Caries of Infancy, Healthy Women
Conditions
Brief summary
This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics. A two-arm, parallel cluster-randomized controlled trial (1:1 allocation) will be implemented, where the study group receives Anticipatory Guidance (AG) through Motivational Interviewing (MI), and the control group receives conventional MOH AG. Mothers aged ≥18 years who can understand Bahasa Malaysia and their healthy 6-month-old infants (full-term, without congenital conditions) are eligible. Mothers with postpartum depression and infants requiring special oral healthcare are excluded. A total of 228 mother-infant pairs will be recruited using multistage sampling. Three MCHCs from Setiu and three randomly selected MCHCs from Hulu Terengganu will participate. Systematic sampling will be applied within each clinic. Data collection occurs at infant ages 6, 9, and 12 months during routine immunization visits. At each visit, infants undergo oral examination using ICDAS and a caries risk assessment. Mothers complete age-specific validated questionnaires on knowledge and practices. The study group receives two MI sessions (at 6 and 9 months) with follow-up phone calls, while the control group receives routine AG by MOH staff. The MI protocol will be developed based on established MI frameworks and be validated through expert review, will be pretested among mothers and dental officers/therapists in MOH MCHC and MOH dental clinic in Besut district. While fidelity assessment of MI sessions conducted will be done using MITI 4.2.1 guidelines. All MI sessions will be delivered by the trained principal investigator. Approximately 8 minutes are required for infant oral examination, 7 minutes for questionnaire completion, and 30 minutes for MI. Data will be analysed using descriptive statistics, paired t-tests, independent t-tests, McNemar's test, and Chi-Square test with significance set at p \< 0.05. Ethical approval was obtained from Jawatankuasa Etika Penyelidikan Manusia USM (JEPeM)/ Human Research Ethics Committee USM (HREC) and Medical Research and Ethics Committee (MREC) MOH. Participation is voluntary, with confidentiality ensured. No major risks are expected.
Interventions
BEHAVIORALAnticipatory Guidance Using Motivational Interviewing
A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors
BEHAVIORALConventional Ministry of Health Anticipatory Guidance
A process of providing practical developmentally appropriate health information about their children to parents so that they know what to expect during the child's current and approaching stage of development.
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Mothers: * Malaysian citizens * Can read and understand Bahasa Malaysia * Aged 18 years old and above * Infants: * Aged 6 months old (with or without erupted teeth) * Born full-term (≥37 weeks of gestation) * Without diagnosed congenital anomalies or syndromes
Exclusion criteria
* Mothers o Mothers experiencing postpartum depression or other significant postnatal issues * Infants * Diagnosed with special needs, chronic diseases, or developmental defects * Infants who are at risk for oral health problems due to pre-existing medical conditions * Infants requiring specialized oral healthcare, such as those with cleft lip and palate, enamel hypoplasia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mothers' knowledge regarding infant oral health care | 6 months | Questionnaire from Mukhtar et al., 2023 |
| Mother's practice regarding infant oral health care | 6 months | Questionnaire from Mukhtar et al., 2023 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ECC of infants | 6 months | Incidence of early childhood caries on infants (using charts from Evans et al., 2017) |
| Dental caries risk status of infants | 6 months | Dental caries risk status of infants (using Caries Risk Assessment from Evans et al., 2017) |
Contacts
CONTACTABDUL MALIK NOR AIDA, DOCTOR OF DENTAL SURGERY
Outcome results
None listed