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

Knowledge, Attitudes, Practice Clinical Trial

— MOH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06000293
• Other study ID #: USM/JEPeM/KK/23020194
• Secondary ID: NMRR ID-23-00845
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Universiti Sains Malaysia
• Contact: Munalizaini Mukhtar
• Phone: +60136636632
• Email: munalizaini2020[@]student.usm.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

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.

Related Conditions & MeSH terms

• Early Childhood Caries
• Knowledge, Attitudes, Practice

Intervention

Other:
• Oral health education
Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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