<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/NCT02200536</url>
  </required_header>
  <id_info>
    <org_study_id>DM20AM18</org_study_id>
    <nct_id>NCT02200536</nct_id>
  </id_info>
  <brief_title>Impact of Providing Free Preventive Dental Health Products on Infant's Tooth Brushing and Bottle-feeding Termination Practices</brief_title>
  <official_title>Effectiveness of an Oral Health Promotion Program in Infant's Tooth Brushing and Bottle-feeding Termination Practices: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Governmental initiatives (such as Sure Start in the UK) have integrated an oral health&#xD;
      promotion intervention within their maternal and child health program and delivered dental&#xD;
      education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste&#xD;
      and a trainer cup) to infant's mothers. Whilst this approach has minimal financial&#xD;
      implications of human resources, no evidence exists regarding its effectiveness in&#xD;
      establishing desirable infant's oral health behaviours. In Syria, there is a great need for&#xD;
      developing an infant's oral health promotion program to promote oral hygiene practice,&#xD;
      provide access to fluoride and terminate bottle-feeding practice. Thus, the current study&#xD;
      aimed to test the effectiveness of an integrated infant's oral health promotion intervention&#xD;
      within the Syrian national immunization program, which delivered printed dental education&#xD;
      materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in&#xD;
      establishing one-year old infant's oral hygiene and bottle-feeing termination practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current randomized controlled trail allocated 92 one-year old infants, attending a&#xD;
      maternal and child health center in Sweida city-Syria, to receive their vaccination, into&#xD;
      three groups: test, control 1 and control 2. The test group received an infant oral health&#xD;
      promotion package including a child oral health pamphlet, a baby toothbrush, fluoride&#xD;
      toothpaste (1000 ppm) and a trainer cup. Control 1 received only an infant pamphlet, whilst&#xD;
      Control 2 received no intervention. A mother's self-completed structured questionnaire and an&#xD;
      infant's clinical examination were completed and performed, at baseline and after one month,&#xD;
      to assess tooth brushing and bottle-feeding practices as well as the presence of old plaque&#xD;
      on infant's primary teeth, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.</measure>
    <time_frame>Baseline (T0) and after one month (T1)</time_frame>
    <description>Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Mother's Reported Bottle-feeding Practice.</measure>
    <time_frame>Baseline (T0) and after one month (T1)</time_frame>
    <description>Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Infant's Tooth Brushing</condition>
  <arm_group>
    <arm_group_label>Test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infant oral health promotion package</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Infant oral health pamphlet</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control 2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant oral health promotion package</intervention_name>
    <description>Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
    <arm_group_label>Test</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Infant oral health pamphlet</intervention_name>
    <description>Infant oral health pamphlet</description>
    <arm_group_label>Control 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for infants:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Single (not twins).&#xD;
&#xD;
          -  Full-term (≥37 weeks).&#xD;
&#xD;
          -  Birth weight ≥ 2500 g.&#xD;
&#xD;
          -  Family size ≤3 children (including the infant).&#xD;
&#xD;
          -  Their first tooth erupted.&#xD;
&#xD;
          -  No reported tooth brushing practice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Easter Joury, BDS, DOrth, MSc, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Damascus Univeristy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muna Alghadban, BDS, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Damascus University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Damascus</city>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>February 13, 2015</results_first_submitted>
  <results_first_submitted_qc>March 25, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 27, 2015</results_first_posted>
  <last_update_submitted>March 25, 2015</last_update_submitted>
  <last_update_submitted_qc>March 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Test</title>
          <description>Infant oral health promotion package&#xD;
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
        </group>
        <group group_id="P2">
          <title>Control 1</title>
          <description>Infant oral health pamphlet&#xD;
Infant oral health pamphlet: Infant oral health pamphlet</description>
        </group>
        <group group_id="P3">
          <title>Control 2</title>
          <description>No intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Test</title>
          <description>Infant oral health promotion package&#xD;
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
        </group>
        <group group_id="B2">
          <title>Control 1</title>
          <description>Infant oral health pamphlet&#xD;
Infant oral health pamphlet: Infant oral health pamphlet</description>
        </group>
        <group group_id="B3">
          <title>Control 2</title>
          <description>No intervention.</description>
        </group>
        <group group_id="B4">
          <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="32"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Mother's age</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>≥ 30 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&lt; 30 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Infant's gender, Male/Female</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.</title>
        <description>Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.</description>
        <time_frame>Baseline (T0) and after one month (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Infant oral health promotion package&#xD;
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
          </group>
          <group group_id="O2">
            <title>Control 1</title>
            <description>Infant oral health pamphlet&#xD;
Infant oral health pamphlet: Infant oral health pamphlet</description>
          </group>
          <group group_id="O3">
            <title>Control 2</title>
            <description>No intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.</title>
          <description>Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.</description>
          <units>percentage of mothers</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Mother's Reported Bottle-feeding Practice.</title>
        <description>Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.</description>
        <time_frame>Baseline (T0) and after one month (T1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Test</title>
            <description>Infant oral health promotion package&#xD;
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
          </group>
          <group group_id="O2">
            <title>Control 1</title>
            <description>Infant oral health pamphlet&#xD;
Infant oral health pamphlet: Infant oral health pamphlet</description>
          </group>
          <group group_id="O3">
            <title>Control 2</title>
            <description>No intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Mother's Reported Bottle-feeding Practice.</title>
          <description>Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.</description>
          <units>percentage of mothers</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8"/>
                    <measurement group_id="O2" value="69.2"/>
                    <measurement group_id="O3" value="93.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>Serious or other [non-serious] adverse events were not collected in the current trial, as there were no previously identified adverse events in studies with the same type of interventions.</desc>
      <group_list>
        <group group_id="E1">
          <title>Test</title>
          <description>Infant oral health promotion package&#xD;
Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.</description>
        </group>
        <group group_id="E2">
          <title>Control 1</title>
          <description>Infant oral health pamphlet&#xD;
Infant oral health pamphlet: Infant oral health pamphlet</description>
        </group>
        <group group_id="E3">
          <title>Control 2</title>
          <description>No intervention.</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
              </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>Assistant Professor Easter Joury</name_or_title>
      <organization>Damascus University</organization>
      <phone>00963955650456</phone>
      <email>easterjoury@icloud.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/NCT02200536
org study id: DM20AM18
nct id: NCT02200536
lead sponsor: 
has dmc: Yes
Governmental initiatives (such as Sure Start in the UK) have integrated an oral health
      promotion intervention within their maternal and child health program and delivered dental
      education and enabling resources (a gift bag including a baby toothbrush, fluoride toothpaste
      and a trainer cup) to infant's mothers. Whilst this approach has minimal financial
      implications of human resources, no evidence exists regarding its effectiveness in
      establishing desirable infant's oral health behaviours. In Syria, there is a great need for
      developing an infant's oral health promotion program to promote oral hygiene practice,
      provide access to fluoride and terminate bottle-feeding practice. Thus, the current study
      aimed to test the effectiveness of an integrated infant's oral health promotion intervention
      within the Syrian national immunization program, which delivered printed dental education
      materials, a baby tooth brush, fluoride toothpaste (1000 ppm) and a trainer cup, in
      establishing one-year old infant's oral hygiene and bottle-feeing termination practices.
The current randomized controlled trail allocated 92 one-year old infants, attending a
      maternal and child health center in Sweida city-Syria, to receive their vaccination, into
      three groups: test, control 1 and control 2. The test group received an infant oral health
      promotion package including a child oral health pamphlet, a baby toothbrush, fluoride
      toothpaste (1000 ppm) and a trainer cup. Control 1 received only an infant pamphlet, whilst
      Control 2 received no intervention. A mother's self-completed structured questionnaire and an
      infant's clinical examination were completed and performed, at baseline and after one month,
      to assess tooth brushing and bottle-feeding practices as well as the presence of old plaque
      on infant's primary teeth, respectively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Mother's Reported Infant's Twice-a-day Tooth Brushing Practice.
time frame: Baseline (T0) and after one month (T1)
description: Change in mother's reported infant's twice-a-day tooth brushing practice was measured by comparing mother's reported infant's twice-a-day tooth brushing practice at follow up and baseline. Change was present when mother's reported infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline. Change was not present when mother's did not report infant's twice-a-day tooth brushing practice after one month compared to mother's reported no infant's twice-a-day tooth brushing practice at baseline.
measure: Change in Mother's Reported Bottle-feeding Practice.
time frame: Baseline (T0) and after one month (T1)
description: Change in mother's reported bottle-feeding practice was measured by comparing mother's reported bottle-feeding practice at follow up and baseline. Change was present when mother's reported no bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline. Change was not present when mother's reported bottle-feeding practice after one month compared to mother's reported bottle-feeding practice at baseline.
arm group label: Test
arm group type: Experimental
description: Infant oral health promotion package
arm group label: Control 1
arm group type: Active Comparator
description: Infant oral health pamphlet
arm group label: Control 2
arm group type: No Intervention
intervention type: Other
intervention name: Infant oral health promotion package
description: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.
arm group label: Test
intervention type: Other
intervention name: Infant oral health pamphlet
description: Infant oral health pamphlet
arm group label: Control 1
criteria: 
gender: All
minimum age: 12 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Easter Joury, BDS, DOrth, MSc, PhD
role: Study Director
affiliation: Damascus Univeristy
last name: Muna Alghadban, BDS, MSc
role: Principal Investigator
affiliation: Damascus University
facility: 
country: Syrian Arab Republic
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 