NCT06944977

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

1.3 years

First QC Date

April 11, 2025

Last Update Submit

April 17, 2025

Conditions

Dental Caries

Keywords

anticipatory guidancehome visitearly childhood caries

Outcome Measures

Primary Outcomes (1)

  • Changes in dental caries experience of the children from the age of 6 month to 18 months

    All surfaces of the four upper and lower front teeth of the children were examined at three time points: when the child reached 6 months old, 12 months old, and 18 months old. A sound tooth with no evidence of caries was coded as 0, while a tooth with evidence of caries, whether non-cavitated (such as white or brown spot lesions) or cavitated, was coded as 1.

    From the age of 6 month to 18 months

Secondary Outcomes (1)

  • 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

    From enrollment to the end of the intervention at 18 months postpartum

Study Arms (2)

BASIS program

EXPERIMENTAL

Prenatal and postnatal anticipatory guidance with home visits

Behavioral: Anticipatory guidance and postnatal home visits

Ministry of Health early childhood oral healthcare program

ACTIVE COMPARATOR

Postnatal anticipatory guidance

Behavioral: Anticipatory guidance

Interventions

Anticipatory guidance and postnatal home visitsBEHAVIORAL

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

BASIS program
Anticipatory guidanceBEHAVIORAL

Postnatal anticipatory guidance

Ministry of Health early childhood oral healthcare program

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study enrolled pregnant women. Therefore, only females are eligible to participate
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Diagnosed with cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tudan Health Clinic

Miri, Sarawak, 98000, Malaysia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR DR.

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 25, 2025

Study Start

October 15, 2021

Primary Completion

February 8, 2023

Study Completion

February 8, 2023

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Ethical considerations

Locations

MY(1)