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Effectiveness of Strengthened Anticipatory Guidance Used in the MOH Malaysia Infant Oral Health Care Programme (MOH)

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ClinicalTrials.gov Identifier: NCT06000293
Recruitment Status : Not yet recruiting
First Posted : August 21, 2023
Last Update Posted : August 23, 2023
Sponsor:
Information provided by (Responsible Party):
Munalizaini binti Mukhtar, Universiti Sains Malaysia

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Early Childhood Caries Knowledge, Attitudes, Practice Other: Oral health education Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
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
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group

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.

 Other: Oral health education
Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group
Other Name: Dental health education
No Intervention: Control Group

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.


Outcome Measures
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Primary Outcome Measures :
  1. Early dental caries lesion and dental caries risk exposure among infants [ Time Frame: 6 months ]
    The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.

  2. Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers) [ Time Frame: 6 months ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The infant and primary caregivers (parents/ caregivers) are a Malaysian citizen
  • Primary caregivers can read and understand Bahasa Malaysia. This is because the AG will be conducted in Bahasa Malaysia, and the questionnaires are also in Bahasa Malaysia.

Exclusion Criteria:

  • Infants with special needs, chronic diseases or conditions (e.g., stunting, failure to thrive and low birth weight) who are at risk for oral problems (e.g., higher risk of caries due to presence of hypomineralisation and hyperplasia) and require special oral health care.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06000293


Contacts
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Contact: Munalizaini Mukhtar +60136636632 munalizaini2020@student.usm.my

Sponsors and Collaborators
Universiti Sains Malaysia
Investigators
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Principal Investigator: Munalizaini Mukhtar Universiti Sains Malaysia
More Information
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Responsible Party: Munalizaini binti Mukhtar, Principal Investigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT06000293    
Other Study ID Numbers: USM/JEPeM/KK/23020194
NMRR ID-23-00845-JXN (IIR) ( Other Identifier: Medical Research & Ethics Committee (MREC) MOH Malaysia )
First Posted: August 21, 2023    Key Record Dates
Last Update Posted: August 23, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Munalizaini binti Mukhtar, Universiti Sains Malaysia:
Early Childhood Caries
Knowledge
Practice