<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/NCT02969538</url>
  </required_header>
  <id_info>
    <org_study_id>UFSantaMaria1</org_study_id>
    <nct_id>NCT02969538</nct_id>
  </id_info>
  <brief_title>Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth</brief_title>
  <official_title>Effect of Shortening the Etching Time on the Clinical Performance of Resin Composite Restorations in Primary Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Santa Maria</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Santa Maria</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effect of shortening the etching time on the&#xD;
      18-month clinical performance of resin composite restorations in primary molars after partial&#xD;
      carious removal. This randomized clinical trial will include subjects (5-10 year-old&#xD;
      children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will&#xD;
      consist of 70 primary molars presenting active cavitated carious lesions (with radiographic&#xD;
      involvement of the outer half of the dentin), located on the occlusal surface. The sample&#xD;
      will be randomly divided into two groups according to the etching time of the dentin prior&#xD;
      adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds)&#xD;
      and half-reduced etching time (7 seconds). The restorations will be clinically followed every&#xD;
      6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival&#xD;
      estimates for restoration longevity will be evaluated using the Kaplan-Meier method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate the effect of shortening the etching time on the&#xD;
      18-month clinical performance of resin composite restorations in primary molars after partial&#xD;
      carious removal. This randomized clinical trial will include subjects (5-10 year-old&#xD;
      children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will&#xD;
      consist of 70 primary molars presenting active cavitated carious lesions (with radiographic&#xD;
      involvement of the outer half of the dentin), located on the occlusal surface. The sample&#xD;
      will be randomly divided into two groups according to the etching time of the dentin prior&#xD;
      adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s&#xD;
      - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be&#xD;
      clinically followed every 6 months for up to 18-month using the FDI criteria for clinical&#xD;
      evaluation. Survival estimates for restoration longevity will be evaluated using the&#xD;
      Kaplan-Meier method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">November 2017</completion_date>
  <primary_completion_date type="Anticipated">May 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Failure of restorations</measure>
    <time_frame>18 months after restorations' placement</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Total etching time</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Half-reduced etching time</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dentin etching (35% phosphoric acid) by 7 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Total etching time</intervention_name>
    <description>Apply 35% phosphoric acid on dentin and enamel by 15 seconds.</description>
    <arm_group_label>Total etching time</arm_group_label>
    <other_name>(dental conditioner - 35% phosphoric acid)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Half-reduced etching time</intervention_name>
    <description>Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.</description>
    <arm_group_label>Half-reduced etching time</arm_group_label>
    <other_name>(dental conditioner - 35% phosphoric acid)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        *Active carious lesion in middle dentin limited to the occlusal surfaces of primary molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who refuse or fail to cooperate with the completion of clinical procedure;&#xD;
&#xD;
          -  Teeth without antagonist;&#xD;
&#xD;
          -  Carious lesions in inner half of dentin;&#xD;
&#xD;
          -  Presence of painful symptoms or signs of pulpal changes.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rachel Rocha, PhD</last_name>
    <phone>*55 5532209266</phone>
    <email>rachelrocha@smail.ufsm.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federal University of Santa Maria</name>
      <address>
        <city>Santa Maria</city>
        <state>Rio Grande do Sul</state>
        <zip>97015372</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Tathiane Lenzi, PhD</last_name>
      <phone>+55 55 3220 9266</phone>
      <email>tathilenzi@usp.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>April 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 16, 2016</last_update_submitted>
  <last_update_submitted_qc>November 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Santa Maria</investigator_affiliation>
    <investigator_full_name>Tathiane Lenzi</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <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/NCT02969538
org study id: UFSantaMaria1
nct id: NCT02969538
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the effect of shortening the etching time on the
      18-month clinical performance of resin composite restorations in primary molars after partial
      carious removal. This randomized clinical trial will include subjects (5-10 year-old
      children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will
      consist of 70 primary molars presenting active cavitated carious lesions (with radiographic
      involvement of the outer half of the dentin), located on the occlusal surface. The sample
      will be randomly divided into two groups according to the etching time of the dentin prior
      adhesive application (Adper Single Bond 2; 3M ESPE): recommend by manufacturers (15 seconds)
      and half-reduced etching time (7 seconds). The restorations will be clinically followed every
      6 months for up to 18-month using the FDI criteria for clinical evaluation. Survival
      estimates for restoration longevity will be evaluated using the Kaplan-Meier method.
The aim of this study is to evaluate the effect of shortening the etching time on the
      18-month clinical performance of resin composite restorations in primary molars after partial
      carious removal. This randomized clinical trial will include subjects (5-10 year-old
      children) selected at Pediatric Clinic of Federal University of Santa Maria. The sample will
      consist of 70 primary molars presenting active cavitated carious lesions (with radiographic
      involvement of the outer half of the dentin), located on the occlusal surface. The sample
      will be randomly divided into two groups according to the etching time of the dentin prior
      adhesive application (Adper Single Bond 2; 3M ESPE): applying of 35% phosphoric acid by 15 s
      - recommend by manufacturers and half-reduced etching time (7 s). The restorations will be
      clinically followed every 6 months for up to 18-month using the FDI criteria for clinical
      evaluation. Survival estimates for restoration longevity will be evaluated using the
      Kaplan-Meier method.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Failure of restorations
time frame: 18 months after restorations' placement
arm group label: Total etching time
arm group type: Other
description: Dentin etching (35% phosphoric acid) by time recommend by manufacturer (15 seconds)
arm group label: Half-reduced etching time
arm group type: Experimental
description: Dentin etching (35% phosphoric acid) by 7 seconds
intervention type: Other
intervention name: Total etching time
description: Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
arm group label: Total etching time
other name: (dental conditioner - 35% phosphoric acid)
intervention type: Other
intervention name: Half-reduced etching time
description: Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.
arm group label: Half-reduced etching time
other name: (dental conditioner - 35% phosphoric acid)
criteria: 
gender: All
minimum age: 5 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rachel Rocha, PhD
phone: *55 5532209266
email: rachelrocha@smail.ufsm.br
facility: 
contact: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Santa Maria
investigator full name: Tathiane Lenzi
investigator title: Principal investigator
mesh term: Dental Caries
sharing ipd: Undecided