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NCT Number: NCT07538219

The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anticipatory Guidance Using Motivational Interviewing

Behavioral

A collaborative, patient-centered communication approach that helps strengthen patients' motivation to change health behaviors

Conventional Ministry of Health Anticipatory Guidance

Behavioral

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.

Primary outcomes

  1. Mothers' knowledge regarding infant oral health care

    Time frame: 6 months

    Questionnaire from Mukhtar et al., 2023

  2. Mother's practice regarding infant oral health care

    Time frame: 6 months

    Questionnaire from Mukhtar et al., 2023

Secondary outcomes

  1. Incidence of ECC of infants

    Time frame: 6 months

    Incidence of early childhood caries on infants (using charts from Evans et al., 2017)

  2. Dental caries risk status of infants

    Time frame: 6 months

    Dental caries risk status of infants (using Caries Risk Assessment from Evans et al., 2017)

Study contacts

Contact information is provided by the study sponsor or research team.

ABDUL MALIK NOR AIDA, DOCTOR OF DENTAL SURGERY

CONTACT

[email protected]

+60139127520

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries: A Cluster Randomised Controlled Trial Among Mothers of Infants in Terengganu.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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