Single Bond
      2 and Single Bond Universal (3M ESPE); and two composite resins: nanoparticulated (Filtek ™
      Z-350- 3M ESPE) and nanohybrid (IPS Empress Direct - Ivoclar Vivadent). The randomization
      will be stratified according to the risk of caries and cavity type. The primary outcomes will
      be longevity, annual failure rate (AFR) and the success of the restorations, and the
      secondary outcome will be causes for restorations' failure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a prospective randomized clinical trial, triple-blind, (patients, investigator and clinical evaluator) with parallel groups. After completing the ICDAS (International Caries Detection and Assessment), clinical occlusal stress examination and questionnaire application on occlusal stress, patients will be randomly divided into two types of dental adhesives and two types of composite resin. Randomization will be stratified according to the risk of caries determined by the ICDAS and the type of cavity to be filled. Operators (Master students and undergraduate students from the last year of the School of Dentistry, Federal University of Pelotas) will place the restorations supervised by highly trained clinicians.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Survival of the restorations
time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
description: Survival of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, regardless of need of small interventions, such as repair or refurbishment. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
Two trained and calibrated evaluators, unrelated to making the restorations, blinded to the type of material used, independently performed the clinical evaluations.
measure: Success of the restorations
time frame: Changes in the dental restorations status compared to baseline will be assessed yearly up to 10 years.
description: Success of the restoration is defined as any case where the restoration remains functional in the mouth at the time of evaluation, without any need of new interventions, and attending the patients demands. The restorations were evaluated shortly after baseline and in prospective periods through a direct clinical inspection, with an explorer probe and a clinical mirror, according to the criteria for clinical evaluation of restorations proposed by the FDI (International Dental Federation) (Hickel et al., 2010), the risks of caries and occlusal stress were also evaluated again.
measure: Patient satisfaction with the treatment
time frame: Changes in the patient's satisfaction status compared to baseline will be assessed yearly up to 10 years.
description: Patient satisfaction will be recorded with FDI criteria
arm group label: Nanoparticulated composite - self-etch
arm group type: Active Comparator
arm group label: Nanoparticulated composite - total-etch
arm group type: Active Comparator
arm group label: Nanohybrid composite - self-etch
arm group type: Active Comparator
arm group label: Nanohybrid composite - total-etch
arm group type: Active Comparator
intervention type: Procedure
intervention name: Restorations with nanoparticulated composites and self etch adhesives
description: The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)
arm group label: Nanoparticulated composite - self-etch
intervention type: Procedure
intervention name: Restorations with nanoparticulated composites and total-etch adhesives
description: The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)
arm group label: Nanoparticulated composite - total-etch
intervention type: Procedure
intervention name: Restorations with nanohybrid composites and self etch adhesives
description: The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
arm group label: Nanohybrid composite - self-etch
intervention type: Procedure
intervention name: Restorations with nanohybrid composites and total-etch adhesives
description: The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
arm group label: Nanohybrid composite - total-etch
criteria: 
gender: All
minimum age: 9 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maximiliano S Cenci
role: Principal Investigator
affiliation: Graduate Program in Dentistry - Federal University of Pelotas
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Pelotas
investigator full name: Maximiliano Sergio Cenci
investigator title: Associate Professor, Principal Investigator
sharing ipd: Undecided