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

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

Completed

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tudan Health Clinic

Miri, Sarawak, 98000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anticipatory guidance and postnatal home visits

Behavioral

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

Anticipatory guidance

Behavioral

Postnatal anticipatory guidance

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

NORKHAFIZAH SADDKI

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Apr 25, 2025
Registry last updated: Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed