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

NCT ID: NCT06944977

Last Updated: 2025-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2023-02-08

Brief Summary

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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

Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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BASIS program

Prenatal and postnatal anticipatory guidance with home visits

Group Type EXPERIMENTAL

Anticipatory guidance and postnatal home visits

Intervention Type BEHAVIORAL

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

Ministry of Health early childhood oral healthcare program

Postnatal anticipatory guidance

Group Type ACTIVE_COMPARATOR

Anticipatory guidance

Intervention Type BEHAVIORAL

Postnatal anticipatory guidance

Interventions

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Anticipatory guidance and postnatal home visits

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

Intervention Type BEHAVIORAL

Anticipatory guidance

Postnatal anticipatory guidance

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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NORKHAFIZAH SADDKI

OTHER

Sponsor Role lead

Responsible Party

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NORKHAFIZAH SADDKI

ASSOCIATE PROFESSOR DR.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tudan Health Clinic

Miri, Sarawak, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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IRB00010568

Identifier Type: -

Identifier Source: org_study_id

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