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

Sponsor
Universiti Sains Malaysia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06000293
Collaborator
(none)
220
2
6

Study Details

Study Description

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
  • Other: Oral health education
N/A

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

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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 Names:
  • 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

    Primary Outcome Measures

    1. Early dental caries lesion and dental caries risk exposure among infants [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) [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

    Criteria

    Ages Eligible for Study:
    6 Months to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universiti Sains Malaysia

    Investigators

    • Principal Investigator: Munalizaini Mukhtar, Universiti Sains Malaysia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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)
    First Posted:
    Aug 21, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Munalizaini binti Mukhtar, Principal Investigator, Universiti Sains Malaysia

    Study Results

    No Results Posted as of Aug 23, 2023