<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/NCT03254693</url>
  </required_header>
  <id_info>
    <org_study_id>56013116.0.0000.0107</org_study_id>
    <nct_id>NCT03254693</nct_id>
  </id_info>
  <brief_title>BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE</brief_title>
  <acronym>RCT</acronym>
  <official_title>STRATEGIES FOR BONDING TO ENAMEL USING A UNIVERSAL ADHESIVE ON SELF-ETCHING MODE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual de Ponta Grossa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Estadual de Ponta Grossa</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>
      Objective: This double-blind randomized clinical trial evaluates strategies for improving the&#xD;
      bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new&#xD;
      universal multi-mode adhesive (Ambar Universal; FGM).&#xD;
&#xD;
      Methods: A total of 134 restorations were randomly placed in 19 patients according to the&#xD;
      following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+&#xD;
      - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The&#xD;
      restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and&#xD;
      USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventions: restorative procedure All the patients selected for this study received dental&#xD;
      prophylaxis with a suspension of pumice and water in a rubber cup and signed an informed&#xD;
      consent form two weeks before the restorative procedures.&#xD;
&#xD;
      The degree of sclerotic dentin from the NCCLs was measured according to the criteria&#xD;
      described by Swift and others. The cavity dimensions in millimeters (height, width, and&#xD;
      depth), the geometry of the cavity (evaluated by profile photograph and labeled at &lt;45o,&#xD;
      45o-90o, 90o&lt;135o, and &gt;135o), the presence of an antagonist, and the presence of attrition&#xD;
      facets were observed and recorded. Pre-operative sensitivity was also evaluated by applying&#xD;
      air for 10 s from a dental syringe placed 2 cm from the tooth surface and with an explorer.&#xD;
      These features were recorded to allow comparison of the baseline features of the dentin&#xD;
      cavities among experimental groups.&#xD;
&#xD;
      To calibrate the restorative procedure, the study director placed one restoration of each&#xD;
      group to identify all steps involved in the application technique. Then, the two operators,&#xD;
      who were resident dentists with more than five years of clinical experience in operative&#xD;
      dentistry, placed four restorations, one of each group, under the supervision of the study&#xD;
      director in a clinical setting. The restoration failures were shown to the operators prior to&#xD;
      starting the study. At this point, the operators were considered calibrated to perform the&#xD;
      restorative procedures.&#xD;
&#xD;
      The operators restored all teeth. All participants received four restorations, one of each&#xD;
      experimental group in different lesions previously selected according to the inclusion&#xD;
      criteria.&#xD;
&#xD;
      Before restorative procedures, the operators anesthetized the teeth with a 3% mepivacaine&#xD;
      solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned all lesions with pumice&#xD;
      and water in a rubber cup, followed by rinsing and drying. Then, shade selection was made&#xD;
      using a shade guide.&#xD;
&#xD;
      Cleaning of all lesions with pumice and water in a rubber cup was carried out, followed by&#xD;
      rinsing and drying. Using a shade-selection guide, the proper shade of the composite was&#xD;
      determined. Following the ADA guidelines, the operators did not prepare any additional&#xD;
      retention or bevel.&#xD;
&#xD;
      The NCCLs received the multimode adhesive system applied in different modes: 1-step self-etch&#xD;
      approach (SE), selective enamel etching (SEE), 1-step self-etch applied for double time in&#xD;
      the enamel (SE2X), 1-step self-etch approach with additional layer (SE1+) was applied as&#xD;
      described below. The compositions, more details regarding the adhesion strategies used and&#xD;
      batch numbers are described in Table 2.&#xD;
&#xD;
      The adhesives were light-cured with a LED light-curing unit (1,000 mW/cm2) (Radii-cal),&#xD;
      according to the manufacturer's instructions (Table 2). Opallis (FGM) composite resin was&#xD;
      used in 2 to 3 increments, each one being light-cured (Radii-cal) for 30 s. The restorations&#xD;
      were finished immediately with fine #2200 diamond burs (KG Sorensen). Polishing was performed&#xD;
      with rubber points (Astropol, Ivoclar Vivadent, Liechtenstein).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2016</start_date>
  <completion_date type="Actual">August 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>This was a double-blind, equivalence superiority, split-mouth randomized clinical trial. The restoration procedures were carried out within the clinics of the Dental School of the Federal University of Rio de Janeiro in Rio de Janeiro (Rio de Janeiro, Brazil) and at the State University Oeste do Paraná in Cascavel (Paraná, Brazil) from July 2016 to August 2017.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>staff member not involved in the research protocol performed the randomization process with computer-generated tables. Details of the allocated groups were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. Opening the envelope only on the day of the restorative procedure guaranteed the concealment of the random sequence. The examiners were not involved with the restoration procedures and therefore blinded to the group assignment, performed the clinical evaluation. Patient were also blinded to group assignment in a double-blind randomized clinical trial design.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>6 montths</time_frame>
    <description>The primary clinical endpoint was restoration retention/fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal Adaptation</measure>
    <time_frame>6 months</time_frame>
    <description>Restoration marginal adaptation.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Clinical Trial</condition>
  <arm_group>
    <arm_group_label>1-step self-etch approach (SE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to the manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>selective enamel etching (SEE)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>According to the manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1-step self-etch for double time (SE2X)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the manufacturer's instructions, but for the double time (20 s) in the each application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1-step self-etch additional layer (SE1+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>According to the manufacturer's instructions, but apply tree times.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>1-step self-etch approach (SE)</intervention_name>
    <description>Application mode - Do not use etchan. According to the manufacturer's instructions.</description>
    <arm_group_label>1-step self-etch approach (SE)</arm_group_label>
    <other_name>SE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>selective enamel etching (SEE)</intervention_name>
    <description>Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.</description>
    <arm_group_label>selective enamel etching (SEE)</arm_group_label>
    <other_name>SEE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1-step self-etch for double time (SE2X)</intervention_name>
    <description>Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.</description>
    <arm_group_label>1-step self-etch for double time (SE2X)</arm_group_label>
    <other_name>SE2X</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>1-step self-etch additional layer (SE1+)</intervention_name>
    <description>Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.</description>
    <arm_group_label>1-step self-etch additional layer (SE1+)</arm_group_label>
    <other_name>SE1+</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants had to be in good general health.&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Have an acceptable oral hygiene level&#xD;
&#xD;
          -  Present at least 20 teeth under occlusion&#xD;
&#xD;
          -  At least four NCCLs in four different teeth&#xD;
&#xD;
          -  These lesions had to be non-carious, non-retentive, deeper than 1 mm, and involve both&#xD;
             the enamel and dentin of vital teeth without mobility.&#xD;
&#xD;
          -  The cavo-surface margin could not involve more than 50% of enamel, and all lesions had&#xD;
             cervical margins ending in dentin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants had not be in good general health.&#xD;
&#xD;
          -  At less 18 years old&#xD;
&#xD;
          -  Have not an acceptable oral hygiene level&#xD;
&#xD;
          -  Present at less 20 teeth under occlusion&#xD;
&#xD;
          -  At less four NCCLs in four different teeth, these lesions had not be non-carious,&#xD;
             retentive and involve only enamel of vital teeth with mobility.&#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>Rafael Scheffer, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Estadual do Oeste do Paraná</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Estadual do Oeste do Paraná</name>
      <address>
        <city>Cascavel</city>
        <state>Paraná</state>
        <zip>85819-110</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>August 27, 2017</last_update_submitted>
  <last_update_submitted_qc>August 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual do Oeste do Paraná</investigator_affiliation>
    <investigator_full_name>Eloisa Andrade de Paula</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>Non-carious cervical lesions; Universal system; Longevity.</keyword>
  <!-- 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/NCT03254693
org study id: 56013116.0.0000.0107
nct id: NCT03254693
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: This double-blind randomized clinical trial evaluates strategies for improving the
      bonding of universal adhesive to enamel in non-carious cervical lesions (NCCL) of a new
      universal multi-mode adhesive (Ambar Universal; FGM).

      Methods: A total of 134 restorations were randomly placed in 19 patients according to the
      following groups: SE - Self-etch; SEE - Selective etching; SE2X - Self-etch doble time; SE1+
      - Self-etch additional layer. The resin composite Opallis (FGM) was placed incrementally. The
      restorations were evaluated after one week (baseline), 6 and 12 months, using the FDI and
      USPHS criteria. Statistical analyses were performed using appropriate tests (=0.05).
Interventions: restorative procedure All the patients selected for this study received dental
      prophylaxis with a suspension of pumice and water in a rubber cup and signed an informed
      consent form two weeks before the restorative procedures.

      The degree of sclerotic dentin from the NCCLs was measured according to the criteria
      described by Swift and others. The cavity dimensions in millimeters (height, width, and
      depth), the geometry of the cavity (evaluated by profile photograph and labeled at <45o,
      45o-90o, 90o<135o, and >135o), the presence of an antagonist, and the presence of attrition
      facets were observed and recorded. Pre-operative sensitivity was also evaluated by applying
      air for 10 s from a dental syringe placed 2 cm from the tooth surface and with an explorer.
      These features were recorded to allow comparison of the baseline features of the dentin
      cavities among experimental groups.

      To calibrate the restorative procedure, the study director placed one restoration of each
      group to identify all steps involved in the application technique. Then, the two operators,
      who were resident dentists with more than five years of clinical experience in operative
      dentistry, placed four restorations, one of each group, under the supervision of the study
      director in a clinical setting. The restoration failures were shown to the operators prior to
      starting the study. At this point, the operators were considered calibrated to perform the
      restorative procedures.

      The operators restored all teeth. All participants received four restorations, one of each
      experimental group in different lesions previously selected according to the inclusion
      criteria.

      Before restorative procedures, the operators anesthetized the teeth with a 3% mepivacaine
      solution (Mepisv, Nova DFL, Rio de Janeiro, RJ, Brazil) and cleaned all lesions with pumice
      and water in a rubber cup, followed by rinsing and drying. Then, shade selection was made
      using a shade guide.

      Cleaning of all lesions with pumice and water in a rubber cup was carried out, followed by
      rinsing and drying. Using a shade-selection guide, the proper shade of the composite was
      determined. Following the ADA guidelines, the operators did not prepare any additional
      retention or bevel.

      The NCCLs received the multimode adhesive system applied in different modes: 1-step self-etch
      approach (SE), selective enamel etching (SEE), 1-step self-etch applied for double time in
      the enamel (SE2X), 1-step self-etch approach with additional layer (SE1+) was applied as
      described below. The compositions, more details regarding the adhesion strategies used and
      batch numbers are described in Table 2.

      The adhesives were light-cured with a LED light-curing unit (1,000 mW/cm2) (Radii-cal),
      according to the manufacturer's instructions (Table 2). Opallis (FGM) composite resin was
      used in 2 to 3 increments, each one being light-cured (Radii-cal) for 30 s. The restorations
      were finished immediately with fine #2200 diamond burs (KG Sorensen). Polishing was performed
      with rubber points (Astropol, Ivoclar Vivadent, Liechtenstein).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This was a double-blind, equivalence superiority, split-mouth randomized clinical trial. The restoration procedures were carried out within the clinics of the Dental School of the Federal University of Rio de Janeiro in Rio de Janeiro (Rio de Janeiro, Brazil) and at the State University Oeste do Paraná in Cascavel (Paraná, Brazil) from July 2016 to August 2017.
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: staff member not involved in the research protocol performed the randomization process with computer-generated tables. Details of the allocated groups were recorded on cards contained in sequentially numbered, opaque, sealed envelopes. Opening the envelope only on the day of the restorative procedure guaranteed the concealment of the random sequence. The examiners were not involved with the restoration procedures and therefore blinded to the group assignment, performed the clinical evaluation. Patient were also blinded to group assignment in a double-blind randomized clinical trial design.
measure: Retention
time frame: 6 montths
description: The primary clinical endpoint was restoration retention/fracture.
measure: Marginal Adaptation
time frame: 6 months
description: Restoration marginal adaptation.
arm group label: 1-step self-etch approach (SE)
arm group type: Active Comparator
description: According to the manufacturer's instructions.
arm group label: selective enamel etching (SEE)
arm group type: Active Comparator
description: According to the manufacturer's instructions.
arm group label: 1-step self-etch for double time (SE2X)
arm group type: Experimental
description: According to the manufacturer's instructions, but for the double time (20 s) in the each application.
arm group label: 1-step self-etch additional layer (SE1+)
arm group type: Experimental
description: According to the manufacturer's instructions, but apply tree times.
intervention type: Combination Product
intervention name: 1-step self-etch approach (SE)
description: Application mode - Do not use etchan. According to the manufacturer's instructions.
arm group label: 1-step self-etch approach (SE)
other name: SE
intervention type: Combination Product
intervention name: selective enamel etching (SEE)
description: Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.
arm group label: selective enamel etching (SEE)
other name: SEE
intervention type: Other
intervention name: 1-step self-etch for double time (SE2X)
description: Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.
arm group label: 1-step self-etch for double time (SE2X)
other name: SE2X
intervention type: Other
intervention name: 1-step self-etch additional layer (SE1+)
description: Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.
arm group label: 1-step self-etch additional layer (SE1+)
other name: SE1+
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rafael Scheffer, Master
role: Study Chair
affiliation: Universidade Estadual do Oeste do Paraná
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual do Oeste do Paraná
investigator full name: Eloisa Andrade de Paula
investigator title: Doctor