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

NCT06944977 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2025-04-25

No results posted yet for this study

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

Conditions

  • Dental Caries

Interventions

BEHAVIORAL

Anticipatory guidance and postnatal home visits

Anticipatory guidance to pregnant women, followed by scheduled home visits at 6, 12, and 18 months

BEHAVIORAL

Anticipatory guidance

Postnatal anticipatory guidance

Sponsors & Collaborators

  • NORKHAFIZAH SADDKI

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2023-02-08
Completion
2023-02-08

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944977 on ClinicalTrials.gov