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

NCT ID: NCT06000293

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-02-29

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.

Conditions

Early Childhood Caries; Knowledge, Attitudes, Practice

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral health education

Intervention Type: OTHER

Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral health education

Anticipatory Guidance (AG) provided to the primary caregivers-infant pairs in the intervention group

Intervention Type: OTHER

Other Intervention Names

Dental health education

Eligibility 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universiti Sains Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Munalizaini binti Mukhtar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Munalizaini Mukhtar

Role: PRINCIPAL_INVESTIGATOR

Universiti Sains Malaysia

Central Contacts

Munalizaini Mukhtar

Role: CONTACT

munalizaini2020@student.usm.my

+60136636632

Other Identifiers

NMRR ID-23-00845-JXN (IIR)

Identifier Type: OTHER

Identifier Source: secondary_id

USM/JEPeM/KK/23020194

Identifier Type: -

Identifier Source: org_study_id