<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/NCT03254706</url>
  </required_header>
  <id_info>
    <org_study_id>57317816.6.0000.5084</org_study_id>
    <nct_id>NCT03254706</nct_id>
  </id_info>
  <brief_title>Effect of Increased Improve Time on Adhesive System</brief_title>
  <acronym>RCT</acronym>
  <official_title>Effect of Increased Improve Time on Adhesive System: A RANDOMIZED CLINICAL TRIAL</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 the influence of increased&#xD;
      application time of a new etch-and-rinse two-step adhesive Single Link; (Angelus Dental&#xD;
      Products Industry) applied in non-carious cervical lesions (NCCLs).&#xD;
&#xD;
      Methods: A total of 221 restorations were randomly placed in 35 patients assigned in four&#xD;
      groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P) (Ultradent&#xD;
      Products Ind) and Single Link (SL) (Angelus Dental Products Industry). The adhesives systems&#xD;
      were applied on the NCCLs follows: P1 - applied according to the manufacturer's; P2X -&#xD;
      applied for the double time; SL1 and; SL2X. The resin composite Amelogen (Ultradent) was&#xD;
      placed incrementally. The restorations were evaluated imediataly (baseline), 6 and 12 months,&#xD;
      using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests&#xD;
      (=0.05).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods:&#xD;
&#xD;
      Recruitment Patients were recruited as they seek for treatment in the clinics of Dentistry of&#xD;
      the local university. No advertisement was made for participant recruitment. Patients were&#xD;
      recruited in the order in which they reported for the screening session, thus forming a&#xD;
      sample of convenience.&#xD;
&#xD;
      Eligibility criteria A total of 183 participants were examined by two calibrated dental&#xD;
      students to check if they met the inclusion and exclusion criteria.&#xD;
&#xD;
      Sample size calculation The annual retention rate to one-step self-etch adhesives in NCCLs&#xD;
      was reported to be 4.4% in a recent systematic review. Considering that this decline follow a&#xD;
      linear trend, the overall retention rate of one-step self-etch adhesives will be&#xD;
      approximately 78% after 5-year of clinical service. With an of 0.05, a power of 80%, and a&#xD;
      two-sided test, the minimal sample size will be 41 restorations in each group in order to&#xD;
      detect a difference of equivalence of 15% among the test groups.&#xD;
&#xD;
      Interventions A total of 221 restorations were randomly placed in 35 patients assigned in&#xD;
      four groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P)&#xD;
      (Ultradent Products Ind) and Single Link (SL) (Angelus Dental Products Industry).&#xD;
&#xD;
      The adhesives systems were applied on the NCCLs follows: P1 - applied according to the&#xD;
      manufacturer's; P2X - applied for the double time; SL1 and; SL2X. The resin composite&#xD;
      Amelogen (Ultradent) was placed incrementally. The restorations were evaluated imediataly&#xD;
      (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were&#xD;
      performed using appropriate tests (=0.05).&#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>N/A</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, superiority, split-mouth randomized clinical trial. The study was carried out in the clinics of the School of Dentistry at the local University from August 2015 to August 2017.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>A 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/fracture</measure>
    <time_frame>6 months</time_frame>
    <description>The primary clinical endpoint was restoration retention/fracture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal staining</measure>
    <time_frame>6 months</time_frame>
    <description>restoration Marginal staining</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>marginal adaptation</measure>
    <time_frame>6 months</time_frame>
    <description>restoration marginal adaptation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postoperative sensitivity</measure>
    <time_frame>6 months</time_frame>
    <description>restoration postoperative sensitivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrence of caries.</measure>
    <time_frame>6 months</time_frame>
    <description>restauration recurrence of caries</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Clinical Trial</condition>
  <arm_group>
    <arm_group_label>Peak etch-and-rinse (P1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application Mode - According to the manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peak applied for double time(P2X)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application Mode - According to the manufacturer's instructions, but for the double time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Link etch-and-rinse (SL1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Application Mode - According to the manufacturer's instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single Link double time (SL2X)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Application Mode - According to the manufacturer's instructions, but for the double time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peak etch-and-rinse (P1)</intervention_name>
    <description>Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.</description>
    <arm_group_label>Peak etch-and-rinse (P1)</arm_group_label>
    <other_name>P1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Peak applied for double time(P2X)</intervention_name>
    <description>Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.</description>
    <arm_group_label>Peak applied for double time(P2X)</arm_group_label>
    <other_name>P2X</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single Link etch-and-rinse (SL1)</intervention_name>
    <description>Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.</description>
    <arm_group_label>Single Link etch-and-rinse (SL1)</arm_group_label>
    <other_name>SL1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single Link double time (SL2X)</intervention_name>
    <description>Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.</description>
    <arm_group_label>Single Link double time (SL2X)</arm_group_label>
    <other_name>SL2X</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants had to be in good general health, at least 18 years old, have an acceptable&#xD;
        oral hygiene level, and present at least 20 teeth under occlusion, at least four NCCLs in&#xD;
        four different teeth, these lesions had to be non-carious, non-retentive, deeper than 1 mm,&#xD;
        and involve both the enamel and dentin of vital teeth without mobility. The cavo-surface&#xD;
        margin could not involve more than 50% of enamel, and all lesions had cervical margins&#xD;
        ending in dentin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants had not be in good general health, at less 18 years old, have not an&#xD;
        acceptable oral hygiene level, and present at less 20 teeth under occlusion, at less four&#xD;
        NCCLs in four different teeth, these lesions had not be non-carious, retentive and involve&#xD;
        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>Márcio Camargo, 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>PR</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>Dentin adhesive; Non-carious cervical lesions; 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/NCT03254706
org study id: 57317816.6.0000.5084
nct id: NCT03254706
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Objective: This double-blind randomized clinical trial evaluates the influence of increased
      application time of a new etch-and-rinse two-step adhesive Single Link; (Angelus Dental
      Products Industry) applied in non-carious cervical lesions (NCCLs).

      Methods: A total of 221 restorations were randomly placed in 35 patients assigned in four
      groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P) (Ultradent
      Products Ind) and Single Link (SL) (Angelus Dental Products Industry). The adhesives systems
      were applied on the NCCLs follows: P1 - applied according to the manufacturer's; P2X -
      applied for the double time; SL1 and; SL2X. The resin composite Amelogen (Ultradent) was
      placed incrementally. The restorations were evaluated imediataly (baseline), 6 and 12 months,
      using the FDI and USPHS criteria. Statistical analyses were performed using appropriate tests
      (=0.05).
Methods:

      Recruitment Patients were recruited as they seek for treatment in the clinics of Dentistry of
      the local university. No advertisement was made for participant recruitment. Patients were
      recruited in the order in which they reported for the screening session, thus forming a
      sample of convenience.

      Eligibility criteria A total of 183 participants were examined by two calibrated dental
      students to check if they met the inclusion and exclusion criteria.

      Sample size calculation The annual retention rate to one-step self-etch adhesives in NCCLs
      was reported to be 4.4% in a recent systematic review. Considering that this decline follow a
      linear trend, the overall retention rate of one-step self-etch adhesives will be
      approximately 78% after 5-year of clinical service. With an of 0.05, a power of 80%, and a
      two-sided test, the minimal sample size will be 41 restorations in each group in order to
      detect a difference of equivalence of 15% among the test groups.

      Interventions A total of 221 restorations were randomly placed in 35 patients assigned in
      four groups to two different etch-and-rinse two-step adhesive Peak® Universal Bond (P)
      (Ultradent Products Ind) and Single Link (SL) (Angelus Dental Products Industry).

      The adhesives systems were applied on the NCCLs follows: P1 - applied according to the
      manufacturer's; P2X - applied for the double time; SL1 and; SL2X. The resin composite
      Amelogen (Ultradent) was placed incrementally. The restorations were evaluated imediataly
      (baseline), 6 and 12 months, using the FDI and USPHS criteria. Statistical analyses were
      performed using appropriate tests (=0.05).
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: This was a double-blind, superiority, split-mouth randomized clinical trial. The study was carried out in the clinics of the School of Dentistry at the local University from August 2015 to August 2017.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: A 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/fracture
time frame: 6 months
description: The primary clinical endpoint was restoration retention/fracture
measure: Marginal staining
time frame: 6 months
description: restoration Marginal staining
measure: marginal adaptation
time frame: 6 months
description: restoration marginal adaptation
measure: postoperative sensitivity
time frame: 6 months
description: restoration postoperative sensitivity
measure: recurrence of caries.
time frame: 6 months
description: restauration recurrence of caries
arm group label: Peak etch-and-rinse (P1)
arm group type: Active Comparator
description: Application Mode - According to the manufacturer's instructions.
arm group label: Peak applied for double time(P2X)
arm group type: Experimental
description: Application Mode - According to the manufacturer's instructions, but for the double time.
arm group label: Single Link etch-and-rinse (SL1)
arm group type: Active Comparator
description: Application Mode - According to the manufacturer's instructions.
arm group label: Single Link double time (SL2X)
arm group type: Experimental
description: Application Mode - According to the manufacturer's instructions, but for the double time.
intervention type: Other
intervention name: Peak etch-and-rinse (P1)
description: Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.
arm group label: Peak etch-and-rinse (P1)
other name: P1
intervention type: Other
intervention name: Peak applied for double time(P2X)
description: Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.
arm group label: Peak applied for double time(P2X)
other name: P2X
intervention type: Other
intervention name: Single Link etch-and-rinse (SL1)
description: Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.
arm group label: Single Link etch-and-rinse (SL1)
other name: SL1
intervention type: Other
intervention name: Single Link double time (SL2X)
description: Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.
arm group label: Single Link double time (SL2X)
other name: SL2X
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Márcio Camargo, 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