xml: <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/NCT06000293</url>
    </required_header>
    <id_info>
      <org_study_id>USM/JEPeM/KK/23020194</org_study_id>
      <secondary_id>NMRR ID-23-00845-JXN (IIR)</secondary_id>
      <nct_id>NCT06000293</nct_id>
    </id_info>
    <brief_title>Effectiveness of Strengthened Anticipatory Guidance Used in the MOH Malaysia Infant Oral Health Care Programme</brief_title>
    <acronym>MOH</acronym>
    <official_title>The Effectiveness of Strengthened Anticipatory Guidance Used in the Ministry of Health Malaysia Infant Oral Health Care Programme: A Cluster Randomised Control Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universiti Sains Malaysia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universiti Sains Malaysia</source>
    <oversight_info>
      <has_dmc>Yes</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 aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used&#xD;
        in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC)&#xD;
        lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's&#xD;
        knowledge and practice on infant oral healthcare&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomised control trial study will be conducted at six government Maternal and Child&#xD;
        Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220&#xD;
        primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the&#xD;
        control group). A strengthened infant oral health module named the Oral Health Infant Module&#xD;
        Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the&#xD;
        intervention group at three-month intervals over 6 months. The control group will receive the&#xD;
        conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG&#xD;
        on early signs of childhood caries lesions development, caries risk of infants, and primary&#xD;
        caregivers's knowledge and practice on infant oral healthcare will be assessed after six&#xD;
        months of intervention.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</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>Other</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Early dental caries lesion and dental caries risk exposure among infants</measure>
      <time_frame>6 months</time_frame>
      <description>The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)</measure>
      <time_frame>6 months</time_frame>
      <description>The knowledge and practice score on infant oral health care between primary caregivers in the intervention and control groups.&#xD;
  The response options for knowledge items are true, false and don't know. A score of 1 will be given to correct answers and a score of 0 for incorrect and don't know answers. A higher score indicates better knowledge.&#xD;
  Each practice item is given 4 response options, including a never. The remaining three responses will include one correct or appropriate practice and two incorrect or inappropriate responses. A score of 1 will be given for the correct or appropriate answers, and a score of 0 will be given for inaccurate or inappropriate and never answers. A higher score indicates better practice.&#xD;
  In addition to individual domain scores, an overall score for knowledge and practice on infant oral health care can be determined by dividing the summed score from knowledge and practice domains by the total possible score.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Early Childhood Caries</condition>
    <condition>Knowledge, Attitudes, Practice</condition>
    <arm_group>
      <arm_group_label>Treatment Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 6-9 months old infants.&#xD;
  Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 9-12 months old infants.&#xD;
  After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will be allowed to receive the conventional MOH AG given by oral healthcare providers from the nearest dental clinic.&#xD;
  Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old.&#xD;
  After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Oral health education</intervention_name>
      <description>Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group</description>
      <arm_group_label>Treatment Group</arm_group_label>
      <other_name>Dental health education</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen&#xD;
  &#xD;
            -  Primary caregivers can read and understand Bahasa Malaysia. This is because the AG&#xD;
               will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa&#xD;
               Malaysia.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to&#xD;
               thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of&#xD;
               caries due to presence of hypomineralisation and hyperplasia) and require special oral&#xD;
               health care.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>12 Months</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Munalizaini Mukhtar</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universiti Sains Malaysia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Munalizaini Mukhtar</last_name>
      <phone>+60136636632</phone>
      <email>munalizaini2020@student.usm.my</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universiti Sains Malaysia</investigator_affiliation>
      <investigator_full_name>Munalizaini binti Mukhtar</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Early Childhood Caries</keyword>
    <keyword>Knowledge</keyword>
    <keyword>Practice</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data obtained from this study will be published for knowledge purposes and will be presented as grouped data and thus will not identify the respondents individually. The data of subjects will be kept private and confidential for up to about five years after this study is completed and will be destroyed. Subjects can write to the investigators to request access to study findings. The data will not be disclosed to any parties working on this project unrelated to this study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000293
  org study id: USM/JEPeM/KK/23020194
  secondary id: NMRR ID-23-00845-JXN (IIR)
  nct id: NCT06000293
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the effectiveness of strengthened anticipatory guidance (AG) used
        in MOH Malaysia Infant Oral Healthcare Programme in preventing early childhood caries (ECC)
        lesions and improving caries risk of infants in Negeri Sembilan and their primary caregiver's
        knowledge and practice on infant oral healthcare
  This randomised control trial study will be conducted at six government Maternal and Child
        Health Clinics (MCHCs) in Negeri Sembilan District, Malaysia. The samples comprised of 220
        primary caregivers-infant pairs (110 pairs in the intervention group, and 110 pairs in the
        control group). A strengthened infant oral health module named the Oral Health Infant Module
        Anticipatory Guidance (OHIM AG) was designed to provide anticipatory guidance to the
        intervention group at three-month intervals over 6 months. The control group will receive the
        conventional Ministry of Health Anticipatory Guidance (MOH AG). The effectiveness of OHIM AG
        on early signs of childhood caries lesions development, caries risk of infants, and primary
        caregivers's knowledge and practice on infant oral healthcare will be assessed after six
        months of intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: Single (Participant)
  measure: Early dental caries lesion and dental caries risk exposure among infants
  time frame: 6 months
  description: The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.
  measure: Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)
  time frame: 6 months
  description: The knowledge and practice score on infant oral health care between primary caregivers in the intervention and control groups.
  The response options for knowledge items are true, false and don't know. A score of 1 will be given to correct answers and a score of 0 for incorrect and don't know answers. A higher score indicates better knowledge.
  Each practice item is given 4 response options, including a never. The remaining three responses will include one correct or appropriate practice and two incorrect or inappropriate responses. A score of 1 will be given for the correct or appropriate answers, and a score of 0 will be given for inaccurate or inappropriate and never answers. A higher score indicates better practice.
  In addition to individual domain scores, an overall score for knowledge and practice on infant oral health care can be determined by dividing the summed score from knowledge and practice domains by the total possible score.
  arm group label: Treatment Group
  arm group type: Experimental
  description: At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 6-9 months old infants.
  Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old. The primary caregivers will then be given the strengthened MOH AG intervention for 9-12 months old infants.
  After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old.
  arm group label: Control Group
  arm group type: No Intervention
  description: At baseline, the eligible infant aged 6 months old will undergo clinical oral examination and their primary caregivers will be given the pre-evaluation questionnaires for 6-9 months old. The primary caregivers will be allowed to receive the conventional MOH AG given by oral healthcare providers from the nearest dental clinic.
  Following three months, at evaluation 1, the 9-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 6-9 months old and pre-evaluation questionnaires for 9-12 months old.
  After three months, at evaluation 2, the 12-month-old infant will undergo a clinical oral examination, and their primary caregivers will be given the post-evaluation questionnaires for 9-12 months old.
  intervention type: Other
  intervention name: Oral health education
  description: Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group
  arm group label: Treatment Group
  other name: Dental health education
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: 12 Months
  healthy volunteers: Accepts Healthy Volunteers
  last name: Munalizaini Mukhtar
  role: Principal Investigator
  affiliation: Universiti Sains Malaysia
  last name: Munalizaini Mukhtar
  phone: +60136636632
  email: munalizaini2020@student.usm.my
  responsible party type: Principal Investigator
  investigator affiliation: Universiti Sains Malaysia
  investigator full name: Munalizaini binti Mukhtar
  investigator title: Principal Investigator
  sharing ipd: No
  ipd description: Data obtained from this study will be published for knowledge purposes and will be presented as grouped data and thus will not identify the respondents individually. The data of subjects will be kept private and confidential for up to about five years after this study is completed and will be destroyed. Subjects can write to the investigators to request access to study findings. The data will not be disclosed to any parties working on this project unrelated to this study.