Clinical trial NCT06944977: Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)
Official title: Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: anticipatory guidance
home visit
early childhood caries
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this two-arm, parallel-group cluster randomized controlled trial was to assess the effectiveness of the mother-child initiated oral health care program, termed BASIS, in preventing early childhood caries (ECC).

The main questions it aims to answer are:

* To compare mean knowledge and attitudes scores in the prevention of ECC among mothers of toddlers in the study group before and after receiving the BASIS program.
* To compare mean knowledge and attitude scores in the prevention of ECC between mothers of toddlers in the study group after receiving the BASIS program and mothers of toddlers in the control group after receiving the current Ministry of Health (MOH) programs.
* To compare oral health care practices in the prevention of ECC between mothers in the study group after receiving the BASIS program and mothers in the control group after receiving the current MOH program.
* To compare caries incidence between toddlers in the study group and toddlers in the control group after mothers' exposure to the BASIS program and the current MOH program, respectively.

Researchers will compare the BASIS program to the MOH program to see if the BASIS is effective to prevent ECC.

Participants of the BASIS program:

* Received anticipatory guidance delivered during pregnancy and after given birth at 6 months and 12 months
* Complete self-administered questionnaires measuring the knowledge, attitudes and practices related to the prevention of ECC during pregnancy and after given birth at 6 months, 12 months and 18 months
* Have their child oral cavity clinically examined at 6 months, 12 months and 18 months


Eligibility criteria: Inclusion Criteria:

* First-time pregnant women
* Aged 18 years and above
* In their third trimester
* Singleton pregnancy
* Able to read and write in Malay language
* Own a mobile phone with WhatsApp
* Will be the primary caretaker of their newborn

Exclusion Criteria:

• Diagnosed with cognitive disorders

Primary outcomes:
measure: Changes in dental caries experience of the children from the age of 6 month to 18 months
timeFrame: From the age of 6 month to 18 months
Secondary outcomes:
measure: Change in knowledge, attitudes, and practices of mothers regarding the prevention of ECC assessed by self-administered questionnaire from enrollment to the end of the intervention at 18 months postpartum
timeFrame: From enrollment to the end of the intervention at 18 months postpartum
Other outcomes:
Locations:
city: Miri
country: Malaysia
facility: Tudan Health Clinic
state: Sarawak
Study officials:
References: