<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/NCT03788616</url>
  </required_header>
  <id_info>
    <org_study_id>PED18-5M</org_study_id>
    <nct_id>NCT03788616</nct_id>
  </id_info>
  <brief_title>Fluoride Release,Compressive Strength and Clinical Performance of a Bioactive Restorative Material in ART</brief_title>
  <official_title>Evaluation of Fluoride Release and Compressive Strength of a Bioactive Restorative Material and Its Clinical Performance in Atraumatic Restorative Treatment in Primary Molars (An in Vitro Study &amp; A Randomized Controlled Trial )</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marina F Fahmy, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will be two parallel group, triple blinded randomized controlled clinical trial&#xD;
      that based on CONSORT (consolidated standards of reporting trials) guideline .The selected&#xD;
      participants according to inclusion and exclusion criteria will be randomly allocated in two&#xD;
      groups using (Research Randomizer Program) .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blinding All participants don't know the type of received restorative material (ACTIVA Kids&#xD;
      or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner&#xD;
      other than operator who doesn't know the type of received restorative material also.&#xD;
&#xD;
      Study setting The study will be performed at pediatric Department and Dental Public Health&#xD;
      Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate&#xD;
      Studies and Research, Ain Shams University.&#xD;
&#xD;
      Sample size: 60 participants Recruitment/Setting The all participants of this study have been&#xD;
      selected after complete clinical examination has been done with full medical and dental&#xD;
      history , history of medications and history of hospitalization. In patients who receive&#xD;
      dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health&#xD;
      Department at faculty of dentistry, Ain-Shams University.&#xD;
&#xD;
      Informed consent designed to include all data about dental procedures in this study and clear&#xD;
      more details about time consuming in the procedure and follow up visits, used materials and&#xD;
      adverse event of this procedure . All participants have the wright to withdraw from this&#xD;
      study at any time .The consent will be assigned from each patient by the patient's parents or&#xD;
      guardians after explanation of the study.&#xD;
&#xD;
      The full mouth rehabilitation will be performed by postgraduate student registered at the&#xD;
      master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of&#xD;
      Dentistry, Ain- Shams University All subjects receive instructions on oral health,&#xD;
      particularly in relation to oral hygiene and sugar consumption&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2018</start_date>
  <completion_date type="Actual">November 17, 2019</completion_date>
  <primary_completion_date type="Actual">November 17, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth</measure>
    <time_frame>12 Month</time_frame>
    <description>Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fuji IX EXTRA</intervention_name>
    <description>High-viscosity glass ionomer (Fuji IX EXTRA)</description>
    <arm_group_label>Group I</arm_group_label>
    <other_name>Extra fast GIC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ACTIVA KIDS bioactive restorative material</intervention_name>
    <description>Modified composite (ACTIVA KIDS)</description>
    <arm_group_label>Group II</arm_group_label>
    <other_name>ACTIVA , Modified composite</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Children aged from 4 to 8 years old, in good general health&#xD;
&#xD;
          2. Children classified as class 3 or 4 based on Frankel et al. classification. (26)&#xD;
&#xD;
          3. The children have at least one primary molar with class I carious lesion.&#xD;
&#xD;
          4. Asymptomatic teeth (without spontaneous pain)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Medically compromised patient&#xD;
&#xD;
          2. Presence of pulp exposure, pain, mobility&#xD;
&#xD;
          3. Presence of swelling, abscess or fistula near the tooth&#xD;
&#xD;
          4. Not accessible carious lesion to hand instruments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amr Mahmoud Abd EL Aziz</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of Pediatric Dentistry and Dental Public Health Department -ASU</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Reham Khaled Abou El Fadl</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marina Fakhry Fahmy Saad</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <results_first_submitted>November 6, 2021</results_first_submitted>
  <results_first_submitted_qc>December 22, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 19, 2023</results_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Marina F Fahmy, MD</investigator_full_name>
    <investigator_title>Assistant lecturer of pediatric dentistry, pediatric dentistry and public health department, Ain Shams University</investigator_title>
  </responsible_party>
  <keyword>Bioactive Restorative Material , ART</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03788616/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of patients was done from a convenient sample of children who attended the outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain-Shams University seeking dental treatment, or for regular checkups. All patients who met the eligibility criteria of the study were invited to participate. Pre-operative comprehensive clinical examination was performed and caries experience was determined using dmft index</recruitment_details>
      <pre_assignment_details>Excluded (n = 40)&#xD;
- Tooth not meeting inclusion criteria</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Fuji IX Extra Group I</title>
          <description>Group I: will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with an ART approach&#xD;
Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA)</description>
        </group>
        <group group_id="P2">
          <title>Bioactive Composite Group II</title>
          <description>Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.&#xD;
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>carious primary molars limited to occlusal table (class I cavity) in 4-8 yrs old patients</population>
      <group_list>
        <group group_id="B1">
          <title>Group I</title>
          <description>Group I: will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach&#xD;
Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA)</description>
        </group>
        <group group_id="B2">
          <title>Group II</title>
          <description>Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.&#xD;
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)</description>
        </group>
        <group group_id="B3">
          <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="35"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
        <analyzed>
          <units>primary molars</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="70"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>not meeting the inclusion criteria</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.6" spread="1.49"/>
                    <measurement group_id="B2" value="5.9" spread="1.49"/>
                    <measurement group_id="B3" value="5.7" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>not meeting the inclusion criteria&#xD;
not complete the treatment plane</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <units_analyzed>Participants</units_analyzed>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth</title>
        <description>Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure.</description>
        <time_frame>12 Month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Fuji IX Extra GIC With ART</title>
            <description>Group I: will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach&#xD;
Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA)</description>
          </group>
          <group group_id="O2">
            <title>ACTIVA KIDS With ART</title>
            <description>Group II: will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.&#xD;
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)</description>
          </group>
        </group_list>
        <measure>
          <title>the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth</title>
          <description>Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure.</description>
          <units>primary molars</units>
          <param>Number</param>
          <units_analyzed>primary molars</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>primary molars</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>success rate after 3 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>success rate after 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>success rate after 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>assuming 95% power of the study</non_inferiority_desc>
            <p_value>0.478</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Median Difference (Final Values)</param_type>
            <param_value>0.05</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months, 6 months,1 year</time_frame>
      <desc>failure of restorations in participated primary molars. (non-serious adverse event)</desc>
      <group_list>
        <group group_id="E1">
          <title>Fuji IX EXTRA GIC With ART</title>
          <description>Group I : will consist of 35 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach&#xD;
Fuji IX EXTRA: High-viscosity glass ionomer (Fuji IX EXTRA)</description>
        </group>
        <group group_id="E2">
          <title>ACTIVA KIDS With ART</title>
          <description>Group II : will consist of 35 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.&#xD;
ACTIVA KIDS bioactive restorative material: Modified composite (ACTIVA KIDS)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>failure of restoration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr. Marina Fakhry assistant lecturer of pediatric dentistry</name_or_title>
      <organization>Faculty of dentistry, Ain Shams University</organization>
      <phone>01273731722 ext +02</phone>
      <email>Dr.marina.fakhry@gmail.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/NCT03788616
org study id: PED18-5M
nct id: NCT03788616
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The study will be two parallel group, triple blinded randomized controlled clinical trial
      that based on CONSORT (consolidated standards of reporting trials) guideline .The selected
      participants according to inclusion and exclusion criteria will be randomly allocated in two
      groups using (Research Randomizer Program) .
Blinding All participants don't know the type of received restorative material (ACTIVA Kids
      or High -viscosity GI restorative material) and the outcome will be evaluated by a examiner
      other than operator who doesn't know the type of received restorative material also.

      Study setting The study will be performed at pediatric Department and Dental Public Health
      Department of Faculty of Dentistry, Ain Shams University, and at the institute of Graduate
      Studies and Research, Ain Shams University.

      Sample size: 60 participants Recruitment/Setting The all participants of this study have been
      selected after complete clinical examination has been done with full medical and dental
      history , history of medications and history of hospitalization. In patients who receive
      dental treatment as an usual care in clinics of Pediatric Dentistry and Dental Public Health
      Department at faculty of dentistry, Ain-Shams University.

      Informed consent designed to include all data about dental procedures in this study and clear
      more details about time consuming in the procedure and follow up visits, used materials and
      adverse event of this procedure . All participants have the wright to withdraw from this
      study at any time .The consent will be assigned from each patient by the patient's parents or
      guardians after explanation of the study.

      The full mouth rehabilitation will be performed by postgraduate student registered at the
      master Degree at the Pediatric Dentistry and Dental Public Health Department Faculty of
      Dentistry, Ain- Shams University All subjects receive instructions on oral health,
      particularly in relation to oral hygiene and sugar consumption
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: the Success Rate of ACTIVA BIOACTIVE and Fuji IX Extra GIC With ART in Class I Carious Cavity of Primary Teeth
time frame: 12 Month
description: Using Atraumatic restorative treatment criteria from 0 to 9, The restorations were considered to have survived when given scores 0,1, or 7 and to have failed with scores 2,3,4,8, while those scores 5,6 were considered to be unrelated to success and failure.
arm group label: Group I
arm group type: Active Comparator
description: Group I : will consist of 30 teeth that will be restored by high-viscosity glass ionomer (Fuji IX Extra) with ART approach
arm group label: Group II
arm group type: Active Comparator
description: Group II : will consist of 30 teeth that will be restored by bioactive restorative material (ACTIVA KIDS bioactive restorative material) with ART approach.
intervention type: Drug
intervention name: Fuji IX EXTRA
description: High-viscosity glass ionomer (Fuji IX EXTRA)
arm group label: Group I
other name: Extra fast GIC
intervention type: Drug
intervention name: ACTIVA KIDS bioactive restorative material
description: Modified composite (ACTIVA KIDS)
arm group label: Group II
other name: ACTIVA , Modified composite
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Amr Mahmoud Abd EL Aziz
role: Study Chair
affiliation: Professor of Pediatric Dentistry and Dental Public Health Department -ASU
last name: Reham Khaled Abou El Fadl
role: Study Director
affiliation: Lecturer of Pediatric Dentistry and Dental Public Health Department -ASU
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Marina F Fahmy, MD
investigator title: Assistant lecturer of pediatric dentistry, pediatric dentistry and public health department, Ain Shams University
mesh term: Dental Caries
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 