<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/NCT01726179</url>
  </required_header>
  <id_info>
    <org_study_id>ECIPRJ13</org_study_id>
    <nct_id>NCT01726179</nct_id>
  </id_info>
  <brief_title>Efficacy of Proximal Caries Infiltration</brief_title>
  <official_title>Efficacy of Resin Infiltration of Proximal Caries Lesions in Primary Molars: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DMG Dental Material Gesellschaft mbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rio de Janeiro State Research Supporting Foundation (FAPERJ)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>DMG Dental Material Gesellschaft mbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the project is to investigate the clinical efficacy of management of early caries&#xD;
      lesions by resin infiltration and to further scrutinize the patient stress experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to test the clinical efficacy of caries infiltration to arrest&#xD;
      proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test&#xD;
      lesions) will progress significantly less than non infiltrated lesions (control lesions).&#xD;
      Additionally, it was hypothesized that dental anxiety and stress related to caries&#xD;
      infiltration will be significantly less than dental anxiety related to a conventional&#xD;
      restorative procedure. The study will be a controlled clinical trial with a split mouth&#xD;
      design and blind evaluation of the outcome (caries progression). Caries progression will be&#xD;
      evaluated annually, 12, 24, and 36 months after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caries progression rate</measure>
    <time_frame>1 year</time_frame>
    <description>Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress reaction during treatment</measure>
    <time_frame>Immediate</time_frame>
    <description>To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.&#xD;
A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caries risk</measure>
    <time_frame>Baseline, 6 months, 1 year, 2 years, 3 years</time_frame>
    <description>Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caries progression rate</measure>
    <time_frame>2 years, 3 years</time_frame>
    <description>Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Dental Health</condition>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>Resin infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm &quot;Control&quot;. Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.&#xD;
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm &quot;Resin infiltration&quot;. Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.&#xD;
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resin infiltration</intervention_name>
    <description>Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.</description>
    <arm_group_label>Resin infiltration</arm_group_label>
    <other_name>Icon (DMG, Germany), Approximal resin infiltration kit</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children with one tooth surface with active caries lesions&#xD;
&#xD;
          -  two primary molars with proximal lesion detected on the x-ray (scores 2 (E2) or 3 (D1)&#xD;
             in Mejàre et al. scoring system with less depth&#xD;
&#xD;
          -  asigned informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children who do not cooperate during dental appointments&#xD;
&#xD;
          -  primary molars supposed to exfoliate in less than two years&#xD;
&#xD;
          -  lesions showing obvious cavitation or clear sings of inactivity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vera M Soviero, Prof., Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia.</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20551-031</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.</citation>
    <PMID>28990122</PMID>
  </results_reference>
  <results_reference>
    <citation>Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.</citation>
    <PMID>31465818</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caries infiltration</keyword>
  <keyword>caries arrest</keyword>
  <keyword>dental anxiety</keyword>
  <keyword>dental stress</keyword>
  <keyword>resin infiltration</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/NCT01726179
org study id: ECIPRJ13
nct id: NCT01726179
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The goal of the project is to investigate the clinical efficacy of management of early caries
      lesions by resin infiltration and to further scrutinize the patient stress experiences.
The aim of this study is to test the clinical efficacy of caries infiltration to arrest
      proximal caries lesions in primary molars. It was hypothesized that infiltrated lesions (test
      lesions) will progress significantly less than non infiltrated lesions (control lesions).
      Additionally, it was hypothesized that dental anxiety and stress related to caries
      infiltration will be significantly less than dental anxiety related to a conventional
      restorative procedure. The study will be a controlled clinical trial with a split mouth
      design and blind evaluation of the outcome (caries progression). Caries progression will be
      evaluated annually, 12, 24, and 36 months after treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Caries progression rate
time frame: 1 year
description: Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
measure: Stress reaction during treatment
time frame: Immediate
description: To evaluate dental anxiety and stress reactions in relation to the caries infiltration procedure in comparison with a dental examination appointment and conventional resin restoration appointment.
A facial image scale with five faces ranging from very happy (1) to very unhappy (5) will be used.
measure: Caries risk
time frame: Baseline, 6 months, 1 year, 2 years, 3 years
description: Caries risk is asses based on caries index (Nyvad criteria), proximal plaque index (0 = no visible plaque; 1 = visible plaque) and gingival bleeding index (0 = no bleeding after flossing; 1 = bleeding after flossing), dietary habits, and exposition to fluorides based on the Cariogram model.
measure: Caries progression rate
time frame: 2 years, 3 years
description: Radiographic evaluation of infiltrated and control caries lesions to evaluate caries progression in long term. This is done by pairwise comparison of digital bitewing radiographs by one calibrated, blinded examiner.
arm group label: Resin infiltration
arm group type: Experimental
description: This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Control". Teeth in this arm are treated by the resin infiltration technique using Icon (DMG, Germany) according to manufactures´ instructions. In addition patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
arm group label: Control
arm group type: Other
description: This study is a split mouth design. One tooth with a proximal caries lesion is randomized into this arm and another tooth to the arm "Resin infiltration". Teeth randomized into this arm do not recieve any special treatment except general oral nonivasiv treatment (flossing and brushing). Patients and their guardians are instructed to floss once a day and to brush with fluoridated toothpaste twice a day.
Digital bitewing radiographs will be taken at baseline and repeated after 12 months. Additionally caries risk will be evaluated.
intervention type: Device
intervention name: Resin infiltration
description: Proximal caries lesions that are selected for this intervention will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, local anesthesia of the gingival papila, application of rubber dam, etching of the lesion surface for 120 s using 15%HCl gel, washing the lesion with water spray for 30 s, drying the lesion with 100% ethanol for 30 s and subsequent air blowing, application of the infiltrant for 180 s using an applicator provided with the kit, removing excess material from the lesion surface by air blowing and flossing, light curing of the infiltrant for 40 s, repeated application for 60 s, light curing for 40 s, polishing, and removal of the rubber dam.
arm group label: Resin infiltration
other name: Icon (DMG, Germany), Approximal resin infiltration kit
intervention type: Device
intervention name: Control
description: Proximal caries lesions do not recieve a placebo treatment, but simply left untreated.
arm group label: Control
criteria: 
gender: All
minimum age: 5 Years
maximum age: 9 Years
healthy volunteers: No
last name: Vera M Soviero, Prof., Dr.
role: Principal Investigator
affiliation: Universidade do Estado do Rio de Janeiro, Faculdade de Odontologia
facility: 
country: Brazil
citation: Ammari MM, Jorge RC, Souza IPR, Soviero VM. Efficacy of resin infiltration of proximal caries in primary molars: 1-year follow-up of a split-mouth randomized controlled clinical trial. Clin Oral Investig. 2018 Apr;22(3):1355-1362. doi: 10.1007/s00784-017-2227-7. Epub 2017 Oct 8.
PMID: 28990122
citation: Jorge RC, Ammari MM, Soviero VM, Souza IPR. Randomized controlled clinical trial of resin infiltration in primary molars: 2 years follow-up. J Dent. 2019 Nov;90:103184. doi: 10.1016/j.jdent.2019.103184. Epub 2019 Aug 26.
PMID: 31465818
responsible party type: Sponsor