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

The Effectiveness of Strengthened Anticipatory Guidance Used in the Ministry of Health Malaysia Infant Oral Health Care Programme: A Cluster Randomised Control Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Knowledge, Attitudes, Practice; Early Childhood Caries
• Intervention / Treatment: Other: Oral health education

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 Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Munalizaini Mukhtar; Phone Number: +60136636632; Email: munalizaini2020@student.usm.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early dental caries lesion and dental caries risk exposure among infants	The prevalence of early dental caries lesion and dental caries risk exposure between infants in the intervention and control groups.	6 months
Knowledge and practice score on infant oral health care among primary caregivers (parents/ caregivers)	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.	6 months

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Investigators: Principal Investigator: Munalizaini Mukhtar, Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): February 1, 2024

Study Registration Dates

• First Submitted: August 12, 2023
• First Submitted That Met QC Criteria: August 12, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Knowledge; Early Childhood Caries; Practice
• Other Study ID Numbers: USM/JEPeM/KK/23020194; NMRR ID-23-00845-JXN (IIR) (Other Identifier: Medical Research & Ethics Committee (MREC) MOH Malaysia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No