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

Not Applicable

Not yet recruiting

• Conditions: Early Childhood Caries; Knowledge, Attitudes, Practice
• Interventions: Other: Oral health education

• Registration Number: NCT06000293
• Lead Sponsor: Universiti Sains Malaysia

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

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 Timeline

• Status Verified: 2023-08
• Study Start: 2023-08
• Study First Submitted: 2023-08-12
• Study First Submitted QC: 2023-08-12
• Last Update Submitted: 2023-08-18
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-23
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Oral health education	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.

Primary Outcome Measures

Name	Time	Method
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.
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.