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Early Childhood Caries Prevention: Effectiveness of Mother-Child Oral Health Care Programme (BASIS)

N

NORKHAFIZAH SADDKI

Status

Completed

Conditions

Dental Caries

Treatments

Behavioral: Anticipatory guidance
Behavioral: Anticipatory guidance and postnatal home visits

Study type

Interventional

Funder types

Other

Identifiers

NCT06944977
IRB00010568

Details and patient eligibility

About

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

Enrollment

154 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

154 participants in 2 patient groups

BASIS program
Experimental group
Description:
Prenatal and postnatal anticipatory guidance with home visits
Treatment:
Behavioral: Anticipatory guidance and postnatal home visits
Ministry of Health early childhood oral healthcare program
Active Comparator group
Description:
Postnatal anticipatory guidance
Treatment:
Behavioral: Anticipatory guidance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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