<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/NCT01733888</url>
  </required_header>
  <id_info>
    <org_study_id>FLUORIC</org_study_id>
    <nct_id>NCT01733888</nct_id>
  </id_info>
  <brief_title>Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Fluorosis Stains</brief_title>
  <official_title>Evaluating the Effect of Resin Infiltration and Resin Infiltration With Bleaching in Improving the Esthetics for Non Pitted Fluorosis Stains in Indian Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DMG Dental Material Gesellschaft mbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DMG Dental Material Gesellschaft mbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride&#xD;
      during the tooth development.&#xD;
&#xD;
      The present study is planned to evaluate the efficacy of Resin Infiltration technique in&#xD;
      improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin&#xD;
      infiltration is a novel method that has shown its efficacy in improving the esthetics of&#xD;
      various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ&#xD;
      and in-vivo studies. The Resin Infiltration technique is also known to stop the progression&#xD;
      of caries in non cavitated lesions in both, smooth surface and interproximal lesions.&#xD;
&#xD;
      Therefore, the following trial will be conducted to assess the esthetic improvement of&#xD;
      fluorosed permanent anterior teeth after resin infiltration and compare it with standard&#xD;
      bleaching procedure and a combination of bleaching and Resin infiltration therapy in children&#xD;
      with fluorosed teeth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Esthetic Changes</measure>
    <time_frame>Immediate</time_frame>
    <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement in Brown Stains/ Change in White Opacities</measure>
    <time_frame>Immediate</time_frame>
    <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Caries Infiltration</condition>
  <condition>Fluorosis</condition>
  <condition>Dental Care</condition>
  <arm_group>
    <arm_group_label>Office Bleaching</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin Infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>White spots in fluorosed teeth will be infiltrated using the resin infiltrant &quot;Icon&quot; (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin Infiltration twice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>White spots in fluorosed teeth will be infiltrated using the resin infiltrant Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. Here, the infiltrant &quot;Icon&quot; is applied twice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Office Bleaching + Resin Infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia). After a 20 day wash over period, these teeth will be treated with the resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Office Bleaching</intervention_name>
    <description>Teeth will be cleaned with pumice first, followed by placing cheek retractors and covering of the lip surface with petroleum gel. Thereafter, teeth will be dried and gingival barrier will be applied to both arches - slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds. This is followed by homogeneous mixing of the powder and liquid in a powder pot the application of a thick layer of the resulting gel to all teeth undergoing treatment (35 % Hydrogen Peroxide, Pola Office, SDI, Australia). The gel will be left in place for 8 minutes and subsequently removed using a surgical aspirator tip.</description>
    <arm_group_label>Office Bleaching</arm_group_label>
    <other_name>35 % Hydrogen Peroxide, Pola Office, SDI, Australia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resin Infiltration</intervention_name>
    <description>Fluorosed teeth will be isolated using a rubber dam and the resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. In short, tooth surface will be dried using cotton rolls and air syringe. This is followed by an etching (Icon Etch) and drying step (Icon-Dry) to open the lesion surface. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds and subsequent cleaning of the surface with pumice and rubber polishing cup as well as rinsing with water for 30 sec.</description>
    <arm_group_label>Resin Infiltration</arm_group_label>
    <other_name>Icon, Kit for caries infiltration, DMG, Hamburg, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resin Infiltration twice</intervention_name>
    <description>The intervention will be done similar to the &quot;Resin infiltration&quot; arm, which the exception that the icon infiltration step will be done twice.</description>
    <arm_group_label>Resin Infiltration twice</arm_group_label>
    <other_name>Icon Kit for caries infiltration, DMG, Hamburg, Germany</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bleaching + Resin Infiltration</intervention_name>
    <description>In this arm, the fluorosed teeth of the patients will first be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) as explained in the intervention arm &quot;Office bleaching&quot;; followed by wash over period of 20 days. After these 20 days, patients will be recalled and the fluorosed teeth will treated according to the description in the &quot;Resin infiltrant&quot; intervention arm using the resin infiltrant (Icon, DMG, Hamburg, Germany) as per manufactures' instructions.</description>
    <arm_group_label>Office Bleaching + Resin Infiltration</arm_group_label>
    <other_name>Icon Kit for Caries Infiltration, DMG, Hamburg, Germany</other_name>
    <other_name>35 % Hydrogen Peroxide, Pola Office, SDI, Australia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only the non-pitted Fluorosis opacities shall be included for this purpose; opacities&#xD;
             in anterior teeth shall be classified according to Russell's criteria for&#xD;
             differentiating fluoride and non- fluoride opacities&#xD;
&#xD;
          -  Subjects classified /Teeth classified with dental fluorosis of 1-4 according to&#xD;
             Thylstrup, Fejerskov classification of dental fluorosis 20&#xD;
&#xD;
          -  Patients who will be willing to participate in the study and who will be accepting for&#xD;
             recall visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy towards any dental material.&#xD;
&#xD;
          -  Teeth classified as non-fluoride opacities&#xD;
&#xD;
          -  Subjects with any systemic and local conditions not permitting the treatment&#xD;
&#xD;
          -  Subjects who had undergone any treatment for dental fluorosis earlier&#xD;
&#xD;
          -  Subjects with direct or indirect restorations in maxillary central or lateral&#xD;
             incisors.&#xD;
&#xD;
          -  Subjects not willing to participate in the study&#xD;
&#xD;
          -  Subjects with fractured teeth maxillary central or lateral incisors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neeraj Gugunani, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Pediatric and Preventive Dentistry DAV Dental College</name>
      <address>
        <city>Yamuna Nagar</city>
        <state>Haryana</state>
        <zip>135001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Pediatric and Preventive Dentistry DRIDS Dental College</name>
      <address>
        <city>Faridkot</city>
        <state>Punjab</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <results_reference>
    <citation>Gugnani N, Pandit IK, Gupta M, Gugnani S, Soni S, Goyal V. Comparative evaluation of esthetic changes in nonpitted fluorosis stains when treated with resin infiltration, in-office bleaching, and combination therapies. J Esthet Restor Dent. 2017 Sep;29(5):317-324. doi: 10.1111/jerd.12312. Epub 2017 Jun 27.</citation>
    <PMID>28654721</PMID>
  </results_reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <results_first_submitted>November 13, 2018</results_first_submitted>
  <results_first_submitted_qc>May 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 25, 2022</results_first_posted>
  <last_update_submitted>May 24, 2022</last_update_submitted>
  <last_update_submitted_qc>May 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caries</keyword>
  <keyword>caries infiltration</keyword>
  <keyword>fluorosis treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorosis, Dental</mesh_term>
    <mesh_term>Fluoride Poisoning</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hydrogen Peroxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>In-office Bleaching</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
        </group>
        <group group_id="P2">
          <title>Resin Infiltration</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
        </group>
        <group group_id="P3">
          <title>Resin Infiltration Twice</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant &quot;Icon&quot; is applied twice.</description>
        </group>
        <group group_id="P4">
          <title>In-office Bleaching + Resin Infiltration</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients with non-pitted fluorosis were selected from a high fluoride belt.</population>
      <group_list>
        <group group_id="B1">
          <title>In-office Bleaching</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
        </group>
        <group group_id="B2">
          <title>Resin Infiltration</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
        </group>
        <group group_id="B3">
          <title>Resin Infiltration Twice</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant &quot;Icon&quot; is applied twice.</description>
        </group>
        <group group_id="B4">
          <title>In-office Bleaching + Resin Infiltration</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="20"/>
            <count group_id="B4" value="20"/>
            <count group_id="B5" value="80"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.3" spread="0.5"/>
                    <measurement group_id="B2" value="11.1" spread="0.9"/>
                    <measurement group_id="B3" value="11.6" spread="0.5"/>
                    <measurement group_id="B4" value="11.1" spread="0.8"/>
                    <measurement group_id="B5" value="11.3" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hindu</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sikh</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>India</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Esthetic Changes</title>
        <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
        <time_frame>Immediate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-office Bleaching</title>
            <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
          </group>
          <group group_id="O2">
            <title>Resin Infiltration</title>
            <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
          </group>
          <group group_id="O3">
            <title>Resin Infiltration Twice</title>
            <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant &quot;Icon&quot; is applied twice.</description>
          </group>
          <group group_id="O4">
            <title>In-office Bleaching + Resin Infiltration</title>
            <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
          </group>
        </group_list>
        <measure>
          <title>Esthetic Changes</title>
          <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.90" spread="0.95"/>
                    <measurement group_id="O2" value="5.50" spread="1.00"/>
                    <measurement group_id="O3" value="5.53" spread="1.97"/>
                    <measurement group_id="O4" value="5.35" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Improvement in Brown Stains/ Change in White Opacities</title>
        <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
        <time_frame>Immediate</time_frame>
        <group_list>
          <group group_id="O1">
            <title>In-office Bleaching</title>
            <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
          </group>
          <group group_id="O2">
            <title>Resin Infiltration</title>
            <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
          </group>
          <group group_id="O3">
            <title>Resin Infiltration Twice</title>
            <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant &quot;Icon&quot; is applied twice.</description>
          </group>
          <group group_id="O4">
            <title>In-office Bleaching + Resin Infiltration</title>
            <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
          </group>
        </group_list>
        <measure>
          <title>Improvement in Brown Stains/ Change in White Opacities</title>
          <description>Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with &quot;1 = no improvement&quot; and &quot;7 = exceptional improvement&quot;.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.53" spread="1.07"/>
                    <measurement group_id="O2" value="4.98" spread="0.98"/>
                    <measurement group_id="O3" value="5.18" spread="1.29"/>
                    <measurement group_id="O4" value="4.40" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>In-office Bleaching</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.</description>
        </group>
        <group group_id="E2">
          <title>Resin Infiltration</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions.</description>
        </group>
        <group group_id="E3">
          <title>Resin Infiltration Twice</title>
          <description>Resin infiltration of white spots in fluorosed teeth using Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. The infiltrant &quot;Icon&quot; is applied twice.</description>
        </group>
        <group group_id="E4">
          <title>In-office Bleaching + Resin Infiltration</title>
          <description>In-office bleaching of fluorosed teeth with 35 % hydrogen peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction. After a 20 day washout period, the white spots in these teeth will be treated with resin infiltration intervention (Icon, DMG, Hamburg, Germany).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Manager Clinical Research</name_or_title>
      <organization>DMG Dental Material Gesellschaft</organization>
      <phone>+494084006 ext 0</phone>
      <email>clinicalresearch@mtcompanies.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01733888
org study id: FLUORIC
nct id: NCT01733888
lead sponsor: 
has dmc: No
Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride
      during the tooth development.

      The present study is planned to evaluate the efficacy of Resin Infiltration technique in
      improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin
      infiltration is a novel method that has shown its efficacy in improving the esthetics of
      various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ
      and in-vivo studies. The Resin Infiltration technique is also known to stop the progression
      of caries in non cavitated lesions in both, smooth surface and interproximal lesions.

      Therefore, the following trial will be conducted to assess the esthetic improvement of
      fluorosed permanent anterior teeth after resin infiltration and compare it with standard
      bleaching procedure and a combination of bleaching and Resin infiltration therapy in children
      with fluorosed teeth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Esthetic Changes
time frame: Immediate
description: Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
measure: Improvement in Brown Stains/ Change in White Opacities
time frame: Immediate
description: Pre-operative and immediate post-operative digital images are taken. These images are evaluated by two blinded evaluators using a VAS scale ranging from 1 to 7, with "1 = no improvement" and "7 = exceptional improvement".
arm group label: Office Bleaching
arm group type: Active Comparator
description: Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) according to manufactures´ instruction.
arm group label: Resin Infiltration
arm group type: Experimental
description: White spots in fluorosed teeth will be infiltrated using the resin infiltrant "Icon" (DMG, Hamburg, Germany) according to manufactures´ instructions.
arm group label: Resin Infiltration twice
arm group type: Experimental
description: White spots in fluorosed teeth will be infiltrated using the resin infiltrant Icon (DMG, Hamburg, Germany) according to manufactures´ instructions. Here, the infiltrant "Icon" is applied twice.
arm group label: Office Bleaching + Resin Infiltration
arm group type: Experimental
description: Fluorosed teeth will be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia). After a 20 day wash over period, these teeth will be treated with the resin infiltration intervention (Icon, DMG, Hamburg, Germany).
intervention type: Device
intervention name: Office Bleaching
description: Teeth will be cleaned with pumice first, followed by placing cheek retractors and covering of the lip surface with petroleum gel. Thereafter, teeth will be dried and gingival barrier will be applied to both arches - slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds. This is followed by homogeneous mixing of the powder and liquid in a powder pot the application of a thick layer of the resulting gel to all teeth undergoing treatment (35 % Hydrogen Peroxide, Pola Office, SDI, Australia). The gel will be left in place for 8 minutes and subsequently removed using a surgical aspirator tip.
arm group label: Office Bleaching
other name: 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
intervention type: Device
intervention name: Resin Infiltration
description: Fluorosed teeth will be isolated using a rubber dam and the resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. In short, tooth surface will be dried using cotton rolls and air syringe. This is followed by an etching (Icon Etch) and drying step (Icon-Dry) to open the lesion surface. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds and subsequent cleaning of the surface with pumice and rubber polishing cup as well as rinsing with water for 30 sec.
arm group label: Resin Infiltration
other name: Icon, Kit for caries infiltration, DMG, Hamburg, Germany
intervention type: Device
intervention name: Resin Infiltration twice
description: The intervention will be done similar to the "Resin infiltration" arm, which the exception that the icon infiltration step will be done twice.
arm group label: Resin Infiltration twice
other name: Icon Kit for caries infiltration, DMG, Hamburg, Germany
intervention type: Device
intervention name: Bleaching + Resin Infiltration
description: In this arm, the fluorosed teeth of the patients will first be bleached using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia) as explained in the intervention arm "Office bleaching"; followed by wash over period of 20 days. After these 20 days, patients will be recalled and the fluorosed teeth will treated according to the description in the "Resin infiltrant" intervention arm using the resin infiltrant (Icon, DMG, Hamburg, Germany) as per manufactures' instructions.
arm group label: Office Bleaching + Resin Infiltration
other name: Icon Kit for Caries Infiltration, DMG, Hamburg, Germany
other name: 35 % Hydrogen Peroxide, Pola Office, SDI, Australia
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Neeraj Gugunani, Prof. Dr.
role: Principal Investigator
affiliation: Department of Pediatric and Preventive Dentistry DAV Dental College Yamuna Nagar 135001 Haryana India
facility: 
facility: 
country: India
citation: Gugnani N, Pandit IK, Gupta M, Gugnani S, Soni S, Goyal V. Comparative evaluation of esthetic changes in nonpitted fluorosis stains when treated with resin infiltration, in-office bleaching, and combination therapies. J Esthet Restor Dent. 2017 Sep;29(5):317-324. doi: 10.1111/jerd.12312. Epub 2017 Jun 27.
PMID: 28654721
responsible party type: Sponsor
mesh term: Fluorosis, Dental
mesh term: Fluoride Poisoning
mesh term: Hydrogen Peroxide
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 