<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/NCT04440137</url>
  </required_header>
  <id_info>
    <org_study_id>DRPG/08/19</org_study_id>
    <nct_id>NCT04440137</nct_id>
  </id_info>
  <brief_title>Effectiveness of Oral Health Promotion in Bottle Fed Children</brief_title>
  <official_title>Effectiveness of Oral Health Promotion in Bottle Fed Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Malaya</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the effectiveness of oral health promotion in the prevention of ECC&#xD;
      (early childhood caries) in bottle-fed children. Half of the patient will receive oral health&#xD;
      promotion which emphasizing more on the benefit of stopping the bottle feeding habit, a&#xD;
      free-flow cup and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride).&#xD;
      The other half of the patient will receive standard of care oral hygiene promotion and oral&#xD;
      hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Malaysia, even though there are decreasing trend in caries prevalence from a survey&#xD;
      conduct in 1995 to 2015 (87.1% 1995, 76.2% 2005 and 71.3% 2015) [NOHPS 2015], yet the&#xD;
      difference is just 15.8% in a period of 20 years. One of the factors which contribute to the&#xD;
      development of ECC in children in prolonged bottle-feeding. Many literatures had mentioned&#xD;
      association of bottle feeding and ECC however there are no controlled studies done on the&#xD;
      effect of bottle feeding and ECC. Despite antenatal oral health promotion program done by&#xD;
      Ministry of Health Malaysia and incorporation of oral hygiene education and oral hygiene&#xD;
      instruction during dental visit, the prevalence of ECC remains high. This study will provide&#xD;
      evidence regarding the effectiveness of oral health promotion in preventing early childhood&#xD;
      caries by early termination of bottle feeding in toddlers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>
    <intervention_model_description>Collection of Samples Randomization will be carried out.&#xD;
Research Briefing and Questionnaire Distribution Research briefing will be carried out and details of the study will be explained.&#xD;
Questionnaire Collection and Dental Examination at baseline&#xD;
After obtaining informed consent, questionnaires will be distributed.&#xD;
Caries experience of children will be recorded using ICDAS score. Caries experience also will be recorded in DMFT with cavitated and DMFT without cavitated.&#xD;
Intervention group will be provided with intervention brochure, kid toothbrush and toothpaste and a free-flow cup. Control group will receive brochure with standard of care info and kid toothbrush and toothpaste.&#xD;
An electronic form of OHP, will be given every 3 months to both group&#xD;
Dental check-up will be done every 6 months at the respective woman and child clinic.&#xD;
After a period of 1 year, the patient will be given a questionnaire again and dental check-up to compare any difference.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To identify changes in caries incidence</measure>
    <time_frame>Baseline, 6 month, 12 month</time_frame>
    <description>After the measurement of caries experience during the first visit, subject will be seen again in period of 6 month and 12 month to measure caries incidence on both group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Bottle Feeding</condition>
  <condition>Dental Caries in Children</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mother of children will receive a brochure with a standard of care info (with only essential information regarding the harmful effect of bottle feeding) and kid toothbrush and toothpaste (1000ppm of fluoride).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mother of the children will be provided with intervention brochure (which include detailed information regarding the harmful effect of bottle feeding), kid toothbrush and toothpaste (1000ppm of fluoride) and a sippy cup.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Bottle-feeding cessation program</intervention_name>
    <description>Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Malaysian citizen&#xD;
&#xD;
          -  Child age 12 to 24 months old&#xD;
&#xD;
          -  Child with bottle feeding habit (patients from Klinik Kesihatan Ibu &amp; Anak (KKIA))&#xD;
&#xD;
          -  Having at least 2 upper and 2 lower incisors at the time of recruitment&#xD;
&#xD;
          -  Child is taken care predominantly by their mother (housewife)&#xD;
&#xD;
          -  The parent who can read and write in Bahasa Melayu&#xD;
&#xD;
          -  Full Term baby&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with medical problems&#xD;
&#xD;
          -  Cleft lip or cleft palate or both&#xD;
&#xD;
          -  Patient with a craniofacial anomaly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamad Haziq</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty Of Dentistry, University Of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shani Ann Mani</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty Of Dentistry, University Of Malaya</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sharifah Wade'ah Wafa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty Of Dentistry, University Of Malaya</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamad Zawawi</last_name>
    <phone>+0139736415</phone>
    <email>haziqmzh@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty Of Dentistry, University of Malaya</name>
      <address>
        <city>Kuala Lumpur</city>
        <state>Wilayah Persekutuan Kuala Lumpur</state>
        <zip>50603</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Puan Norazlinda</last_name>
      <phone>+603 7967 4802</phone>
      <phone_ext>2476</phone_ext>
      <email>norazlinda@um.edu.my</email>
    </contact>
    <investigator>
      <last_name>Mohamad Haziq Mohamad zawawi</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shani Ann Mani</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sharifah Wade'ah W Wafa S.S.T</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infant</keyword>
  <keyword>Health promotion</keyword>
  <keyword>Program development</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04440137
org study id: DRPG/08/19
nct id: NCT04440137
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate the effectiveness of oral health promotion in the prevention of ECC
      (early childhood caries) in bottle-fed children. Half of the patient will receive oral health
      promotion which emphasizing more on the benefit of stopping the bottle feeding habit, a
      free-flow cup and oral hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride).
      The other half of the patient will receive standard of care oral hygiene promotion and oral
      hygiene kit which include a toothbrush, toothpaste (1000ppm fluoride)
In Malaysia, even though there are decreasing trend in caries prevalence from a survey
      conduct in 1995 to 2015 (87.1% 1995, 76.2% 2005 and 71.3% 2015) [NOHPS 2015], yet the
      difference is just 15.8% in a period of 20 years. One of the factors which contribute to the
      development of ECC in children in prolonged bottle-feeding. Many literatures had mentioned
      association of bottle feeding and ECC however there are no controlled studies done on the
      effect of bottle feeding and ECC. Despite antenatal oral health promotion program done by
      Ministry of Health Malaysia and incorporation of oral hygiene education and oral hygiene
      instruction during dental visit, the prevalence of ECC remains high. This study will provide
      evidence regarding the effectiveness of oral health promotion in preventing early childhood
      caries by early termination of bottle feeding in toddlers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Collection of Samples Randomization will be carried out.
Research Briefing and Questionnaire Distribution Research briefing will be carried out and details of the study will be explained.
Questionnaire Collection and Dental Examination at baseline
After obtaining informed consent, questionnaires will be distributed.
Caries experience of children will be recorded using ICDAS score. Caries experience also will be recorded in DMFT with cavitated and DMFT without cavitated.
Intervention group will be provided with intervention brochure, kid toothbrush and toothpaste and a free-flow cup. Control group will receive brochure with standard of care info and kid toothbrush and toothpaste.
An electronic form of OHP, will be given every 3 months to both group
Dental check-up will be done every 6 months at the respective woman and child clinic.
After a period of 1 year, the patient will be given a questionnaire again and dental check-up to compare any difference.
primary purpose: Prevention
masking: Single (Participant)
measure: To identify changes in caries incidence
time frame: Baseline, 6 month, 12 month
description: After the measurement of caries experience during the first visit, subject will be seen again in period of 6 month and 12 month to measure caries incidence on both group
arm group label: Control Group
arm group type: No Intervention
description: Mother of children will receive a brochure with a standard of care info (with only essential information regarding the harmful effect of bottle feeding) and kid toothbrush and toothpaste (1000ppm of fluoride).
arm group label: Intervention group
arm group type: Experimental
description: Mother of the children will be provided with intervention brochure (which include detailed information regarding the harmful effect of bottle feeding), kid toothbrush and toothpaste (1000ppm of fluoride) and a sippy cup.
intervention type: Behavioral
intervention name: Bottle-feeding cessation program
description: Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject
arm group label: Intervention group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 3 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamad Haziq
role: Principal Investigator
affiliation: Faculty Of Dentistry, University Of Malaya
last name: Shani Ann Mani
role: Principal Investigator
affiliation: Faculty Of Dentistry, University Of Malaya
last name: Sharifah Wade'ah Wafa
role: Principal Investigator
affiliation: Faculty Of Dentistry, University Of Malaya
last name: Mohamad Zawawi
phone: +0139736415
email: haziqmzh@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Malaysia
responsible party type: Sponsor
mesh term: Dental Caries