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

April 17, 2025 updated by: NORKHAFIZAH SADDKI

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Sarawak
      • Miri, Sarawak, Malaysia, 98000
        • Tudan Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BASIS program
Prenatal and postnatal anticipatory guidance with home visits
Behavioral: Anticipatory guidance and postnatal home visits
Anticipatory guidance to pregnant women, followed by scheduled home visits at 6, 12, and 18 months
Active Comparator: Ministry of Health early childhood oral healthcare program
Postnatal anticipatory guidance
Behavioral: Anticipatory guidance
Postnatal anticipatory guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in dental caries experience of the children from the age of 6 month to 18 months
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: From enrollment to the end of the intervention at 18 months postpartum
The knowledge section of the questionnaire includes 30 items with responses in a close-ended format (true, false, and do not know). Correct answers receive 1 mark, while incorrect and 'do not know' responses receive no marks, resulting in a total score ranging from 0 to 30, with higher scores indicating better knowledge. The attitude domain consists of 12 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree), with negatively worded statements re-coded in reverse. The total attitude scores range from 12 to 60, with higher scores reflecting a more positive attitude. The practices domain includes 21 items, with most questions using a yes or no response. Two items-feeding the child sweet food and cleaning the child's mouth/teeth in a day in a week-are assessed on a frequency scale. Responses for each practice item are described in terms of frequency and percentage, rather than being numerically scored and summed.
From enrollment to the end of the intervention at 18 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NORKHAFIZAH SADDKI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

February 8, 2023

Study Completion (Actual)

February 8, 2023

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical considerations

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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